StemCell Therapy

With this research service, our Transformational Health team provides critical insights into the global biologics industry highlighting the growth opportunities, market revenue segmentation, and technology trends influencing its growth.

New York, Aug. 11, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Curative Oncology and Rare Disease Therapies Transforming the Global Biologics Market, 20202024" - https://www.reportlinker.com/p05950884/?utm_source=GNW The global biologics market covered in this study includes 4 major segments antibody therapies, recombinant proteins, vaccines, and regenerative medicine.

The forecast for the global biologics market till 2024 reveals interesting trend and paradigm shifts that are set to take place in the industry. Importantly, the study also identifies actionable growth opportunities for industry participants to profit upon.This research service identifies the largest revenue-generating segments and key therapeutic areas for the global biologics industry. Accelerated regulatory approvals for biologic products and the emergence of next-generation technologies are highlighted, in addition to their influence on market trends during the forecast period. The study highlights the dynamics of the biologics industry and the sub-segments of the biologics market. Growth opportunities in antibody-drug conjugate (ADC), RNA therapy, and gene therapy platforms are also explored. Further, the study discusses the impact (such as the accelerated development of vaccines) of the COVID-19 pandemic on the biologics industry and the market. Current challenges facing the biologics industry such as the sluggish growth rate of vaccines, and recombinant proteins are discussed. Most importantly, this research service discusses possible future market trends such as the accelerated development of mRNA-based vaccines and the increasing importance of specialty bio-CDMOs for the development and commercialization of regenerative medicine. Based on the market trends and revenue forecasts, our group of analysts highlight key growth opportunities in ADC, RNA, and gene therapy platforms through successful drug launches such as Belantamab Malfodotin, Inclisiran, and Zolgensma.Read the full report: https://www.reportlinker.com/p05950884/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

__________________________

Link:
Curative Oncology and Rare Disease Therapies Transforming the Global Biologics Market, 20202024 - Yahoo Finance

- StrataGraft Skin Tissue, If Approved, Could Reduce or Eliminate the Need for Autografting of Healthy Skin to Treat Burn Wounds -

STAINES-UPON-THAMES, United Kingdom, Aug. 10, 2020 /PRNewswire/ --Mallinckrodt plc(NYSE: MNK), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Stratatech Biologics License Application (BLA) for StrataGraft, an investigational regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns. The FDA granted the application priority review and assigned a Prescription Drug User Fee Act (PDUFA) target date ofFebruary 2, 2021.

Autograft, the current standard of care for deep partial-thickness thermal burns, involves the surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, leaving the patient with more wounded areas requiring care. Each year, approximately 40,000 patients in the U.S. require hospitalization for the treatment of severe burns.1 The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), expressed interest in StrataGraft skin tissue asa medical countermeasure in response to large-scale burn incidents, and provided funding and technical support for the continued development of StrataGraft skin tissue.

"Treatment advances are needed that can help minimize or eliminate the need for autografting. The FDA's acceptance of the BLA submission for StrataGraft skin tissue for review takes us one step closer to providing adult burn patients in the United States with a potential new treatment option for deep partial-thickness thermal burns," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We are focused on delivering solutions to patients with severe and critical conditions, and look forward to working with the FDA during the regulatory review process for StrataGraft skin tissue."

The StrataGraft skin tissue BLA is based on data from the pivotal Phase 3 STRATA2016clinical trial, previously publishedas an abstract in the Journal of Burn Care & Research and presented via a prerecorded video at the virtual American Burn Association 52nd Annual Meeting, with support from the STRATA2011clinical trial, previously published in Burns. Top-line results from the Phase 3 trial of StrataGraft skin tissue, which met both primary endpoints in adults with deep partial-thickness thermal burns, including autograft sparing and durable wound closure, were announcedin September 2019.

The completion of the BLA rolling submission was announcedon June 9, 2020. The FDA granted StrataGraft skintissue orphan drug designation, and it was among the first products designated by the Agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act.

About StrataGraft StrataGraft regenerative skin tissue is an investigational treatment being developed to reduce autograft in patients with severe thermal burns. An engineered, bilayer tissue, StrataGraft skin tissue is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers. StrataGraft skin tissue can be sutured, stapled or secured with an adhesive. StrataGraft skin tissue is cryopreserved in order to deliver viable cells upon application.

Story continues

Mallinckrodt is currently conducting a StrataGraft skin tissue continued access clinical trial (StrataCAT, NCT04123548) under an Expanded Access Program (EAP). The trial sites involved in the pivotal Phase 3 trial (STRATA2016, NCT03005106) have the opportunity to participate in this multicenter, open-label study. The company is planning to evaluate StrataGraftskintissue for the treatment of adults with full-thickness burns (also referred to as third-degree burns). Additionally, Mallinckrodt plans to conduct a study evaluating StrataGraft skin tissue in treatment of pediatric populations.

StrataGraft skintissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.

The continued development of StrataGraft skin tissue, including the pivotal Phase 3 clinical study (STRATA2016) and the BLA process for StrataGraft skin tissue in the United States, is being supported through a partnership with BARDA, under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under Project BioShield Contract No. HHSO100201500027C. These efforts are part of BARDA's strategy to build emergency preparedness in response to mass casualty events involving trauma and thermal burns by developing novel medical countermeasures for adult and at-risk populations. In the case of a mass casualty thermal burn event, the Government Accountability Office estimates that more than 10,000 patients might require thermal burn care.2The limited number of specialized burn centers and related medical infrastructure in the United States creates a public health need for therapies that could be deployed quickly for use in these and other care sites.

About Deep Partial-Thickness Thermal BurnsDeep partial-thickness thermal burns are complex skin injuries in which the damage extends through the entire epidermis (outermost layer of skin) and into the lower part of the dermis (innermost layer of skin).

Autograft is considered to be a standard of care by many for deep partial-thickness thermal burns. It involves the surgical harvesting of healthy skin tissue from an uninjured site on the patient and transplanting the skin graft to the injury. While this process can be effective in providing closure of the original wound, it has significant limitations related to the donor site wounds created during surgical removal of the skin tissue for grafting. Donor site wounds are painful and can create risks of additional scarring and infection. In addition, the amount of healthy skin available for harvesting is frequently limited in those patients with large burns, necessitating sequential re-harvesting of available donor sites. As a result, there is a need for alternatives to donor site harvesting for the treatment of severe burns.

About Mallinckrodt Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit http://www.mallinckrodt.com.

Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

Cautionary Statements Related to Forward-Looking StatementsThis release includes forward-looking statements concerning StrataGraft regenerative skin tissue, including the anticipated regulatory review process, its potential impact on patients, and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

CONTACTS

For Trade Media InquiriesSheryl SeapyW2O 213-262-9390sseapy@w2ogroup.com

For Financial/Dailies Media InquiriesRon BartlettH+K Strategies Senior Vice President813 545 2399ron.bartlett@hkstrategies.com

Investor Relations Daniel J. SpecialeVice President, Investor Relations and IRO314-654-3638daniel.speciale@mnk.com

Government AffairsMark TyndallSenior Vice President, Government Affairs & Chief Counsel, Litigation202-459-4141mark.tyndall@mnk.com

Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.

2020 Mallinckrodt. US-2001226 07/20.

________________________1 American Burn Association. Burn Incidence Fact Sheet. http://ameriburn.org/who-we-are/media/burn-incidence-fact-sheet/. Accessed May 15, 2020.2 United States Government Accountability Office. National Preparedness: Countermeasures for Thermal Burns. https://www.gao.gov/assets/590/588738.pdf. Accessed February 12, 2020.

View original content to download multimedia:http://www.prnewswire.com/news-releases/mallinckrodt-announces-us-fda-filing-acceptance-of-biologics-license-application-for-stratagraft-regenerative-skin-tissue-for-treatment-of-adults-with-deep-partial-thickness-thermal-burns-301108836.html

SOURCE Mallinckrodt plc

Continued here:
Mallinckrodt Announces U.S. FDA Filing Acceptance of Biologics License Application for StrataGraft Regenerative Skin Tissue for Treatment of Adults...

DUBLIN, Aug. 11, 2020 /PRNewswire/ -- The "Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report" report has been added to ResearchAndMarkets.com's offering.

Since the discovery of induced pluripotent stem cells (iPSCs) a large and thriving research product market has grown into existence, largely because the cells are non-controversial and can be generated directly from adult cells. It is clear that iPSCs represent a lucrative market segment because methods for commercializing this cell type are expanding every year and clinical studies investigating iPSCs are swelling in number.

Therapeutic applications of iPSCs have surged in recent years. 2013 was a landmark year in Japan because it saw the first cellular therapy involving the transplant of iPSCs into humans initiated at the RIKEN Center in Kobe, Japan. Led by Masayo Takahashi of the RIKEN Center for Developmental Biology (CDB), it investigated the safety of iPSC-derived cell sheets in patients with macular degeneration. In another world-first, Cynata Therapeutics received approval in 2016 to launch the world's first formal clinical trial of an allogeneic iPSC-derived cell product (CYP-001) for the treatment of GvHD. Riding the momentum within the CAR-T field, Fate Therapeutics is developing FT819, its off-the-shelf iPSC-derived CAR-T cell product candidate. Numerous physician-led studies using iPSCs are also underway in Japan, a leading country for basic and applied iPSC applications.

iPS Cell Commercialization

Methods of commercializing induced pluripotent stem cells (iPSCs) are diverse and continue to expand. iPSC cell applications include, but are not limited to:

Since the discovery of iPSC technology in 2006, significant progress has been made in stem cell biology and regenerative medicine. New pathological mechanisms have been identified and explained, new drugs identified by iPSC screens are in the pipeline, and the first clinical trials employing human iPSC-derived cell types have been initiated. The main objectives of this report are to describe the current status of iPSC research, patents, funding events, industry partnerships, biomedical applications, technologies, and clinical trials for the development of iPSC-based therapeutics.

Key Topics Covered:

1. Report Overview

2. Introduction

3. History of Induced Pluripotent Stem Cells (IPSCS)

4. Research Publications on IPSCS

5. IPSCS: Patent Landscape

6. Clinical Trials Involving IPSCS

7. Funding for IPSC

8. Generation of Induced Pluripotent Stem Cells: An Overview

9. Human IPSC Banking

10. Biomedical Applications of IPSCS

11. Other Novel Applications of IPSCS

12. Deals in the IPSCS Sector

13. Market Overview

14. Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/kpc95y

About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

http://www.researchandmarkets.com

Visit link:
Opportunities in the Global Induced Pluripotent Stem Cell (iPS Cell) Industry - PRNewswire

The U.S. government bought 100 million doses of mRNA-1273 from Moderna Inc., of Cambridge, Mass., with a new award worth up to $1.525 billion. The deal, part of Operation Warp Speed, also brings a U.S. government option to buy up to an additional 400 million doses from Moderna. The implied price per dose is about $15.25, below SVB Leerinks $22 price per dose model from previous Moderna-Operation Warp Speed deals. On July 27, Moderna dosed the first of what could be as many as 30,000 healthy volunteers as it began its phase III COVID-19 vaccine trial. Those volunteers at increased risk of contracting COVID-19, with a large percentage being elderly or people with co-morbidities those most at risk for life-threatening COVID-19 infections are receiving placebo or mRNA-1273.

Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the infections themselves, theres one point of agreement: the pandemic has been a painful experience that everyone needs to learn from. Im hoping that memory is not short, Mike Piccarreta, a partner at global consulting firm Kearney, told BioWorld. Clearly we were not prepared for this type of pandemic in terms of government response and manufacturing capacity, he added. Had the U.S. and other countries acted on lessons that should have been learned in the past, they would have been better prepared for COVID. And if they allow the current lessons to fade with time, they will not be ready for the next pandemic.

LONDON Antifungal specialist F2G Ltd. has closed a $60.8 million round, providing the means to complete phase III development of the lead product olorofim, a treatment for life-threatening invasive infections, and to scale up in preparation for commercialization. Olorofim is the first of a new class of drugs called orotomides, discovered and developed to phase IIb by F2G. If approved, it will be the first new antifungal based on a novel mechanism in nearly 20 years.

A bid by top shareholders and managers of the U.S.-China cell therapy developer Cellular Biomedicine Group Inc. to take the company private pushed shares (NASDAQ:CBMG) 35% higher Wednesday, just shy of the offering price. "As a private company, we will have access to the resources and long-term commitment needed to better pursue new capital investment in existing assets and targeted acquisition opportunities as our sector continues to evolve, including further geographic and product diversification," CBMG's CEO Tony Liu told employees.

As part of its earnings report earlier this week, Reata Pharmaceuticals Inc. provided a regulatory update that caused some chagrin among investors. The company said the FDA is not convinced that the Moxie Part 2 results will support a single study approval without additional evidence that lends persuasiveness to the results. A phase II study with omaveloxolone for Friedreichs ataxia, Moxie Part 2 had gained the agencys sign-off regarding its primary endpoint; improvement on the modified Friedreich Ataxia Rating Scale. Reata said an NDA submission is now targeted for the first quarter of next year, assuming regulators accept the trial design of the companys planned crossover study. The company provided more encouraging news about the progress of bardoxolone in Alport syndrome. Shares (NASDAQ:RETA) took a hit Monday, dropping from $156.20 to $105.40, and were trading midday at $103.09.

Newly founded Lianbio, with offices in Shanghai and San Francisco, aims to quickly establish a presence in China and Asia with late-stage assets in-licensed from Bridgebio Pharma Inc. and Myokardia Inc. in two deals amounting to $531.5 million and $187.5 million, respectively. Launched on Aug. 11, Lianbio was founded, seeded and incubated by hedge fund Perceptive Advisors with the aim of bringing in first-in-class drugs. Perceptive will help the startup pick assets that have a good chance of becoming clinically successful.

PERTH, Australia Aussie regenerative medicine company Regeneus Ltd. has out-licensed its lead mesenchymal stem cell and secretome therapy, Progenza, to Japans Kyocera Corp. for osteoarthritis of the knee for the Japan market. Under the terms of the deal, Regeneus will receive $19 million in up-front and milestone payments, consisting of $9 million up front and $10 million in regulatory and development milestones. Regeneus will also receive double-digit royalties on sales. The company retains rights to negotiate licenses with other partners for additional indications inside and outside of Japan.

HONG KONG Singapore-based Tessa Therapeutics Pte Ltd. released the results of two independent phase I/II trials led by Baylor College of Medicine and the University of North Carolina Lineberger Comprehensive Cancer Center. It was found that Tessas autologous CD30 CAR T-cell therapy (TT-11) showed a high rate of durable complete responses and a very favorable safety profile in patients with relapsed/refractory Hodgkin lymphoma.

Adverum, Akari, Arca, Ascendis, Azurrx, Beroni, Blade, Boehringer Ingelheim,Botanix, Cellular Biomedicine, Cytovia, Eli Lilly, Eloxx, Epirium, Eyegate, Genscript, Helix, Hepion, Horizon, Ikena Oncology, India Globalization Capital, Inhibrx, Innovent, Kahr Medical, Kineta, Monopar, Nektar, Nicox, Nymox, Omeros, PDL, Pliant, Redhill, Regeneron, Sapience, Seattle Genetics, Seres, Theranexus, Therapeutic Solutions, Trevena, Vaccibody, VBL

Go here to see the original:
Moderna receives $1.525B more in COVID-19 funding from Operation Warp Speed - BioWorld Online

A new intelligence report Advanced Wound Management Technologies Market has been recently added to Adroit Market Research collection of top-line market research reports. Global Advanced Wound Management Technologies Market report is a meticulous all-inclusive analysis of the market that offers access to direct first-hand insights on the growth trail of market in near term and long term. On the basis of factual information sourced from authentic industry experts and extensive primary industry research, the report offers insights on the historic growth pattern of Advanced Wound Management Technologies Market and current market scenario. It then provides short- and long-term market growth projections.

Projections are purely based on the detailed analysis of key market dynamics that are expected to influence Advanced Wound Management Technologies Market performance and their intensity of impacting market growth over the course of assessment period.

Request Sample Report @ https://www.persistencemarketresearch.co/samples/3540

In addition to evaluation of dynamics, the report provides in-depth examination of key industry trends that are expected to act more prominently in global Advanced Wound Management Technologies Market. The study also offers valued information about the existing and upcoming growth opportunities in Advanced Wound Management Technologies Market that the key players and new market entrants can capitalize on.

Competitive companies and manufacturers in global market

Some of the major companies operating in the global advanced wound management technologies market are 3M, Bard Medical Division, Coloplast A/S, Derma Sciences Inc., Hartmann Group, Shire Regenerative Medicine and Baxter International Inc. In addition, some other companies operating in global advanced wound management technologies market are Ethicon Inc., Smith & Nephew Plc, Convatec Inc. and Genzyme Corporation, a Sanofi company.

Key geographies evaluated in this report are:

Key features of this report

Request Report Methodology @ https://www.persistencemarketresearch.co/methodology/3540

Opportunity assessment offered in this Advanced Wound Management Technologies Market report is important in terms of understanding the lucrative areas of investment, which prove to be the actionable insights for leading market players, suppliers, distributors, and other stakeholders in Advanced Wound Management Technologies Market.

In-depth global Advanced Wound Management Technologies Market taxonomy presented in this report provides detailed insights about each of the market segments and their sub-segments, which are categorized based on t par various parameters. An exhaustive regional analysis of global Advanced Wound Management Technologies Market breaks down global market landscape into key geographies.

Regional outlook and country-wise analysis of Advanced Wound Management Technologies Market allows for the evaluation of multi-faceted performance of market in all the key economies. This information intends to offer a broader scope of report to readers and identify the most relevant profitable areas in global market place.

Key Regions and Countries Covered in Global Advanced Wound Management Technologies Market Report-

Taxonomy and geographical analysis of the global Advanced Wound Management Technologies Market enables readers to spot profits in existing opportunities and capture upcoming growth opportunities even before they approach the market place. The analysis offered in report is purely intended to unroll the economic, social, regulatory and political scenarios of the market specific to each region and country, which could help potential market entrants in Advanced Wound Management Technologies Market landscape to understand the nitty-gritty of target market areas and devise their strategies accordingly.

For any queries get in touch with Industry Expert @ https://www.persistencemarketresearch.co/ask-an-expert/3540

Advanced Wound Management Technologies Market Table of Contents

View post:
Advanced Wound Management Technologies Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2015 2021 - Jewish Life News

A recent stem cell study has shown that SARS-CoV-2, the novel coronavirus, can infect heart cells via the same receptor present in the lungs. This may be responsible for the cardiac complications associated with COVID-19.

Experts initially thought that COVID-19 was a respiratory disease, with symptoms including cough, shortness of breath, and pneumonia. However, more recent evidence into COVID-19 shows that the disease can also cause neurological and cardiac symptoms.

Physicians have reported changes to the circulatory system in people with COVID-19, sometimes leading to blood clots, as well as cardiac complications, such as changes to the heart rhythm, damage to heart tissue, and heart attacks.

Although there is widespread agreement that COVID-19 is a risk to the heart, whether these symptoms are due to the virus directly or a consequence of other disease processes, such as inflammation, has been unclear.

Stay informed with live updates on the current COVID-19 outbreak and visit our coronavirus hub for more advice on prevention and treatment.

In a new study appearing in the journal Cell Reports Medicine, scientists have helped resolve this mystery by showing that SARS-CoV-2 can infect heart cells and change their function.

Their findings, from experiments in human stem cells, suggest that the cardiac symptoms of COVID-19 may be the direct result of the infection of heart tissue.

The scientists used a type of stem cell called induced pluripotent stem cells (iPSCs) to generate heart cells.

Scientists can create iPSCs from a persons skin cells and then reprogram them to become any cell type in the body. They provide a useful tool for research into human disease and a way to test new treatments.

In this study, the team programmed the iPSCs to become heart cells and later incubated them with SARS-CoV-2. Using microscopes and genetic sequencing techniques, the researchers found that SARS-CoV-2 could directly infect the heart cells.

They also showed that the virus can rapidly divide inside heart cells, which caused changes to the hearts ability to beat after a period of under 3 days.

We not only uncovered that these stem cell-derived heart cells are susceptible to infection by [the] novel coronavirus, but that the virus can also quickly divide within the heart muscle cells, explains first study author Dr. Arun Sharma, a research fellow at the Regenerative Medicine Institute of Cedars-Sinai Medical Center in Los Angeles, CA.

Additional experiments focused on the different genes expressed by heart cells before and after the virus infected them. These studies showed activation of the innate immune response and antiviral clearance pathways to help fight the virus.

However, how does the virus get into the heart in the first place? The researchers suggest that one way in which it gains access may be by using angiotensin-converting enzyme 2 (ACE2). This is the same receptor the virus uses to infect cells in the lungs.

Importantly, studies have shown that treatment with an ACE2 antibody can help stop SARS-CoV-2 from replicating and save cells in the heart.

By blocking the ACE2 protein with an antibody, the virus is not as easily able to bind to the ACE2 protein, and thus cannot easily enter the cell. This not only helps us understand the mechanisms of how this virus functions, but also suggests therapeutic approaches that could be used as a potential treatment for SARS-CoV-2 infection.

Dr. Arun Sharma

The researchers suggest that scientists could use stem cell-derived heart cells to screen new drugs and find compounds able to stop the infection of heart cells.

This key experimental system could be useful to understand the differences in disease processes of related coronaviral pathogens SARS and MERS, adds study author Dr. Vaithilingaraja Arumugaswami, an associate professor at the University of California, Los Angeles.

There are some limitations to this approach, however. These include the fact that stem cell-derived heart cells are not exactly the same as the real thing.

The researchers also studied the cells in a dish, an isolated system lacking the immune interactions that would occur in the human body.

Nevertheless, the experiments clearly showed that the cells became infected with SARS-CoV-2, which is in line with some clinical data showing the virus in the hearts of people who died from COVID-19.

For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.

Read the original:
COVID-19 could directly affect the heart - Medical News Today

Global Coronavirus pandemic has impacted all industries across the globe, Cell Culture Supporting Instrument market being no exception. As Global economy heads towards major recession post 2009 crisis, Cognitive Market Research has published a recent study which meticulously studies impact of this crisis on Global Cell Culture Supporting Instrument market and suggests possible measures to curtail them. This press release is a snapshot of research study and further information can be gathered by accessing complete report. To Contact Research Advisor Mail us @ [emailprotected] or call us on +1-312-376-8303.

Cognitive Market Research has added a new research report to their collection titled: Cell Culture Supporting Instrument Market. In the research report various factors of the market & industry on the whole have been studies/researched and compiled together. Various in-depth factors explained in the report are: size of the industry, drivers, challenges faced by the market/restraints, opportunities, forecast analysis, regional analysis and various other factors that show the entire market functioning.

Manufacturers are facing continued downward pressure on demand, production and revenues as the COVID-19 pandemic strengthens.manufacturers should be prepared for major global supply chain disruptions. Thus, some of the key players are mainly focusing on research & development to provide inovative products to clint. The report provides an in-depth analysis regarding key players of the market along with their company profiles that contains all the information of its happening and recent developments. Various factors influencing the market development and growth as well as latest development strategies implemented by key players that can influence the growth of the market is explained. Thermo Fisher Scientific Inc. U.S., Merck KGaA Germany, GE Healthcare U.K., Lonza Group AG Switzerland, Becton Dickinson and Company U.S., Corning Inc. U.S., Eppendorf AG Germany, Hi Media Laboratories India, Sartorius AG Germany, Promocell GmbH Germany are some of the key players operating in this market.

Enquire Here For Discount (COVID-19 Impact Analysis Updated Sample): Click Here>Download Sample Report of Cell Culture Supporting Instrument Market Report 2020 (Coronavirus Impact Analysis on Cell Culture Supporting Instrument Market)

The global Cell Culture Supporting Instrument Market can be segmented into various type and application. All the type and application segments have been analyzed based on present and future trends and the market is estimated from 2020 to 2027. Moreover, study also provides quantitative and qualitative analysis of each type to understand the driving factors for the fastest growing type segment for Cell Culture Supporting Instrument market.

Global Cell Culture Supporting Instrument Market Segmentation: By Types Cell Counters, Filtration Systems, Centrifuges, CO2 Incubators, Autoclaves, Microscopes, Biosafety Cabinets, Others

Global Cell Culture Supporting Instrument Market segmentation: By Applications Biopharmaceutical/Therapeutics, Stem Cell Technology, Cancer Research, Drug Screening & Development, Tissue Engineering & Regenerative Medicine, Others

Take Note that: The Covid-19 situation and its impacts are studied by our analysts in such a way that the recovery state post covid-19 of the market is explained which shows lucrative rate for the manufacturers and producers. And also, other information related to Covid-19 like: consumer behaviour, impact on industry & market, latest strategies that can benefit the market players is explained in the report.

Free report sample of Cell Culture Supporting Instrument Market available: https://www.cognitivemarketresearch.com/medical-devicesconsumables/cell-culture-supporting-instrument-market-report#download_report

The Cell Culture Supporting Instrument research report contains executive summary, market introduction & analysis, industry analysis, key-players & their in-depth information, raw-materials and various other parameters. All the data is provided in theory as well as with help of graphical representations like: graphs, tables, charts etc as this can make it easy for a decision maker to understand the information briefly & in easier manner. The global level opportunities and position of the market along with the challenges are explained in-depth in the report. The report showcases data form the base year 2020 till the forecast year 2027 along with the revenue and compound annual growth rate. The report also provides historical data for the year 2015 to 2019.

Advantages of purchasing the Cell Culture Supporting Instrument Market report:XXX research report provides all the necessary information from introduction to conclusion by covering every aspect, scenario and latest development of the market. Hence it provides entrepreneurs, decision makers to strengthen their firms, start-up companies and other influencers of a company to improvise and implement the factors mention in the report. Some of the crucial factors that are of interest to the companies have been specifically identified & studied. For instance, market segmentation, revenue, Covid-19 impact, forecast analysis, major players, regional analysis, product types & applications, new innovation strategies & product introduction and various other factors have been regarding growth of the market have been mentioned. Hence this report can serve as an informative blueprint for a business.

Customization of report available: According to the needs of the buyer we customize the parts that are essential for your business. Connect with us to know more and to get all the information regarding the research report based on what suits you.Checkout Inquiry for Buying or Customization of Report: https://www.cognitivemarketresearch.com/medical-devicesconsumables/cell-culture-supporting-instrument-market-report#download_report.

The report also provides regional data analysis for North America, Europe, Asia Pacific, South America, and the Middle East and Africa. Furthermore, it highlights the specific region that holds higher revenue as compare to the other regions and explains reason responsible for this upper hand of particular region.The Cell Culture Supporting Instrument research report also covers various drivers of the market, opportunities & restraints. It also provides information related to the overall market by evaluating various elements to provide the SWOT & PESTEL analysis. Overall information covering all the factors, aspects, scenarios& situations of the market on a global standard have been mentioned in the research report.

About Us: Cognitive Market Research is one of the finest and most efficient Market Research and Consulting firm. The company strives to provide research studies which include syndicate research, customized research, round the clock assistance service, monthly subscription services, and consulting services to our clients. We focus on making sure that based on our reports, our clients are enabled to make most vital business decisions in easiest and yet effective way. Hence, we are committed to delivering them outcomes from market intelligence studies which are based on relevant and fact-based research across the global market.Contact Us: +1-312-376-8303Email: [emailprotected]Web: https://www.cognitivemarketresearch.com/

Continued here:
Global and Asia Pacific Cell Culture Supporting Instrument Market Research Report 2020 CoronaVirus Efect on Industry and Companies, Thermo Fisher...

HealthCare Intelligence Markets unravels its new study titled Virtual Reality in Medicine and Healthcare Market. Effective exploratory techniques such as qualitative and quantitative analysis have been used to discover accurate data. For an effective business outlook, it studies North America, Latin America, Asia-Pacific, Japan, and India by considering different aspects such as type, size, as well as applications. SWOT and Porters five analysis have been used to analyse cost, prices, revenue, and end-users. Various aspects of businesses such as primary application areas, financial overview, and requirement of the industries have been mentioned to give a brief to the readers. This research study further offers mergers, acquisitions and product portfolio of the businesses.

Ask for sample copy of this [emailprotected]https://www.healthcareintelligencemarkets.com/request_sample.php?id=135939

Profiling Key players: Google, Orca Health, Brain Power, Medsights Tech, AccuVein, Microsoft, EchoPixel, Augmedix, Atheer, Aira.

Global Virtual Reality in Medicine and Healthcare Market Report Illuminates:

Ask for a discount on this [emailprotected]https://www.healthcareintelligencemarkets.com/ask_for_discount.php?id=135939

Table of Contents:

For more information ask our experts @https://www.healthcareintelligencemarkets.com/enquiry_before_buying.php?id=135939

If you have any special requirements, please let us know and we will offer you the report as per your requirements.

About Us:

HealthCare Intelligence Markets Reports provides market intelligence & consulting services to a global clientele spread over 145 countries. Being a B2B firm, we help businesses to meet the challenges of an ever-evolving market with unbridled confidence. We craft customized and syndicated market research reports that help market players to build game-changing strategies. Besides, we also provide upcoming trends & future market prospects in our reports pertaining to Drug development, Clinical & healthcare IT industries. Our intelligence enables our clients to make decisions with which in turn proves a game-changer for them. We constantly strive to serve our clients better by directly allowing them sessions with our research analysts so the report is at par with their expectations.

Contact Us:Address: 90, State Office Center,90, State Street Suite 700,Albany, NY 12207Email:[emailprotected]Website:www.healthcareintelligencemarkets.comPhone:+1 (888) 616-2766

View post:
New Comprehensive Report on Virtual Reality in Medicine and Healthcare Market with Profiling Global Key Players by 2027| Google, Orca Health, Brain...

Stem cells have been holding great promise for regenerative medicine for ages. In the last decade, many studies have revealed this form of cell, which in Spanish is calledmother cell due to its ability to contribute to various different cell types, may be applied in regenerative medicine to diseases such as muscle and nervous system disorders, among others.

Scientists and stem cell leaders Sir John B. Gurdon and Shinya Yamanaka received the Nobel Prize in Physiology and Medicine in 2012 for this idea.

However, one of the key constraints in the application of these herbal remedies is the caliber of the stem cells that may be made in the lab, which impedes their use for curative purposes.

Currently, a team in the Cell Division and Cancer Group of the Spanish National Cancer Research Centre (CNIO), headed by researcher Marcos Malumbres, has recently developed a fresh, easy and fast technology that enhances in vitro and in vivo the possibility of stem cells to differentiate into adult cells. The study results will be released this week in The EMBO Journal.

In recent years, several protocols have been proposed to obtain reprogrammed stem cells in the laboratory from adult cells, but very few to improve the cells we already have.The method we developed is able to significantly increase the quality of stem cells obtained by any other protocol, thus favouring the efficiency of the production of specialised cell types.Mara Salazar-Roa, Study First Author and Researcher, Centro Nacional de Investigaciones Oncolgicas

Roa is likewise the co-corresponding author of this analysis.

Within this study, the researchers identified an RNA sequence, called microRNA 203, that can be found at the earliest embryonic stages before the embryo implants in the uterus and when stem cells have their highest ability to generate all the different cells.When they added this molecule to stem cells from the laboratory, they discovered that the cells ability to convert into other cell types improved appreciably.

To corroborate them, they used stem cells of both human and murine origin, and of genetically altered mice. The results were so spectacular, both in mouse cells and in human cells

Application of the microRNA for just 5 days boosts the potential of stem cells in most situations we tested and improves their ability to become other specialised cells, even months after being connected with the microRNA. Says Salazar-Roa.

According to the research, cells modified by this new protocol are more efficient in generating functional cardiac cells, opening the doorway to a better generation of different cell types essential for the cure of degenerative disorders.

Malumbres, mind of the CNIO Cell and Cancer Division Group, states:To deliver this asset to the clinic, cooperation with labs or companies that are looking to exploit that technology is now essential in each particular case.

In this circumstance, Salazar-Roa recently participated, in close collaboration with all the CNIOs Innovation group, in prestigious creation programs like IDEA2 International of the Massachusetts Institute of Technology (MIT) and also CaixaImpulse of thisLa Caixa Foundation, where they also obtained funding to start the maturation of the technology.

Original post:
New technology May Raise the quality of stem cells Found in regenerative medicine - Microbioz India

Hitachi, Ltd and ThinkCyte, Inc. announced that they have entered into a collaboration focused on developing an artificial intelligence (AI)-driven cell analysis and sorting system. Hitachi and ThinkCyte are promoting collaboration with pharmaceutical companies and research institutes working in the field of regenerative medicine and cell therapy to expedite the development of the system toward commercialization.

Founded in 2016 and headquartered in Tokyo, Japan, ThinkCyte, is a biotechnology company that develops life science research, diagnostics, and treatments using integrated multidisciplinary technologies. It has been performing research and development focused on high-throughput single cell analysis and sorting technology to precisely analyze and isolate target cells. ThinkCyte has developed the Ghost Cytometry technology to achieve high-throughput and high-content single cell sorting and has been conducting collaborative research projects with multiple pharmaceutical companies and research institutes to utilize this technology in life science and medical fields.

Hitachi has been providing large-scale automated induced pluripotent stem (iPS) cell culture equipment, cell processing facilities (CPFs), manufacturing execution systems(MES), and biosafety cabinets among other products to pharmaceutical companies and research institutes, and has developed a value chain to meet a variety of customer needs in the regenerative medicine and cell therapy industry. Hitachi has also been carrying out collaborative research projects with universities, research institutes, and other companies to develop core technologies for pharmaceutical manufacturing instruments and in vitro diagnostic medical devices, prototyping for mass production, and working on manufacturing cost reduction and the development of stable and reliable instruments.

Hitachi and ThinkCyte have initiated a joint development of the AI-driven cell analysis and sorting system based on their respective technologies, expertise, and know-how. By combining ThinkCyte's high-throughput and high-content label-free single cell sorting technology and Hitachi's know-how and capability to producing stably operative instruments on a large scale, the two companies will together develop a novel reliable system to enable high-speed label-free cell isolation with high accuracy, which has been difficult to achieve with the existing cell sorting techniques, and to realize stable, low-cost and large-scale production of cells for regenerative medicine and cell therapy.

Hitachi and ThinkCyte will further advance partnerships with pharmaceutical companies and research institutes that have been developing and manufacturing regenerative medicines and cell therapy products in Japan and other countries where demand is expected to be significant, such as North America, in order to make this technology a platform for the production of regenerative medicines and cell therapy products.

More:
Hitachi and ThinkCyte to Develop an AI-driven Cell Analysis | ARC Advisory - ARC Viewpoints

Over the past 20 years the Segway has become ubiquitous on city streets and industrial campuses, in malls and even on wooded trails. The electrically charged, stand-and-ride personal transporter, an oft-parodied icon of the Silicon Valley tech world, quickly gained popularity among law enforcement and security agencies, as well as recreational tour operators around the world.

But the time for the original self-balancing standing scooter has come to a close. According to All Things Considered, Ninebot, the company that now owns Segway, will retire the device on July 15. But its creator, Dean Kamen, has bold new plans.

Kamen made a name for himself as an inventor of medical devices, including the insulin pump. Initially, the Segway grew out of his work on a self-balancing wheelchair. When the Segway launched in December 2001, Kamen believed the new device would transform cities, replacing cars and their pollution with residents gliding down green streets, each one on a segway, writes Liz Brody for OneZero. He told Time magazine it would be to the car what the car was to the horse and buggy.

Despite their widespread use, Segways never became the mobility machines of the future that Kamen dreamed, and in fact, have been criticized for being the cause of countless accidental injuries and deaths. But these incidents did not deter Kamen who, Brody writes, is still busy inventing. Kamen currently holds more than 440 patents in the United States and internationally. And, if successful, his next bright idea, unlike the Segway, might actually have a positive impact on human health: Kamen is now in the market to mass-produce human organs.

More than 110,000 people in the U.S. alone are in need of an organ transplant, and each day 20 people die waiting for a replacement organ. Those who do receive transplants can be at high risk of their body rejecting the organ. For those suffering from failing organs, some hope sprang in the 1990s when scientists began engineering human tissues.

Significant progress has been made in the field since the 90s, and just last year researchers from Tel Aviv University announced they were the first to bioprint a human heart, reports FreeThinks Kristen Houser. Using methods similar to those employed when 3-D printing solid objects from digital models, bioprinting uses living cells to create computer-generated tissue grafts.

Mass availability of lab-grown organs may seem far off to some, but Kamen is poised to spearhead production when the time comes. In 2016, Kamen teamed up with Martine Rothblatt, the head of biotech company United Therapeutics, who was, at the time, working on growing artificial lungs. According to OneZero, the two had already begun collaborating when they heard about a U.S. Department of Defense (DOD) grant opportunity for a scalable process of manufacturing human organs. Kamen and his collaborators won the $80 million DOD grant to manufacture replacement tissue and organs on-demand.

"We need to essentially make the printing press for the world of regenerative medicine, said Kamen at the time.

The grant kickstarted the formation of Advanced Regenerative Manufacturing Institute (ARMI), a nonprofit consortium of around 170 companies, institutions and organizations from across the country, which works hand-in-hand with Kamens BioFabUSA. With a staff and board of directors boasting FDA, Microsoft and Boston Scientific alumni, the group has continued to contribute and raise additional funds, and set up shop in a New Hampshire millyard.

This collaboration is what could enable Kamen to have the world-transformative impact hes hoped for. While other endeavors in the field have been siloedwith policy, robotics, organ and stem-cell research, and biotech engineering all operating more or less independentlynone have yet achieved the printing press factory model that Kamen described.

When youre in this industry and youre thinking about scale, you cant go to Home Depot, Michael Lehmicke, director of science and industry affairs at the Alliance for Regenerative Medicine, told OneZero. Whats unique about ARMI, is theyre thinking of how you would actually scale the system when it is fully commercialized.

Of course, while some have been critical, or at the very least skeptical of Kamens work in the past, Gizmodos Joanna Nelius, for one, is intrigued by the latest prospect.

I had knee surgery to replace my torn ACL over 10 years ago, but the cadaver tendon used to replace it disintegrated inside my joint, so Ive been living without that connective tissue for a decade, she writes. All thats left are two screws that once held it in place, one burrowed into my tibia and the other in my femur. If Kamens vision comes true, then perhaps in the future Ill have my own printed tissue put in its place.

Continue reading here:
As Segway Retires, Its Inventor Gears Up to Grow Organs - Smithsonian Magazine

AVITA Therapeutics, Inc. (NASDAQ: RCEL, ASX:AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today preliminary unaudited results for the fourth quarter and full year ended June 30, 2020, together with a company update.

Preliminary Unaudited Results for Three Month Period Ended June 30, 2020

With effect from July 1, 2020, the Company is reporting financial results in United States dollars (US$), and prepared in accordance with U.S. Generally Accepted Accounting Principles (U.S. GAAP).

To compare with the Companys previously reported results (as reported under IFRS) fourth quarter net revenue was approximately A$6.08M, versus A$5.96M in the third quarter, or an increase of 2.0%.

"We are pleased with our fourth quarter results given the challenges and limited patient and facility access that we have experienced with the onset of the COVID-19 pandemic," said Dr. Mike Perry, AVITA Therapeutics Chief Executive Officer. "Like many others, this quarter we witnessed the most challenging commercial conditions since the RECELL System was launched in the U.S. in early 2019. While burns are not considered elective procedures, the incidence of burns was not immune to the impact of COVID-19 as nationwide protective (executive) orders drove a reduction in accidents resulting in burn injuries. Despite the tough macro environment, the clear benefits of the RECELL System including shortened length of hospital stays, together with less invasive and fewer surgeries, continues to resonate with hospitals, physicians, and patients, which is reflected in our results this quarter."

Preliminary Unaudited Results for the Full Year Ended June 30, 2020

To compare with the Companys previously reported results (as reported under IFRS) fiscal 2020 sales were approximately A$21.72M, an increase of A$14.02M or 182% over the A$7.71M recognized during the previous full year.

To compare with the Companys previously reported results (as reported under IFRS) fiscal 2020 sales were approximately A$21.03M, an increase of A$14.82M or 238% over the A$6.21M recognized during the previous full year.

Company Update

Quarter Ended June 30, 2020

During the fourth quarter we witnessed a wide degree of variability with both revenue and procedural volumes, together with an environment where our customers mandated highly restrictive access practices for our field force given the COVID-19 pandemic. Face-to-face interaction with our burn caregivers continues to be exclusively at "physician request" for case support within the operating theater only, and does not permit participation in the aftercare setting or otherwise enable clinical and business development, for example, to expand utilization of the RECELL System across different burns and users. Given the current state of affairs, we have no reason to believe that these measures, and our limited access, will change in the short term.

As previously stated, burn procedures are neither elective nor deferrable, however the rate of occurrence of these events is very dependent on broader economic activity and "people movement". As such, we saw many of our customers initially experience reduced burn volumes due to the social distancing and shelter-in-place restrictions that have been implemented across the nation.

The reprioritization of hospital resources to support COVID-19 readiness meant that our April results were the lowest monthly revenue and procedural volumes seen this calendar year. Fortunately, as the quarter developed, the benefits of the RECELL System providing reduced hospital stays, and fewer and smaller surgeries, together with both a gradual uptick in burn incidence and hospitals (partially) reverting back from a COVID-19 centric focus, enabled a recovery of both revenue and procedural volume growth through May and June. As with many companies in the current pandemic environment, it is difficult to predict revenue and procedural volume over the coming months, but we are pleased with current utilization rates and our physician commitment.

BARDA

The Company continues to work with the U.S. Biomedical Advanced Research and Development Authority (BARDA) on the procurement of the RECELL System for the U.S. strategic national stockpile for public health medical emergencies (with an estimated contract value of US$7.6 million). The Company is hopeful of providing further updates on this topic during this quarter.

Future Market Opportunities

Set out below is an update on our various future market opportunities:

On July 1, 2020, the FDA approved the IDE application for the pivotal study which is titled "A Prospective Multi-Arm Blinded-Evaluator Within-Subject Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo."

The Company is continuing to work with FDA to finalize two (2) outstanding study design considerations and will provide further updates, including details regarding the study and initiation plan, over the next several weeks.

The Company expects to commence enrollment in the vitiligo pivotal study in the second half of this calendar year.

The Company continues to have a high degree of confidence that the RECELL System can be an effective therapeutic offering for patients with stable vitiligo. More than 1,000 patients have been treated with the RECELL System for vitiligo outside of the United States, and to date there are eight (8) publications demonstrating the benefits of the RECELL System in vitiligo.

By comparison, since October 1, 2019 the Company has benefited from various reimbursement codes for patients admitted for burn treatment in the inpatient hospital setting (under the Hospital Inpatient Prospective Payment System (IPPS)), including the following:

Medicare reimburses hospitals for inpatient services using MS-DRGs (Medicare Severity Diagnosis-Related Groups) (see MS-DRG 927, 928 and 929 for various types of burns (which are non-specific to the RECELL System)).

Specific ICD-10-PCS code series describing our "cell suspension technique" for the use of the RECELL System (see the "OHR" codes within ICD-10-PCS). These procedure codes are assigned to the same DRGs for payment as other skin grafts.

Current Procedural Terminology (CPT) for physicians to support reimbursement for physician rendered healthcare services.

There is no procedure-specific CPT code for the RECELL Systems cell suspension autografting and so, per recommendations from the American Burn Association, providers using the RECELL System are guided to the existing long-standing epidermal autografting codes (e.g. CPT code 151101 and 15115)2.

In the outpatient setting, the Company has been seeking a New Technology Ambulatory Payment Classification (APC) under the Outpatient Prospective Payment System (OPPS) since late 2019. However, based on feedback from The Centers for Medicare & Medicaid Services (CMS) and given recent changes to the OPPS payments system discussed below, the Company will now instead pursue a Transitional Pass-through Payment Application (TPT) to support separate additional Medicare payment for the RECELL System.

CMS has advised the Company that the availability of the long-standing CPT code 15110 and CPT code 15115 (which providers may presently utilize in both the inpatient and outpatient hospital setting) excludes our ability to apply for a New Technology APC for use in the outpatient setting.

On January 1, 2020, CMS implemented changes to the OPPS and ambulatory surgical centers (ASC) payment systems to permit medical devices, including the RECELL System, "that have received FDA marketing authorization and are part of the Breakthrough Devices Program [to] be approved [by CMS for TPT] through the quarterly [review] process" (as opposed to the typical annual review process).

TPT was established by CMS to provide an alternative payment pathway for "transformative medical devices". Similar to the New Technology APC, if approved CMS would create a new C code and would allow the RECELL System to be billed and paid separately in hospital outpatient facilities and ASCs.

As a recipient of Breakthrough Device status, AVITA Therapeutics will work with CMS through the next CMS scheduled quarterly review cycle and is hopeful of having a C code in place for the RECELL System on January 1, 2021 (which should not change our current commercialization timeline for the outpatient hospital setting).

Enrollment of clinical studies across the United States are largely paused at present and the Companys enrollment of the aforementioned studies are accordingly largely on hold.

The Company has enrolled three (3) patients in the pediatric scald study and one (1) patient in the soft tissue reconstruction study.

The Company anticipates that enrollment will resume in the ensuing quarter.

Publications

Notable publications released during the quarter were as follows:

Japan

AVITA Therapeutics continues to work with our Japanese marketing partner, COSMOTEC, to advance our application for approval to market the RECELL System in Japan pursuant to Japans Pharmaceuticals and Medical Devices Act. The application has been constructed broadly to seek approval for the treatment of patients with burns, chronic wounds and vitiligo in three (3) size configurations of the RECELL System.

Story continues

Progress on the application has been delayed due to the COVID-19 pandemic and the associated State of Emergency declaration in Japan. In addition, Japans regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), has now requested various non-clinical "raw data" (e.g., original hand written copies of data entry forms or records) of a small subset of our historic studies, some of which were conducted more than ten (10) years ago. To facilitate PDMAs request, AVITA Therapeutics is repeating three (3) non-clinical or "benchtop" tests. These tests are expected to be completed and submitted in August, and the Company hopes to then advance our application for approval of the RECELL System in Japan.

Other Updates

Authorized for release by the Chief Executive Officer of Avita Therapeutics, Inc.

ABOUT AVITA THERAPEUTICS, INC.

AVITA Therapeutics is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Therapeutics 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 Therapeutics 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.

1 CPT code 15110: Epidermal autograft, trunks, arms, legs; CPT code 15115: Epidermal autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and / or multiple digits.2 It should be noted that the CPT code may be used in both the inpatient and the outpatient hospital setting.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200709005311/en/

Contacts

FOR FURTHER INFORMATION:

U.S. Media Sam Brown, Inc. Christy CurranPhone +1 615 414 8668christycurran@sambrown.com

O.U.S Media Monsoon Communications Rudi MichelsonPhone +61 (0)3 9620 3333Mobile +61 (0)411 402 737rudim@monsoon.com.au

Investors: Westwicke Partners Caroline CornerPhone +1 415 202 5678caroline.corner@westwicke.com

AVITA Therapeutics, Inc. David McIntyreChief Financial OfficerPhone +1 661 367 9178dmcintyre@avitamedical.com

Go here to see the original:
AVITA Therapeutics Provides Company Update and Preliminary Unaudited Results for the Fourth Quarter and Fiscal Year 2020 - Yahoo Finance

Latest update on Orthopedic Regenerative Medicine Market Analysis report published with an extensive market research, Orthopedic Regenerative Medicine market growth. This report is highly predictive as it holds the overall market analysis of topmost companies into the Orthopedic Regenerative Medicine industry. With the classified Orthopedic Regenerative Medicine market research based on various growing regions this report provide leading players portfolio along with sales, growth, market share and so on.

In 2018, the consumables segment held a largest market share of the Orthopedic Regenerative Medicine market, by product. The consumables segment is also expected to dominate its market share in 2027 as the consumables are widely used for several times. The rising number of research and developments and clinical activities are likely to grow market. The segment is also anticipated to witness the fastest growth rate during the forecast period, 2020 to 2027.

To learn more about this report, request a sample copy*

* The sample copy includes: Report Summary, Table of Contents, Segmentation, Competitive Landscape, Report Structure, and Methodology.

Request a sample copy of this report @ https://www.coherentmarketinsights.com/insight/request-sample/3566

Orthopedic Regenerative MedicineMarket Competitive Landscape

Key players operating in theOrthopedic Regenerative Medicine market include Curasan, Inc., Carmell Therapeutics Corporation, Anika Therapeutics, Inc., Conatus Pharmaceuticals Inc., Histogen Inc., Royal Biologics, Ortho Regenerative Technologies, Inc., Swiss Biomed Orthopaedics AG, Osiris Therapeutics, Inc., and Octane Medical Inc.

Orthopedic Regenerative Medicine Market Regional Analysis

For comprehensive understanding of market dynamics, the Global Orthopedic Regenerative Medicine Market is analyzed across key geographies namely North America, Europe, China, Japan, Southeast Asia, India, Central & South America. Each of these regions is analyzed on basis of market findings across major countries in these regions for a macro-level understanding of the market.

What will you get in this report?

An exhaustive analysis of the global Orthopedic Regenerative Medicine market with detailed studies on different topics that will help key players to create effective development strategies and strengthen a strong position in the Orthopedic Regenerative Medicine industry.

It gives a complete mapping of the behaviors of Orthopedic Regenerative Medicine market contributors and the vendor landscape. Existing companies could use the report to prepare themselves well to face future market challenges and strongly compete in the global Orthopedic Regenerative Medicine market.

Also, the analysts have provided a thorough assessment of the impact of these strategies on Orthopedic Regenerative Medicine market growth and competition and many more

A competitive portfolio of Orthopedic Regenerative Medicine market in the different regions including their growth factors, pitfall challenges, investment structure, advancement in all aspects, customer base etc.

Note: *The Download PDF brochure only consist of Table of Content, Research Framework, and Research Methodology.

Request PDF Research Report Brochure @https://www.coherentmarketinsights.com/insight/request-pdf/3566

A Pin-point overview of TOC of Orthopedic Regenerative Medicine Market are:

Overview and Scope of Orthopedic Regenerative Medicine Market

Orthopedic Regenerative Medicine Market Insights

Industry analysis Porters Five Force

Company Market Share Analysis

Need a discount?

Note: *The discount is offered on the Standard Price of the report.

Request discount for this report @https://www.coherentmarketinsights.com/insight/request-discount/3566

About Us:

Coherent Market Insights is a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity.

Contacts US:

Mr. ShahEmail:[emailprotected]Phone: US +1-206-701-6702/UK +44-020 8133 4027

Original post:
Impact of the COVID-19 on Orthopedic Regenerative Medicine Market is Growing Rapidly by 2027 | Curasan, Inc., Carmell Therapeutics Corporation, Anika...

The Global Collagen Market for Regenerative Medicine is projected to reach $679.9 Million, at a CAGR of 10.1% during the forecast period. The GlobalGelatin Market for Regenerative Medicine is projected reach $94.9 Million, at a CAGR of 7.8% during the forecast period.

According to the new market research report "Collagen and Gelatin Market for Regenerative Medicine (by Source (Bovine, Porcine, Marine), Application (Wound Care, Orthopedic, Cardiovascular)), Value and Volume Analysis - Global Forecast" published by MarketsandMarkets

Major Market Growth Drivers:

Browse155 Market Data Tables and48 Figures spread through177 Pages and in-depth TOC -Request Research Sample Pages:www.marketsandmarkets.com/requestd=95663122

Market Segmentation in Depth:

The bovine collagen segment accounted for the largest share of the market

By source, the global collagen market for regenerative medicine has been segmented into bovine collagen, porcine collagen, marine collagen, and other sources. The bovine collagen segment is expected to command the largest share of the global collagen market for regenerative medicine.

The large share of this segment is attributed to the lower cost and extensive availability of bovine collagen.

The orthopedic applications accounted for the largest share of the global collagenmarket for regenerative medicine

On the basis of application, the global collagen market for regenerative medicine has been segmented into orthopedic, wound care, cardiovascular, and other applications. The orthopedic applications segment is expected to command the largest share of the global collagen market for regenerative medicine.

The large share of this segment can primarily be attributed to the high prevalence of osteoporosis.

Download PDF Brochure:www.marketsandmarkets.com/pdfdownd=95663122

Geographical Regions Mapped in Report:

North America is expected to account for the largest share of the collagen market for regenerative medicine. The high incidence of periodontitis, increasing prevalence of heart diseases and diabetes in the U.S., and growing number of research studies in Canada are the major factors supporting the growth of this market.

The Asia-Pacific region is projected to register the highest growth rate during the forecast period.

Major Key Players Mapped in Research Report:

The major players operating in the global collagen market for regenerative medicine include Integra LifeSciences Holding Corporation (U.S.), Collagen Matrix, Inc. (U.S.), Collagen Solutions plc (U.K.), Royal DSM (Netherlands), Vornia Biomaterials, Ltd.(Ireland), SYMATESE (France), and NuCollagen, LLC. (U.S.).

The major players operating in the global gelatin market for regenerative medicine include GELITA AG (Germany), Nitta Gelatin, Inc. (Japan), and PB Gelatin (Belgium).

This email address is being protected from spambots. You need JavaScript enabled to view it.

Follow this link:
Explore the Collagen and Gelatin Market for Regenerative Medicine | growth drivers, segmentation & geographical analysis - WhaTech Technology and...

The Global Stem Cells Group (GSCG) a world leader in Regenerative Medicine Technologies has signed an agreement with South Korean-based Rokit Healthcare, an esteemed bioprinter manufacturer that is committed to advancing the field of regenerative medicine and bettering the quality of life of people around the world.

The field of bioprinting is an extremely new one, but it shows great promise. Simply, it is the automated, computer aided deposition of bio-materials (which are cells, growth factors, and biocompatible polymers) for the manufacturing of functional human tissues or organs. Growth factors are harvested and used with a proprietary printing technology to create or regenerative damaged or diseased organs. Rokit Healthcare does this primarily through the proliferation of a machine that they dub an organ regenerator it looks like a 3D printer, but instead of using plastics to create things, they use cells and materials that will be safe to implant within the human body.

The process of 3D bioprinting human tissues and organs is a revolutionary technology in the field of tissue engineering. One of the major challenges in regenerative medicine research and tissue engineering is mimicking the micro and macro environment of human tissues. In response to this challenge, advances in additive manufacturing have inspired scientists in Korea to develop novel bioprinting technology, for human tissues and organs.

With the advancements of 3D printing and regenerative medicine working together, the potential is seemingly limitless for the spreading of bioprinting technology, a process that is known as 4D Printing and Global Stem Cells Group, in an effort make this revolutionary technology available to patients, has forged an agreement with Rokit Healthcare to promote, and distribute the companys technology in Latin America-

The Invivo 4D Printer is Rokit Healthcares flagship product, and it is one that revolutionizes the application of regenerative medicine and growth factor-based therapies. creating a solution for personalized and improved patient care. By leveraging a combination of 3D and bioprinting technologies, it can better distribute a patients autologous tissues and cells, making it an invaluable tool for those that are looking to improve the efficacy of their results, especially for certain dermatological conditions including scarring.

Were extremely excited about this new opportunity and look forward to working with Rokit, Says Benito Novas, CEO of the Global Stem Cells Group, The Invivo 4D Printer is in a position to turn the practice of regenerative medicine onto its head, and we are planning on creating a training center in Cancun, Mexico exclusively to showcase and instruct other physicians in this cutting-edge technology,

About Global Stem Cells Group

Global Stem Cells Group (GSCG) is a worldwide network that combines seven major medical corporations, each focused on furthering scientific and technological advancements to lead cutting-edge stem cell development, treatments, and training. The united efforts of GSCGs affiliate companies provide medical practitioners with a one-stop hub for regenerative medicine solutions that adhere to the highest medical standards.

About ROKIT :

ROKIT Healthcare is a global healthcare company that is committed to providing an effective and autologous organ regeneration platform. In order to undertake this daunting task, the company uses proprietary biofabrication technologies that show promise in treating several types of diseases in the field of regenerative medicine. Through the proliferation of 4D bioprinting technology, autologous stem cell technologies, ROKIT Healthcare believes that supplying an avenue for organ regeneration will drastically change the way that everyday people trust and manage their own body.

About Global Stem Cells Group

Global Stem Cells Group (GSCG) is a worldwide network that combines seven major medical corporations, each focused on furthering scientific and technological advancements to lead cutting-edge stem cell development, treatments, and training. The united efforts of GSCGs affiliate companies provide medical practitioners with a one-stop hub for stem cell solutions that adhere to the highest medical standards.

Read more from the original source:
Global Stem Cells Group has Announced an Agreement with Rokit Healthcare - PRUnderground

Can a pill provide the same cognitive benefits as exercise? [University of California, San Francisco]

The results of research in mice suggest that a little-studied liver enzyme called Gpld1 may be responsible for the well-known benefits of exercise on the aging brain, and that its regenerative effects may be transferrable directly from one animal to another. The studies, headed by scientists at the University of California, San Francisco (UCSF), Eli and Edythe Broad Center for Regeneration Medicine and Stem Cell Research, showed that when aged, sedentary mice received plasma transfusions from regularly exercising mice, they gained the same beneficial neurological effects without having to hit the running wheel themselves.

The findings could feasibly lead to new therapies that confer the neuroprotective effects of physical activity on people who cant exercise due to physical limitations. If there were a drug that produced the same brain benefits as exercise, everyone would be taking it, said Saul Villeda, PhD, a UCSF assistant professor in the departments of anatomy and of physical therapy and rehabilitation science. Now our study suggests that at least some of these benefits might one day be available in pill form. Research lead Villeda is senior author of the teams published paper in Science, which is titled, Blood factors transfer beneficial effects of exercise on neurogenesis and cognition to the aged brain.

Exercise is one of the best-studied and most powerful ways of protecting the brain from age-related cognitive decline. Exercise has been shown to improve cognition in individuals at risk of neurodegenerative diseases such as Alzheimers disease (AD) and frontotemporal dementia, even for individuals who carry rare gene variants that inevitably lead to dementia.

In the context of dementia-related neurodegenerative diseases, exercise is correlated with reduced risk for cognitive decline in the elderly, improves cognition in populations at risk for AD, and is associated with better neurobehavioral outcomes even in autosomal dominant AD, the scientists wrote. However, not everyone is able to exercise regularly as they get older, perhaps due to physical limitations or other disabilities. Despite the evident benefit of exercise, its application is hindered in the elderly, as physical frailty or poor health can decrease a persons ability or willingness to exercise, the authors continued. Researchers have long searched for strategies that could confer some of the same neurological benefits of exercise to people with low physical activity levels.

Villedas lab has previously shown thatbiological factorspresent in the blood of young mice can rejuvenate theaging mouse brain, and conversely, factors in the blood of older mice can bring on premature age-related cognitive decline in young mice. transfer of blood from young animals, either by heterochronic parabiosis (in which young and old circulatory systems are joined) or by administration of young blood plasma, improves regenerative capacity and cognition in aged mice, the authors noted.

These previous results led Alana Horowitz, a graduate student in the Villeda lab, and postdoctoral researcher Xuelai Fan, PhD, to look for blood-borne factors that might also confer the benefits of exercise, which is known to rejuvenate the aging brain in a similar fashion to that seen in the labs young blood experiments. Given parallels between the effects of exercise and young blood, we tested whether exercise-induced circulating blood factors could confer the beneficial effects of exercise on regenerative and cognitive function in the aged brain, the scientists continued.

To do this Horowitz and Fan took blood from aged mice who had exercised regularly for seven weeks and administered it to sedentary aged mice. They found that four weeks of this treatment produced dramatic improvements in learning and memory in the older mice, similar to that seen in the mice who had exercised regularly. When they examined the animals brains, they found evidence of enhanced production of new neurons in the hippocampus, a well-documented proxy for the rejuvenating benefits of exercise.

To discover what specific biological factors in the blood might be behind these effects, Horowitz, Fan, and colleagues measured the amounts of different soluble proteins in the blood of active versus sedentary mice. They identified 30 candidate proteins, 19 of which, to their surprise, were predominantly derived from the liver and many of which had previously been linked to functions in controlling the bodys metabolism. Two of these proteins, Gpld1 and Pon1m stood out as particularly important for metabolic processes, and the researchers chose to study Gpld1 in more detail because few previous studies had investigated its function. We figured that if the protein had already been investigated thoroughly, someone would have stumbled upon this effect, Villeda said. I like to sayif youre going to take a risk by exploring something new, you might as well go big!

The team found that Gpld1 increased in the blood circulation of mice following exercise, and that levels of the protein correlated closely with improvements in the animals cognitive performance. Analysis of human data collected as part of the UCSF Memory and Aging Centers Hillblom Aging Network study also found elevated blood levels in healthy, active elderly adults, compared with levels in less active elders. These data identify Gpld1 as an exercise-induced circulating blood factor in aged mice and humans with potential relevance to cognitive function in mice, they wrote.

To test whether Gpld1 itself could drive the observed benefits of exercise, the researchers then engineered mice to overexpress Gpld1 in the liver, and evaluated the animals performance in multiple tests that measure various aspects of cognition and memory. To their amazement, three weeks of the treatment produced effects similar to six weeks of regular exercise, and also generated dramatic increases in new neuron growth in the hippocampus. Together, these data indicate that selectively increasing liver-derived systemic concentrations of Gpld1 is sufficient to improve adult neurogenesis and cognitive function in the aged hippocampus, the scientists stated.

To be honest, I didnt expect to succeed in finding a single molecule that could account for so much of the benefits of exercise on the brain, Villeda noted. It seemed more likely that exercise would exert many small, subtle effects that add up to a large benefit, but which would be hard to isolate. When I saw these data, I was completely floored Through this protein, the liver is responding to physical activity and telling the old brain to get young. Further laboratory experiments have shown that Gpld1 produced by the liver does not pass through the blood-brain barrier. Instead, the protein appears to exert its effects on the brain via pathways that reduce inflammation and blood coagulation throughout the body. Both blood coagulation and inflammation are known to be elevated with age and have been linked to dementia and age-related cognitive decline.

This is a remarkable example of liver-to-brain communication that, to the best of our knowledge, no one knew existed, Villeda continued. It makes me wonder what else we have been missing in neuroscience by largely ignoring the dramatic effects other organs might have on the brain, and vice versa.

The findings could have more broad-ranging implications, the authors suggested. Cumulatively, our data show that beneficial effects of exercise on the aged brain can be transferred through administration of blood components Given that transfer of young blood simultaneously elicits central and peripheral enhancements in regenerative capacity in aged mice, our data raise the possibility that the beneficial effects of exercise could be promoted broadly across tissues through circulating blood factors.

The Villeda lab is now working to better understand precisely how Gpld1 interacts with other biochemical signaling systems to produce its brain-boosting effects. The hope is to identify specific targets for therapeutics that could one day confer many of the protective benefits of exercise for the aging brain.

Go here to see the original:
Could Some of the Benefits of Exercise on the Brain be Captured in a Pill? - Genetic Engineering & Biotechnology News

NEW YORK, July 7, 2020 /PRNewswire/ --Americord Registry, the nation's fastest-growing cord blood bank, announced today that it will be distributing tens of thousands of additional surgical face masks, as well as informational pieces about COVID-19,to obstetric practitioners and their patients nationwide amid the ongoing pandemic.

The announcement comes as some states are seeing a resurgence in infection rates. CHF Industries partnered with Americord to make the additional face masks available. "I heard about what Americord was doing and reached out to Martin [Smithmyer, Americord CEO] through our YPO chapters to see if we could assist," said Spencer Foley, CEO of CHF Industries.

The masks and informational pieces will be distributed to practitioners as well as office staff who are on the front lines, beginning the week of July 6th.

"We began donating masks to obstetricians in April when we saw an opportunity to help thousands of offices facing critical shortages of PPE, and are so happy we can continue to provide not only protective equipment, but also assist in helping provide answers to questions pregnant patients are asking about COVID-19 and how it may impact their pregnancies," Smithmyer added.

Americord Registry continues to provide its clients with best-in-industry solutions to the preservation of umbilical cord stem cells and tissues. The COVID-19 pandemic has highlighted another potential use of mesenchymal stem cells found in cord tissue as a potential treatment. Working with researchers around the country to advance the use of stem cells in regenerative medicine is a strategic objective of the company.

For more information please contact:

Jean RolandOutreach Manager, Americord Registry646.768.8432[emailprotected]

SOURCE Americord Registry

americordblood.com

Read more:
Americord Registry Announces Distribution of Additional Thousands of Masks Amid COVID-19 Resurgence - PRNewswire

VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--AVITA Therapeutics, Inc. (NASDAQ: RCEL, ASX:AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today preliminary unaudited results for the fourth quarter and full year ended June 30, 2020, together with a company update.

Preliminary Unaudited Results for Three Month Period Ended June 30, 2020

With effect from July 1, 2020, the Company is reporting financial results in United States dollars (US$), and prepared in accordance with U.S. Generally Accepted Accounting Principles (U.S. GAAP).

To compare with the Companys previously reported results (as reported under IFRS) fourth quarter net revenue was approximately A$6.08M, versus A$5.96M in the third quarter, or an increase of 2.0%.

We are pleased with our fourth quarter results given the challenges and limited patient and facility access that we have experienced with the onset of the COVID-19 pandemic, said Dr. Mike Perry, AVITA Therapeutics Chief Executive Officer. Like many others, this quarter we witnessed the most challenging commercial conditions since the RECELL System was launched in the U.S. in early 2019. While burns are not considered elective procedures, the incidence of burns was not immune to the impact of COVID-19 as nationwide protective (executive) orders drove a reduction in accidents resulting in burn injuries. Despite the tough macro environment, the clear benefits of the RECELL System including shortened length of hospital stays, together with less invasive and fewer surgeries, continues to resonate with hospitals, physicians, and patients, which is reflected in our results this quarter.

Preliminary Unaudited Results for the Full Year Ended June 30, 2020

To compare with the Companys previously reported results (as reported under IFRS) fiscal 2020 sales were approximately A$21.72M, an increase of A$14.02M or 182% over the A$7.71M recognized during the previous full year.

To compare with the Companys previously reported results (as reported under IFRS) fiscal 2020 sales were approximately A$21.03M, an increase of A$14.82M or 238% over the A$6.21M recognized during the previous full year.

Company Update

Quarter Ended June 30, 2020

During the fourth quarter we witnessed a wide degree of variability with both revenue and procedural volumes, together with an environment where our customers mandated highly restrictive access practices for our field force given the COVID-19 pandemic. Face-to-face interaction with our burn caregivers continues to be exclusively at physician request for case support within the operating theater only, and does not permit participation in the aftercare setting or otherwise enable clinical and business development, for example, to expand utilization of the RECELL System across different burns and users. Given the current state of affairs, we have no reason to believe that these measures, and our limited access, will change in the short term.

As previously stated, burn procedures are neither elective nor deferrable, however the rate of occurrence of these events is very dependent on broader economic activity and people movement. As such, we saw many of our customers initially experience reduced burn volumes due to the social distancing and shelter-in-place restrictions that have been implemented across the nation.

The reprioritization of hospital resources to support COVID-19 readiness meant that our April results were the lowest monthly revenue and procedural volumes seen this calendar year. Fortunately, as the quarter developed, the benefits of the RECELL System providing reduced hospital stays, and fewer and smaller surgeries, together with both a gradual uptick in burn incidence and hospitals (partially) reverting back from a COVID-19 centric focus, enabled a recovery of both revenue and procedural volume growth through May and June. As with many companies in the current pandemic environment, it is difficult to predict revenue and procedural volume over the coming months, but we are pleased with current utilization rates and our physician commitment.

BARDA

The Company continues to work with the U.S. Biomedical Advanced Research and Development Authority (BARDA) on the procurement of the RECELL System for the U.S. strategic national stockpile for public health medical emergencies (with an estimated contract value of US$7.6 million). The Company is hopeful of providing further updates on this topic during this quarter.

Future Market Opportunities

Set out below is an update on our various future market opportunities:

On July 1, 2020, the FDA approved the IDE application for the pivotal study which is titled A Prospective Multi-Arm Blinded-Evaluator Within-Subject Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo.

The Company is continuing to work with FDA to finalize two (2) outstanding study design considerations and will provide further updates, including details regarding the study and initiation plan, over the next several weeks.

The Company expects to commence enrollment in the vitiligo pivotal study in the second half of this calendar year.

The Company continues to have a high degree of confidence that the RECELL System can be an effective therapeutic offering for patients with stable vitiligo. More than 1,000 patients have been treated with the RECELL System for vitiligo outside of the United States, and to date there are eight (8) publications demonstrating the benefits of the RECELL System in vitiligo.

By comparison, since October 1, 2019 the Company has benefited from various reimbursement codes for patients admitted for burn treatment in the inpatient hospital setting (under the Hospital Inpatient Prospective Payment System (IPPS)), including the following:

Medicare reimburses hospitals for inpatient services using MS-DRGs (Medicare Severity Diagnosis-Related Groups) (see MS-DRG 927, 928 and 929 for various types of burns (which are non-specific to the RECELL System)).

Specific ICD-10-PCS code series describing our cell suspension technique for the use of the RECELL System (see the OHR codes within ICD-10-PCS). These procedure codes are assigned to the same DRGs for payment as other skin grafts.

Current Procedural Terminology (CPT) for physicians to support reimbursement for physician rendered healthcare services.

There is no procedure-specific CPT code for the RECELL Systems cell suspension autografting and so, per recommendations from the American Burn Association, providers using the RECELL System are guided to the existing long-standing epidermal autografting codes (e.g. CPT code 151101 and 15115)2.

In the outpatient setting, the Company has been seeking a New Technology Ambulatory Payment Classification (APC) under the Outpatient Prospective Payment System (OPPS) since late 2019. However, based on feedback from The Centers for Medicare & Medicaid Services (CMS) and given recent changes to the OPPS payments system discussed below, the Company will now instead pursue a Transitional Pass-through Payment Application (TPT) to support separate additional Medicare payment for the RECELL System.

CMS has advised the Company that the availability of the long-standing CPT code 15110 and CPT code 15115 (which providers may presently utilize in both the inpatient and outpatient hospital setting) excludes our ability to apply for a New Technology APC for use in the outpatient setting.

On January 1, 2020, CMS implemented changes to the OPPS and ambulatory surgical centers (ASC) payment systems to permit medical devices, including the RECELL System, that have received FDA marketing authorization and are part of the Breakthrough Devices Program [to] be approved [by CMS for TPT] through the quarterly [review] process (as opposed to the typical annual review process).

TPT was established by CMS to provide an alternative payment pathway for transformative medical devices. Similar to the New Technology APC, if approved CMS would create a new C code and would allow the RECELL System to be billed and paid separately in hospital outpatient facilities and ASCs.

As a recipient of Breakthrough Device status, AVITA Therapeutics will work with CMS through the next CMS scheduled quarterly review cycle and is hopeful of having a C code in place for the RECELL System on January 1, 2021 (which should not change our current commercialization timeline for the outpatient hospital setting).

Enrollment of clinical studies across the United States are largely paused at present and the Companys enrollment of the aforementioned studies are accordingly largely on hold.

The Company has enrolled three (3) patients in the pediatric scald study and one (1) patient in the soft tissue reconstruction study.

The Company anticipates that enrollment will resume in the ensuing quarter.

Publications

Notable publications released during the quarter were as follows:

Japan

AVITA Therapeutics continues to work with our Japanese marketing partner, COSMOTEC, to advance our application for approval to market the RECELL System in Japan pursuant to Japans Pharmaceuticals and Medical Devices Act. The application has been constructed broadly to seek approval for the treatment of patients with burns, chronic wounds and vitiligo in three (3) size configurations of the RECELL System.

Progress on the application has been delayed due to the COVID-19 pandemic and the associated State of Emergency declaration in Japan. In addition, Japans regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), has now requested various non-clinical raw data (e.g., original hand written copies of data entry forms or records) of a small subset of our historic studies, some of which were conducted more than ten (10) years ago. To facilitate PDMAs request, AVITA Therapeutics is repeating three (3) non-clinical or benchtop tests. These tests are expected to be completed and submitted in August, and the Company hopes to then advance our application for approval of the RECELL System in Japan.

Other Updates

Authorized for release by the Chief Executive Officer of Avita Therapeutics, Inc.

ABOUT AVITA THERAPEUTICS, INC.

AVITA Therapeutics is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Therapeutics 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 Therapeutics 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.

1 CPT code 15110: Epidermal autograft, trunks, arms, legs; CPT code 15115: Epidermal autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and / or multiple digits.2 It should be noted that the CPT code may be used in both the inpatient and the outpatient hospital setting.

Go here to read the rest:
AVITA Therapeutics Provides Company Update and Preliminary Unaudited Results for the Fourth Quarter and Fiscal Year 2020 - Business Wire

In our new financial reality, our state and you as voters are faced with tough decisions. Come November, you will decide the fate of Californias stem cell institute. This decision has never been more important to the future of Californias health care, for the patients and their families, than it is now.

Californians overwhelmingly approved the states first stem cell initiative in 2004, with nearly 60% of the vote, and widespread support from patient advocacy organizations, labor, business and elected officials. The 2004 initiative established the California Institute for Regenerative Medicine (CIRM) to fund medical research and the development of new treatments and cures.

If Californians do not pass Proposition 14, vital lifesaving research will come to a halt.

CIRM funding has advanced research and therapy development for more than 75 different diseases and conditions, more than 90 clinical trials, more than 1,000 medical projects at 70 institutions across California and nearly 3,000 published medical discoveries. This investment has already saved and improved lives, including a high school student who was paralyzed in a diving accident and was able to regain function in his upper body and go on to college, a mother who went blind from a genetic disease has had some of her eyesight restored, two FDA-approved cancer treatments are already saving lives, and many more.

As funding for Californias stem cell research program has now run out, Californians have a critical opportunity to pass the 2020 stem cell initiative Proposition 14 to continue to advance lifesaving research and treatment development. Proposition 14 just recently qualified for the November ballot with early support from more than 65 patient advocacy organizations, the University of California and Nobel Prize winners.

If Californians do not pass Proposition 14, vital lifesaving research will come to a halt. Medical discoveries wont be able to progress to clinical trials, delaying lifesaving and life-changing treatments for cancer, diabetes, heart disease, Alzheimers, Parkinsons, infectious diseases like COVID-19 and more for years or decades.

Additionally, not passing Proposition 14 would eliminate a critical economic and jobs stimulus for our state.

Arguably, our state leaders are rightfully concerned about the state budget amid the current landscape. But as we enter a period of economic crisis, this bond measure will act as an economic recovery and jobs stimulus.

It is not a tax; it is a general obligation bond that will be repaid by the state, over decades, beginning in 2026.

Proposition 14 will increase the amount of state funds available to tackle other issues for the next 10 years by increasing state tax revenues through 2030 potentially providing more state revenue than the cost of bond payments during that time. To date, Californias stem cell research program has generated $10.7 billion in increased state economic activity and hundreds of millions in additional state revenues. Californias stem cell research program also creates tens of thousands of jobs at every level from lab technicians and maintenance workers to nurses and physicians.

Proposition 14 is exactly the kind of long-term investment we should make now to rebuild our economy. The initiative was specifically designed to be fiscally responsible. It is not a tax; it is a general obligation bond that will be repaid by the state, over decades, beginning in 2026 a full five years after its passage.

We cant afford not to fund Proposition 14.

Chronic diseases are the leading cause of death and the leading driver of annual health care spending and bankruptcies. In California alone, more than 30% of the states budget is spent on health care. With this cost rising every year, it is a growing strain on California families and our state budget.

If we hesitate to fund proper research to develop cures for chronic illnesses, our health care costs will financially drain California families, as well as our struggling state budget. Reducing the cost of treating just 6 of 80 major chronic diseases or injuries by 1-2% would pay for the Initiative twice over.

The decision you make in November will have lasting impacts on the state funds available to tackle priorities California needs to address now, and in the future, including housing, education, or the environment. Proposition 14 will generate additional revenue to help address these issues now, and potentially save California tens of billions for the future.

Proposition 14 will cost the state an average of less than $5 per person, per year about the cost of a bottle of aspirin. That is a small price to pay to potentially save millions of lives and tens of billions of dollars in health care costs in the coming decades. At the end of the day, Proposition 14 could save your life or the life of someone you love how can we afford not to make this investment?Editors Note: Bob Klein is chairman of Californians for Stem Cell Research, Treatments and Cures.

Continue reading here:
Stem cell initiative: Save lives and energize the economy - Capitol Weekly

Wound care products include dressings and bandages and play an imperative role in assisting in medical cases in hospitals and clinics. They offer the first line of treatment to patients and have induced a massive demand due to increase in chronic and acute disorders. The global wound care market report prepared by analysts at Market Research Future (MRFR) contains insightful trends and drivers which can make industry leaders in making sizeable decisions for the future.

Wound Care Market Overview

The global wound care market size is touted to exceed a value of USD 29,900 million by 2027. It stood at USD 15,456.2 million in 2016. It is expected to experience an enjoyable run over the period of 2017 to 2027 (forecast period) due to high prevalence of chronic injuries. Emphasis on patient care is likely to trigger the development of new variants of existing products and bolster the market demand till the end of the forecast period. Rise of the general populace and favorable reimbursement policies can work in favor of the market.

Latest Free Sample PDF Available with Covid19 Impact @https://www.marketresearchfuture.com/sample_request/926

Rise in the number of surgeries, increase in accident rates, and high number of burn cases are factors which can drive market growth. The increase in the numbers of the geriatric populace is one of the biggest drivers of the global wound care market. The use of wound care products for expediting the healing of scars and small injuries can bode well for the market revenue. Inclination of patients towards these products can boost the global market volume till 2027.

Wound Care Market Segmentation

The global Wound Care Market report is segmented on the basis of product, type, application, and end-user.

By product, it is segmented into wound care products, traditional wound care products, active wound care products, wound therapy devices, and advanced wound management products. The advanced wound management products segment accounted for close to 31% share in 2016. The use of these products in the treatment of acute and chronic wounds can bolster the market share of the segment by 2027. On the other hand, traditional wound care products can gain a larger market share due to its inexpensive nature and easy availability.

By type, it is segmented into acute and chronic wound. The chronic wound segment accounted for 60.3% share in 2016.

By application, it is segmented into trauma wounds, surgical wound, burn, and ulcer. The surgical wound segment is the biggest application of the market due to its use in the treatment of grievous injuries. It accounted for 35% market share in 2016. On the other hand, the ulcer segment accounted for 22.1% share in the same year.

By end-user, it is segmented into trauma centers, home healthcare, clinics, and hospitals. Hospitals accounted for 37.5% share in 2016, while clinics accounted for 26% share in the same year. Improved patient care in hospitals can drive the market demand for the segment exponentially till 2027.

Wound Care Market Regional Analysis

The Middle East & Africa (MEA), North America, Latin America, Asia Pacific (APAC), and Europe are the regions become the centerpoint in the global wound care market report.

North America is likely to dominate the global market till the end of the forecast timespan due to the large diabetic population. The high healthcare expenditure and investments by hospitals and clinics to improve their current healthcare services can drive the regional market growth. The U.S. is one of the biggest contributors to the regional market revenue due to a sophisticated healthcare framework and a large patient pool.

The APAC region is anticipated to exhibit a CAGR exceeding 6% during the forecast timespan due to large number of chronic diseases, large geriatric populace, and rising incidence of chronic wounds.

Wound Care Market Competition Outlook

Some of the key players profiled in the market report include CanvaTec, Kinetic Concepts, Inc., Smith & Nephew, Ethican, Inc., B. Braun Melsungen AG, 3M, and Baxter. Mergers, acquisitions, and collaborations are major strategies being employed by these players to gain a significant edge in the market. Recently, 3M decided to acquire Acelity Inc. for USD 6.7 billion. This would considerably extend the product offering list of the former and cater to a large number of clients.

OBTAIN RESEARCH REPORT DETAILS WITH TOC @ https://www.marketresearchfuture.com/reports/wound-care-market-926

About Market Research Future:

At Market Research Future (MRFR), we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Raw Research Reports (3R), Continuous-Feed Research (CFR), and Market Research & Consulting Services.

MRFR team have supreme objective to provide the optimum quality market research and intelligence services to our clients. Our market research studies by Components, Application, Logistics and market players for global, regional, and country level market segments, enable our clients to see more, know more, and do more, which help to answer all their most important questions.

In order to stay updated with technology and work process of the industry, MRFR often plans & conducts meet with the industry experts and industrial visits for its research analyst members.

Contact:Market Research FutureOffice No. 528, Amanora ChambersMagarpatta Road, Hadapsar,Pune 411028Maharashtra, India+1 646 845 9312Email: [emailprotected]

NOTE : Our team of researchers are studying Covid19 and its impact on various industry verticals and wherever required we will be considering covid19 footprints for a better analysis of markets and industries. Cordially get in touch for more details.

Read this article:
Applications in Regenerative Medicine to Expand Global Wound Care Market Opportunities till 2027 - Cole of Duty