Category Archives: Regenerative Medicine

The global Biologics Safety Testing Market was valued at USD 2.18 billion in 2016 and is projected to reach USD 6.10billion by 2025, growing at a CAGR of 12.13% from 2017 to 2025.

Stability or Safety Testing can be used to demonstrate short and long term stability of a drug substance/product after exposure to a variety of environmental factors including temperature, humidity and light.It can be used to determine the genetic disorders, health conditions, Testing of Vaccines before public launch.

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The Final Report will cover the impact analysis of COVID-19 on this industry:

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Market Dynamics:1. Market Drivers1.1 Increasing investments in Biotechnology and pharmaceutical companies1.2 Positive developments in R&D sector1.3 Growing Drug Discoveries1.4 Prevalence of chronic diseases

2. Market Restraints2.1 Dearth of IT Professionals

Market Segmentation:1. Global Biologics Safety Testing Market, by Test Type:1.1 Endotoxin Tests1.2 Sterility Tests1.3 Cell Line Authentication and Characterization Tests1.4 Bioburden Tests1.5 Residual Host Contaminant Detection Tests1.6 Adventitious Agent Detection Tests1.7 Other Tests

2.Global Biologics Safety Testing Market, by Products and Services:2.1 Kits & Reagents2.2 Services2.3 Instruments

3. Global Biologics Safety Testing Market, by Application:3.1 Vaccine & Therapeutics Development3.2 Blood and Blood-Related Products Testing3.3 Cellular and Gene Therapy3.4 Tissue and Tissue-Related Products Testing3.5 Stem Cell Research

4. Global Biologics Safety Testing Market, by Region:4.1 North America (U.S., Canada, Mexico)4.2 Europe (Germany, UK, France, Rest of Europe)4.3 Asia Pacific (China, India, Japan, Rest of Asia Pacific)4.4 Latin America (Brazil, Argentina, Rest of Latin America)4.5 Middle East & Africa

Competitive Landscape:The major players in the market are as follows:1. Charles River Laboratories International, Inc.2. Merck KGaA3. Lonza Group Ltd.4. SGS S.A.5. Thermo Fisher Scientific Inc.6. Wuxi Apptec7. Sartorius AG8. Cytovance Biologics, Inc.9. Pace Analytical Services Inc.10. Toxikon Corporation11. Eurofins Scientific Se12. Avance Biosciences Inc.13. Source BioscienceThese major players have adopted various organic as well as inorganic growth strategies such as mergers & acquisitions, new product launches, expansions, agreements, joint ventures, partnerships, and others to strengthen their position in this market.

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RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH:Research study on the Biologics Safety Testing Marketwas performed in five phases which include Secondary research, Primary research, subject matter expert advice, quality check and final review.The market data was analyzed and forecasted using market statistical and coherent models. Also market shares and key trends were taken into consideration while making the report. Apart from this, other data models include Vendor Positioning Grid, Market Time Line Analysis, Market Overview and Guide, Company Positioning Grid, Company Market Share Analysis, Standards of Measurement, Top to Bottom Analysis and Vendor Share Analysis.

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Biologics Safety Testing Market Is Projected to Expanding at a CAGR of 12.13% By The End of 2025 (Study With Impact of COVID-19 on Global Market) -...

Giroctocogene fitelparvovec is being developed as part of an agreement between Sangamo and Pfizer for the global development of gene therapies for hemophilia A. Credit: Coolcaesar.

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Pfizer and Sangamo Therapeutics have reported positive follow-up data from the Phase I/II Alta study of giroctocogene fitelparvovec (PF-07055480) to treat patients with severe hemophilia A.

The investigational gene therapy Giroctocogene fitelparvovec consists of a recombinant adeno-associated virus serotype 6 vector (AAV6) encoding the complementary deoxyribonucleic acid for B domain deleted human FVIII.

The open-label, dose-ranging, multi-centre Alta clinical trial has been designed to assess the safety and tolerability of the therapy in severe hemophilia A patients.

Across four dose cohorts, the mean age of the 11 patients assessed is 30 years and all are male.

All five patients with severe hemophilia A were given the 3e13 vg/kg dose and they showed sustained factor VIII (FVIII) activity levels, with a median of 64.2% via chromogenic assay.

No patients experienced bleeding events or required FVIII infusions during the trial.

Pfizer Rare Disease Research Unit senior vice-president and chief scientific officer Seng Cheng said: We are excited that these data affirm previous findings from this Phase I/II study, and that all five patients have sustained levels of factor VIII activity with no bleeding events or use of factor replacement therapy.

The Phase III lead in study is ongoing, and we look forward to dosing patients with this investigational gene therapy in the pivotal Phase III trial later this year.

Giroctocogene fitelparvovec received orphan drug, fast track, and regenerative medicine advanced therapy (RMAT) designations from the US Food and Drug Administration and Orphan Medicinal Product designation from the European Medicines Agency.

The therapy is being developed as part of a collaboration agreement between Sangamo and Pfizer for the global development and commercialisation of gene therapies for hemophilia A.

Sangamo chief medical officer Bettina Cockroft said: These follow-up data indicate that treatment with giroctocogene fitelparvovec resulted in sustained factor levels up to 14 months following treatment and suggests the potential of this investigational gene therapy to alleviate the treatment burden of current hemophilia disease management.

Continued here:
Pfizer and Sangamo report positive data from hemophilia A therapy trial - Clinical Trials Arena

Researchstore.biz has published an exclusive report named Global Cell Expansion Supporting Equipment Market 2020 by Manufacturers, Regions, Type and Application, Forecast to 2025 which consists of overall market scenario with prevalent and future growth prospects. The report delivers the analytical elaboration and other industry-linked information in an aim to supply specific and reliable analysis on the global Cell Expansion Supporting Equipment market. The report focuses on market dynamics, growth-driving factors, restraints, and limitations this market is currently facing and is expected to face in the coming years (2020-2025). The report is further divided by company, by country, and by application/types for the competitive landscape analysis. It estimates production chain, manufacturing capacity, sales volume, and revenue.

The report provides a detailed analysis of global market size, regional and country-level market size, segmentation market growth, market share, competitive landscape, sales analysis, the impact of domestic and global market players. It contains advanced information associated with the global Cell Expansion Supporting Equipment market status, trends analysis, segment, and forecasts from 2020-2025. It explains market scenarios, comparative pricing between major players, cost, and profit of the specified market regions.

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Key Players Analysis:

The report analyzes the top manufacturers, exporters, and retailers (if applicable) around the world concerning their company profile, product portfolio, capacity, price, cost, and revenue. For competitor segment, the report covers the following global Cell Expansion Supporting Equipment market key players and some other small players: Beckman Coulter, Inc. (U.S.), STEMCELL Technologies, Inc. (Canada), GE Healthcare (U.K.), Becton, Dickinson and Company (U.S.), Miltenyi Biotec (Germany), Corning, Inc. (U.S.), Thermo Fisher Scientific, Inc. (U.S.), Merck KGaA (Germany), Lonza (Switzerland), Terumo BCT, Inc. (U.S.)

In market segmentation by types, the report covers: Flow cytometer, Cell counters, Centrifuges, Others,

In market segmentation by applications, the report covers the following uses: Regenerative Medicine and Stem Cell Research, Cancer and Cell-based Research, Others,

Regionally, this report focuses on several key regions: North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India, Southeast Asia and Australia), South America (Brazil, Argentina, Colombia), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Moreover, the report exhaustively investigates business opportunities, market scope, threats, and barriers. The report aims to help companies in strategizing their decisions in a better way and finally attains their business goals. The research answers important business questions like how the global Cell Expansion Supporting Equipment market will perform in the existing market scenario. It also presents the potential industry supply, market demand, market value, market competition, key market players, and the industry estimate from 2020-2025.

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Global Cell Expansion Supporting Equipment Market Research with COVID-19 After Effects - Cole of Duty

A new market report by Market Research Intellect on the Regenerative Medicine Products Market has been released with reliable information and accurate forecasts for a better understanding of the current and future market scenarios. The report offers an in-depth analysis of the global market, including qualitative and quantitative insights, historical data, and estimated projections about the market size and share in the forecast period. The forecasts mentioned in the report have been acquired by using proven research assumptions and methodologies. Hence, this research study serves as an important depository of the information for every market landscape. The report is segmented on the basis of types, end-users, applications, and regional markets.

The research study includes the latest updates about the COVID-19 impact on the Regenerative Medicine Products sector. The outbreak has broadly influenced the global economic landscape. The report contains a complete breakdown of the current situation in the ever-evolving business sector and estimates the aftereffects of the outbreak on the overall economy.

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The report also emphasizes the initiatives undertaken by the companies operating in the market including product innovation, product launches, and technological development to help their organization offer more effective products in the market. It also studies notable business events, including corporate deals, mergers and acquisitions, joint ventures, partnerships, product launches, and brand promotions.

Leading Regenerative Medicine Products manufacturers/companies operating at both regional and global levels:

Sales and sales broken down by Product:

Sales and sales divided by Applications:

The report also inspects the financial standing of the leading companies, which includes gross profit, revenue generation, sales volume, sales revenue, manufacturing cost, individual growth rate, and other financial ratios.

The report also focuses on the global industry trends, development patterns of industries, governing factors, growth rate, and competitive analysis of the market, growth opportunities, challenges, investment strategies, and forecasts till 2026. The Regenerative Medicine Products Market was estimated at USD XX Million/Billion in 2016 and is estimated to reach USD XX Million/Billion by 2026, expanding at a rate of XX% over the forecast period. To calculate the market size, the report provides a thorough analysis of the market by accumulating, studying, and synthesizing primary and secondary data from multiple sources.

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The market is predicted to witness significant growth over the forecast period, owing to the growing consumer awareness about the benefits of Regenerative Medicine Products. The increase in disposable income across the key geographies has also impacted the market positively. Moreover, factors like urbanization, high population growth, and a growing middle-class population with higher disposable income are also forecasted to drive market growth.

According to the research report, one of the key challenges that might hinder the market growth is the presence of counter fit products. The market is witnessing the entry of a surging number of alternative products that use inferior ingredients.

Key factors influencing market growth:

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To summarize, the Regenerative Medicine Products market report studies the contemporary market to forecast the growth prospects, challenges, opportunities, risks, threats, and the trends observed in the market that can either propel or curtail the growth rate of the industry. The market factors impacting the global sector also include provincial trade policies, international trade disputes, entry barriers, and other regulatory restrictions.

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Regenerative Medicine Products Market 2019 Break Down by Top Companies, Countries, Applications, Challenges, Opportunities and Forecast 2026 - Cole of...

STAINES-UPON-THAMES, United Kingdom, June 9, 2020 /PRNewswire/ --Mallinckrodt plc(NYSE: MNK), a global biopharmaceutical company, today announced that Stratatech, aMallinckrodtcompany, has completed its rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for StrataGraft, a regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns. The company previously announcedinitiation of the rolling submission in April. StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.

"Completion of the BLA submission is the culmination of many years of hard work and brings us one step closer to our goal of providing StrataGraft skin tissue as a new treatment option for patients in the United States with deep partial-thickness thermal burns, if approved," said Steven Romano, M.D., executive vice president and chief scientific officer at Mallinckrodt. "We would like to thank the many researchers, clinical trial investigators and patients who helped us reach this important milestone. We look forward to working closely with the FDA during the regulatory review process."

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 accepted for presentationat the American Burn Association 52nd Annual Meeting, with support from the STRATA2011clinical trial, previously published in Burns.

The FDA granted StrataGraft skintissue orphan drug status, 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.

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.

Funding and technical support for the continued development of StrataGraft skin tissue, including the pivotal Phase 3 clinical study (STRATA2016) and the Biological Licensing Application process for StrataGraft tissue in the United States, is being provided by the Biomedical Advanced Research and Development Authority (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.1 The 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 Statements This release includes forward-looking statements concerning StrataGraft regenerative skin tissue, including expectations with regard to related regulatory filings, 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

Media RelationsSheryl SeapyW2O for Mallinckrodt213-262-9390[emailprotected]

Investor Relations Daniel J. Speciale, CPAVice President, Investor Relations and IRO314-654-3638[emailprotected]

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-2000850 05/20.

1https://www.gao.gov/assets/590/588738.pdf. Accessed February 12, 2020.

SOURCE Mallinckrodt plc

http://www.mallinckrodt.com

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Mallinckrodt Completes Rolling Submission of Biologics License Application for StrataGraft Regenerative Skin Tissue to US Food and Drug Administration...

The global Regenerative Medicine Market is projected to grow with a striking growth rate of 24.2 % over the forecast period 20192026 divulges the latest research report presented by Big Market Research.

The report represents a basic overview of the market status, competitor segment with a basic introduction of key vendors, top regions, product types and end industries. This report gives a historical overview of the market trends, growth, revenue, capacity, cost structure, and key drivers analysis.

The report is an exhaustive analysis of this market across the world. It offers an overview of the market including its definition, applications, key drivers, key market players, key segments, and manufacturing technology. In addition, the study presents statistical data on the status of the market and hence is a valuable source of guidance for companies and individuals interested in the industry. Additionally, detailed insights on the company profile, product specifications, capacity, production value, and market shares for key vendors are presented in the report.

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The total market is further segmented based on company, country, and application/type for competitive landscape analysis. On the contrary, information on industry chain structure, emerging applications, and technological developments in the market makes the report a must-read document.

The report reveals detailed information about the global key players as well as some small players of the Regenerative Medicine sector.

Target Audience of the Global Regenerative Medicine Market in Market Study:Key Consulting Companies & AdvisorsLarge, medium-sized, and small enterprisesVenture capitalistsValue-Added Resellers (VARs)Third-party knowledge providersInvestment bankersInvestors

These insights help determine the strength of competition and take the necessary steps to obtain a leading position in the Regenerative Medicine industry.

Additionally, the research provides a detailed analysis of the key segments of the market with the help of charts and tables. An overview of each market segment such as type, application, and region are also provided in the report. These insights help in understanding the global trends in the Regenerative Medicine industry and form strategies to be implemented in the future.

The regional analysis of global Regenerative Medicine market is considered for the key regions such as Asia Pacific, North America, Europe, Latin America and Rest of the World. North America is the leading/significant region across the world in terms of market share owing to the high disposable income coupled with rising trend of interior designing in the region. Whereas, Asia-Pacific is also anticipated to exhibit highest growth rate / CAGR over the forecast period 2019-2026

Our analysis involves the study of the market taking into consideration the impact of the COVID-19 pandemic. Please get in touch with us to get your hands on exhaustive coverage of the impact of the current situation on the market. Our expert team of analysts will provide as per report customized to your requirement. For more connect with us at [emailprotected] or call toll free: +1-800-910-6452

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Key Market Segments

The key players profiled in this report include: AcelityL.P.Inc., NuvasiveInc., VericelCorporation, OsirisTherapeuticsInc., StrykerCorporation, MedtronicPLC

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to the coming eight years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study.

Furthermore, the report also caters the detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, the report shall also incorporate available opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players. The detailed segments and sub-segment of the market are explained below:

The key product type of Regenerative Medicine market are: Stem Cell Therapy, Biomaterial, Tissue Engineering, Others

The study clearly reveals that the Regenerative Medicine industry has attained remarkable growth since 2019-2026. This research report is prepared based on an in-depth analysis of the market by experts. As a final point, stakeholders, investors, product managers, marketing executives, and other professionals seeking unbiased data on supply, demand, and future forecasts would find the report valuable.

Table of Contents

Chapter 1. Global Regenerative Medicine Market Definition and ScopeChapter 2. Research MethodologyChapter 3. Executive SummaryChapter 4. Global Regenerative Medicine Market DynamicsChapter 5. Regenerative Medicine Market, by ComponentChapter 6. Global Regenerative Medicine Market, by ServicesChapter 7. Global Regenerative Medicine Market, by Organization SizeChapter 8. Regenerative Medicine Market, by VerticalChapter 9. Regenerative Medicine Market, by Regional AnalysisChapter 10. Competitive Intelligence

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Global Regenerative Medicine Market | Industry Outlines, Growth, Trends, In-Depth Analysis And Outlook Till 2026 - Cole of Duty

VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--AVITA Medical Limited ACN 058 466 523 (Company) is pleased to confirm that the general meeting to consider a resolution to approve the proposed scheme of arrangement to effect a redomiciliation of the Company and its subsidiaries from Australia to the United States of America (Scheme Meeting) is being held by way of live webcast at 9.00am (AEST) on Monday, 15 June 2020 (being 7.00pm (EDT) on Sunday, 14 June 2020).

The Scheme Booklet prepared in relation to the proposed scheme of arrangement was despatched (by post or electronically) to Company shareholders on 14 May 2020. A copy of the Scheme Booklet can also be found on the Companys website (https://avitamedical.com/virtual-shareholders-meeting).

The Notice of Scheme Meeting is contained in Appendix F of the Scheme Booklet.

Shareholders are reminded that due to the restrictions imposed by the Australian government in response to the COVID-19 pandemic, the Scheme Meeting is being held exclusively as a virtual meeting by way of the live webcast.

Taking part in the live webcast will enable shareholders to listen to the Scheme Meeting live and view slides and proxy results. Shareholders who are registered as at 9.00am (AEST) on 13 June 2020 will be entitled to ask questions and cast their vote at the appropriate times whilst the Scheme Meeting is in progress. Holders of American Depositary Shares (ADS Holders) are able to listen to the live webcast, however, will not be able to ask questions or vote via the live webcast.

The Company will also provide a brief corporate update to shareholders at the conclusion of the Scheme Meeting.

Shareholders can access the live webcast by following the instructions below.

Participating in the Scheme Meeting

Shareholders are invited to participate in the Scheme Meeting by way of the live webcast on two available platforms:

Once you have accessed the Lumi platform on your web browser or mobile device, you will be prompted to enter the meeting ID, which is: 316-817-384.

Your username is your SRN / HIN (which can be found towards the top right hand corner of your holding statement and on shareholder communications).

Your password is the postcode registered to your holding if you are a shareholder in Australia. If you are a shareholder outside of Australia, your password is your three letter country code (for example, USA for United States of America). A full list of country codes is provided in the attached Scheme Meeting User Guide.

ADS Holders are able to listen to the live webcast of the Scheme Meeting as a visitor by selecting the guest option after entering the meeting ID.

Further details and instructions on how to participate in the Scheme Meeting are contained in the Scheme Meeting User Guide, and on the Companys website (https://avitamedical.com/virtual-shareholders-meeting).

Voting by Proxy

Shareholders who are unable to take part in the Scheme Meeting by way of the live webcast, or choose not to do so, are encouraged to submit their votes by proxy by no later than 9.00am (AEST) on 13 June 2020. Details on how to appoint a proxy are set out in section 3.8 of the Scheme Booklet.

Update details with the Companys share registry

Shareholders are encouraged to update their details with the Companys share registry, Computershare Investor Services Pty Ltd (Computershare), by accessing Computershares website (www.computershare.com.au/easyupdate/avh) to ensure that payment instructions are up-to-date in advance of the anticipated implementation date of the proposed scheme of arrangement.

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

ABOUT AVITA MEDICAL LIMITED

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

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

INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.

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

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

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This announcement 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 announcement 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 announcement 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 announcement. 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 announcement speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

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AVITA Medical Limited Proposed Redomiciliation to the United States of America - Scheme Meeting on Monday, 15 June 2020 at 9.00am (AEST) - Business...

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Regenerative Medicine Market Size, Share, Tools-Applications, Emerging-Trends, 2019 Growth-Projections, Overview, Business-Opportunities, Software,...

SUWANEE, GA, June 09, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc. (OTCQB: SNWV)announced today that the Company will host a live webcast and conference call on Wednesday, June 10, 2020, beginning at 9AM Eastern Time to provide a business update.

Shareholders and other interested parties can participate in the live webcast athttps://www.webcaster4.com/Webcast/Page/2249/35268.

Shareholders and other interested parties can also participate in the conference call by dialing 844-602-0380 (U.S.) or 862-298-0970 (international). Please join the call at least 10 minutes before the start time.

A replay of the webcast and conference call will be available beginning two hours after its completion through June 17, 2020, by dialing 877-481-4010 (U.S.) or 919-882-2331 and entering replay passcode 35268 and a replay of the webcast will be available athttps://www.webcaster4.com/Webcast/Page/2249/35268 until September 10, 2020.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB:SNWV) (www.SANUWAVE.com) is a shockwave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVEs portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the bodys normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE, is US FDA cleared for the treatment of Diabetic Foot Ulcers. The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTrondevice, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotronand orthoPACEdevices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVEs shockwave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Companys ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Companys product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Companys ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Companys periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visitwww.sanuwave.com.

Contact:

Millennium Park Capital LLCChristopher Wynne312-724-7845cwynne@mparkcm.com

SANUWAVE Health, Inc.Kevin Richardson IIChairman of the Board978-922-2447investorrelations@sanuwave.com

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SANUWAVE Health to Hold Investor Live Webcast on Wednesday, June 10, 2020 - GlobeNewswire

June 9, 2020

This has certainly been a year unlike any other for BioHealth Capital Region (BHCR) life science companies of all sizes and kinds. Just a few months into 2020, the coronavirus pandemic swept the region, seriously disrupting, albeit temporarily, the best laid plans of aspiring founders, entrepreneurs, emerging startups, pre-clinical and more established, larger biohealth organizations in Virginia, Washington, D.C. and Maryland.

No one has escaped the reach of COVID-19 in the BHCR, the rest of the U.S., or around the globe. While this industry continues to be uniquely positioned to weather a storm like this, many were still impacted via delayed clinical trials and having to adjust to near 100% remote work for non-bench role employees. Some areas like Travel Medicine have been hit hard, as most are canceling their 2020 trips. Sadly, even when daily life resembles a new normal, Travel Medicine is likely to have a longer recovery as many organizations have adapted to virtual meetings that will potentially reduce future travel significantly.

The regional life science ecosystem was prepared and pivoted rapidly to not only ensure continued operations, but also to redirect resources, talent and technologies to creating testing, developing COVID-19 therapies and progressing SARS-CoV-2 vaccine candidates.

The BHCR life science community has been remarkably resilient and innovative during this time, for certain, despite myriad challenges caused by COVID-19 across VC funding, the supply chain, and clinical trials, to name just a few.

Despite all of the tumult and turmoil, VC funding deals are still getting done in the BHCR, though perhaps currently on a slightly slower pace and scale. Well see what the second half holds on the VC funding front, but with signs of a slow, steady, and careful reopening afoot in the region, its possible that funding deals will pick back up in the latter half of 2020.

With that, lets take a look at funding deals that were announced in the BHCR in Q1/Q2 of 2020, the year of the pandemic.

Immunomic Therapeutics Incorporated (ITI), located in Rockville, Maryland recently announced it had closed on $61.3M in financing, exceeding its initial fundraising projections by over $11M. The Korean investment group HLB Co., LTD led the financing round, which is just the latest accomplishment for the clinical-stage biotechnology company that launched in 2006.

Read more about CEO Bill Hearls plans for ITI in our recent BioBuzz story, Marylands Immunomic Therapeutics Exceeds Fundraising Goal, Envisions Future IPO.

LifeSprout, a privately-held regenerative medicine company located in Baltimore, Maryland, recently announced the closing of a $28.5M Series A financing round, marking a significant milestone in its history. The round was led by Redmile Group, LLC, with new institutional investors Nexus Management, LP, Emerald Development Managers, LP, and Baltimores Abell Foundation joining the investment group.

You can read more about LifeSprouts story and plans in our recent featured story, Baltimore, Marylands LifeSprout Closes $28.5M Series-A, Looks Toward the Future.

Integrated Biotherapeutics subsidiary IBT Vaccines, which is located in Rockville, Maryland received $3.9M in funding as part of a larger $48M investment in eight companies by Novo Holdings REPAIR Impact Fund.

The funding will be used to advance its advance the development of the IBT-V02 vaccine for Staphylococcus aureus induced recurrent skin and skin structure infections (SSSI), according to the companys press release in early January 2020. At the time of the announcement, the vaccine was in the late clinical development stage and is potentially a first-to-market, multivalent vaccine for antibiotic resistant Staphylococcus aureus.

Vigene Biosciences, which just recently opened its new headquarters in Rockville, Maryland, announced in late March that it had secured institutional investment from Signet Healthcare Partners (Signet), a New York-based growth equity firm specializing in healthcare investments.

Vigene is a leading provider of viral vector products and services used in gene therapy. According to Washington Business Journal reporting, the round was close to $3M.

We wrote about Vigenes new HQ grand opening and its remarkable relationships with the families it serves. You can read Maryland Biotech Opens New Gene Therapy Contract Manufacturing Facility To Support Rapid Growth to learn more.

College Park, Marylands Pathotrak announced it had closed a seed round of $1.2M in mid-May 2020. The company has developed a rapid food test for salmonella and E. coli in food. The companys new test has the potential to cut down food safety test result turnaround times by nearly one full day, which could have a significant positive financial impact on the food industry while improving food safety for companies and consumers.

The Maryland Momentum Fund contributed $150K, the Dingman Angels, which is a program within the Robert H. Smith School of Business at the University of Maryland, invested $310K, and a global life sciences company with a food safety division also invested in pathOtrack.

You can read more here about Pathtracks novel test and the company in a story BioBuzz recently published.

ARMR Systems, a Maryland BioPark-affiliated startup, received seed money from local funding sources to support its hemorrhagic control systems designed to increase the survivability of battlefield trauma when advanced medical support is not immediately available.

The seed funding included a $350,000 joint investment from the University of Maryland, Baltimore, and the Maryland Momentum Fund and also included funding from the Tamiami Angel Fund.

ARMR Systems was featured in the BioBuzz story, Baltimores Top 10 BioHealth Startup CEOs.

There were several large HealthTech investments in this first half of the year that include:

Timonium, Marylands b.well Connected Health secured $16M in Series A financing to back its patient-facing health management tool. The round was led by UnityPoint Health Ventures, with participation from ThedaCare and Well Ventures.

B.wells management tool integrates data, insights, and partners into a single customized solution that helps people take control of their healthcare experience, according to the companys website. The company is located at The Grid, which is located at the Lion Brothers Building one block south of the University of Maryland Biopark. The company will use the Series A funding to scale as it enters a growth and hiring phase.

Bethesda, Marylands Aledade, a data analytics and healthcare practice workflow company, closed a $64M Series C round led by OMERS Growth Equity. California Medical Association, Echo Health Ventures, and Meritech Capital and GV also contributed to the round. Aledade has created a network of approximately 550 doctor-led Accountable Care Organizations (AOC) that utilize an outcome-based rather than a fee for service business model. The company plans to use the Series C funding to expand its U.S. footprint and AOC practice network.

In the first half of 2020, the resilient nature of the BioHealth Capital Region has been on full display, yet a sobering reality exists: we still dont have a COVID-19 vaccine. And while many companies around the world and region work day and night to create one, the region must remain diligent and smart in how it continues to weather this storm. The second half of 2020 will be interesting to watch, as the region slowly and carefully reopens to a new COVID-19 normal.

If the transition to the post COVID-19 environment goes well, will VC firms come off the sidelines in droves, releasing a flood of new funding? Will companies move forward with M&A thats been held close and delayed? Will a BioHealth Capital Region life science company be the first to get COVID-19 vaccine approved and manufactured? Its difficult to answer any of these questions, but it is certain that Q3/Q4 of 2020 will be fascinating to watch.

Steve has over 20 years experience in copywriting, developing brand messaging and creating marketing strategies across a wide range of industries, including the biopharmaceutical, senior living, commercial real estate, IT and renewable energy sectors, among others. He is currently the Principal/Owner of StoryCore, a Frederick, Maryland-based content creation and execution consultancy focused on telling the unique stories of Maryland organizations.

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2020 Life Science Venture Capital Funding Roundup for Q1/Q2 in the BioHealth Capital Region - BioBuzz