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Category Archives: Regenerative Medicine

How Coronavirus Pandemic Will Impact Regenerative Medicine Products Market, Share, Growth, Trends And Forecast To 2026 – Jewish Life News

Posted: April 27, 2020 at 2:49 pm

Analysis of the Global Regenerative Medicine Products Market

The report on the global Regenerative Medicine Products market reveals that the market is expected to grow at a CAGR of ~XX% during the considered forecast period (2019-2029) and estimated to reach a value of ~US$XX by the end of 2029. The latest report is a valuable tool for stakeholders, established market players, emerging players, and other entities to devise effective strategies to combat the impact of COVID-19

Further, by leveraging the insights enclosed in the report, market players can devise concise, impactful, and highly effective growth strategies to solidify their position in the Regenerative Medicine Products market.

Research on the Regenerative Medicine Products Market Addresses the Following Queries

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Competitive Landscape

The competitive landscape section offers valuable insights related to the business prospects of leading market players operating in the Regenerative Medicine Products market. The market share, product portfolio, pricing strategy, and growth strategies adopted by each market player is included in the report. The major steps taken by key players to address the business challenges put forward by the novel COVID-19 pandemic is discussed in the report.

Regional Landscape

The regional landscape section provides a deep understanding of the regulatory framework, current market trends, opportunities, and challenges faced by market players in each regional market. The various regions covered in the report include:

End-User Assessment

The report bifurcates the Regenerative Medicine Products market based on different end users. The supply-demand ratio and consumption volume of each end-user is accurately depicted in the report.

Market Segment AnalysisThe research report includes specific segments by Type and by Application. This study provides information about the sales and revenue during the historic and forecasted period of 2015 to 2026. Understanding the segments helps in identifying the importance of different factors that aid the market growth.Segment by Type, the Regenerative Medicine Products market is segmented intoCell TherapyTissue EngineeringBiomaterialOthers

Segment by ApplicationDermatologyCardiovascularCNSOrthopedicOthers

Global Regenerative Medicine Products Market: Regional AnalysisThe Regenerative Medicine Products market is analysed and market size information is provided by regions (countries). The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type and by Application segment in terms of sales and revenue for the period 2015-2026.The key regions covered in the Regenerative Medicine Products market report are:North AmericaU.S.CanadaEuropeGermanyFranceU.K.ItalyRussiaAsia-PacificChinaJapanSouth KoreaIndiaAustraliaTaiwanIndonesiaThailandMalaysiaPhilippinesVietnamLatin AmericaMexicoBrazilArgentinaMiddle East & AfricaTurkeySaudi ArabiaU.A.EGlobal Regenerative Medicine Products Market: Competitive AnalysisThis section of the report identifies various key manufacturers of the market. It helps the reader understand the strategies and collaborations that players are focusing on combat competition in the market. The comprehensive report provides a significant microscopic look at the market. The reader can identify the footprints of the manufacturers by knowing about the global revenue of manufacturers, the global price of manufacturers, and sales by manufacturers during the forecast period of 2015 to 2019.The major players in global Regenerative Medicine Products market include:AcelityDePuy SynthesMedtronicZimmerBiometStrykerMiMedx GroupOrganogenesisUniQureCellular Dynamics InternationalOsiris TherapeuticsVcanbioGamida CellGolden MeditechCytori TherapeuticsCelgeneVericel CorporationGuanhao BiotechMesoblastStemcell TechnologesBellicum Pharmaceuticals

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Essential Findings of the Regenerative Medicine Products Market Report:

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How Coronavirus Pandemic Will Impact Regenerative Medicine Products Market, Share, Growth, Trends And Forecast To 2026 - Jewish Life News

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Pluristem Secures 50 Million Non-Dilutive Financing from the European Investment Bank to Support its COVID-19 Project and Phase III StudiesEXPECTED…

Posted: April 27, 2020 at 2:49 pm

HAIFA, Israel, April 24, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that the European Investment Bank (EIB) has approved a 50 million non-dilutive financing for the Company (the Approved Financing). This Approved Financing, once received, will support Pluristems research and development in the EU to further advance its regenerative cell therapy platform, and to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19. The Approved Financing will be deployed in three tranches, subject to the achievement of certain clinical, regulatory and scaling up milestones, with the first tranche consisting of 20 million. The expected signing date of the financing agreement relating to the Approved Financing is April 30, 2020.

Pluristem recently formed a wholly-owned subsidiary in Berlin, Germany, underscoring the Companys commitment to having a physical presence in Europe to advance research and development, and to prepare for commercialization, for its product candidates.

The Approved Financing is backed by a guarantee from the European Fund for Strategic Investments (EFSI), the financial pillar of the Investment Plan for Europe, under which the EIB and the European Commission are working together as strategic partners to boost Europes economic competitiveness. The transaction has been initiated by kENUP Foundation, a global partnership in innovation, promoting research-based innovation for Europe with public and societal benefit.

The Approved Financing, once granted, will not be secured and will be payable to the EIB in a single payment following five years from the disbursement of the first and second tranches and in two annual payments starting on the fourth year from disbursement of the third tranche, with each tranche having an interest rate of between 3% to 4%. The Approved Financing will support up to 50% of Pluristems R&D project cost. In addition, the EIB would be entitled to receive royalties from future revenues for a period of seven years starting 2024, at a rate of 0.2% to 2.3%, pro-rated to the amounts that the Company received from the Approved Financing.

We are extremely honored to have been selected by the EIB for this prestigious financing. We believe that this financing will allow us to significantly advance the clinical development of our lead product candidates, which if successful we expect will improve the quality of life for millions of patients around the world. Having established research partnerships with leading European institutions such as Charit University of Medicine Berlin, BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT), as well as formed a subsidiary in Berlin, we understand the importance of having a physical presence in key markets, stated Pluristem CEO and President, Yaky Yanay. As we move forward into a multinational clinical trial for PLX cells to treat patients suffering from complications associated with COVID-19, we expect this EIB financing will accelerate our path to approval and to making a potentially effective COVID-19 treatment available worldwide.

About the European Investment Bank The European Investment Bank (EIB) is the long-term lending institution of the European Union, owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals.

Investment Plan for Europe The Investment Plan for Europe (the Juncker Plan) is one of the EU's key actions to boost investment in Europe, thereby creating jobs and fostering growth. To this end, smarter use will be made of new and existing financial resources. The EIB Group, consisting of the European Investment Bank and the European Investment Fund, is playing a vital role in this investment plan. With guarantees from the European Fund for Strategic Investments (EFSI), the EIB and EIF are able to take on a higher share of project risk, encouraging private investors to participate in the projects. In addition to EFSI, the new European Investment Advisory Hub (EIAH) helps public and private sector project promoters to structure investment projects more professionally. The projects and agreements approved under EFSI (European Fund for Strategic Investments) so far are expected to mobilise almost 466 billion of investments and will benefit over 1 million start-ups and SMEs (Small Medium Enterprises) in the 27 Member States.

About Pluristem TherapeuticsPluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses its expectation that it will execute a definitive agreement for the Approved Financing and the proposed terms of such Approved Financing, the belief that the Approved Financing will support its research and development in the EU to further advance its regenerative cell therapy platform, to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19, that such Approved Financing will allow it to significantly advance its clinical development of its lead product candidates which it expects will improve the quality of life for millions of patients around the world and the expectation that the Approved Financing will accelerate its path to approval of its COVID-19 multinational clinical trial and to making a potentially effective COVID-19 treatment available worldwide. While the EIB has announced the approval of the Approved Financing, there is no guarantee that the Company and the EIB will execute the definitive agreement on April 30, 2020, if at all, or that it will achieve the milestones necessary to receive any or all of the three tranches. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Contact:Dana RubinDirector of Investor Relations+972-74-7107194danar@pluristem.com

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Pluristem Secures 50 Million Non-Dilutive Financing from the European Investment Bank to Support its COVID-19 Project and Phase III StudiesEXPECTED...

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Regenerative Medicine Products Market Overview, Top Companies, Region, Application and Global Forecast by 2026 – Latest Herald

Posted: April 27, 2020 at 2:49 pm

Bellicum Pharmaceuticals

Global Regenerative Medicine Products Market Segmentation

This market was divided into types, applications and regions. The growth of each segment provides an accurate calculation and forecast of sales by type and application in terms of volume and value for the period between 2020 and 2026. This analysis can help you develop your business by targeting niche markets. Market share data are available at global and regional levels. The regions covered by the report are North America, Europe, the Asia-Pacific region, the Middle East, and Africa and Latin America. Research analysts understand the competitive forces and provide competitive analysis for each competitor separately.

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Regenerative Medicine Products Market Region Coverage (Regional Production, Demand & Forecast by Countries etc.):

North America (U.S., Canada, Mexico)

Europe (Germany, U.K., France, Italy, Russia, Spain etc.)

Asia-Pacific (China, India, Japan, Southeast Asia etc.)

South America (Brazil, Argentina etc.)

Middle East & Africa (Saudi Arabia, South Africa etc.)

Some Notable Report Offerings:

-> We will give you an assessment of the extent to which the market acquire commercial characteristics along with examples or instances of information that helps your assessment.

-> We will also support to identify standard/customary terms and conditions such as discounts, warranties, inspection, buyer financing, and acceptance for the Regenerative Medicine Products industry.

-> We will further help you in finding any price ranges, pricing issues, and determination of price fluctuation of products in Regenerative Medicine Products industry.

-> Furthermore, we will help you to identify any crucial trends to predict Regenerative Medicine Products market growth rate up to 2026.

-> Lastly, the analyzed report will predict the general tendency for supply and demand in the Regenerative Medicine Products market.

Have Any Query? Ask Our Expert@ https://www.marketresearchintellect.com/need-customization/?rid=222856&utm_source=LHN&utm_medium=888

Table of Contents:

Study Coverage: It includes study objectives, years considered for the research study, growth rate and Regenerative Medicine Products market size of type and application segments, key manufacturers covered, product scope, and highlights of segmental analysis.

Executive Summary: In this section, the report focuses on analysis of macroscopic indicators, market issues, drivers, and trends, competitive landscape, CAGR of the global Regenerative Medicine Products market, and global production. Under the global production chapter, the authors of the report have included market pricing and trends, global capacity, global production, and global revenue forecasts.

Regenerative Medicine Products Market Size by Manufacturer: Here, the report concentrates on revenue and production shares of manufacturers for all the years of the forecast period. It also focuses on price by manufacturer and expansion plans and mergers and acquisitions of companies.

Production by Region: It shows how the revenue and production in the global market are distributed among different regions. Each regional market is extensively studied here on the basis of import and export, key players, revenue, and production.

About Us:

Market Research Intellect provides syndicated and customized research reports to clients from various industries and organizations with the aim of delivering functional expertise. We provide reports for all industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverage and more. These reports deliver an in-depth study of the market with industry analysis, market value for regions and countries and trends that are pertinent to the industry.

Contact Us:

Mr. Steven Fernandes

Market Research Intellect

New Jersey ( USA )

Tel: +1-650-781-4080

Tags: Regenerative Medicine Products Market Size, Regenerative Medicine Products Market Growth, Regenerative Medicine Products Market Forecast, Regenerative Medicine Products Market Analysis

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Regenerative Medicine Market Segmentation, Application, Technology, Analysis Research Report and Forecast to 2026 – Cole of Duty

Posted: April 27, 2020 at 2:49 pm

Stryker Corporation and NuVasive

Global Regenerative Medicine Market Segmentation

This market was divided into types, applications and regions. The growth of each segment provides an accurate calculation and forecast of sales by type and application in terms of volume and value for the period between 2020 and 2026. This analysis can help you develop your business by targeting niche markets. Market share data are available at global and regional levels. The regions covered by the report are North America, Europe, the Asia-Pacific region, the Middle East, and Africa and Latin America. Research analysts understand the competitive forces and provide competitive analysis for each competitor separately.

To get Incredible Discounts on this Premium Report, Click Here @ https://www.verifiedmarketresearch.com/ask-for-discount/?rid=7157&utm_source=COD&utm_medium=005

Regenerative Medicine Market Region Coverage (Regional Production, Demand & Forecast by Countries etc.):

North America (U.S., Canada, Mexico)

Europe (Germany, U.K., France, Italy, Russia, Spain etc.)

Asia-Pacific (China, India, Japan, Southeast Asia etc.)

South America (Brazil, Argentina etc.)

Middle East & Africa (Saudi Arabia, South Africa etc.)

Some Notable Report Offerings:

-> We will give you an assessment of the extent to which the market acquire commercial characteristics along with examples or instances of information that helps your assessment.

-> We will also support to identify standard/customary terms and conditions such as discounts, warranties, inspection, buyer financing, and acceptance for the Regenerative Medicine industry.

-> We will further help you in finding any price ranges, pricing issues, and determination of price fluctuation of products in Regenerative Medicine industry.

-> Furthermore, we will help you to identify any crucial trends to predict Regenerative Medicine market growth rate up to 2026.

-> Lastly, the analyzed report will predict the general tendency for supply and demand in the Regenerative Medicine market.

Have Any Query? Ask Our Expert @ https://www.verifiedmarketresearch.com/product/global-regenerative-medicine-market/?utm_source=COD&utm_medium=005

Table of Contents:

Study Coverage: It includes study objectives, years considered for the research study, growth rate and Regenerative Medicine market size of type and application segments, key manufacturers covered, product scope, and highlights of segmental analysis.

Executive Summary: In this section, the report focuses on analysis of macroscopic indicators, market issues, drivers, and trends, competitive landscape, CAGR of the global Regenerative Medicine market, and global production. Under the global production chapter, the authors of the report have included market pricing and trends, global capacity, global production, and global revenue forecasts.

Regenerative Medicine Market Size by Manufacturer: Here, the report concentrates on revenue and production shares of manufacturers for all the years of the forecast period. It also focuses on price by manufacturer and expansion plans and mergers and acquisitions of companies.

Production by Region: It shows how the revenue and production in the global market are distributed among different regions. Each regional market is extensively studied here on the basis of import and export, key players, revenue, and production.

About us:

Verified market research partners with the customer and offer an insight into strategic and growth analyzes, Data necessary to achieve corporate goals and objectives. Our core values are trust, integrity and authenticity for our customers.

Analysts with a high level of expertise in data collection and governance use industrial techniques to collect and analyze data in all phases. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise and years of collective experience to produce informative and accurate research reports.

Contact us:

Mr. Edwyne FernandesCall: +1 (650) 781 4080Email: [emailprotected]

Tags: Regenerative Medicine Market Size, Regenerative Medicine Market Trends, Regenerative Medicine Market Growth, Regenerative Medicine Market Forecast, Regenerative Medicine Market Analysis

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Regenerative Medicine Market Segmentation, Application, Technology, Analysis Research Report and Forecast to 2026 - Cole of Duty

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NFL Alumni Providing COVID-19 Rapid Antibody Screening Tests by Teaming Up With 1271 Partners, Streamline Medical Group, and RayBiotech – PRNewswire

Posted: April 27, 2020 at 2:49 pm

MOUNT LAUREL, N.J., April 23, 2020 /PRNewswire/ --1271 Partners, Streamline Medical Group, and RayBiotech have partnered to provide COVID-19 testing to the NFL Alumni Association and its members. The partnership is offering Coronavirus (COVID-19) IgM/IgG Dual Antibody Rapid Test Kits as a member benefit to NFL Alumni members with telemedicine consultations to help families screen and possibly prevent the spread of the virus.

1271 Partners and Streamline Medical Group have executed a distribution agreement that provides an exclusive license to provide RayBiotech's IgM/IgG Dual Antibody Rapid Test Kits to all of the professional sports leagues and arenas, such as the NFL, NBA, MLB, etc. In addition, 1271 Partners and Streamline can distribute the Rapid Test Kits in North America, South America, and Europe on a non-exclusive basis.

"As an ongoing effort to fight the COVID-19 crisis we are fortunate to offer, our members and NFL Alumni families,an option for a rapid screening test, thanks toRayBiotech, 1271 Partners and Streamline Medical Group's relationships," said NFLA CEO Beasley Reece.

"Streamline Medical Group has always been on the forefront of optimal health and wellness through our blood testing for our patients. Streamline now has the opportunity to address the emergency need for valid COVID-19 rapid screening in partnership with the NFL Alumni Association Athletica and 1271 Partners," says Gary Brecka, CEO of Streamline Medical Group. "Along with 1271 Partners, we chose to become a distribution partner with RayBiotech because of their location right here in the USA and their history of providing cutting-edge array technologies for the discovery of regenerative medicine and disease-related protein biomarkers. We have a very high degree of confidence in their testing capabilities."

"As a managing member of 1271 Partners and a fellow NFL Alumnus, I am more than thrilled to offer our constituents, families and consumers-at large through the NFL Alumni Athletica platform, the opportunity to distribute COVID-19 Rapid Test Kits manufactured right here in the U.S. We are all living in challenging times and to provide a quick solution for some peace of mind is very satisfying," said 1271 Partners Managing Member, Billy Davis.

"We are very excited to partner with this excellent group of organizations to help provide access to COVID-19 screening kits for its members, the sporting community, all the fans and businesses that surround them. Specifically having the ability to work with the NFL Alumni and the 35 chapters throughout the country, will provide a gateway of solutions not only for the Alumni members but also the consumers and local businesses trying to get back to work in a safe and effective manner,"said RayBiotech Senior Business Development Manager, Jarad Wilson.

About NFL Alumni:NFL Alumni, a non-profit organization founded in 1967, is comprised of former NFL players, coaches, staffers, cheerleaders, spouses, and associate members whose mission is to serve, assist and inform former players and their families. The NFL Alumni offers a variety of medical, financial, and social programs to help members lead healthy, productive and connected lives, as well as community initiatives under its "Caring for Kids" programs. Pro Football Legends is the commercial marketing arm of the NFL Alumni. For more information, please visitwww.nflalumni.org.

About 1271 Partners:1271 Partners LLC is the managing entity for the NFL Alumni Athletica. Empowering healthcare consumers with leading scientific, evidence-based treatment options. The same standards of medical care received by elite and professional athletes should be made available to all. 1271 Partners LLC is a premier distributor of tissue and medical device products to the healthcare markets. We have deep experience in sales, operations, and logistics to lead the industry in effectively innovating in order to serve evolving market demands.

About Streamline Medical Group:Streamline Medical Group, along with Streamline Wellness, an organization with anti-aging and regenerative medicine clinics across the U.S., is focused on empowering patients to take control of their health and wellness to help them reach optimal wellness and reduce their healthcare costs. Streamline bases its personalized treatment protocols on each patient's unique biomarkers and prescribes a variety of products and services to help that patient reach their health and wellness goals. Streamline's ability to educate and empower the patient is enhanced with its proprietary report called the Streamline360 that simply explains how each biomarker ties in to specific bodily functions and, when optimized, how that correlates to optimal wellness. For more information, please visithttps://www.streamlinewellness.com

About RayBiotech:RayBiotech is a leading life sciences company providing proteomic discovery tools. RayBiotech has nearly 150 employees whose objectives are to provide excellent products and service worldwide to RayBiotech customers which include scientists in industry, academic and research institutes in over 41 countries. RayBiotech is committed to accelerating customer success through innovation and leadership in the Life Sciences. For more information, please visithttps://www.raybiotech.com

MEDIA CONTACT:Benjamin LeeStreamline Medical Group561.628.8488[emailprotected]

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SOURCE National Football League Alumni Association

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NFL Alumni Providing COVID-19 Rapid Antibody Screening Tests by Teaming Up With 1271 Partners, Streamline Medical Group, and RayBiotech - PRNewswire

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Healing the heart by returning it to its infancy – FierceBiotech

Posted: April 27, 2020 at 2:49 pm

Nearly a decade ago, researchers at UT Southwestern Medical Center discovered that when mouse hearts were damaged in the first seven days of life, they would regenerate. They reasoned that if they could find a way to recreate that regenerative ability later in life, it might provide a new way to treat heart damage.

Now, that same team has discovered that a protein called calcineurin plays a key role in blocking the ability of heart muscle to regenerate after the first week of life. The discovery could be used to develop treatments that reverse this process, in essence returning the heart to its developmental stage, they reported in the journal Nature.

The discovery builds on previous work at UT Southwestern that focused on the protein Meis1, a transcription factor that prevents heart cells from dividing. When the researchers deleted the gene in mice that makes that protein, their cardiomyocytes continued to divide after the first week of life. But the effect was transient.

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This virtual event will bring together industry experts to discuss the increasing pace of pharmaceutical innovation, the need to maintain data quality and integrity as new technologies are implemented and understand regulatory challenges to ensure compliance.

RELATED: Stem cells don't repair injured hearts, but inflammation might, study finds

Then the researchers discovered that another protein called Hoxb13 was also key, because it shuttles Meis1 into the cell nucleus. So they deleted the genes for both Meis1 and Hoxb13 in adult mice to see what would happen after a heart attack.

It worked. The ability of the animals hearts to pump blood quickly returned to near-normal levels, they said. Even though the mice were adults, their hearts looked much like they would in animals that were still developing.

After a series of further experiments, the UT Southwestern scientists discovered that calcineurin regulates both Hoxb13 and Meis1. Inhibiting calcineurin prolongs the window of cardiomyocyte proliferation, they wrote in the study.

The idea of treating heart damage by turning back the clock isnt new. In fact, several research teams have tried using stem cells to repair damaged heart tissue. But those efforts have been disappointing so far.

Last year, a team from the Cincinnati Children's Hospital Medical Center tracked stem cells injected into the hearts of mice and concluded that it was not the cells themselves, but rather their ability to activate macrophage cells from the immune system that promoted healing. That led the researchers to suggest that efforts to regenerate the heart focus less on stem cells and more on other processes in the body that might promote healing.

The discovery of calcineurins role in regulating the regeneration of the heart is notable due to the fact that there are already drugs on the market that target the protein. Thats because calcineurin plays a role in a variety of diseases, including rheumatoid arthritis and diabetes. Testing these drugs, either individually or in combination, and developing new medicines that target calcineurin directly could offer new strategies for repairing hearts damaged by heart attacks, high blood pressure, viruses and more, suggested co-author Hesham Sadek, M.D., Ph.D., a professor of internal medicine, molecular biology and biophysics at UT Southwestern.

"By building up the story of the fundamental mechanisms of heart cell division and what blocks it, Sadek said in a statement, we are now significantly closer to being able to harness these pathways to save lives.

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Healing the heart by returning it to its infancy - FierceBiotech

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AVITA Medical Announces Intention to Redomicile to the United States of America – Yahoo Finance

Posted: April 23, 2020 at 12:53 pm

Intention to establish primary listing on NASDAQ with continued (secondary) listing on ASX

AVITA Medical Limited (Company) (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, announced today its intention to redomicile the Company and its subsidiaries (Avita Group) from Australia to the United States of America by way of a scheme of arrangement under Part 5.1 of the Corporations Act 2001 (Cth) (Redomiciliation).

To implement the Redomiciliation, the Company has entered into a Scheme Implementation Agreement dated 20 April 2020 with AVITA Therapeutics, Inc. (Avita US), a newly-formed company incorporated in Delaware in the United States. A copy of the Scheme Implementation Agreement is attached and will be available on the Companys website.

The Redomiciliation is subject to regulatory and court approvals, as well as approval by the Companys shareholders at an extraordinary general meeting which will be convened to address the Redomiciliation (Scheme Meeting).

After carefully considering the advantages, disadvantages and risks of the Redomiciliation, the directors of the Company (Board) are of the unanimous view that the advantages of the Redomiciliation materially outweigh its disadvantages and risks. In particular, the Board believes that the Redomiciliation will:

The Board unanimously recommends that shareholders vote in favour of the resolution to approve the Redomiciliation at the Scheme Meeting. Each member of the Board intends to vote the shares in the Company which they hold (or which are held on their behalf) in favour of that resolution.

The Company has engaged BDO Corporate Finance Limited (Independent Expert) to report on whether the Redomiciliation is in the best interests of shareholders as a whole. The scheme booklet in connection with the Redomiciliation (Scheme Booklet) will include the report of the Independent Expert.

- shareholders in eligible jurisdictions who hold Shares (other than the ADS Depositary) will receive 5 CHESS depositary interests (CDIs) in Avita US (Avita US CDIs) for every 100 Shares held by them on the record date for the Redomiciliation (Record Date); and

- the ADS Depositary (who holds Shares for the benefit of holders of the Companys ADSs) will receive one Avita US Share for every 100 Shares held by it on the Record Date and will distribute to ADS holders one Avita US Share for every 5 ADSs held by them on the Record Date (upon surrender by them of their ADSs and payment of the ADS Depositarys fee for that surrender).

Therefore, shareholders in eligible jurisdictions and ADS holders (on the Record Date), upon receiving Avita US CDIs or Avita US Shares, will hold an equivalent proportional interest in Avita US as they held in the Company prior to implementation of the Redomiciliation.

Shareholders (on the Record Date) in certain ineligible jurisdictions (which are listed under the definition of "Ineligible Shareholder" in the Scheme Implementation Agreement) will have their entitlements sold pursuant to a sale facility, and those holders will receive the relevant net proceeds of that sale. In addition, shareholders (on the Record Date) who have a fractional entitlement to an Avita US Share or an entitlement to Avita US CDIs that is not sufficient to equate to a whole Avita US Share, will have those fractional interests sold pursuant to the same sale facility and those holders will receive the relevant net proceeds of that sale.

Implementation of the Redomiciliation is conditional upon the satisfaction of certain conditions, which are set out in the Implementation Agreement, including:

For the Redomiciliation to be implemented, a requisite majority of shareholders must vote to approve the Redomiciliation at the Scheme Meeting, which is intended to be held in June 2020.

Due to the COVID-19 pandemic and the restrictions imposed by Australian governments in response to it, the Company will be making an application to the Federal Court of Australia for orders to permit the Scheme Meeting to be conducted exclusively as a virtual meeting. Accordingly, it is proposed that the Scheme Meeting will be conducted by way of a live webcast only.

Further details on how to participate in the Scheme Meeting by way of live webcast and on how to vote (including by way of proxy, attorney or corporate representative) will be provided in the Scheme Booklet.

Any changes to the proposal that the Scheme Meeting be conducted exclusively as a virtual meeting will be outlined in the Scheme Booklet and thereafter on the ASX, NASDAQ and via news release, and will also be notified on the Companys website (https://www.avitamedical.com/).

ADS holders will be entitled to vote and participate in the Scheme Meeting through the Bank of New York Mellon, the ADS depositary.

Indicative timetable and next steps

Shareholders do not need to take any action at this time.

The Scheme Booklet is intended to be sent to shareholders in May 2020. The Scheme Booklet will contain, amongst other things, further information relating to the Redomiciliation, reasons for the Boards unanimous recommendation, information on the Scheme Meeting and on how to vote and the report of the Independent Expert.

If approved by the requisite majorities of shareholders (and subject to regulatory and court approvals), the Avita Group is targeting to implement the Redomiciliation by 30 June 2020, following which Avita US Shares and Avita US CDIs will be issued and can be traded on NASDAQ and the ASX respectively.

These dates are indicative only and subject to, amongst other things, court availability (particularly in the current environment) and the conditions precedent to completion of the Redomiciliation (as set out in the Scheme Implementation Agreement) being satisfied or waived.

Authorized for release by the Chief Financial Officer of AVITA Medical Limited.

###

ABOUT AVITA MEDICAL LIMITED

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a RES REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

To learn more, visit http://www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "intend," "could," "may," "will," "believe," "estimate," "look forward," "forecast," "goal," "target," "project," "continue," "outlook," "guidance," "future," other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

SCHEME IMPLEMENTATION AGREEMENT

AVITA Medical Limited

AVITA Therapeutics, Inc.

KPMG Law

KPMGInternational Towers Sydney 3300 Barangaroo AvenueSydney NSW 2000ABN 78 399 289 481 | DX1056 Sydney

Liability limited by a scheme approved under Professional Standards Legislation

CONTENTS

1. DEFINITIONS AND INTERPRETATION2. SCHEME3. OPTIONS, RSUS AND WARRANTS IN AVITA AUSTRALIA4. CONDITIONS5. GENERAL OBLIGATIONS OF PARTIES6. AVITA AUSTRALIA OBLIGATIONS7. AVITA US OBLIGATIONS8. ANNOUNCEMENT9. TERMINATION10. REPRESENTATIONS AND WARRANTIES11. RELEASE12. COSTS AND STAMP DUTY13. GST14. NOTICES15. AMENDMENT AND ASSIGNMENT16. GENERAL

DATED 20 April 2020

PARTIES

AVITA Medical Limited ACN 058 466 523 of Level 7, 330 Collins Street, Melbourne, 3000, Victoria, Australia (Avita Australia)

AVITA Therapeutics, Inc., a company incorporated in the State of Delaware in the United States of America, with a principal business address of 28159 Avenue Stanford, Suite 220, Valencia, California 91355 (Avita US)

RECITALS

Avita Australia is an Australian public company listed on the ASX (as its primary listing) and on NASDAQ (as its secondary listing).

The Avita Australia securities quoted for trading on the ASX are Avita Australia Shares, and the Avita Australia securities quoted for trading on NASDAQ are Avita Australia ADSs.

Avita US is a company incorporated in Delaware in the United States, which has been established for the purpose of effecting a redomiciliation of the Avita Group to the United States.

The Avita Group wishes to effect a redomiciliation from Australia to the United States by Avita US acquiring all of the Avita Australia Shares by way of a scheme of arrangement between Avita Australia and the Avita Australia Shareholders under Part 5.1 of the Corporations Act.

Avita Australia and Avita US propose to implement the Scheme on the terms and conditions of this agreement.

OPERATIVE PROVISIONS

1. DEFINITIONS AND INTERPRETATION

1.1. Definitions

The following definitions apply in this agreement, unless the context requires otherwise:

ADS means an American Depositary Share.

ADS Depositary means The Bank of New York Mellon.

ADS Holder means a holder of Avita Australia ADSs.

Announcement means an announcement, press release or other public statement (other than a draft explanatory statement, an explanatory statement or a supplementary explanatory statement as required under Part 5.1 of the Corporations Act).

ASIC means the Australian Securities and Investments Commission.

ASIC Policy means the regulatory policies (including regulatory guides) issued by ASIC as at the date of this agreement setting out its policy in relation to (among other things) the interpretation and enforcement of relevant sections of the Corporations Act.

ASX means ASX Limited (ABN 98 008 624 691) or the securities market which it operates, as the context requires.

ASX Settlement means ASX Settlement Pty Limited (ABN 49 008 504 532) as the holder of a licence to operate a clearing and settlement facility.

ASX Settlement Operating Rules means the operating rules of the clearing and settlement facility operated by ASX Settlement for the time being and from time to time, as modified by any express written exemption or waiver given by ASX or ASX Settlement.

ATO means the Australian Taxation Office.

ATO Class Ruling means the class ruling which Avita Australia will seek from the ATO to the effect that Australian resident Scheme Participants who hold their Avita Australia Shares (or Australian resident ADS Holders who hold their Avita Australia ADSs) on capital account and who make a capital gain from the exchange of their Avita Australia Shares (or Avita Australia ADSs) for Avita US Shares or Avita US CDIs under the Scheme will be eligible for scrip-for-scrip roll-over relief under the relevant Australian tax laws.

Authorisation means:

(a)

an approval, authorisation, consent, declaration, exemption, licence, notarisation, permit or waiver (however it is described), including any amendment or renewal and any condition attaching to it by or from a Government Authority; and

(b)

in relation to anything that could be prohibited or restricted by law if a Government Authority acts in any way within a specified period, the expiry of that period without that action being taken.

Authorised Nominee means CHESS Depositary Nominees Pty Limited (ACN 071 346 503, Australian Financial Services Licence number 254514), an approved general participant of ASX Settlement and a wholly-owned subsidiary of ASX.

Avita Australia means AVITA Medical Limited ACN 058 466 523.

Avita Australia ADS means an ADS representing 20 Avita Australia Shares, which trade on NASDAQ under the ticker code "RCEL".

Avita Australia Share means an issued fully paid ordinary share in the capital of Avita Australia.

Avita Australia Shareholder means a person entered in the Register as the holder of one or more Avita Australia Shares.

Avita Australia Shareholder Approval means the Scheme Resolution being passed by the majorities of Avita Australia Shareholders required under section 411(4)(a)(ii) of the Corporations Act.

Avita Group means Avita Australia and its Subsidiaries and, after implementation of the Scheme, Avita US and its Subsidiaries.

Avita US means AVITA Therapeutics, Inc..

Avita US CDI means a CDI representing a beneficial interest in 1/5 of an Avita US Share.

Avita US Share means a fully paid share of voting common stock in the capital of Avita US.

Business Day means a day that is not a Saturday, Sunday or a public holiday or bank holiday in Melbourne, Australia.

CDI means a CHESS Depositary Interest, being a unit of beneficial ownership in a share that is registered in the name of the Authorised Nominee in accordance with the ASX Settlement Operating Rules for the purpose of enabling that share to be recorded and transferred in accordance with those operating rules.

Condition means a condition precedent set out in clause 4.1.

Corporations Act means the Australian Corporations Act 2001 (Cth).

Court means the Federal Court of Australia or any other court of competent jurisdiction under the Corporations Act agreed in writing by Avita Australia and Avita US.

Deed Poll means the deed poll to be executed by Avita US substantially in the form of Schedule 3, pursuant to which Avita US covenants in favour of Scheme Participants to perform certain of its obligations under this agreement and certain steps attributed to it under the Scheme, with such amendments as are approved in accordance with its terms.

Effective means, in relation to the Scheme, the coming into effect, under section 411(10) of the Corporations Act, of the order of the Court made under section 411(4)(b) of the Corporations Act in relation to the Scheme, but in any event at no time before an office copy of the order of the Court is lodged with ASIC.

Effective Date means the date on which the Scheme becomes Effective.

FATA means the Foreign Acquisitions and Takeovers Act 1975 (Cth).

FIRB means the Australian Foreign Investment Review Board.

First Court Hearing Date means the first day of the hearing of the Court of an application for an order under section 411(1) of the Corporations Act convening the Scheme Meeting.

Fractional Avita US Share has the meaning given in clause 2.7.

Government Authority means:

(a)

a government, whether foreign, federal, state, territorial or local;

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AIVITA Biomedical Publishes Study Comparing Immune Responses and Associated Survivals Induced by Dendritic and Tumor Cell Vaccines – BioSpace

Posted: April 23, 2020 at 12:53 pm

Findings confirmed that patient-specific autologous dendritic cell vaccines (DCV) induced a different immune response associated with longer survival than autologous tumor cell vaccines (TCV)

IRVINE, Calif.--(BUSINESS WIRE)-- AIVITA Biomedical, Inc., a biotechnology company specializing in innovative cell therapy applications, announced today the publication of a paper titled, Cytokine network analysis of immune responses before and after autologous dendritic cell and tumor cell vaccine immunotherapies in a randomized trial, in the Journal of Translational Medicine. Robert O. Dillman, M.D., chief medical officer at AIVITA, and Gabriel I Nistor, M.D., chief scientific officer at AIVITA, authored the article.

The publication provides insight into the innate and adaptive immune responses induced by patient-specific autologous dendritic cell vaccines (DCV) and autologous tumor cell vaccines (TCV), and their impact on survival. DCV was associated with a multipronged innate and adaptive immune response and correlated with improved survival compared to TCV.

In a randomized Phase 2 trial conducted in patients with melanoma, blood samples were obtained at one week before and one week after a course of three weekly injections, which either included dendritic cells loaded ex vivo with antigens from autologous irradiated tumor-initiating cells (DCV), or autologous irradiated tumor-initiating cells alone (TCV). Cytokine network analysis techniques used to analyze the serologic immune responses generated by each immunotherapy confirmed they triggered differing responses. The results help provide insight into a potential underlying immunologic mechanism of action that contributes to improved survival in DCV-treated patients.

This analysis reinforces conclusions from our patient-specific cancer vaccine survival data, which suggested that ex-vivo processing of the same tumor antigens by autologous dendritic cells induces a more advantageous immune response than antigen-only based tumor cell vaccines, said Dr. Nistor. This is reassuring as we continue to further optimize our unique approach in which we use enhanced autologous dendritic cells for targeting each patients own tumor.

AIVITA is currently conducting three independent clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN skincare line to support the development of its cancer therapeutic pipeline.

About AIVITAS Clinical Trials

OVARIAN CANCER

AIVITAs ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITAs AVOVA-1 trial patients can visit: http://www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITAs glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITAs AV-GBM-1 trial please visit: http://www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITAs melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITAs tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

For additional information about AIVITAs AV-MEL-1 trial please visit: http://www.clinicaltrials.gov/ct2/show/NCT03743298

About AIVITA Biomedical

AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. Founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its therapeutic pipeline and commercial line of skin care products. All proceeds from the sale of AIVITAs skin care products support the treatment of people with cancer.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200423005260/en/

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Regenerative Medicine Products Market Analysis by Size, Share, Top Key Manufacturers, Demand Overview, Regional Outlook And Growth Forecast to 2026 -…

Posted: April 23, 2020 at 12:53 pm

Bellicum Pharmaceuticals

Global Regenerative Medicine Products Market Segmentation

This market was divided into types, applications and regions. The growth of each segment provides an accurate calculation and forecast of sales by type and application in terms of volume and value for the period between 2020 and 2026. This analysis can help you develop your business by targeting niche markets. Market share data are available at global and regional levels. The regions covered by the report are North America, Europe, the Asia-Pacific region, the Middle East, and Africa and Latin America. Research analysts understand the competitive forces and provide competitive analysis for each competitor separately.

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Global Regenerative Medicine Products Market Regions and Countries Level Analysis

The regional analysis is a very complete part of this report. This segmentation highlights Regenerative Medicine Products sales at regional and national levels. This data provides a detailed and accurate analysis of volume by country and an analysis of market size by region of the world market.

The report provides an in-depth assessment of growth and other aspects of the market in key countries such as the United States, Canada, Mexico, Germany, France, the United Kingdom, Russia and the United States Italy, China, Japan, South Korea, India, Australia, Brazil and Saudi Arabia. The chapter on the competitive landscape of the global market report contains important information on market participants such as business overview, total sales (financial data), market potential, global presence, Regenerative Medicine Products sales and earnings, market share, prices, production locations and facilities, products offered and applied strategies. This study provides Regenerative Medicine Products sales, revenue, and market share for each player covered in this report for a period between 2016 and 2020.

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We offer state of the art critical reports with accurate information about the future of the market.

Our reports have been evaluated by some industry experts in the market, which makes them beneficial for the company to maximize their return on investment.

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Our report helps readers decipher the current and future constraints of the Regenerative Medicine Products market and formulate optimal business strategies to maximize market growth.

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Table of Contents:

Study Coverage: It includes study objectives, years considered for the research study, growth rate and Regenerative Medicine Products market size of type and application segments, key manufacturers covered, product scope, and highlights of segmental analysis.

Executive Summary: In this section, the report focuses on analysis of macroscopic indicators, market issues, drivers, and trends, competitive landscape, CAGR of the global Regenerative Medicine Products market, and global production. Under the global production chapter, the authors of the report have included market pricing and trends, global capacity, global production, and global revenue forecasts.

Regenerative Medicine Products Market Size by Manufacturer: Here, the report concentrates on revenue and production shares of manufacturers for all the years of the forecast period. It also focuses on price by manufacturer and expansion plans and mergers and acquisitions of companies.

Production by Region: It shows how the revenue and production in the global market are distributed among different regions. Each regional market is extensively studied here on the basis of import and export, key players, revenue, and production.

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Tags: Regenerative Medicine Products Market Size, Regenerative Medicine Products Market Growth, Regenerative Medicine Products Market Forecast, Regenerative Medicine Products Market Analysis

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Mustang Bio Receives Advanced Therapy Medicinal Product Classification from European Medicines Agency for MB-107 Lentiviral Gene Therapy for X-Linked…

Posted: April 23, 2020 at 12:53 pm

NEW YORK, April 20, 2020 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (Mustang) (MBIO), a clinical-stage biopharmaceutical company focused on translating todays medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced that the European Medicines Agency (EMA) has granted Advanced Therapy Medicinal Product (ATMP) classification to MB-107, Mustangs lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (XSCID), also known as bubble boy disease. The U.S. Food and Drug Administration (FDA) previously granted Regenerative Medicine Advanced Therapy (RMAT) designation to MB-107 for the treatment of XSCID in August 2019.

EMA grants ATMP classifications to new therapeutics that are based on genes or cells and intended as long-term or permanent therapeutic solutions to acute or chronic human diseases at a genetic, cellular or tissue level. The ATMP program provides specific regulatory guidelines for preclinical development, manufacturing and product quality testing of ATMPs and offers incentives, including fee reductions for regulatory advice, recommendations and evaluation and certification of quality and non-clinical data.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, We are extremely encouraged that the EMA has granted MB-107 with ATMP classification, an important step in establishing our path to market approval and commercialization in Europe. This classification complements the RMAT designation we received last year from the FDA and brings us closer to realizing our goal of commercializing MB-107 for XSCID patients, as these patients are in desperate need of innovative and potentially curative treatment options.

MB-107 is currently being assessed in two Phase 1/2 clinical trials for XSCID: the first in newly diagnosed infants under the age of two at St. Jude Childrens Research Hospital (St. Jude), UCSF Benioff Childrens Hospital in San Francisco and Seattle Childrens Hospital and the second in patients over the age of two who have received prior hematopoietic stem cell transplantation at the National Institutes of Health. Under a licensing partnership with St. Jude, Mustang intends to develop the lentiviral gene therapy for commercial use as MB-107.

About Mustang BioMustang Bio, Inc. (Mustang) is a clinical-stage biopharmaceutical company focused on translating todays medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR T therapies across multiple cancers, as well as a lentiviral gene therapy for XSCID. Mustang is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the U.S. Securities and Exchange Commission. Mustang was founded by Fortress Biotech, Inc. (FBIO). For more information, visit http://www.mustangbio.com.

ForwardLooking StatementsThis press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on managements current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

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