From the University of California, Berkeley:

The yellow monkeyflower's distinctive red spots serve as 'landing pads' for bees and other pollinators, helping them access the sweet nectar inside. A new study reveals the genetic programming that creates these attractive patterns.

The intricate spotted patterns dappling the bright blooms of the monkeyflower plant may be a delight to humans, but they also serve a key function for the plant. These patterns act as "bee landing pads," attracting nearby pollinators to the flower and signaling the best approach to access the sweet nectar inside.

"They are like runway landing lights, helping the bees orient so they come in right side up instead of upside down," said Benjamin Blackman, assistant professor of plant and molecular biology at the University of California, Berkeley.

In a new paper, Blackman and his group at UC Berkeley, in collaboration with Yaowu Yuan and his group at the University of Connecticut, reveal for the first time the genetic programming that helps the monkeyflower and likely other patterned flowers achieve their spotted glory. The study was published online today (Thursday, Feb. 20) in the journal Current Biology.

"While we know a good deal about how hue is specified in flower petals whether it is red or orange or blue, for instance we don't know a lot about how those pigments are then painted into patterns on petals during development to give rise to these spots and stripes that are often critical for interacting with pollinators," Blackman said. "Our lab, in collaboration with others, has developed the genetic tools to be able to identify the genes related to these patterns and perturb them so that we can confirm what's actually going on."

In the study, the research team used CRISPR-Cas9 gene editing to recreate the yellow monkeyflower patterns found in nature. On the left, a wild-type monkeyflower exhibits the typical spotted pattern. In the middle, a heterozygote with one normal RTO gene and one damaged RTO gene exhibits blotchier spots. And on the right, homozygote with two copies of the damaged RTO gene is all red, with no spots.

The positions of petals' spots aren't mapped out ahead of time, like submarines in a game of battleship, Blackman said. Instead, scientists have long theorized that they could come about through the workings of an activator-repressor system, following what is known as a reaction-diffusion model, in which an activator molecule stimulates a cell to produce the red-colored pigment that produces a spot. At the same time, a repressor molecule is expressed and sent to neighboring cells to instruct them not to produce the red pigment.

The results are small, dispersed bunches of red cells surrounded by cells that keep the background yellow color.

"By tweaking the parameters how strongly a cell turns on an inhibitor, how strongly the inhibitor can inhibit the activator, how quickly it moves between cells it can lead to big spots, small spots, striped patterns, really interesting periodic patterns," Blackman said.

In the study, UC Berkeley postdoctoral researcher Srinidhi Holalu and research associate Erin Patterson identified two natural varieties of the yellow monkeyflower one type with the typical red spots in the throat of the flower and a second type with an all-red throat appearing in multiple natural populations in California and Oregon, including at the UC Davis McLaughlin Reserve. In parallel, UConn postdoctoral researcher Baoqing Ding worked with a very similar plant with fully red-throated flowers found when surveying a population of Lewis's monkeyflower that had induced DNA mutations.

Monkeyflower plants with the RTO gene knocked out by CRISPR-Cas9 gene editing produce one big patch where all flowers exhibit a fully red throat, in contrast to wild fields where red-tongued flowers appear in small dispersed spots.

In a previous study, the Yuan lab had found that a gene called NEGAN (nectar guide anthocyanin) acts as an activator in the monkeyflower petals, signaling the cells to produce the red pigment. Through detailed genomic analysis in both monkeyflower species, the two groups were able to pinpoint that a gene called RTO, short for red tongue, acts as the inhibitor.

The red-throated forms of the monkeyflower have defective RTO inhibitor genes, resulting in a characteristic all-red throat, rather than red spots. To confirm their findings, Holalu used the CRISPR-Cas9 gene editing system to knock out the RTO gene in spotted variants of the flower. The result was flowers with a flashy red throat. Further experiments revealed how the functional form of the RTO protein moves to neighboring cells and represses NEGAN to prevent the spread of pigmentation beyond the local spots. This study is the first reported use of CRISPR-Cas9 editing to research the biology of monkeyflowers.

The team also collaborated with Michael Blinov at the UConn School of Medicine to develop a mathematical model to explain how different self-organized patterns might arise from this genetic system.

"This work is the simplest demonstration of the reaction-diffusion theory of how patterns arise in biological systems," said Yaowu Yuan, associate professor of ecology and evolutionary biology at UConn. "We are closer to understanding how these patterns arise throughout nature."

This press release was produced by the University of California, Berkeley. The views expressed here are the author's own.

Link:
How The Monkeyflower Gets Its Spots | Berkeley - Patch.com

Recommendation and review posted by Bethany Smith

WALTHAM Feb 21, 2020 (Thomson StreetEvents) -- Edited Transcript of Repligen Corp earnings conference call or presentation Thursday, February 20, 2020 at 1:30:00pm GMT

* Anthony J. Hunt

Repligen Corporation - CEO, President, Director & Member of Scientific Advisory Board

* Jon K. Snodgres

* Sondra S. Newman

Stifel, Nicolaus & Company, Incorporated, Research Division - MD & Senior Analyst

H.C. Wainwright & Co, LLC, Research Division - Equity Research Associate

* Jacob K. Johnson

William Blair & Company L.L.C., Research Division - Partner & Healthcare Services Analyst

* Joseph P. Munda

Janney Montgomery Scott LLC, Research Division - MD, Head of Healthcare Research & Senior Equity Research Analyst

SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst

Good day, ladies and gentlemen, and welcome to the Repligen Corporation's Year-End and Fourth Quarter of 2019 Earnings Conference Call. My name is Rocco, and I will be your coordinator. (Operator Instructions) Please note, today's event is being recorded.

I would now like to turn the call over to your host for today's call, Sondra Newman, Global Head of Investor Relations for Repligen. Please go ahead.

Sondra S. Newman, Repligen Corporation - Senior Director of IR [2]

Great. Good morning, everyone. Thanks for joining our call today. On this call, we'll cover our financial results and business highlights for Repligen's fourth fiscal quarter and full year 2019, and we'll provide financial guidance for the year 2020. Our President and CEO, Tony Hunt, will cover business updates and our CFO, Jon Snodgres, will cover our financial results and guidance.

As a reminder, the forward-looking statements that we make during this call, including those regarding our business goals and expectations for financial performance of the company are subject to risks and uncertainties that may cause actual events or results to differ.

Additional information concerning risk factors is included in our annual report on Form 10-K, the current report on Form 8-K, which we filed today and other filings that we make with the Securities and Exchange Commission. Today's comments reflect our current views, which could change as a result of new information, future events or otherwise. And the company does not obligate or commit itself to update forward-looking statements, except as required by law.

During this call, we are providing non-GAAP results and guidance. Reconciliations of GAAP to non-GAAP financial measures are included in the press release that we issued this morning, which is posted to Repligen's website and on sec.gov. The non-GAAP figures in today's report include revenue growth at constant currency, gross profit and gross margin, operating expenses, including R&D and SG&A, operating income and operating margin, income tax expense, net income and earnings per share as well as EBITDA and adjusted EBITDA. These adjusted financial measures should not be viewed as an alternative to GAAP measures, but are intended to better enable investors to benchmark Repligen's current results against historical performance and the performance of peers.

Now I'll turn the call over to Tony Hunt.

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Anthony J. Hunt, Repligen Corporation - CEO, President, Director & Member of Scientific Advisory Board [3]

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Thank you, Sondra. Good morning, everyone, and welcome to our 2019 year-end update. We are delighted with the way we finished off the year with 21% organic growth in the fourth quarter, 33% organic growth for the full year and overall 2019 growth for the company, coming in at 39%. All 3 franchises accelerated in 2019 as we benefited from customers scaling up on mAb processes and new customers implementing our technologies, especially in the area of gene therapy, where we now have greater than 50 significant customers today and just as many smaller customers.

Throughout the year, our team continued to execute on our long-term growth strategy with M&A and R&D remaining at the core of our success.

In 2019, we completed our acquisition of C Technologies, establishing an important new vertical for the company in process analytics.

Our R&D team delivered TFDF filtration technology, a game-changing technology and harvest clarification, an area that has seen little innovation over the last 10 to 20 years. Supporting our growth strategy and operational investments in 2019, we completed a series of financings that leave us with over $500 million in cash at year-end and positions us well for the future.

Looking back at the year, there were 5 key drivers of growth. First, as I mentioned, we saw strong adoption of gene therapy accounts where we help to deliver yield and efficiency improvements in viral vector manufacturing. Gene therapy represented approximately 15% of our overall 2019 revenue with filtration products accounting for 60% and chromatography products accounting for 35% of sales into these accounts. We saw a fairly even split between CDMO and gene therapy developers at 52% and 48% of revenue, respectively. And with the strong base of core customers and differentiated technology, we are really well positioned for growth in gene therapy. Second, we saw increased adoption of our XCell ATF products in both N-1 seed train, a traditional perfusion applications. The expansion of ATF applications into fed-batch processes is a key growth driver for us as it is the catalyst for sustained long-term growth north of 20%.

Third, we saw significant uptick of our TFF systems portfolio where we put more focus on tying systems and consumables into targeted upstream and downstream applications. We made the decision 12 months ago to focus on building out systems for our TFF portfolio. And not only has this team delivered on more traditional UF/DF applications, but they've also delivered on the development and launch of TFDF technology and fed-batch harvest clarification.

Fourth, we saw accelerated adoption of our OPUS prepacked columns as CDMOs and pharma customers continue to scale and expand. Combined with new demand for OPUS and gene therapy, we delivered approximately 1,400 comps to our customer base in 2019, up from 700 comps in 2018.

To ensure our ability to stay ahead of demand, we made significant investments in 2019 and here again in 2020 to expand our capacity and resources at OPUS production. And finally, just the overall strength of the biologics market, where in the U.S. alone, 10 new mAbs and 2 gene therapy drugs were approved in 2019. With a rich pipeline of over 1,000 biological drug candidates, the expectations are high for strong growth in the years ahead.

Before jumping into the quarter, I also wanted to highlight some of our key accomplishments in 2019. Starting with C Technologies, which was our first acquisition in process analytics. During our 7 months of C Tech ownership in 2019, we focused our efforts on commercial expansion, R&D acceleration and building out the financial team and implementing public company processes at C Tech.

We successfully built our commercial team with 10 dedicated reps, we focused R&D efforts on accelerating next-gen FlowVPE, and we completed the build-out of the finance team. For the year, C Tech products contributed close to $16.4 million in revenue, right in line with our $16 million to $17 million projection. We look forward to seeing the impact of our new commercial team in 2020, where we expect C Technologies to generate approximately $32 million in revenue.

Moving now to R&D. 2019 was a year where we made significant progress. A key goal for us entering the year was to develop and launch TFDF technology. We did a very successful technical launch of the product in September, and then our systems team followed up with the development of benched-up and production scale systems, which will be launched here in Q1. We also made progress with our next-gen ATF controller, which is scheduled to launch in late Q1, early Q2. In addition, key products like SIUS gamma and next-gen ligands are reaching their final stages of product development and will soon be available in the marketplace. From a capacity and infrastructure standpoint, 2019 was a huge year for us. We increased our office capacity fivefold and have dedicated programs in place to expand again in 2020. Our operations team also expanded and centralized manufacturing of XCell ATF in Marlborough and completed the Phase I implementation of SAP. Financially, we were able to raise close to $500 million net through a series of equity and convertible debt financings, again, putting us in a strong position for future M&A.

So moving now to our Q4 results and full year 2019 performance. As reported today, we had a great quarter with $69.5 million in sales. The story of the quarter was our organic growth performance against difficult comps. Each of our proteins, filtration and chromatography franchises performed well and together delivered 20% plus organic growth in the quarter and 20%, 30% and 40% organic growth, respectively, for the year.

In filtration, our XCell ATF product line had a record year. Our customers scaled up into late stage trials, and we saw increased use of ATF and N-1 seed train applications, reflecting a broader application of the technology into fed-batch processes. Single-use ATF continued to perform well in 2019, with revenue growth of 45%. Our SIUS flat sheet TFF cassette business also had a very strong quarter and year, up over 25%. The story continues to be around new accounts and key wins in gene therapy applications. Our hollow fiber portfolio also had a good quarter in Europe, 30% with the robust demand for single-use flow paths, hollow fiber modules and KrosFlo systems. We expect that our hollow fiber business will have another strong year in 2020. And our overall filtration franchise will grow approximately 25%.

Moving to chromatography for our OPUS business finished up over 30% for the quarter and 50% for the year. The story in the quarter was the continued adoption of our prepacked column technology in CDMOs and gene therapy accounts, which now account for 20% of our OPUS revenue. In parallel, we were able to improve our lead times significantly by bringing 5 new production suites online in December. We also saw accelerating adoption to focus ATF columns, as customers put our technology into late-stage and commercial processes.

We expect continued momentum for OPUS in 2020 as our customers scale and expand. We expect our OPUS franchise to grow at or above 20%, with overall chromatography at 15% in 2020.

Our OEM proteins business performed well in Q4 and was up 20% for the full year, led by strengthened growth factors with 50% growth from ligands. As mentioned, throughout 2019, we expect GE to transition to in-house ligand manufacturing here in 2020, creating a $12 million to $13 million or 4% to 5% headwind for the company. We expect that NGL-Impact A ligand will continue to gain traction in the marketplace as customers implement this technology in early-stage clinical trials. So overall, we expect the company to grow at 14% to 18% in 2020, with organic growth in the 10% to 14% range.

We expect H2 to be stronger than H1 as some of the larger scale-up projects is in the second half of 2020. Unlike other companies, it will take a few more months to understand what the long-term impact might be on overall company performance from the coronavirus in China in fiscal year 2020. For quarter 1, there may be some shift in revenue into Q2 based on customer timing.

As we move into 2020, our strategic priorities will center on the following: new product launches with a focus on TFDF and ATF controllers, expanding our market presence in harvest clarification applications with TFDF technology, further expanding our market presence in gene therapy through our filtration and chromatography franchises; broadening the customer base and applications for C Technologies; implementing capacity expansion and operating margin improvement programs; and finally, evaluating M&A opportunities to supplement our organic growth.

In summary, we believe we are well positioned to gain further share by processing. We believe that the blueprint we've put in place over the last 5 years around building out a world-class commercial team, bringing disruptive technologies to market and supplementing our technology base with select M&As will be the catalyst for growth over the coming years. Also, based on the investments we've made in R&D over the last 3 years, we expect 2020 to be a milestone year for us in terms of product launches.

Before concluding, I wish to recognize our employees around the globe for their commitment and leadership in 2019. I also want to thank our loyal shareholders and customers for their parts in Repligen's success and we look forward to another strong year for the company and bioprocessing.

With that, I'll turn the call over to Jon for a more detailed financial report.

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Jon K. Snodgres, Repligen Corporation - CFO & Secretary [4]

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Thank you, Tony, and good morning, everyone. Today, we are reporting our financial results for the fourth quarter and full year 2019, as well as providing our financial guidance for the year 2020. Unless otherwise mentioned, all financial measures discussed reflect non-GAAP measures. As you've seen in our press release this morning, we delivered strong financial performance for both the fourth quarter and full year 2019. We had another strong quarter with revenues of $69.5 million, representing 34% reported growth and 21% organic growth. For full year 2019, we reported record revenue of $270.2 million. The year-over-year increase of $76 million represents 39% overall growth, including 2 points of foreign currency headwind and 33% organic growth, $16 million or 8% of our revenue growth was attributed to our June 2019 acquisition of C Technologies.

Operationally, we continue to prioritize key areas of investments in the company. In 2019, 7% of revenue supported R&D programs that continue to produce disruptive technologies, like our new TFDF platform that we launched in the second half of the year. We also made important capital investments in our manufacturing sites, with a significant portion of our spend dedicated to increasing overall production capacity and expanding and upgrading our IT systems and infrastructure.

Now to provide more insights into our overall financial performance. As Tony mentioned earlier, our direct-to-customer franchises continue to perform well. Our direct products represented 79% of the company's total revenue in the fourth quarter and 76% for the full year compared to 72% for full year 2018. On a regional basis, for the full year, pro forma direct product revenue growth was fairly consistent across regions, with approximately 30% growth in North America, Europe and Asia. For the full year 2019, Asia represented 16% of direct revenue, while Europe and North America accounted for 28% and 56%, respectively.

Now moving to our income statement. Fourth quarter adjusted gross profit was $39.8 million, representing an increase of $11.3 million or 40% over the fourth quarter of 2018. Our adjusted gross margin was 57.2% for the fourth quarter of 2019 compared to 54.8% for the same period in 2018. The 240 basis point improvement was driven by favorable OPUS column to resin mix in our chromatography franchise and by increased demand for growth factor products in our proteins franchise. Full year 2019 adjusted gross profit of $154.1 million reflects an increase of $45.9 million or 42% compared to the full year of 2018. Adjusted gross margin was 57% for the full year 2019 compared to 55.8% for 2018, with the 120 basis point increase, driven by overall sales volume leverage in our factories, our new C Technologies product line and favorable product mix, partially offset by investments in capacity and operations.

With respect to operating expenses. Adjusted research and development costs for the fourth quarter of 2019 were $4.9 million compared to $3 million for the fourth quarter of 2018. For the full year 2019, adjusted R&D expenses were $18.8 million compared to $15.7 million in 2018. Key drivers of the year-over-year increase were the timing of our C Technologies acquisition, investments in our next-generation filtration technologies, as well as continued investments in our ligand programs.

Overall, R&D expenses finished the year at 7% of revenue.

Adjusted SG&A for the fourth quarter of 2019 was $22.2 million compared to $14.4 million for the fourth quarter of 2018. Full year adjusted SG&A was $71.8 million in 2019 compared to $53.1 million in 2018. The year-over-year increase in adjusted SG&A was related to the timing of our C Technologies acquisition and the build-out of our process analytics commercial team, as well as expansions and enhancements of our facilities, IT systems and commercial team.

Now moving to adjusted earnings and EPS. In the fourth quarter of 2019, our adjusted operating income was $12.7 million, a 15% increase compared to $11.1 million reported in the fourth quarter of 2018. Our adjusted operating margin was 18.3% compared to 21.3% for the fourth quarter of 2018. Our operating costs during the fourth quarter of 2019 included approximately $1 million of nonrecurring expenses, mostly in IT and recruiting. For the full year of 2019, our adjusted operating income was $63.5 million, a 61% increase compared to $39.4 million for the full year of 2018.

Our 2019 full year adjusted operating margin was 23.5%, a 320 basis point improvement compared to 20.3% for the 2018 period, reflecting a strong year of growth and operational execution in our business.

Adjusted net income for the fourth quarter of 2019 was $10.8 million, an increase of 21% compared to $8.9 million in the same period in 2018. Full year 2019 adjusted net income was $52.5 million, an increase of 74% compared to $30.1 million for the full year 2018.

Adjusted EPS for the fourth quarter of 2019 increased to $0.20 per fully diluted share from $0.19 for the fourth quarter of 2018.

For the full year of 2019, adjusted EPS increased to $1.07, up 62% from $0.66 in 2018.

Our cash and cash equivalents, which are GAAP metrics, totaled $528.4 million at December 31, 2019. For full year 2019, we generated free cash flow of $44.1 million, inclusive of $67.2 million of operating cash flow, less $23.2 million of capital investments primarily related to our facility and capacity expansion projects and IT systems investments.

Now moving to 2020 full year guidance. Our GAAP to non-GAAP reconciliations for our 2020 financial guidance are included in the reconciliation tables in today's earnings press release. As previously mentioned, unless otherwise noted, all 2020 financial guidance discussed will be non-GAAP. Please also keep in mind that our 2020 guidance may be impacted by fluctuations in foreign exchange rates beyond our current projection of a net 0 impact on full year sales and does not include the potential impact of any new acquisitions that the company may pursue.

Today, we are setting our 2020 full year revenue guidance, a GAAP metric at $309 million to $319 million, reflecting growth in the range of 14% to 18% as reported and 10% to 14% on an organic basis. Our adjusted gross margin guidance for 2020 is 55% to 56%, which reflects the impacts of expected headwinds from lighter GE volumes and investments in our facilities, capacity, IT systems and staffing to support expected strength and long-term market demand and overall growth. Adjusted operating income is expected to be in the range of $70 million to $74 million, with adjusted operating margins in the range of 22% to 23% of revenue for the year.

We are expecting 2020 adjusted income tax expense of approximately 23% of adjusted pretax income, which anticipates impacts from strong international revenue growth in higher tax rate countries in Europe and Asia.

We are expecting full year 2020 adjusted net income in the range of $57 million to $60 million for the year, and adjusted EPS in the range of $1.07 to $1.12 per fully diluted share. Please note that our 2020 adjusted EPS guidance reflects a $0.09 dilution impact due to share count increases, primarily related to our 2019 financing activities.

Our guidance reflects an estimated 53.4 million fully diluted shares outstanding for the full year, an increase of approximately 4 million. Adjusted EBITDA is now expected to be in the range of $80 million to $84 million for the full year 2020, with depreciation and intangible amortization expense is expected to be approximately $10.5 million and $15.5 million, respectively.

The company again expects to invest an estimated $20 million to $22 million in 2020 for capital expenditures as we proceed with our build-out of our OPUS manufacturing facility in Breda, planned capacity expansions in our Massachusetts and California facilities and with continued investments in SAP.

We expect 2020 year-end cash and cash equivalents, a GAAP metric to be in the range of $580 million to $590 million, with our CapEx investments being fully funded by cash generation from our operations. As you can see, we've executed on another strong year of performance in 2019, including making substantial investments in the company as part of our 2-year plan to prepare us for continued long-term growth.

This completes our financial report, and I will now turn the call back to the operator to open the lines for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Today's first question comes from Dan Arias of Stifel.

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Daniel Anthony Arias, Stifel, Nicolaus & Company, Incorporated, Research Division - MD & Senior Analyst [2]

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Maybe just to start on guidance. 32% organic is a pretty big year. So obviously, you have a tough comp there. When you look at the momentum that you're exiting 2019 with though, can you just talk about the approach to the 2020 outlook in terms of being conservative or not conservative? And then how you feel about just the shape of the business and the drivers that you have relative to this time last year when you guided to, I believe, 13% to 17% organic growth. So less than half of what you ended up doing?

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Anthony J. Hunt, Repligen Corporation - CEO, President, Director & Member of Scientific Advisory Board [3]

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Yes. Thanks, Dan. Yes, I think in general, we finished off the year. We had good momentum through the second half of the year. I think as we looked at 2020 guidance, I think it was important for us to really gauge what was going on in each of the businesses, right, in each of the divisions. So within chromatography and filtration, we feel pretty good about it. Our OPUS business came off a massive year last year, up over 50%. And our filtration product line also had a really, really big year. So we've got really difficult comps in 2020. We expect that our filtration franchise will grow 25%. We think that our OPUS franchise will grow 20% plus. Our proteins business is probably the main headwind that we have and so we know we have a 4% to 5% headwind going into 2020. So if you take our 10% to 14% guidance. And we didn't have that headwind, we would really be doing 14 -- 15% to 19%. So we think, actually, the guidance we're putting out there right now is very realistic. While we feel really good about our businesses, really good about our products, we think this is the right guidance for us.

To your second part of your question about last year where we guided mid-teens, and we came in at 30%. I think the piece that really surprised us last year was the proteins business, right? And we had guided down 5%, and it came in really, really strong. So if you take that out of the equation, it would really drop down the overall organic growth pretty significantly. So I think that was a big factor. I think the other factor last year is that no one really in the industry predicted how fast the gene therapy market was going to grow. And I think we all kind of missed that a little bit. And so that's kind of the explanation for last year.

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Daniel Anthony Arias, Stifel, Nicolaus & Company, Incorporated, Research Division - MD & Senior Analyst [4]

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Yes. Okay. That's actually my second question. Just on gene therapy, is there some color you can give on just how you feel about the expansion and the evolution of that market in terms of new activity and the scale of our project work. And then I guess, along those lines, I mean, one of the things that it sounded like you were trying to stay grounded on last year was this idea that a lot of things went right in 2019 in that field. And that, that always doesn't happen, Phase I don't always go to Phase II, et cetera. So I guess the question is that sitting 2 months into the new year, how are you looking at things relative to the way that you would have hoped they would have been 6 to 12 months ago?

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Anthony J. Hunt, Repligen Corporation - CEO, President, Director & Member of Scientific Advisory Board [5]

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Yes. I think when you look at how we finished in Q4, the gene therapy customer base was again strong for us in terms of shipments, in terms of orders as we -- it's difficult for us to see much beyond the first half of the year. We know, as I said earlier in my prepared remarks that we know there are some significant scale-up programs that are happening in the second half of the year. But in general, we haven't seen any slowdown in gene therapy, and we're expecting gene therapy will drive -- will grow about 30% for us in 2020.

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Daniel Anthony Arias, Stifel, Nicolaus & Company, Incorporated, Research Division - MD & Senior Analyst [6]

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Okay. It sounds like you've given the 3 questions here, so I'll take the opportunity. Maybe just on TFDF, that sounds like it's one of the more meaningful products in the portfolio these days. So what is the thought on just the industry coming around to the dual filtration benefit that you get there. My sense is that, that might take 1 year or 2 for that to ramp and be a material contributor. Is that the way that you're thinking about it? And then what does the runway look like if you wanted to look beyond just this year and into 2021 and 2022?

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Anthony J. Hunt, Repligen Corporation - CEO, President, Director & Member of Scientific Advisory Board [7]

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Yes, I think you have it spot on. The -- it's going to take a couple of years for TFDF to take off, but we've got a significant number of trials lined up here in Q1. We expect it will generate $1 million, $2 million in revenue for us this year. But every year, going forward, we expect that revenue will double. And so it's not one of those product lines that we expect to grow at 20%, 25%, 30%. We expect that over the next few years, this is a technology that's going to scale quickly. But obviously, we've to get through the trials, we've got to prove the technology. We've done that so far, but on a limited basis, and I think we're very confident that the technology is going to be a key technology for us. That said, I wouldn't underestimate the rest of the product launches that we're bringing to market this year. So we really are bringing innovation in ATF. We're bringing out the next-generation FlowVPE technology in the second half of the year. We've got new ligands coming through. We've got next-generation, SIUS gamma. Really feel this year is a key year for us in terms of product launches that will set us up really well for 2021 and beyond.

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Continued here:
Edited Transcript of RGEN earnings conference call or presentation 20-Feb-20 1:30pm GMT - Yahoo Finance

Recommendation and review posted by Bethany Smith

Presented positive clinical and pre-clinical data from its MarzAA and DalcA hemophilia programs

Announced a global license and collaboration agreement with Biogen to develop and commercialize pegylated CB 2782 for Dry AMD

SOUTH SAN FRANCISCO, Calif., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (CBIO), today announced its operating and financial results for the fourth quarter and full-year ending December 31, 2019 and provided a corporate update.

We made exceptional progress in both our subcutaneously-dosed (SQ) MarzAA (FVIIa) and SQ DalcA (FIX) programs this past year. Earlier this month at EAHAD, positive data was presented in an oral presentation from the Companys Phase 2b SQ DalcA trial in subjects with hemophilia B clearly demonstrating efficacy and safety. We also presented data from MarzAA and Factor IX gene therapy programs in three posters, said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. Catalysts therapies have demonstrated the potential to effectively treat hemophilia subcutaneously in a $3.4 billion market.

Dr. Usman continued, "Additionally, our February 2020 financing combined with our current cash provides funding through several major milestones for our lead Phase 3 ready MarzAA and Phase 2b DalcA product candidates, as well as our FIX gene therapy and complement inhibitor programs."

Recent Milestones:

Expected Milestones

Fourth Quarter and Full-year 2019 Results and Financial Highlights

About Catalyst Biosciences

Catalyst is a clinical-stage biopharmaceutical company focused on addressing unmet needs in rare diseases and systemic complement mediated disorders. Our protease engineering platform includes development programs in hemophilia and a research program on subcutaneous (SQ) systemic complement inhibitors. Our engineered coagulation factors are designed to overcome the significant limitations of current IV treatment options, facilitate prophylaxis, and ultimately deliver substantially better outcomes for patients using SQ dosing. Our lead asset, MarzAA has completed Phase 2 development having met its primary endpoint of significantly reducing the annualized bleed rate (ABR) in individuals with hemophilia A or B with inhibitors. Our second hemophilia asset, DalcA is completing a Phase 2b clinical trial and is being developed for the treatment of hemophilia B. We also have a global license and collaboration agreement with Biogen for the development and commercialization of pegylated CB 2782 for the potential treatment of geographic atrophy associated dry age-related macular degeneration.

For more information, please visit http://www.catalystbiosciences.com.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements about the potential uses and benefits of MarzAA and DalcA to effectively and therapeutically treat hemophilia subcutaneously, the potential market opportunity for MarzAA and DalcA, plans to start a Phase 3 trial of MarzAA in second half of 2020 and report final data in the second quarter of 2020 from a MarzAA Phase 1 pharmacokinetic and pharmacodynamic study to support future SQ treatment of bleed studies, to announce final Phase 2b trial data for DalcA in the second quarter of 2020, plans to announce primate data for Factor IX gene therapy in the second quarter of 2020, and potential future milestone and royalty payments from Biogen. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially, including, but not limited to, the risk that trials and studies may be delayed and may not have satisfactory outcomes, that additional human trials will not replicate the results from earlier trials, that potential adverse effects may arise from the testing or use of DalcA, or MarzAA, including the generation of antibodies, which has been observed in patients previously treated with DalcA, the risk that costs required to develop or manufacture the Companys products will be higher than anticipated, the risk that Biogen will terminate our agreement with them, competition and other risks described in the Risk Factors section of the Companys quarterly report filed with the Securities and Exchange Commission on November 7, 2019, and in other filings with the Securities and Exchange Commission. The Company does not assume any obligation to update any forward-looking statements, except as required by law.

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Ana KaporCatalyst Biosciences, Inc.investors@catbio.com

Catalyst Biosciences, Inc.Consolidated Balance Sheets(In thousands, except shares and per share amounts)

Catalyst Biosciences, Inc.Consolidated Statements of Operations(In thousands, except share and per share amounts)

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Catalyst Biosciences Reports Fourth Quarter and Full-Year 2019 Operating & Financial Results and Provides a Corporate Update - Yahoo Finance

Recommendation and review posted by Bethany Smith

Facts & Factors (FnF), A leading market research firm added a research report on Cell and Gene Therapy Consumables Market By Product Type (Kits & Buffers, Diagnostic Assay, Culture Medium, and Cryopreservation Media) and By Application/ Therapeutics (Cardiovascular, Urology, Dermatology, Critical Care, Respiratory, Endocrine & Metabolic, Neuroscience, Hematology & Oncology, Obstetrics, Immunology, and Gastroenterology): Global Industry Perspective, Comprehensive Analysis, and Forecast, 2018 2027 to its research database. This Cell and Gene Therapy Consumables Market report analyzes the comprehensive overview of the market comprising an executive summary that covers core trends evolving in the market.

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Some of Major Market Player ProfilesIncluded in this Report Are:

Amgen Inc., ATLANTA BIOLOGICALS, bluebird bio, Inc., Cook, Dendreon Pharmaceuticals, LLC, Fibrocell Science, Inc., General Electric, Kolon TissueGene, Inc., Orchard Therapeutics plc., Pfizer, Inc., PromoCell GmbH, RENOVA THERAPEUTICS, Sibiono GeneTech Co. Ltd., Spark Therapeutics, Inc., Vericel, Helixmith Co., Ltd., and Vitrolife

The Cell and Gene Therapy Consumables Market report provides objective, evenhanded evaluation, and assessment of opportunities in the Cell and Gene Therapy Consumables market with a methodical market research report including numerous other market-associated fundamental factors. Our experienced industry analysts estimate the growth opportunities, cost, market sizing, technologies, applications, supply chains, companies, import & export, market share, and so on, with the exclusive endeavor of helping our customers to make well-informed business decisions.

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The major region covered in this report:

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Cell and Gene Therapy Consumables Market 2019-2026 by Top Key Players, Industry Size, Share, Demand, Revenue Overview Report - Instant Tech News

Recommendation and review posted by Bethany Smith

An exclusive Gene Therapy Market research report has been fabricated through the in depth analysis of the market dynamics across five regions including North America, Europe, South America, Asia-Pacific, Middle East and Africa. The segmentation of the market by components, end users, and region was done based on the thorough market analysis and validation through extensive primary inputs from industry experts (key opinion leaders of companies, and stakeholders) and secondary research (global/regional associations, trade journals, technical white papers, companys website, annual report SEC filing, and paid databases). Further, the market has been estimated by utilizing various research methodologies and internal statistical model.

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The key players influencing the market are:

This report contains:

Gene Therapy Market report also provide a in-depth understanding of the cutting-edge competitive analysis of the emerging market trends along with the drivers, restraints, and opportunities in the market to offer worthwhile insights and current scenario for making right decision. The report covers the prominent players in the market with detailed SWOT analysis, financial overview, and key developments of last three years. Moreover, the report also offers a 360 outlook of the market through the competitive landscape of the global industry player and helps the companies to garner Gene Therapy Market revenue by understanding the strategic growth approaches.

Gene Therapy Market is a combination of qualitative as well as quantitative analysis which can be broken down into 40% and 60% respectively. Market estimation and forecasts are presented in the report for the overall global market from 2020 2027, considering 2020 as the base year and 2020 2027 forecast period. Global estimation is further broken down by segments and geographies such as North America, Europe, Asia-Pacific, Middle East & Africa and South America covering major 16 countries across the mentioned regions. The qualitative contents for geographical analysis will cover market trends in each region and country which includes highlights of the key players operating in the respective region/country, PEST analysis of each region which includes political, economic, social and technological factors influencing the growth of the market.

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Gene Therapy Market Growth, Trends and Demands Research Report and Forecast 2027 - Instant Tech News

Recommendation and review posted by Bethany Smith

Viral Vector and Plasmid DNA Manufacturing Market with Insights and Key Business Factors

Reports Monitor offers its latest report on the [Global Viral Vector and Plasmid DNA Manufacturing Market size and CAGR between 2020 and 2025.] report that includes comprehensive analysis on a range of subjects such as segmentation, competition, market dynamics and regional expansion. The report offers highly detailed competitive analysis of theGlobal Viral Vector and Plasmid DNA Manufacturing Market, where the business and industry growth of leading companies are thoroughly evaluated on the basis of production, recent developments, technology, geographical footprint, and various other factors. This will help players to prepare themselves well for any unforeseen situations in the industry competition and give a tough competition to other players in the global Viral Vector and Plasmid DNA Manufacturing Market.

TheMajor Manufacturers Covered in this Report:Merck, uniQure, The Cell and Gene Therapy Catapult, Waisman Biomanufacturing, Addgene, Creative Biogene, Novasep, Cobra Biologics, Aldevron, , and more.

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Scope of the ReportThe research report provides key information on the supply chain of the industry, the markets currency chain, pools of major companies, and market segmentation, geographical market, and technology-oriented perspectives.The authors of the report have also provided qualitative and quantitative analyses of several microeconomic and macroeconomic factors impacting the global Viral Vector and Plasmid DNA Manufacturing market. In addition, the research study helps to understand the changes in the industry supply chain, manufacturing process and cost, sales scenarios, and dynamics of the global Viral Vector and Plasmid DNA Manufacturing market.

Market segment by Type, the product can be split intoAdenovirusRetrovirusPlasmid DNAOthers

Market segment by Application, the product can be split intoBiopharmaceutical CompaniesResearch Institutes

On the basis of geography, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

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Key Benefits for Viral Vector and Plasmid DNA Manufacturing Market:A.In-depth analysis of the market is conducted by constructing market estimations for the key market segments between 2020 and 2025. The report provides an extensive analysis of the current and emerging Viral Vector and Plasmid DNA Manufacturing market trends and dynamics.B. Key market players within the market are profiled in this report and their strategies are analyzed thoroughly, which helps to understand the competitive outlook of the industry.D.Extensive analysis of the market is conducted by following key product positioning and monitoring of the top manufacturers within the market framework.E. A comprehensive analysis of all the regions (North America, Europe, Asia-Pacific, South America, The Middle East and Africa)

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Viral Vector and Plasmid DNA Manufacturing Market 2020 Regional and Growth Opportunity by Top Players: Merck, uniQure, The Cell and Gene Therapy...

Recommendation and review posted by Bethany Smith

Heart disease is the primary cause of death worldwide, principally because the heart has minimal ability to regenerate muscle tissue. Myocardial infarction (heart attack) caused by coronary artery disease leads to heart muscle loss and replacement with scar tissue, and the heart's pumping ability is permanently reduced. Breakthroughs in stem cell biology in the 1990s and 2000s led to the hypothesis that heart muscle cells (cardiomyocytes) could be regenerated by transplanting stem cells or their derivatives. It has been 18 years since the first clinical trials of stem cell therapy for heart repair were initiated (1), mostly using adult cells. Although cell therapy is feasible and largely safe, randomized, controlled trials in patients show little consistent benefit from any of the treatments with adult-derived cells (2). In the meantime, pluripotent stem cells have produced bona fide heart muscle regeneration in animal studies and are emerging as leading candidates for human heart regeneration.

In retrospect, the lack of efficacy in these adult cell trials might have been predicted. The most common cell type delivered has been bone marrow mononuclear cells, but other transplanted cell types include bone marrow mesenchymal stromal cells and skeletal muscle myoblasts, and a few studies have used putative progenitors isolated from the adult heart itself. Although each of these adult cell types was originally postulated to differentiate directly into cardiomyocytes, none of them actually do. Indeed, with the exception of skeletal muscle myoblasts, none of these cell types survive more than a few days in the injured heart (see the figure). Unfortunately, the studies using bone marrow and adult resident cardiac progenitor cells were based on a large body of fraudulent work (3), which has led to the retraction of >30 publications. This has left clinical investigators wondering whether their trials should continue, given the lack of scientific foundation and the low but measurable risk of bleeding, stroke, and infection.

Additionally, investigators have struggled to explain the beneficial effects of adult cell therapy in preclinical animal models. Because none of these injected cell types survive and engraft in meaningful numbers or directly generate new myocardium, the mechanism has always been somewhat mysterious. Most research has focused on paracrine-mediated activation of endogenous repair mechanisms or preventing additional death of cardiomyocytes. Multiple protein factors, exosomes (small extracellular vesicles), and microRNAs have been proposed as the paracrine effectors, and an acute immunomodulatory effect has recently been suggested to underlie the benefits of adult cell therapy (4). Regardless, if cell engraftment or survival is not required, the durability of the therapy and need for actual cells versus their paracrine effectors is unclear.

Of particular importance to clinical translation is whether cell therapy is additive to optimal medical therapy. This remains unclear because almost all preclinical studies do not use standard medical treatment for myocardial infarction. Given the uncertainties about efficacy and concerns over the veracity of much of the underlying data, whether agencies should continue funding clinical trials using adult cells to treat heart disease should be assessed. Perhaps it is time for proponents of adult cardiac cell therapy to reconsider the approach.

Pluripotent stem cells (PSCs) include embryonic stem cells (ESCs) and their reprogrammed cousins, induced pluripotent stem cells (iPSCs). In contrast to adult cells, PSCs can divide indefinitely and differentiate into virtually every cell type in the human body, including cardiomyocytes. These remarkable attributes also make ESCs and iPSCs more challenging to control. Through painstaking development, cell expansion and differentiation protocols have advanced such that batches of 1 billion to 10 billion pharmaceutical-grade cardiomyocytes, at >90% purity, can be generated.

Preclinical studies indicate that PSC-cardiomyocytes can remuscularize infarcted regions of the heart (see the figure). The new myocardium persists for at least 3 months (the longest time studied), and physiological studies indicate that it beats in synchrony with host myocardium. The new myocardium results in substantial improvement in cardiac function in multiple animal models, including nonhuman primates (5). Although the mechanism of action is still under study, there is evidence that these cells directly support the heart's pumping function, in addition to providing paracrine factors. These findings are in line with the original hope for stem cell therapyto regenerate lost tissue and restore organ function. Additional effects, such as mechanically buttressing the injured heart wall, may also contribute.

Breakthroughs in cancer immunotherapy have led to the adoption of cell therapies using patient-derived (autologous) T cells that are genetically modified to express chimeric antigen receptors (CARs) that recognize cancer cell antigens. CAR T cells are the first U.S. Food and Drug Administration (FDA)approved, gene-modified cellular pharmaceutical (6). The clinical and commercial success of autologous CAR T cell transplant to treat B cell malignancies has opened doors for other complex cell therapies, including PSC derivatives. There is now a regulatory path to the clinic, private-sector funding is attracted to this field, and clinical investigators in other areas are encouraged to embrace this technology. Indeed, the first transplants of human ESC-derived cardiac progenitors, surgically delivered as a patch onto the heart's surface, have been carried out (7). In the coming years, multiple attempts to use PSC-derived cardiomyocytes to repair the human heart are likely.

What might the first human trials look like? These studies will probably employ an allogeneic (non-self), off-the-shelf, cryopreserved cell product. Although the discovery of iPSCs raised hopes for widespread use of autologous stem cell therapies, the current technology and regulatory requirements likely make this approach too costly for something as common as heart disease, although this could change as technology and regulations evolve. Given that it would take at least 6 months to generate a therapeutic dose of iPSC-derived cardiomyocytes, such cells could only be applied to patients whose infarcts are in the chronic phase where scarring (fibrosis) and ventricular remodeling are complete. Preclinical data indicate that chronic infarcts benefit less from cardiomyocyte transplantation than do those with active wound-healing processes.

Adult cells from bone marrow or the adult heart secrete beneficial paracrine factors but do not engraft in the infarcted heart. Pluripotent stem cells give rise to cardiomyocytes that engraft long term in animal models, beat in synchrony with the heart, and secrete beneficial paracrine factors. Long-term cardiomyocyte engraftment partially regenerates injured heart, which is hypothesized to bring clinical benefits.

The need for allogeneic cells raises the question of how to prevent immune rejection, both from innate immune responses in the acute phase of transplantation or from adaptive immune responses that develop more slowly through the detection of non-self antigens presented by major histocompatibility complexes (MHCs). A current strategy is the collection of iPSCs from patients who have homozygous MHC loci, which results in exponentially more MHC matches with the general population. However, studies in macaque monkeys suggest that MHC matching will be insufficient. In a macaque model of brain injury, immunosuppression was required to prevent rejection of MHC-matched iPSC-derived neurons (8). Similarly, MHC matching reduced the immunogenicity of iPSC-derived cardiomyocytes transplanted subcutaneously or into the hearts of rhesus macaques, but immunosuppressive drugs were still required to prevent rejection (9).

Numerous immune gene editing approaches have been proposed to circumvent rejection, including preventing MHC class I and II molecule expression, overexpressing immunomodulatory cell-surface factors, such CD47 and human leukocyte antigen E (HLA-E) and HLA-G (two human MHC molecules that promote maternal-fetal immune tolerance), or engineering cells to produce immunosuppressants such as programmed cell death ligand 1 (PDL1) and cytotoxic T lymphocyteassociated antigen 4 (CTLA4) (10). These approaches singly or in combination seem to reduce adaptive immune responses in vitro and in mouse models. Overexpressing HLA-G or CD47 also blunts the innate natural killer cellmediated response that results from deleting MHC class I genes (11). However, these manipulations are not without theoretical risks. It could be difficult to clear viral infections from an immunostealthy patch of tissue, and possible tumors resulting from engraftment of PSCs might be difficult to clear immunologically.

Ventricular arrhythmias have emerged as the major toxicity of cardiomyocyte cell therapy. Initial studies in small animals showed no arrhythmic complications (probably because their heart rates are too fast), but in large animals with human-like heart rates, arrhythmias were consistently observed (5, 12). Stereotypically, these arrhythmias arise a few days after transplantation, peak within a few weeks, and subside after 4 to 6 weeks. The arrhythmias were well tolerated in macaques (5) but were lethal in a subset of pigs (12). Electrophysiological studies indicate that these arrhythmias originate in graft regions from a source that behaves like an ectopic pacemaker. Understanding the mechanism of these arrhythmias and developing solutions are major areas of research. There is particular interest in the hypothesis that the immaturity of PSC-cardiomyocytes contributes to these arrhythmias, and that their maturation in situ caused arrhythmias to subside.

A successful therapy for heart regeneration also requires understanding the host side of the equation. PSC-derived cardiomyocytes engraft despite transplantation into injured myocardium that is ischemic with poor blood flow. Although vessels eventually grow in from the host tissue, normal perfusion is not restored. Achieving a robust arterial input will be key to restoring function, which may require cotransplanting other cell populations or tissue engineering approaches (13, 14). Most PSC-mediated cardiac cell therapy studies have been performed in the subacute window, equivalent to 2 to 4 weeks after myocardial infarction in humans. At this point, there has been insufficient time for a substantial fibrotic response. Fibrosis has multiple deleterious features, including mechanically stiffening the tissue and creating zones of electrical insulation that can cause arrhythmias. Extending this therapy to other clinical situations, such as chronic heart failure, will require additional approaches that address the preexisting fibrosis. Cell therapy may again provide an answer because CAR T cells targeted to cardiac fibroblasts reduced fibrosis (15).

Developing a human cardiomyocyte therapy for heart regeneration will push the limits of cell manufacturing. Each patient will likely require a dose of 1 billion to 10 billion cells. Given the widespread nature of ischemic heart disease, 105 to 106 patients a year are likely to need treatment, which translates to 1014 to 1016 cardiomyocytes per year. Growing cells at this scale will require introduction of next generation bioreactors, development of lower-cost media, construction of large-scale cryopreservation and banking systems, and establishment of a robust supply chain compatible with clinical-grade manufacturing practices.

Beyond PSC-cardiomyocytes, other promising approaches include reactivating cardiomyocyte division and reprogramming fibroblasts to form new cardiomyocytes. However, these approaches are at an earlier stage of development, and currently, PSC-derived cardiomyocyte therapy is the only approach that results in large and lasting new muscle grafts. The hurdles to this treatment are known, and likely addressable, thus multiple clinical trials are anticipated.

Acknowledgments: C.E.M. and W.R.M. are scientific founders of and equity holders in Sana Biotechnology. C.E.M. is an employee of Sana Biotechnology. W.R.M. is a consultant for Sana Biotechnology. C.E.M. and W.R.M. hold issued and pending patents in the field of stem cell and regenerative biology.

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Stem cells and the heartthe road ahead - Science Magazine

Recommendation and review posted by Bethany Smith

Stem Cell Therapy Market Insights 2019, is a professional and in-depth study on the current state of the global Stem Cell Therapy industry with a focus on the Global market. The report provides key statistics on the market status of the Stem Cell Therapy manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry. Overall, the report provides an in-depth insight of 2019-2025 global Stem Cell Therapy market covering all important parameters.

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The key points of the Stem Cell Therapy Market report:

The report provides a basic overview of the Stem Cell Therapy industry including its definition, applications and manufacturing technology.

The report explores the international and Chinese major industry players in detail. In this part, the report presents the company profile, product specifications, capacity, production value, and 2019-2025 market shares for each company.

Through the statistical analysis, the report depicts the global total market of Stem Cell Therapy industry including capacity, production, production value, cost/profit, supply/demand and Chinese import/export.

The total market is further divided by company, by country, and by application/type for the competitive landscape analysis.

The report then estimates 2019-2025 market development trends of Stem Cell Therapy industry. Analysis of upstream raw materials, downstream demand, and current market dynamics is also carried out.

The report makes some important proposals for a new project of Stem Cell Therapy Industry before evaluating its feasibility.

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There are 3 key segments covered in this report: competitor segment, product type segment, end use/application segment.

For competitor segment, the report includes global key players of Stem Cell Therapy are included:

Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Reasons to Purchase this Report:

* Estimates 2019-2025 Stem Cell Therapy market development trends with the recent trends and SWOT analysis

* Market dynamics scenario, along with growth opportunities of the market in the years to come

* Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects

* Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.

* Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years

* Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Read more:
Stem Cell Therapy Market: Business Opportunities, Current Trends and Industry Analysis by 2018 2028 - Instant Tech News

Recommendation and review posted by Bethany Smith

Were deep into half-year reporting season and a swarm of medical companies opened their books to investors overnight.

Being biotechs, some dont make money and many of those never will either, if they cant get the drug or device theyre developing to work.

Others are well on the revenue pathway.

This company is developing treatments that spur the bodys immune system to fight cancer. It technically doesnt make money per se, booking a $6m loss, but does earn money from other companies it has licensed drugs to.

In the half year, Immutep earned a milestone payment of $7.4m from GlaxoSmithKline, which dosed its first patient in a phase II clinical trial evaluating a treatment derived from an Immutep antibody in ulcerative colitis.

Immutep has licensed drugs to Novartis, CYTLIMIC, and Chinese company EOC Pharma.

Pharmaceuticals seller Mayne Pharma reported lower numbers across all metrics. Revenue was down 17 per cent, EBITDA dropped by 47 per cent, its loss widened to $17.5m, and even underlying EBITDA and operating cashflow fell too.

CEO Scott Richards said as previously foreshadowed at the AGM the company had faced aggressive competition on its key generic products in the US. Mayne Pharma cut costs by $10m and dumped some generic products.

Richards is hopeful a new oral contraceptive the company has acquired will help it bounce back.

IVF provider Monash also hasnt had a great half, with all key numbers down: revenue dipped to $77m, profit dropped 15 per cent to just under $10m, all forms of EBITDA and EBIT (there are a few ways to spin those numbers) are also lower .

IVF is a hyper competitive market in Australia. Undercut by cheap operators, who were allowed into the market a few years ago, and with strong rivals in the biggest regions of NSW, Queensland and Victoria, there arent many ways to claw back market share or grow without going overseas.

Tasmania and South Australia performed well for Monash in the half, and more women are wanting expensive genetic screening. But even the companys foray into Malaysia delivered bad news as the number of stimulated cycles women undertook fell.

Cynata is trying to cure disease with stem cells. Japanese company Sumitomo tried to buy it for $2-a-share in the half, but they couldnt agree on terms and the talks fizzled.

The company made money in the quarter because FUJIFILM Corporation paid $US3m to exercise a long-awaited licence option for a treatment for graft-versus-host disease (GvHD), a rare condition when donor bone marrow or stem cells attack their new host. However, Cynata made a $2.5m loss and has $5.9m in cash at the end of calendar 2019.

Cynata has three phase two clinical trials expected to start in 2020 for osteoarthritis, critical limb ischemia and GvHD. Its also looking at sepsis, coronary artery disease, and organ transplant rejection.

Another stem cell biotech, Exopharm listed in the prior corresponding half, so its figures are not as simple to compare.

Revenue rose 6,239 per cent to $39,494, although this is entirely from interest on money in the bank, and its loss widened to $3.7m.

The company mainly spent its money on R&D and employees.

The Alzheimers cure researcher has had to dig deep into its data following a spectacular failure of a phase two trial in May.

In the last half, Actinogen found its lead drug Xanamem produced a statistically significant clinical effect on improving cognition in healthy elderly patients at 20mg daily (rather than the lower dose in the phase two trial).

Without a clinical trial underway the loss fell from $7m to $4m, while R&D costs halved.

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Biotech: Its not a get-rich-quick scheme judging by these HY reports - Stockhead

Recommendation and review posted by Bethany Smith

02/21/2020 | 12:17am EST

Actinium

Pharmaceuticals,Inc.

Mid-Point Analysis of Pivotal Phase 3 SIERRA Trial Including Materials Presented at 2020 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR (TCT)

Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] leads to High Rates of Allogeneic Transplantation and Successful Engraftment in Older Patients with Active, Relapsed or Refractory AML after Failure of Chemotherapy and Targeted Agents: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 SIERRA Trial

SIERRA: Study of Iomab-B in Elderly Relapsed/Refractory AML

Boglarka Gyurkocza, MD, Rajneesh Nath, MD, Patrick J. Stiff, MD, Edward Agura, MD, Mark Litzow, MD, Ben Tomlinson, MD, Hannah K. Choe, MD, Sunil Abhyankar, MD, Stuart Seropian, MD, George L.

Chen, MD, Parameswaran Hari, MBBS, MD, Zaid S. Al-Kadhimi, MD, James M. Foran, MD, Johnnie Orozco, MD, Koen Van Besien, MD, PhD, Mitchell Sabloff, MD, Partow Kebriaei, MD, Camille Abboud, MD, Moshe Yair Levy, MD, Hillard M Lazarus, MD, Sergio A Giralt, MD, Mark S. Berger, MD, Vijay Reddy, MD, PhD and John M. Pagel, MD, PhD

2

Slides adapted from TCT 2020 oral presentation and include additional data from mid-point analysis of 50% of patients from SIERRA trial

Iodine (131I) apamistamab [Iomab-B] CD45 Targeted Conditioning

Leukemic Bone Marrow

Post-Iomab-B Myeloablated Bone Marrow

Iomab-B

SIERRA Phase 3 Trial Design

Study Design (N=150)

Primary End-point:

Durable Complete Response Rate (dCR): CR/CRp lasting 180 days

Secondary End-point:

1-year Overall Survival

SIERRA Key Eligibility Criteria

Two or more cycles of Venetoclax in combination with Azacitidine or Decitabine (newly added)

Analyzing the Inclusion of Targeted Agents in SIERRA

Therapies Prior to Enrollment into the Trial:

85% patients enrolled had failed 2 regimens (induction/re-induction)

33% had failed targeted therapies Therapies After Enrollment: Control Arm

HCT Rate After Iomab-B vs Std of Care Control

100%

(31/31)

Patients of Percentage

18% (7/38) (7/38)

Standard of Care BMT

6

SIERRA Iomab-B Treatment Schedule

Iomab-B Specific

Standard Transplant Procedure

~7 days

~12 days

Therapy Dose

RIC

HCT

Dosimetry

Iomab-B

Iomab-B

FLU

TBI

(~10-20 mCi)

(24 Gy to liver, mean~600mCi)

30 mg/m2/d

200 cGy

-12 to HCT

-4

-3

-2

-1

0

Immunosuppression

Imaging

RIC: Reduced Intensity Conditioning FLU: Fludarabine

TBI: Total Body Irradiation

HCT: Hematopoietic Cell Transplant

Therapy dose individualized and calculated based on upper limit of 24 Gy liver exposure

SIERRA trial: Demographics highlights of first 75 patients (50% Enrollment)

Phase 3 SIERRA Trial Patient Characteristics (N=75)

Randomized to Iomab-B

Randomized to Conventional Care

(N=37)

(N=38)

Age

65 (55-77)

64 (55-76)

median, (range)

Favorable: 0%

Favorable: 5%

Molecular & Cytogenetic Risk1,3

Intermediate: 34%

Intermediate: 29%

Adverse: 66%

Adverse: 66%

% Bone Marrow Blasts at

Randomization

29% (5-88)2

26% (5-97)

median, (range)

Disease Status at Randomization

Primary Induction Failure: 21 (57)

Primary Induction Failure: 18 (47)

First Early Relapse: 6 (16)

First Early Relapse: 6 (16)

N, (%)

Relapse/Refractory: 6 (16)

Relapse/Refractory: 9 (24)

2nd + Relapse: 3 (8)

2nd + Relapse: 5 (13)

# Prior Regimens at

Randomization

3 (1-5)

3 (1-5)

median, (range)

See more here:
Actinium Pharmaceuticals : Mid-Point Analysis of Pivotal Phase 3 SIERRA Trial Including Material Presented at 2020 Transplantation & Cellular...

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So, what are the ingredients behind a female quick?

Genetics clearly play a part. As Perry and Australian team fast-bowling coach Ben Sawyer both acknowledge, young gun Vlaeminck - sadly ruled out of the tournament this week with a foot injury - is unusually flexible, which Sawyer says is one of the reasons the Victorian has regularly been struck down with injury. But they also point out that Vlaeminck bowls with serious intent to reach great speeds, and runs in faster than any of her teammates.

Sawyer and former Australian head coach Fitzpatrick - who remains a coach in the Victorian pathway system - say that attitudes towards fast bowling in womens cricket have changed. Whereas in the past control and accuracy have been prioritised, pace is now king, in part to keep up with the improvement across the board in batting.

You never tell a spinner to stop spinning it," Fitzpatrick said.

Express speed: Australia's Tayla Vlaeminck.Credit:AAP

A lot of the times we try to slow kids down because theyre not consistent, and thats the absolute opposite of what we want to do. Its a lot easier to coach control than it is to coach speed."

Sawyer agrees. The simplest way to put it is we just want to encourage it. I think for too long in the womens game, we spoke about accuracy and you could really tie down a batter with a slow/medium-pace bowler and to some extent that still works, he said.

But I think we want to get way past that, encouraging the girls just to bowl as quickly as they can and be happy when they make mistakes doing that, but knowing thats pushing the game forward.

Perry says the move to full-time professionalism for female cricketers is helping ensure players reach their pace potential.

I think its certainly evolving and I think in the coming years therell certainly be an emphasis on pace, pure pace, becoming a bigger factor in the game, Perry said.

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The game wasnt professional a few years ago, so you only had a limited time to work with players.

While reverse swing is hard to generate given how little red-ball cricket female cricketers play, and the fact a ball is used from either end in one-day internationals meaning a ball never gets more than 25 overs old, Perry and Sawyer were adamant that variations and conventional swing played a crucial role.

Now I think the more consistent you are in the womens game actually works against you because batters have adapted, Perry said.

While Perry noted that people tended to associate variations with changes in pace, she suggested that there was much more to it than that, with wrist position and crease angles playing a part.

So, how fast could a woman conceivably bowl?

English academic Paul Felton is a biomechanics lecturer at Nottingham Trent University who has worked with the England and Wales Cricket Board for the best part of a decade.

He says that while women will inevitably be restricted compared to men by height, strength and slower run-ups, there should still be scope for improvement.

The knowledge around female cricket compared to male cricket is a lot more unknown, Felton said.

New Zealand quick Lea Tahuhu in action for the Renegades during the WBBL.Credit:Getty Images

There was a review paper published in 2018 by Catherine Munro and Candice Christie from Rhodes University in South Africa which highlighted only nine scientific articles featuring female cricketers had ever been published and five of these were looking at injuries. While this is improving, the number may have doubled in the last 18 months, it is going to take a while to catch up.

Much of the research in cricket has been conducted on male cricketers due to the larger population worldwide compared to females. The relevance of the results to females is often ignored and recommendations coached uniformly. Recent research, in particular in fast bowling, suggests that this approach might be wrong due to the differences between males and females from a physiological viewpoint.

Our research suggests that the optimal bowling technique in females is currently limited by strength and flexibility. I suspect that 128 kph will be surpassed since as the professionalisation of the female game continues to see strength and conditioning levels increase but by how far is difficult to predict.

For the moment, the likes of Ismail and Tahuhu hold sway.

But as Tahuhu told The Age during an interview in November, Vlaeminck - when fit - is the one to watch.

I think I might still have her at the moment. But shell continue to hunt me down and no doubt shell overtake me at some stage, Tahuhu said.

Daniel is an Age sports reporter

Read the original here:
The female pace race: who will be the fastest of them all? - Brisbane Times

Recommendation and review posted by Bethany Smith

Hormones are chemical messengers that signal cells throughout the body and coordinate vital functions.

Over time, hormone levels can fluctuate, which disrupts balance and leads to undesirable symptoms like hot flashes, mood changes, and decreased libido.

If you are experiencing hormonal imbalance symptoms, bioidentical hormone replacement therapy may be right for you.

However, before starting this course of treatment, youll likely have a number of questions, including: What are bioidentical hormones? How does bioidentical hormone therapy work? How can I find the best hormone doctor near me?

Heres what patients need to know about BHRT, and what they can expect should they decide to undergo this procedure.

Bioidentical hormones are compounded hormones that are molecularly-similar to the hormones that naturally-occur in the body.

Derived of natural plant sources, bioidentical hormones are inserted under the skin in a simple in office-procedure. Once implanted, they are able to replicate the bodys natural hormone levels.

Individuals who are experiencing symptoms related to hormonal-imbalance, including hot flashes, night sweats, mood swings, low libido, and weight gain, should consider bioidentical hormone replacement therapy.

To start this process, patients may research the procedure online and attempt to locate the best hormone doctor near me.

At an in-person consultation, their provider will evaluate their symptoms and overall health and determine if BHRT can help restore hormonal balance, alleviate symptoms, and offer disease prevention.

During a BHRT procedure, bioidentical hormone pellets, which are smaller than a grain of rice, are inserted in fatty tissue under the skin.

They are then able to consistently release small physiologic doses of hormones into the bloodstream.

A key advantage of BHRT is that it achieves sustained hormone levels throughout the day and avoids fluctuations and undesirable effects. Patients can enjoy BHRT benefits for a period of three-to-five months.

If you are considering BHRT and looking for the best hormone doctor near me, call our office today to schedule a consultation with board-certified gynecologist Dr. Melinda Hall.

Follow this link:
Best Hormone Doctor Near Me - The Menopause Center

Recommendation and review posted by Bethany Smith

Stock image, St. George News

CONTRIBUTED CONTENT Do you take thyroid hormone medication for your thyroid problems but still suffer from fatigue, weight gain, hair loss, constipation, depression, cold hands and feet or other symptoms? Has your doctor told you your lab tests are normal and there isnt anything more to do?

If so, you may respond well to functional medicine for low thyroid problems.

Hypothyroidism, or low thyroid function, affects millions of Americans, most of them women. Its common for people with thyroid problems to go undiagnosed for years. Those who are diagnosed still experience low thyroid symptoms and a gradual worsening of their symptoms despite taking medication. This is because they are not getting the autoimmune disease treatment they need.

Approximately90%of hypothyroidism cases in the United States are caused by Hashimotos, an autoimmune disease that attacks and destroys the thyroid gland. If you have hypothyroidism symptoms, its likely you have autoimmune Hashimotos.

While you still may need thyroid medications in order to function, these meds will not address the underlying autoimmune condition damaging your thyroid gland.This is why its important to seek out Hashimotos disease treatment from a physician trained in functional medicine.

For starters, its not sufficient to only run a blood test for TSH, as most clinics do. Instead, you need to test for TPO and TGB antibodies. If either of these is positive this means you need Hashimotos thyroiditis help.

At the RedRiver Health and Wellness Center, our functional medicine wellness team willhelp you restore balance to your immune system so it stops attacking the thyroid gland.

This is a customized approach that takes into consideration each persons unique triggers for Hashimotos hypothyroidism symptoms. There are numerous approaches to treatment.

Going on a gluten-free diet

Numerous studies show a strong link between Hashimotos hypothyroidism and gluten, the protein found in wheat, barley, rye, spelt and other wheat-like grains. Whats more, studies also show that people who are gluten-intolerant are more prone to Hashimotos. Gluten also cross-reacts with the thyroid gland.

This means that if you are gluten-intolerant and have Hashimotos, your immune system mistakes portions of your thyroid as gluten and attacks it whenever you eat gluten.

The AIP diet for Hashimotos

For some people, going gluten-free works great and improves their thyroid problems. For many others, its not enough and they require spending some time on the autoimmune Paleo or AIP diet. This is an anti-inflammatory diet that eliminates common inflammatory foods, such as dairy, eggs, soy and grains.

After a period of time on the diet, you then introduce foods you eliminated one at a time every three days to monitor for symptoms. Its important to eat a diverse array of plenty of vegetables while on the AIP diet for Hashimotos so you dont risk developing more food sensitivities due to loss of oral tolerance.

Address a leaky gut

A common Hashimotos disease treatment is to address a leaky gut, or intestinal permeability. Its common for leaky gut to play a role in autoimmune diseases such as Hashimotos thyroid problems. Leaky gut happens when the small intestine becomes inflamed and damaged, allowing undigested foods, bacteria and other foreign invaders into the bloodstream. Once in the bloodstream, these pathogens trigger inflammation and autoimmunity in other places in the body.

Balance blood sugar

Balancing blood sugar is an important autoimmune disease management strategy. Many people do not realize how unstable their blood sugar is it is either chronically too low or too high. This is because the normal American diet is typically too high in sugars and processed carbohydrates, such as breads, pastas, pastries and desserts.

Blood sugar imbalances trigger inflammation and hormonal imbalances that make it difficult to effectively manage an autoimmune condition such as Hashimotos hypothyroidism. Blood sugar imbalances also cause unpleasant symptoms such as energy crashes, fatigue, excess belly fat, premenstrual syndrome and other hormone problems, mood swings and sleep issues.

These are just a few of the basics of autoimmune disease treatment for conditions such as Hashimotos hypothyroidism. Its important to manage your autoimmune condition to lower your risk of developing other autoimmune diseases, such as pernicious anemia, rheumatoid arthritis, vitiligo or Type I diabetes.

To learn more about Hashimotos and other factors that can cause hypothyroidism, read my book The Truth About Low Thyroidorcontact one of our functional medicine wellness centers for more information.

If you do not already have a functional medicine provider, call RedRiver Health and Wellness Center St. George at 435-767-9355or emailRedRiverSG@redriverhealthandwellness.com.

Written by JOSH REDD, RedRiver Health and Wellness Center.

S P O N S O R E D C O N T E N T

About RedRiver Health and Wellness Center

One of the main goals at RedRiver Health and Wellness Center is to work with patients to improve their health, well-being and quality of life. The RedRiver Health and Wellness Center team is passionate about helping ailing patients achieve optimal health, and we truly care about the success of each and every patient.

RedRiver chiropractic physicians are great advocates for prescribing physicians and endocrinologists. In fact, many of our patients see their prescribing physicians more frequently while under our care than they would otherwise. Our goal is not to replace our patients primary care physicians and specialists but to complement their care by providing patients with nutrition, diet, lifestyle and educational support and strategies.

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Sponsored content may be submitted to or developed by St. George News for publication on behalf of the sponsor and in the sponsor's interest. It may include promotional pieces, features, announcements, news releases and advertisements. Opinions expressed in sponsored content are those of the sponsor and not representative of St. George News. Sponsors have no influence over St. George News reporting and product apart from their own sponsored content.

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Editor's Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our subscribers each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day's biggest stories. Act on the news with POLITICO Pro .

Democrats debate tonight in Las Vegas as they jockey for position in Saturdays Nevada caucuses.

President Donald Trumps health IT plan could gift Silicon Valley with troves of sensitive medical data.

Voters' top priorities remain reducing health care costs and prescription drug costs, regardless of party, according to a new POLITICO-Harvard survey.

A message from Genentech:

We have come a long way in developing breakthrough solutions for many therapeutic areas including oncology, neurology, immunology and more, but there are still thousands of molecules in our bodies that influence disease and are considered undruggable. Learn about how Genentech is identifying new approaches to expedite drug discovery.

WELCOME TO WEDNESDAY PULSE Where Joe Grogan may be in line for hazard pay after the White House domestic policy chief tweeted last night from the "occupied territory" of California. (The remark provoked frustration from watchdogs and even friendly fire from a certain Fox News host, but controversy sells: Grogan has gained nearly 10 percent more Twitter followers since yesterday.)

PULSE's tipline is open in every state: Find us at acancryn@politico.com or ddiamond@politico.com.

WHAT TO WATCH IN THE DEMOCRATIC DEBATE TONIGHT The 9 p.m. ET debate gives members of the dwindling Democratic field a primetime spotlight to make their case ahead of Saturdays election day.

Slated to be on stage: Sens. Bernie Sanders, Elizabeth Warren and Amy Klobuchar; former Vice President Joe Biden; and former Mayors Pete Buttigieg and Mike Bloomberg.

While Bloombergs surged into the race, buoyed by historic ad spending, tonight would be the first time that hes debated in an election since he ran for New York City mayor in 2009. The transition from well-heeled campaign rooms and soft-pitch TV commercials to a crowded debate stage could lead to a bumpy evening for the billionaire candidate, NYTs Matt Flegenheimer writes.

Expect BLOOMBERG to be pressed on his health care remarks. Sanders campaign has called attention to Bloombergs years-old statements about the need for entitlement reform, seemingly at odds with a Democratic primary thats focused on coverage expansion.

No program to reduce the deficit makes any sense whatsoever unless you address the issue of entitlements, Medicare, Medicaid, Social Security, interest payment on the debt, which you can't touch, and defense spending, Bloomberg said on Face the Nation in 2013. Everything else is tiny compared to that.

Both conservatives and progressives also have circulated a 2011 video clip that shows Bloomberg appearing to say that some elderly cancer patients should be turned away from care, given the cost.

SANDERS could be challenged on the prospects of "Medicare for All." Rep. Alexandria Ocasio-Cortez, one of the senators highest-profile surrogates, told HuffPost last week that a worst-case scenario with Sanders in the White House is a compromise on health care that ends up adding a public option. Some Sanders allies have acknowledged the long odds of getting his signature proposal through Congress, particularly given the likelihood that Republicans will retain control of the Senate in 2021.

But Sanders broke with Ocasio-Cortez on CNN last night, saying that his policy proposal is already a compromise and he doesnt plan to back off it.

SANDERS also reiterated: Hes not sharing any more medical records. I don't think we will, no, the 78-year-old candidate said on CNN last night. Sanders had promised to release comprehensive records after having a heart attack last year, and the apparent reversal could be a topic of conversation tonight.

Anti-Medicare expansion industry group tees up new ad buy. The Partnership for Americas Health Care Future will air a new ad during the debate criticizing Democratic candidates various universal coverage plans, the group told PULSE. The spot which will run on MSNBC and related digital properties groups Medicare for All with more incremental Medicare buy-in and public option plans, arguing that theyd all take choice and control away from patients and lead to higher taxes.

HOW TRUMP COULD HAND SILICON VALLEY YOUR HEALTH DATA A Trump administration bid to give patients more control over their health records could gift Silicon Valley with troves of sensitive medical data, POLITICOs Darius Tahir and Adam Cancryn report.

The long-germinating policy changes would let patients download health records onto their smartphones and direct it to apps of their choice. But they could also give rise to a new tech boom built on vacuuming up and reselling that personal data with few limits.

The issue has pitted GOOGLE and APPLE against EPIC, the health IT incumbent thats lobbied hard against the changes that could threaten its current market dominance. Yet lost in the clash of industry giants are privacy concerns that some consumer advocates argue the administration hasnt fully thought through. The health data is going to give them insights into many other aspects of your life, Jeff Chester, executive director of the Center for Digital Democracy, said of a tech industry already facing scrutiny over its use and protection of consumer data.

Silicon Valleys influential ally: JARED KUSHNER. The presidents son-in-law has played a crucial role in pushing the overhaul, alongside ONC Director Don Rucker and HHS Secretary Alex Azar, who see a chance to jump-start a slew of new health IT business models.

The chief financial officer at the now-shuttered Shelby Regional Medical Center admitted to a federal judge that he made false statements to CMS when he said in November 2012 the hospital was a meaningful user of EHRs that year. | M. Scott Mahaskey/POLITICO

TRUMP COMMUTES SENTENCE OF MEDICARE FRAUDSTER Judith Negron was convicted in 2011 over a $205 million fraud case that was, at the time, the biggest mental health billing scheme. Negron, who was the only defendant in the case to refuse a plea deal and go to trial, was subsequently sentenced to 35 years. See Negrons clemency petition. The Miami Herald has more.

Trump also pardoned MICHAEL MILKEN, the junk-bond king of the 1980s who was convicted of insider trading and later reinvented himself as a philanthropist and health care thought leader. The Los Angeles Times has more.

POLITICO-HARVARD POLL: ITS THE COSTS, STUPID Americans across the political spectrum primarily want one thing ahead of the 2020 election: Lower health care costs.

A new POLITICO-Harvard T.H. Chan survey finds reducing health care and prescription drug costs rank as voters top priorities regardless of party far outpacing the need for major overhauls like Medicare for All or addressing climate change. That suggests Americans are focused on immediate issues affecting their families, rather than the big policy debates that have consumed the Democratic presidential primary.

Eighty percent ranked lower health care costs as "extremely" or "very" important, and more than 7 in 10 similarly prioritized reducing drug prices. There was far less urgency for ideas like a Medicare buy-in or Medicare for All and the poll suggests even GOP voters are losing interest in the partys yearslong goal of repealing and replacing Obamacare. Just 37 percent of Republicans thought it crucial to take another run at gutting the health law.

MEANWHILE: UNIONS SPLIT OVER MEDICARE FOR ALL Organized labor is divided over the prospects for single-payer health care, with some unions worried that theyll lose health benefits that they spent years fighting to achieve, POLITICOs Ian Kullgren and Alice Miranda Ollstein report.

The feuding reached a fever pitch last week when the 60,000-member Culinary Workers Union declined to endorse any Democrat in Nevada, after slamming Sanders health proposal as a threat to the hard-won private health plans they negotiated at the bargaining table.

Its an extremely divisive issue within the labor movement, said Steve Rosenthal, a former political director for the AFL-CIO. Nobodys opinions will be changed during the presidential nominating fight, and unions may well be divided over Democratic candidates until the end.

FIRST IN PULSE: PROTECT OUR CARE TO HOLD 10 DAYS OF ACTION TIED TO OBAMACARE ANNIVERSARY The pro-ACA group is kicking off a bus tour and holding other events next month to celebrate 10 years since the health law was passed.

The bus tour begins March 15 in Minnesota and will stop in battleground states like Iowa, Michigan, North Carolina, Pennsylvania and Wisconsin. The bus will also stop in Washington, D.C., on March 23 the anniversary of the ACAs passage.

NEW SEVEN-FIGURE SURPRISE BILL AD BUY A coalition of largely insurer and employer groups is launching a new ad campaign slamming the policy fix doctors and hospitals support as one that raises costs for everyone.

The Coalition Against Surprise Medical Billing will run ads in the Washington area during prominent TV slots like the Democratic debates to oppose letting an independent mediator resolve payment disputes between providers and insurers.

The ads arent new for Beltway viewers, who often have seen the ads paired with a competing message from Doctor Patient Unity, funded largely by two private-equity backed physician staffing companies arguing for the policy insurers and employers hate.

But the new ad buy comes at a crucial time for surprise billing. Two House committees approved their own legislation last week, leaving four congressional panels to hammer out a fix before a May deadline to pass funding for key health care programs.

FIRST IN PULSE: SHARPTON RAILS AGAINST SURPRISE BILL PLAN The Rev. Al Sharpton is taking aim at major legislation to eliminate surprise medical bills in a letter to the Congressional Black Caucus, blasting a proposal backed by Senate HELP Chair Lamar Alexander and the House Energy and Commerce Committee as a bailout at the expense of Black patients.

Sharptons position puts him in line with hospitals and private equity-backed physician groups that have spent tens of millions of dollars opposing the plan, which would use a federal benchmark payment to settle most disputes between insurers and providers.

But Sharptons objections are misleading. The civil rights activist who says hes been very focused on surprise billing suggested the HELP and E&C bill would let insurers dodge paying for care and stick patients with big medical expenses.

Thats false: The legislation would establish a new system for determining how much insurers must pay providers for out-of-network costs patients couldn't have avoided, such as emergency care. And patients would enjoy new protections insulating them against huge out-of-network charges a feature of all the competing surprise bill proposals.

PAULSEN CHAIRING NEW GENE THERAPY LOBBY Former Minnesota Rep. Erik Paulsen is chairing a new lobbying group in town this one aimed at ensuring coverage for a slew of pricey new gene therapies.

The Institute for Gene Therapies isnt backing specific legislation or regulatory actions yet. But Paulsen, a Republican congressman for a decade before losing his seat in the 2018 Democratic wave, told POLITICOs Sarah Owermohle that the group is focused on steps the administration and Congress can take to accelerate insurer coverage of new treatments.

The Institute is funded by drug manufacturers. Its corporate advisory council includes multiple companies working on gene therapies including Spark Therapeutics, which sells an $850,000 treatment for a rare form of blindness. Johnson & Johnson, PTC Therapeutics and Sarepta Therapeutics are also among those on the council.

A message from Genentech:

Of the estimated 4,000 disease-related targets known to us today, only a quarter have a medicine that can reach and act on them. While some may find these elusive targets to be undruggable, our scientists are taking on this challenge along with our collaborators to pursue new treatment approaches, like T-cell therapy or individualized cancer vaccines. Learn about how were tackling challenges in drug discovery to drive scientific breakthroughs and bring new medicines to patients in our mission to drug the "undruggable."

If health economists ran the U.S. health system, there would be no Medicaid work requirements but people who engage in unhealthy behaviors could be charged more money, Austin Frakt writes in the New York Times, drawing on recent polling.

Missouri lawmakers confirmed that as many as 60,000 children were wrongfully removed from the state's Medicaid program, Joe Gamm writes for the Jefferson City News Tribune.

Meanwhile, a plan to expand Medicaid in Kansas which has the blessing of the state's GOP Senate leader is being held up by another GOP official who says she's worried about abortion spending, Leslie Aguilar reports for KCTV5.

One of the world's largest tobacco companies is struggling after failing to diversify into cannabis and vaping, WSJ's Alexander Gladstone reports.

Originally posted here:
What to watch in tonight's debate - Politico

Recommendation and review posted by Bethany Smith

Jeremiah started showing worrying symptoms at just five months old (Picture: Aneesa)

Jeremiah was a playful, lovable baby but when he was just five months old, mum Aneesa realised something was quite seriously wrong.

Jeremiah started to become floppy and weak, he was unable to lift his head, lie on his tummy to play, or hold his arms and legs like he used to.

He would sleep all the time and simply had no energy not even to play peek-a-boo, which is his favourite thing to do, Aneesa tells Metro.co.uk.

After many weeks of being dismissed by doctors, Aneese persevered because she just knew that something was wrong with Jeremiah. She spent all her time with him and noticed the subtle changes in his behaviour that doctors didnt see.

After finally seeing a skilled therapist, Aneesa was advised to get emergency referrals to a neurologist and a geneticist, but with the waiting times being so long, she turned to Greenwood Genetics and was seen the next day via a video consultation with a doctor.

She did a thorough exam of his body, they collected paternal and maternal data and ordered blood samples, explains Aneesa. They also tried to assist us with the other referrals to see a neurologist and of course I switched paediatricians. In our case, the swift response of Greenwoods team saved my babys life.

Katie Clarkson, MD and GGC clinical geneticist, considered several tests, but with a long list of possible diagnoses, she suggested whole-exome sequencing, a diagnostic test looking for mutations in the coding regions of all 20,000 genes.

Because of Jeremiahs rapid regression, the test that typically takes 10 weeks for a result was fast-tracked by GGCs Diagnostic Laboratory, and an answer came in fewer than three weeks. The doctors identified two changes in the TK2 gene.

This gene is known to cause mitochondrial DNA depletion syndrome, type 2 also called TK2 deficiency.

TK2 deficiency is an incurable disease that progresses quickly, causing muscle weakness, problems with chewing, swallowing, and breathing, loss of motor skills, and slowed mental development.

Aneesa was devastated to receive such a complex and life-altering diagnosis for her son.

I wanted an answer similar to the one the doctor prescribes for the cold take this pill, get some rest or maybe just a physical therapy routine, she says. Instead, I was told that there is no treatment, no cure and that your son has a rare progressive disorder.

It was overwhelming, but due to the time-sensitivity, I was grateful that we had an answer to what dreaded monster we were truly facing. I typed the name of it into Google and cried for days.

Jeremiahs illness has affected his mobility, his nutrition and his other bodily functions. He is connected to oxygen at night to make sure he is breathing, and Aneesa has to keep a suction machine close by in case he produces too much saliva.

He has been rushed to hospital for pain and new symptoms many times since his diagnosis, and sadly, the early the onset of the disease, the more severe it is likely to be, But Aneesa is just happy to have some answers.

I am thankful that Jeremiahs diagnosis was early so that he does not miss running around or doing other activities, she explains. To him, its just a lot of work to get to certain milestones regarding growth and development.

Children are resilient so the impact is cushioned as they adapt easier than we do.

Aneesas family life has changed drastically to cater to Jeremiahs needs, but Aneesa remains hopeful about their future.

We stay indoors most of the time to avoid germs as Jeremiahs immune system is not the strongest, says Aneesa. I no longer work, and I cant attend late-night football or basketball games with my other boys.

They only visit on weekends and now live with their dad. Im positive they would love to see their brother run and play with them, and we hold on to hope that one day he will.

Aneesa says that social media and online support groups have been a lifeline. As has identifying the correct treatments and seeing little improvements in Jeremiahs condition he can now move his arms and legs again, he has less reflux and less need for oxygen.

The medication has seemed to slow the monster of the disease down, says Aneesa.

She says that coping varies depending on different definitions and circumstances, but she believes she is coping.

Coping, to me, is making sure he gets all of his physical, occupation and speech therapy as well as keeping up with his medical specialists on rotations, she says.

Jeremiah sees his pediatrician, an early interventionist, his therapists, a cardiologist, a pulmonologist, a gastroenterologist, a pediatric surgeon, an orthopedic team, neurologists and of course his research team.

His resilience gives me the strength to cope for him and with him.

Ive given up my life so that I can provide the best care but also become an advocate for him and the disease. I post daily on his Facebook page Jeremiah Gracen TK2D Warrior, giving a very personal look into our new life in the hope to inspire others.

Jeremiahs medical diagnosis is a result of a collaboration between Emedgene and Greenwoods Genetic Center, the facility where Jeremiahs life-saving diagnosis was given, and where Emedgenes AI powered solution is integrated.

On average, a patient will see eight doctors before getting the correct diagnosis of TK2d. And time is of the essence. Jeremiahs disease is highly aggressive and is still regularly misdiagnosed, or even undiagnosed, for long periods of time. Experts say using AI is the key to ensuring timely diagnosis for the children who desperately need it.

I truly believe that diseases are only rare because many people are living either undiagnosed or misdiagnosed, says Aneesa.

To get a diagnosis of a rare disease is tough, to say the least, but being able to connect with others sharing similar situations helps tremendously.

Rare diseases give way to new advancements in technology, research and medicine. Rare diseases fuel parents with a sense of supernatural hope where we become medical experts learning about our tiny superheroes.

Rare diseases give room for God to perform miracles, so for us we simply hold on to hope and a firm belief that God makes no mistakes, and regardless of how clich that can sound it helps us to cope.

Just because an illness is rare doesnt mean that we will ever give up on it.

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Whenever Harry Wuest has a doctors appointment in northern Atlantas hospital cluster dubbed Pill Hill, he makes sure to stop by the office of Dr. Douglas Doug Murphy for a quick chat.

And Murphy, unless hes tied up in the operating room, always takes a few minutes to say hello to his former patient. Remember when . . . ? is how the conversation typically starts, and its always tinged with laughter, often joyful, sometimes bittersweet.

Its a reunion of two men who shaped a piece of Georgias medical history.

Almost 35 years ago, Murphy opened the chest of Wuest and sewed in a new heart, giving him a second shot at life. Wuest was the third heart transplant patient at Emory University Hospital.

Tall, lanky, with short curly hair and a quiet demeanor, Wuest is the longest-surviving heart transplant recipient in Georgia and one of the longest-surviving in the world. The 75-year-old accountant still plays golf twice a week and only recently went from working full-time to part-time.

My heart is doing just fine, he says.

Murphy is now the chief of cardiothoracic surgery at Emory Saint Josephs Hospital and still in the operating room almost every day. He has moved on to become the worlds leading expert in robotically assisted heart surgery.

***

Harry Wuest is originally from Long Island, N.Y. After a stint in the U.S. Air Force, he moved to Florida to work and go to school. He wanted to become a physical education teacher. Then, in 1973, he fell ill. It started with some pain on his left side. He didnt think much of it, but when he got increasingly winded and fatigued, he went to see a doctor.

Several months and numerous specialists later, he received the diagnosis: Cardiomyopathy, a disease of the heart muscle that can make the heart become enlarged, thick and rigid, preventing it from pumping enough blood through the body.

They didnt know how I got it, says Wuest, sitting back in a brown leather armchair in the dark, wood-paneled living room of his Stone Mountain home. Maybe it was a virus. And back then, there wasnt much they could do to treat it, except bed rest.

For the next 12 years, Wuest lived life as best as he could. He got a degree in accounting from the University of Central Florida and worked for a real estate developer. There were good days, but there were more bad days. He was often too weak to do anything, and his heart was getting bigger and bigger.

***

The first successful human-to-human heart transplant was performed in Cape Town, South Africa, in 1967 a medical breakthrough that catapulted the surgeon, Dr. Christiaan Barnard, onto the cover of Life magazine and to overnight celebrity status.

This highly publicized event was followed by a brief surge in the procedure around the world, but overall, heart transplants had a rocky start. Most patients died shortly after the surgery, mainly due to organ rejection. Back then, immunosuppressive drugs, which can counteract rejection, were still in their infancy. Many hospitals stopped doing heart transplants in the 1970s.

That changed with the discovery of a highly effective immunosuppressive agent. Cyclosporine got FDA approval in 1983 and altered the world of organ transplants.

It was shortly thereafter when Emory University Hospital decided to launch a heart transplant program, but none of the senior surgeons wanted to do it. Even with the new drug, it was a risky surgery, and mortality was still high.

Its an all-or-nothing operation, Murphy says, as he sits down in his small office overlooking the greyish hospital compound. Hes wearing light blue scrubs from an early morning surgery. At 70, he still has boyish looks, with a lean build and an air of laid-back confidence. If you have a number of bad outcomes initially, it can be detrimental to your career as a surgeon, he says.

But Murphy didnt really have a choice. He remembers that during a meeting of Emorys cardiac surgeons in 1984, he was paged to check on a patient. When he returned, the physicians congratulated him on being appointed the head of the new heart transplant program. He was the youngest in the group and had been recruited from Harvards Massachusetts General Hospital just three years before.

Yeah, thats how I became Emorys first transplant surgeon, says Murphy.

He flew to California to shadow his colleagues at Stanford University Hospital, where most heart transplants were performed at the time. Back home at Emory, he put together a team and rigorously rehearsed the operation. The first transplant patient arrived in April 1985. The surgery was successful, as was the second operation less than a month later.

Around the same time, Harry Wuest wound up in a hospital in Orlando. He needed a transplant, but none of the medical centers in Florida offered the procedure. One of his doctors recommended Emory, and Wuest agreed. I knew I was dying. I could feel it. He was flown to Atlanta by air ambulance and spent several weeks in Emorys cardiac care unit until the evening of May 23, when Murphy walked into his room and said, Weve got a heart.

***

The heart, as the patient later learned, came from a 19-year-old sophomore at Georgia Tech who had been killed in a car crash.

Organ transplants are a meticulously choreographed endeavor, where timing, coordination and logistics are key. While Murphy and his eight-member team were preparing for the surgery, Wuest was getting ready to say farewell to his family his wife and three teenage sons and to thank the staff in the cardiac ward.

I was afraid, he recalls, especially of the anesthesia. It scared the heck out of me. He pauses during the reminiscence, choking briefly. I didnt know if I was going to wake up again.

The surgery took six hours. Transplants usually happen at night because the procurement team, the surgeons who retrieve different organs from the donor, only start working when regularly scheduled patients are out of the operating room.

Despite the cultural mystique surrounding the heart as the seat of life, Murphy says that during a transplant surgery, its not like the big spirit comes down to the operating room. Its very technical. As the team follows a precise routine, emotions are kept outside the door. We dont have time for that. Emotions come later.

After waking up from the anesthesia, Wuests first coherent memory was of Murphy entering the room and saying to a nurse, Lets turn on the TV, so Harry can watch some sports.

Wuest spent the next nine days in the ICU and three more weeks in the hospital ward. In the beginning, he could barely stand up or walk, because he had been bedridden weeks before the surgery and had lost a lot of muscle. But his strength came back quickly. I could finally breathe again, he says. Before the surgery, he felt like he was sucking in air through a tiny straw. I cannot tell you what an amazing feeling that was to suddenly breathe so easily.

Joane Goodroe was the head nurse at Emorys cardiovascular post-op floor back then. When she first met Wuest before the surgery, she recalls him lying in bed and being very, very sick. When she and the other nurses finally saw him stand up and move around, he was a whole different person.

In the early days of Emorys heart transplant program, physicians, nurses and patients were a particularly close-knit group, remembers Goodroe, whos been a nurse for 42 years and now runs a health care consulting firm. There were a lot of firsts for all of us, and we all learned from each other, she said.

Wuest developed friendships with four other early transplant patients at Emory, and he has outlived them all.

When he left the hospital, equipped with a new heart and a fresh hunger for life, Wuest made some radical changes. He decided not to return to Florida but stay in Atlanta. Thats where he felt he got the best care, and where he had found a personal support network. And he got a divorce. Four months after the operation, he went back to working full-time: first in temporary jobs and eventually for a property management company.

After having been sick for 12 years, I was just so excited to be able to work for eight hours a day, he recalls. That was a big, big deal for me.

At 50, he went back to school to get his CPA license. He also found new love.

Martha was a head nurse in the open-heart unit and later ran the cardiac registry at Saint Josephs Hospital. Thats where Wuest received his follow-up care and where they met in 1987. Wuest says for him it was love at first sight, but it took another five years until she finally agreed to go out with him. Six months later, they were married.

Having worked in the transplant office, I saw the good and the bad, Martha Wuest says. A petite woman with short, perfectly groomed silver hair, she sits up very straight on the couch, her small hands folded in her lap.Not every transplant patient did as well as Harry. And I had a lot of fear in the beginning. Now he may well outlive her, she says with a smile and a wink.

Wuests surgeon, meanwhile, went on to fight his own battles. Two and a half years into the program, Murphy was still the only transplant surgeon at Emory and on call to operate whenever a heart became available. Frustrated and exhausted, he quit his position at Emory and signed up with Saint Josephs (which at the time was not part of the Emory system) and started a heart transplant program there.

At St. Joes, Murphy continued transplanting hearts until 2005. In total, he did more than 200 such surgeries.

Being a heart transplant surgeon is a grueling profession, he says, and very much a younger surgeons subspecialty.

He then shifted his focus and became a pioneer in robotically assisted heart surgery.He has done more than 3,000 operations with the robot, mostly mitral valve repairs and replacements more than any other cardiac surgeon in the world.

***

Since Murphy sewed a new heart into Wuest, 35 years ago, there has been major progress in the field of heart transplants,but it has been uneven.

Medications to suppress the immune system have improved, says Dr. Jeffrey Miller, a transplant surgeon and heart failure specialist at Emory. As a result, we are seeing fewer cases of rejections of the donor heart.

Also, there are new methods of preserving and transporting donor hearts.

Yet patients requiring late-stage heart failure therapy, including transplantation, still exceed the number of donor hearts available. In 2019, 3,551 hearts were transplanted in the United States, according to the national Organ Procurement and Transplantation Network. But 700,000 people suffer from advanced heart failure, says the American Heart Association.

New technologies and continued research are providing hope to many of these patients. There has been significant progress in the development of partial artificial hearts, known as Left Ventricular Assist Devices, or LVADs, says Miller.

These are implantable mechanical pumps that assist the failing heart. Patients are back out in society living normal lives while theyre waiting for their donor hearts, he explains.

LVADs are used not only as bridge devices but as destination therapy as well, maintaining certain patients for the remainder of their lives.

Also, total artificial hearts have come a long way since the first artificial pump was implanted in a patient in 1969.

Long-term research continues into xenotransplantation, which involves transplanting animal cells, tissues and organs into human recipients.

Regenerative stem cell therapy is an experimental concept where stem cell injections stimulate the heart to replace the rigid scar tissue with tissue that resumes contraction, allowing for the damaged heart to heal itself after a heart attack or other cardiac disease.

Certain stem cell therapies have shown toreverse the damage to the heart by 30 to 50 percent, says Dr. Joshua Hare, a heart transplant surgeon and the director of the Interdisciplinary Stem Cell Institute at the University of Miamis Miller School of Medicine.

All of these ideas have potential, says Miller. But they have a lot of work before were ready to use them as alternatives to heart transplantation. I dont think were talking about the next few years.

Besides Emory, other health care systems in Georgia that currently have a heart transplant program are Piedmont Healthcare, Childrens Healthcare of Atlanta and Augusta University Health.

Organ rejection remains a major issue, and long-term survival rates have not improved dramatically over the past 35 years. The 10-year survival is currently around 55 percent of patients, which makes long-term-survivors like Harry Wuest rare in the world of heart transplants.

The United Network of Organ Sharing, or UNOS, which allocates donor hearts in the United States, doesnt have comprehensive data prior to 1987. An informal survey of the 20 highest-volume hospitals for heart transplants in the 1980s found only a scattering of long-term survivors.

***

Being one of the longest-living heart transplant recipients is something that Wuest sees as a responsibility to other transplant patients, but also to the donors family, which hes never met. If you as a transplant recipient reject that heart, thats like a second loss for that family.

Part of this responsibility is living a full and active life. Both he and Martha have three children from their previous marriages, and combined they have 15 grandchildren. Most of their families live in Florida, so they travel back and forth frequently. Wuest still works as a CPA during tax season, and he does advocacy for the Georgia Transplant Foundation. In addition to golf, he enjoys lifting weights and riding his bike.

Hes had some health scares over the years. In 2013, he was diagnosed with stage 1 kidney cancer, which is in remission. Also, he crossed paths with his former surgeon, and not just socially. In 2014, Murphy replaced a damaged tricuspid valve in Wuests new heart. That operation went well, too.

Murphy says there are several reasons why Wuest has survived so long. Obviously, his new heart was a very good match. But a patient can have the best heart and the best care and the best medicines and still die a few months or years after the transplantation, the surgeon says. Attitude plays a key role.

Wuest was psychologically stable and never suffered from depression or anxiety, Murphy says. Hes a numbers guy. He knew the transplant was his only chance, and he was set to pursue it.

Wuest attributes his longevity to a good strong heart from his donor; good genetics; great doctors and nurses; and a life that he loves. Im just happy to be here, he says.

Quoting his former surgeon and friend, he adds: Doug always said, Having a transplant is like running a marathon. And Im in for the long haul.

Katja Ridderbusch is an Atlanta-based journalist who reports for news organizations in the U.S. and her native Germany. Her stories have appeared in Kaiser Health News, U.S. News & World Report and several NPR affiliates.

This is a slightly modified version of the article 34 Years with a New Heart, published by Georgia Health News on February 18, 2020.

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34 Years With A New Heart And Counting | 90.1 FM WABE - WABE 90.1 FM

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New research reveals the underlying mechanism for a dangerous heart disorder in which low oxygen levels in the heart produce life-threatening arrhythmias.

The discovery, made with human heart muscle cells derived from pluripotent stem cells, offers new targets for therapies aimed at preventing sudden death from heart attack.

Our research shows that within seconds, at low levels of oxygen (hypoxia), a protein called small ubiquitin-like modifier (SUMO) is linked to the inside of the sodium channels which are responsible for starting each heartbeat, says Steve A. N. Goldstein, vice chancellor for health affairs at the University of California, Irvine and professor in the School of Medicine departments of pediatrics and physiology and biophysics.

And, while SUMOylated channels open as they should to start the heartbeat, they re-open when they should be closed. The result is abnormal sodium currents that predispose to dangerous cardiac rhythms.

Every heartbeat begins when sodium channels open and ions to rush into heart cellsthis starts the action potential that causes the heart muscle to contract. When functioning normally, the sodium channels close quickly after opening and stay closed. After that, potassium channels open, ions leave the heart cells, and the action potential ends in a timely fashion, so the muscle can relax in preparation for the next beat.

If sodium channels re-open and produce late sodium currents, as observed in this study with low oxygen levels, the action potential is prolonged and new electrical activity can begin before the heart has recovered risking dangerous, disorganized rhythms.

Fifteen years ago, the Goldstein group reported SUMO regulation of ion channels at the surface of cells. It was an unexpected finding because the SUMO pathway had been thought to operate solely to control gene expression in the nucleus.

This new research shows how rapid SUMOylation of cell surface cardiac sodium channels causes late sodium current in response to hypoxia, a challenge that confronts many people with heart disease, says Goldstein. Previously, the danger of late sodium current was recognized in patients with rare, inherited mutations of sodium channels that cause cardiac Long QT syndrome, and to result from a common polymorphism in the channel we identified in a subset of babies with sudden infant death syndrome (SIDS).

The information gained through the current study offers new targets for therapeutics to prevent late current and arrhythmia associated with heart attacks, chronic heart failure, and other life-threatening low oxygen cardiac conditions.

The National Institutes of Health funded the study, which appears in Cell Reports.

Source: UC Irvine

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How low oxygen levels in the heart can cause arrhythmias - Futurity: Research News

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(Image from Trinity College Dublin)

Researchers in Ireland have developed a prototype patch that they say does the same job as crucial aspects of heart tissue.

The patch was designed to withstand the mechanical demands of heart tissue and mimic the electrical signaling properties that allow the heart to pump blood throughout the body. The researchers believe it brings medtech one step closer to a functional design that could mend a broken heart.

Cardiac patches lined with heart cells can be applied surgically to restore heart tissue in patients who have had damaged tissue removed after a heart attack and to repair congenital heart defects in infants and children. Ultimately, though, the goal is to create cell-free patches that can restore the synchronous beating of the heart cells, without impairing the heart muscle movement. The bioengineers report their work in the journal Advanced Functional Materials.

Researchers are continuously looking to develop new treatments which can include stem cell treatments, biomaterial gel injections and assistive devices, said senior author Michael Monaghan, an assistant professor at Trinity College Dublin, in a news release. Ours is one of few studies that looks at a traditional material, and through effective design allows us to mimic the direction-dependent mechanical movement of the heart, which can be sustained repeatably. This was achieved through a novel method called melt electrowriting and through close collaboration with the suppliers located nationally we were able to customize the process to fit our design needs.

This work was performed in the Trinity Centre for Biomedical Engineering, based in the Trinity Biomedical Sciences Institute in collaboration with Spraybase, a subsidiary of Avectas Ltd.

The mechanical demands of heart muscle cannot be met using polyester-based thermoplastic polymers, which are predominantly the approved options for biomedical applications, according to the researchers. However, the functionality of thermoplastic polymers could be leveraged by its structural geometry. They made a patch that could control the expansion of a material in multiple directions and tune this using an engineering design approach.

The patches were manufactured via melt electrowriting, a core technology of Spraybase, which the company says is reproducible, accurate and scalable. The patches were also coated with the polymer polypyrrole to provide electrical conductivity while maintaining cell compatibility. The patch withstood repeated stretching, which is a dominant concern for cardiac biomaterials, and showed good elasticity, to accurately mimic that key property of heart muscle.

Essentially, our material addresses a lot of requirements, Monaghan said. The bulk material is currently approved for medical device use, the design accommodates the movement of the pumping heart, and has been functionalized to accommodate signaling between isolated contractile tissues. This study currently reports the development of our method and design, but we are now looking forward to furthering the next generation of designs and materials with the eventual aim of applying this patch as a therapy for a heart attack.

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Could this patch help mend a broken heart? - Medical Design & Outsourcing

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TheGlobalAutologous Stem Cell and Non-Stem Cell Based Therapies Marketis expected to reach USD113.04 billion by 2025, from USD 87.59 billion in 2017 growing at a CAGR of 3.7% during the forecast period of 2018 to 2025. The upcoming market report contains data for historic years 2015 & 2016, the base year of calculation is 2017 and the forecast period is 2018 to 2025.

For In depth Information Get Sample Copy of this Report @https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-autologous-stem-cell-and-non-stem-cell-based-therapies-market&raksh

Some of the major players operating in the global autologous stem cell and non-stem cell based therapies market areAntria (Cro), Bioheart, Brainstorm Cell Therapeutics, Cytori, Dendreon Corporation, Fibrocell, Genesis Biopharma, Georgia Health Sciences University, Neostem, Opexa Therapeutics, Orgenesis, Regenexx, Regeneus, Tengion, Tigenix, Virxsys and many more.

The data and information included in this Global Autologous Stem Cell And Non-Stem Cell Based Therapies business report helps businesses take sound decisions and plan about the advertising and sales promotion strategy more successfully. This Autologous Stem Cell And Non-Stem Cell Based Therapies market research report is generated by taking into account a range of objectives of market research that are vital for the clients success. This report also includes strategic profiling of key players in the market, systematic analysis of their core competencies, and draws a competitive landscape for the Healthcare industry. The Global Autologous Stem Cell And Non-Stem Cell Based Therapies business report includes market shares for global, Europe, North America, Asia Pacific and South America.

Market Definition:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market

In autologous stem-cell transplantation persons own undifferentiated cells or stem cells are collected and transplanted back to the person after intensive therapy. These therapies are performed by means of hematopoietic stem cells, in some of the cases cardiac cells are used to fix the damages caused due to heart attacks. The autologous stem cell and non-stem cell based therapies are used in the treatment of various diseases such as neurodegenerative diseases, cardiovascular diseases, cancer and autoimmune diseases, infectious disease.

According to World Health Organization (WHO), cardiovascular disease (CVD) causes more than half of all deaths across the European Region. The disease leads to death or frequently it is caused by AIDS, tuberculosis and malaria combined in Europe. With the prevalence of cancer and diabetes in all age groups globally the need of steam cell based therapies is increasing, according to article published by the US National Library of Medicine National Institutes of Health, it was reported that around 382 million people had diabetes in 2013 and the number is growing at alarming rate which has increased the need to improve treatment and therapies regarding the diseases.

Browse Detailed TOC Herehttps://www.databridgemarketresearch.com/toc/?dbmr=global-autologous-stem-cell-and-non-stem-cell-based-therapies-market&raksh

Market Segmentation:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market

Competitive Analysis:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market

The global autologous stem cell and non-stem cell based therapies market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of autologous stem cell and non-stem cell based therapies market for global, Europe, North America, Asia Pacific and South America.

Major Autologous Stem Cell and Non-Stem Cell Based Therapies Market Drivers and Restraints:

Introduction of novel autologous stem cell based therapies in regenerative medicine

Reduction in transplant associated risks

Prevalence of cancer and diabetes in all age groups

High cost of autologous cellular therapies

Lack of skilled professionals

Customization of the Report:

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This Autologous Stem Cell And Non-Stem Cell Based Therapies Market report will enable both of the sides in market be an established firm or a relative new entrant. It helps the established firms to know about the moves which are being performed by their competitors and also helps the new entrants by educating them about the market situations and the industry trends. This Autologous Stem Cell And Non-Stem Cell Based Therapies Market report is quite fruitful in helping to understand the market definition and all the aspects of the market including the CAGR value and key profiles.

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Autologous Stem Cell And Non-Stem Cell Based Therapies Market 2020-2025 Booming || Leadinf Players Fibrocell, Genesis Biopharma, Georgia Health...

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U.S. Department of Defense Researchers to Study Ability of siFi2 to Drive Axon Regeneration and Functional Recovery following Spinal Cord Injury

NEW YORK, Feb. 19, 2020 (GLOBE NEWSWIRE) -- MicroCures, a biopharmaceutical company developing novel therapeutics that harness the bodys innate regenerative mechanisms to accelerate tissue repair, today announced that it has entered into a material transfer agreement (MTA) with the Henry M. Jackson Foundation (HJF) for the Advancement of Military Medicine. Under terms of the agreement, United States Department of Defense researchers will conduct a preclinical study of siFi2, MicroCures lead product candidate, in animal models of spinal cord injury. siFi2, a small interfering RNA (siRNA) therapeutic that can be applied topically, is designed to enhance recovery after trauma.

Researchers, led by Kimberly Byrnes, Ph.D. of Uniformed Services University of the Health Sciences, will evaluate the potential of siFi2 treatment to drive axon regeneration and functional recovery in a rat model of spinal cord injury. As part of this study, multiple siFi2 formulations will be evaluated in order to assist in the identification of a lead formulation to be advanced into clinical development.

MicroCures technology is based on foundational scientific research at Albert Einstein College of Medicine regarding the fundamental role that cell movement plays as a driver of the bodys innate capacity to repair tissue, nerves, and organs. The company has shown that complex and dynamic networks of microtubules within cells crucially control cell migration, and that this cell movement can be reliably modulated to achieve a range of therapeutic benefits. Based on these findings, the company has established a first-of-its-kind proprietary platform to create siRNA-based therapeutics capable of precisely controlling the speed and direction of cell movement by selectively silencing microtubule regulatory proteins (MRPs).

Story continues

The company has developed a broad pipeline of therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. Unlike regenerative medicine approaches that rely upon engineered materials or systemic growth factor/stem cell therapeutics, MicroCures technology directs and enhances the bodys inherent healing processes through local, temporary modulation of cell motility. siFi2 is a topical siRNA-based treatment designed to silence the activity of Fidgetin-Like 2 (FL2), a fundamental MRP, within an area of wounded tissue or nerve. In doing so, the therapy temporarily triggers accelerated movement of cells essential for repair into an injury area. Importantly, based on its topical administration, siFi2 can be applied early in the treatment process as a supplement to current standard of care.

The U.S. Department of Defense continues to be a valued and trusted partner for MicroCures as we work to advance research of siFi2 with the goal of ultimately delivering transformative treatments to patients with significant unmet medical needs, said David Sharp, Ph.D., co-founder and chief science officer of MicroCures. With a focus in the area of spinal cord injury, this MTA further demonstrates the broad applicability of our technology platform to a range of therapeutic indications. We look forward to collaborating with Dr. Byrnes and her team at Uniformed Services University of the Health Sciences to continue the advancement of this promising program.

Previously conducted research in a rat model of spinal cord injury has demonstrated that treatment with siFi2 allowed axon growth to occur through the inhibitory barriers that typically appear and prevent healing at the site of injury. Conversely, study results failed to demonstrate similar axon growth through these inhibitory barriers for animals administered a siRNA control treatment. Additional preclinical findings have demonstrated functional improvement in rats with spinal cord injury following treatment with siFi2. This was evidenced by significantly improved hind limb locomotor function in siFi2-treated animals as compared to control subjects at Day 5 (p < 0.05) and Day 7 (p < 0.01).

About MicroCures

MicroCures develops biopharmaceuticals that harness innate cellular mechanisms within the body to precisely control the rate and direction of cell migration, offering the potential to deliver powerful therapeutic benefits for a variety of large and underserved medical applications.

MicroCures has developed a broad pipeline of novel therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. The companys lead therapeutic candidate, siFi2, targets excisional wound healing, a multi-billion dollar market inadequately served by current treatments. Additional applications for the companys cell migration accelerator technology include dermal burn repair, corneal burn repair, cavernous nerve repair/regeneration, spinal cord repair/regeneration, and cardiac tissue repair. Cell migration decelerator applications include combatting cancer metastases and fibrosis. The company protects its unique platform and proprietary therapeutic programs with a robust intellectual property portfolio including eight issued or allowed patents, as well as eight pending patent applications.

For more information please visit: http://www.microcures.com

Contact:

Vida Strategic Partners (On behalf of MicroCures)

Stephanie Diaz (investors)415-675-7401sdiaz@vidasp.com

Tim Brons (media)415-675-7402tbrons@vidasp.com

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MicroCures Announces Material Transfer Agreement with Henry M. Jackson Foundation for the Advancement of Military Medicine to Support Preclinical...

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Key Companies Covered in the IVF Market Research Report are Monash IVF, Ovation Fertility, Bloom IVF Centre, Shady Grove Fertility, Bangkok IVF center, Boston IVF, Pelargos IVF, RSMC, Group Ambroise Par Clinic and other key market players.

Pune, Feb. 20, 2020 (GLOBE NEWSWIRE) -- The global In Vitro Fertilization (IVF) Market size is prophesized to reach USD 36.39 billion by 2026, with a CAGR 10.1% by 2026. This is attributable to the increasing cases of infertility among people worldwide. This is more common in males than female partners. The market value was USD 16.89 billion in 2018. IVF is a fertilization process wherein sperm and eggs are retrieved as a sample and are combined manually in laboratories. Various studies show that almost half a million babies are born by this process or other assistant reproductive processes. Such factors are responsible for the in vitro fertilization market growth.

Fortune Business Insights latest report, titled, In Vitro Fertilization (IVF) Market Size, Share & Industry Analysis, By Type (Conventional IVF, and IVF with ICSI), By Procedure (Fresh Non-donor, Frozen Non-donor, Fresh Donor, and Frozen Donor), By End User (Hospitals, and Fertility Clinics) and Regional Forecasts, 2019-2026 provides a 360-degree overview of the market and its parameters. These include growth drivers, restraints, challenges, and opportunities. The report also provides detailed segmentation of the market with market figures such as base and forecast figure and the compound annual growth rates (CAGRs) as well. Besides this, the report provides interesting insights into the market, key industry developments, and other IVF market trends. The report is available for sale on the company website.

Nowadays, people are more inclined towards career goals rather than family planning, and therefore often tend to opt for late pregnancies. The increasing number of such cases is a major in vitro fertilizer market driver, as mentioned earlier, since complicated cases are often resolved by opting for IVF treatment. This is more common in nations such as the UK, Japan, and the U.S. Besides this, the rise in the number of male infertility is anticipated to increase the adoption of IVF treatment and thus accelerate the in vitro fertilization market size in the coming years. Besides this, government-supported reimbursement policies and awareness programs are aiding the overall in vitro fertilization market growth of the region.

Analysts at Fortune Business Insights said high expenses and risks related to the in vitro fertilization process (IVF) and Intracytoplasmic sperm injection (ICSI) may cause hindrance to the overall in vitro fertilization market revenue. Nevertheless, factors such as increasing obesity cases among people, infertility among men, the practice of sedentary lifestyle, and others are likely to create lucrative IVF market growth opportunities in the coming years.

Europe holds a dominant in vitro fertilization market share with a revenue of USD 7.57 billion generated in the year 2018. This is attributable to the rise in the prevalence of infertility and the increasing popularity of IVF treatment in the region. On the other side, the market in North America will witness steady growth on account of the high cost associated with ICSI and IVF treatment. As per the FertilityIQ data, 2017, in the U.S., the average expenditure of a patient undergoing a single IVF cycle is USD 22,000. Thus, patients in the U.S are travelling to other countries for IVF treatment citing lower costs.

Companies are Investing in Construction of New Fertility Centers for Revenue Generation

Boston IVF, Pelargos IVF, and Monash IVF are currently dominating the market. In vitro fertilization market manufacturers are developing new centers with efficient and high-quality treatment in remote locations for speeding their own revenue generation and making their mark in the market competition. This will ultimately accelerate the overall IVF market size.

Significant Industry Developments in In Vitro Fertilization Market:

May 2019 A new embryo screening test was developed by scientists at Monash IVF for reducing the risk of miscarriage at the time of IVF treatment.

July 2019 The opening of a new full-service IVF center at the Westshore office at Tampa, Florida, was announced by Shady Grove Fertility. The main objective behind the opening of this center is to offer affordable and high-quality fertility treatment options to the regional people.

List of key Companies Operating in the In Vitro Fertilization (IVF) Market include:

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In Vitro Fertilization Market will Reach USD 36.39 Billion by 2026: Increasing Cases of Infertility Among Men to Positively Influence Growth, says...

Recommendation and review posted by Bethany Smith

By Lorena Anderson, UC Merced

Professor Joel Spencer and his lab have made a huge breakthrough in stem cell research.

Professor Joel Spencer was a rising star in college soccer and now he is an emerging scientist in the world of biomedical engineering, capturing for the first time an image of a hematopoietic stem cell (HSC) within the bone marrow of a living organism.

Everyone knew black holes existed, but it took until last year to directly capture an image of one due to the complexity of their environment, Spencer said. Its analogous with stem cells in the bone marrow. Until now, our understanding of HSCs has been limited by the inability to directly visualize them in their native environment.

This work brings an advancement that will open doors to understanding how these cells work which may lead to better therapeutics for hematologic disorders including cancer.

Understanding how HSCs interact within their local environments might help researchers understand how cancers use this same environment in the bone marrow to evade treatment.

Spencer studied biological sciences at UC Irvine where he was the captain of the mens Division 1 soccer team. He initially planned to pursue a career in professional soccer until faculty mentors opened doors for research and introduced Spencer to biophotonics the science that deals with the interactions of light with biological matter.

UC faculty were a big part of my research experience; they became mentors and friends, Spencer said. My first foray into research was as a lab tech, and that is where I met people who were doing biomedical imaging, and it just caught my wonder.

An image of a stem cell in its natural niche

Spencer left his native California to earn his Ph.D. in bioengineering at Tufts University in Boston and took a postdoctoral research position in the Wellman Center for Photomedicine at Massachusetts General Hospital and Harvard Medical School. In Boston, he learned about live-animal imaging and his wonder became a passion.

Now his emphasis is on biomedical optics: building new microscopes and new imaging techniques to visualize and study biological molecules, cells and tissue in their natural niches in living, fully intact small animals.

I work at the interface of engineering and biology. My lab is seeking to answer biological questions that were impossible until the advancements in technology we have seen in the past couple decades, he said. You need to be able to peer inside an organ inside a live animal and see whats happening as it happens.

Based on work conducted at UC Merced and in Boston, he and his collaborators including his grad student Negar Tehrani visualized stem cells inside the bone marrow of live, intact mice.

He and his collaborators have a new paper published in the journal Nature detailing the work they conducted to study HSCs in their native environment in the bone marrow.

We can see how the cells behave in their native niches and how they respond to injuries or stresses which seems to be connected to the constant process of bone remodeling, Tehrani said. Researchers have been trying to answer questions that have gone unanswered for lack of technology, and they have turned to engineering to solve those puzzles.

Its important for researchers to understand the mechanics of stem cells because of the cells potential to regenerate and repair damaged tissue.

Spencer, left, and students from his lab

Spencer returned to California three years ago, joining the Department of Bioengineering in the School of Engineering at UC Merced. Hes also an affiliate of the Health Sciences Research Institute and the NSF CREST Center for Cellular and Biomolecular Machines . This is his third paper in Nature, but the first stemming from work conducted in his current lab.

He didnt come to UC Merced just because he loves biology Spencer also joined the campus because of the students.

Now Im back in the UC system Im a homegrown UC student whos now faculty, Spencer said. As a student within the system I was able to participate in myriad opportunities, including mentorships that advanced my career. Now I try to encourage graduate and undergrad students to follow their dreams. I love being able to give them opportunities its something I really want to do for the next generation.

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Breakthrough in Stem Cell Research: First Image of Niche Environment | Newsroom - UC Merced University News

Recommendation and review posted by Bethany Smith

Nes-Ziona, Israel, Feb. 20, 2020 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage immunotherapy company, today announced that the company wasselected, for a scientific presentation of two posters: (i) Allocetra-OTS: Early Apoptotic Cells for Immune Homeostasis in Human Stem Cell Transplantation (HSCT) and for the Prevention of Graft Versus Host Disease (GvHD), and (ii) Apoptotic Cells Reprogram Resident Macrophages to Support Chimeric Antigen Receptor (CAR) T Cell Therapy Against Peritoneal Solid Tumor, at the Transplantation & Cellular Therapy Meetings Conference of the ASTCT and CIBMTR (TCT), held on February 19-23, 2020, in Orlando, Florida.

Allocetra-OTS: Early Apoptotic Cells for Immune Homeostasis in Human Stem Cell Transplantation (HSCT) and for the Prevention of Graft Versus Host Disease (GvHD)

Results from preclinical and clinical studiesy suggested that a single infusion of donor early apoptotic cells (Allocetra) as prophylaxis for GvHD in myeloablative HSCT is safe and potentially effective and led to 0% (0/6) of acute high grade II-IV GvHD in the two higher dosages compared to 52% in matched historical control. Enlivex is planning to initiate a Phase 2/3 multi-center, open-label, 2-arm study (ENX-CL-01-002), in Israel and Germany, that will evaluate the efficacy and safety of Allocetra-OTS (140x106cells/kg) with or without anti-thymocyte globulin (ATG) for the prevention of GvHD in subjects undergoing HLA-matched HSCT from an unrelated donor.

Apoptotic Cells Reprogram Resident Macrophages to Support Chimeric Antigen Receptor (CAR) T Cell Therapy Against Peritoneal Solid Tumor

Preclinical studies showed significantly increased duration of survival and overall survival for study subjects who were treated with the combination therapy, as compared to stand-alone solid tumor CAR-T therapy. The results of these preclinical studies showed that the mechanism of action significantly increased the anti-tumor macrophage population surrounding the human solid tumor microenvironment in the subjects who were treated with the combination therapy.

ALLOCETRATMby Enlivex was designed toprovide a novel immunotherapy mechanism of actionthat targets life-threatening clinical indications that are defined as unmet medical needs, includingprevention or treatment of complications associated with bone marrow transplantations (BMT) and/or hematopoietic stem cell transplantations (HSCT); organ dysfunction and acute multiple organ failure associated with sepsis; and enablement of an effective treatment of solid tumors via immune checkpoint rebalancing.

ABOUT ENLIVEXEnlivex is a clinical stage immunotherapy company, developing an allogeneic drug pipeline for immune system rebalancing. Immune system rebalancing is critical for the treatment of life-threatening immune and inflammatory conditions which involve an out of control immune system (e.g. Cytokine Release Syndrome) and for which there are no approved treatments (unmet medical needs), as well as solid tumors immune-checkpoint rebalancing. For more information, visit http://www.enlivex.com.

ABOUT EUROPEAN MOLECULAR BIOLOGY ORGANIZATIONThe TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR (TCT Meetings) are the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR).

Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as expects, plans, projects, will, may, anticipates, believes, should, would, intends, estimates, suggests, has the potential to and other words of similar meaning, including statements regarding expected cash balances, market opportunitiesfor the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunitiesfor, ALLOCETRATMprograms, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivexs business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATMproduct line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivexs filings with the Securities and Exchange Commission, including under the heading Risk Factors contained in Enlivexs most recently filed Annual Report on Form 20-F. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.

ENLIVEX CONTACT: Shachar Shlosberger, CFO Enlivex Therapeutics, Ltd.shachar@enlivex-pharm.com

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Data On Enlivex's Allocetra-OTS Immunotherapy for Peritoneal Solid Tumors and for Prevention of GvHD Selected for Presentation at the Transplantation...

Recommendation and review posted by Bethany Smith

Eon Market Research currently generated a research report titled, Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market Research Report 2020. The studies report represents the ability growth opportunities that prevail in the global market. The document is analyzed on the idea of secondary research methodologies acquired from historic and forecast data. The global Autologous Stem Cell and Non-Stem Cell Based Therapies marketplace is predicted to grow significantly and thrive in terms of quantity and price all through the forecast period. The record will provide an perception approximately the growth possibilities and restraints that construct the marketplace. Readers can benefit significant comprehension approximately the destiny of the marketplace.

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Conference Call and Webcast @ 8:00 a.m. Eastern Time Today

NEW YORK, Feb. 18, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announces financial results for fiscal year ended December 31, 2019.

2019 was a tremendous year for BrainStorm, with significant progress and achievements across all clinical and operational fronts, stated Chaim Lebovits, President and Chief Executive Officer of BrainStorm. Most importantly, we fully enrolled our pivotal, double blind, placebo-controlled Phase 3 trial of NurOwn for the treatment of ALS. We announced the trial conducted at six major U.S. medical centers of excellence for ALS, was fully enrolled on October 11, 2019, and on October 28, 2019 the Data and Safety Monitoring Board (DSMB), completed the second planned interim safety analysis for the first 106 patients who received repeat dosing of NurOwn in the Phase 3 trial. The DSMB concluded the trial should continue as planned without any clinical protocol changes. He added, In addition, one of the most prestigious peer-reviewed journals, Neurology, published NurOwn Phase 2 Randomized Clinical Trial in ALS: Safety, Clinical and BioMarker Results, bringing news of our investigational therapy to the global scientific community. And, just last week, we were happy to announce that the Company recently held a high level meeting with the U.S. Food and Drug Administration (FDA) to discuss potential NurOwn regulatory pathways for approval in ALS.

Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer of BrainStorm added, 2019 was also a very significant year for those who suffer from progressive Multiple Sclerosis (MS). In February 2019, we announced Cleveland Clinic would serve as our first contracted site for a Phase 2 open-label, multicenter study of repeated intrathecal administration of NurOwn (autologous MSC-NTF cells) in participants with progressive MS (NCT03799718). We enrolled our first patient in March. We contracted with The Stanford University School of Medicine, The Keck School of Medicine of the University of Southern California, and the Mount Sinai Medical Center to further enroll patients. Dr. Kern added, The importance of our research in progressive MS was acknowledged by a $495,000 grant award from the National Multiple Sclerosis Society through its Fast Forward Program, and mid-December, the Data Safety Monitoring Board completed the first, pre-specified interim analysis, of safety outcomes for 9 participants and after careful review of all available clinical trial data, the DSMB unanimously concluded that the study should continue as planned without any protocol modification. As of December 31, 2019 we have enrolled 10 patients in the study (50% enrollment completed).

Fourth Quarter Corporate Highlights:

Financial Results for the Year Ended December 31, 2019 and Recent Updates

For further details on BrainStorms financials, including financial results for the year ended December 31, 2019, refer to the Form 10-K filed with the SEC today.

Conference Call on Tuesday, February 18th @ 8:00 am Eastern Time

The investment community may participate in the conference call by dialing the following numbers:

Those interested in listening to the conference call live via the internet may do so by visiting the Investors & Media page of BrainStorms website at http://www.ir.brainstorm-cell.com and clicking on the conference call link.

A webcast replay of the conference call will be available for 30 days on the Investors & Media page of BrainStorms website:

About NurOwnNurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

Story continues

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc.is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwnCellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(U.S.FDA) and theEuropean Medicines Agency(EMA) in ALS. Brainstorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S.FDAapproval of autologous MSC-NTF cells in ALS. Brainstorm received U.S.FDAclearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) inDecember 2018and has been enrolling clinical trial participants sinceMarch 2019. For more information, visit the company'swebsite.

Safe-Harbor StatementStatements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com

Investor Relations:Preetam Shah, MBA, PhDChief Financial OfficerBrainStorm Cell Therapeutics Inc.Phone: 862-397-8160pshah@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

BRAINSTORM CELL THERAPEUTICS INC.

CONSOLIDATED BALANCE SHEETSU.S. dollars in thousands(Except share data)

BRAINSTORM CELL THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSSU.S. dollars in thousands(Except share data)

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BrainStorm Announces Operational Highlights and Financial Results for the Year Ended December 31, 2019 - Yahoo Finance

Recommendation and review posted by Bethany Smith