Category Archives: Regenerative Medicine

The report also provides an in-depth analysis of the competitive landscape and behavior of market participants. In this way, market participants can familiarize themselves with the current and future competitive scenario of the global market for Orthopedic Regenerative Medicine and take strategic initiatives to gain a competitive advantage. The market analysts have carried out extensive studies using research methods such as PESTLE and Porters Five Forces analysis. Overall, this report can prove to be a useful tool for market participants to gain deep insight into the global market for Orthopedic Regenerative Medicine and to understand the main perspectives and ways to increase their profit margins.

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The MAJOR COMPANIES covered in Orthopedic Regenerative Medicine are:

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.

Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins. For each manufacturer covered, this report analyzes their Orthopedic Regenerative Medicine manufacturing sites, capacity, production, ex-factory price, and revenue and market share in global market.

Orthopedic Regenerative Medicine Market: Segment Analysis:

The report section contains segmentations such as application, product type and end user. These segments help determine which parts of the market will improve over others. This section analysis provides information on the most important aspects of developing certain categories better than others. It helps readers understand strategies to make solid investments. The market for Orthopedic Regenerative Medicine is segmented according to product type, applications and end users.

The end users/applications and product categories analysis:

On the basis of product, this report displays the sales volume, revenue (Million USD), product price, market share and growth rate of each type, primarily split into-

General Type

On the basis on the end users/applications, this report focuses on the status and outlook for major applications/end users, sales volume, market share and growth rate of Orthopedic Regenerative Medicine for each application, including-

Finally, the feasibility of new investment projects is assessed, and overall research conclusions are offered.

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Table of Contents

Part I Orthopedic Regenerative Medicine Industry Overview

Chapter One Orthopedic Regenerative Medicine Industry Overview

1.1 Orthopedic Regenerative Medicine Definition

1.2 Orthopedic Regenerative Medicine Classification Analysis

1.2.1 Orthopedic Regenerative Medicine Main Classification Analysis

1.2.2 Orthopedic Regenerative Medicine Main Classification Share Analysis

1.3 Orthopedic Regenerative Medicine Application Analysis

1.3.1 Orthopedic Regenerative Medicine Main Application Analysis

1.3.2 Orthopedic Regenerative Medicine Main Application Share Analysis

1.4 Orthopedic Regenerative Medicine Industry Chain Structure Analysis

1.5 Orthopedic Regenerative Medicine Industry Development Overview

1.5.1 Orthopedic Regenerative Medicine Product History Development Overview

1.5.1 Orthopedic Regenerative Medicine Product Market Development Overview

1.6 Orthopedic Regenerative Medicine Global Market Comparison Analysis

1.6.1 Orthopedic Regenerative Medicine Global Import Market Analysis

1.6.2 Orthopedic Regenerative Medicine Global Export Market Analysis

1.6.3 Orthopedic Regenerative Medicine Global Main Region Market Analysis

1.6.4 Orthopedic Regenerative Medicine Global Market Comparison Analysis

1.6.5 Orthopedic Regenerative Medicine Global Market Development Trend Analysis

Chapter Two Orthopedic Regenerative Medicine Up and Down Stream Industry Analysis

2.1 Upstream Raw Materials Analysis

2.1.1 Proportion of Manufacturing Cost

2.1.2 Manufacturing Cost Structure of Orthopedic Regenerative Medicine Analysis

2.2 Down Stream Market Analysis

2.2.1 Down Stream Market Analysis

2.2.2 Down Stream Demand Analysis

2.2.3 Down Stream Market Trend Analysis

Part II Asia Orthopedic Regenerative Medicine Industry (The Report Company Including the Below Listed But Not All)

Chapter Three Asia Orthopedic Regenerative Medicine Market Analysis

3.1 Asia Orthopedic Regenerative Medicine Product Development History

3.2 Asia Orthopedic Regenerative Medicine Competitive Landscape Analysis

3.3 Asia Orthopedic Regenerative Medicine Market Development Trend

Chapter Four 2016-2020 Asia Orthopedic Regenerative Medicine Productions Supply Sales Demand Market Status and Forecast

4.1 2016-2020 Orthopedic Regenerative Medicine Production Overview

4.2 2016-2020 Orthopedic Regenerative Medicine Production Market Share Analysis

4.3 2016-2020 Orthopedic Regenerative Medicine Demand Overview

4.4 2016-2020 Orthopedic Regenerative Medicine Supply Demand and Shortage

4.5 2016-2020 Orthopedic Regenerative Medicine Import Export Consumption

4.6 2016-2020 Orthopedic Regenerative Medicine Cost Price Production Value Gross Margin

Chapter Five Asia Orthopedic Regenerative Medicine Key Manufacturers Analysis

5.1 Company A

5.1.1 Company Profile

5.1.2 Product Picture and Specification

5.1.3 Product Application Analysis

5.1.4 Capacity Production Price Cost Production Value

5.1.5 Contact Information

5.2 Company B

5.2.1 Company Profile

5.2.2 Product Picture and Specification

5.2.3 Product Application Analysis

5.2.4 Capacity Production Price Cost Production Value

5.2.5 Contact Information

5.3 Company C

5.3.1 Company Profile

Continued

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Orthopedic Regenerative Medicine Market Study Based on Growth, Opportunities, Constraints and Development Factors for Next 5 Years - PRnews Leader

LONDON--(BUSINESS WIRE)--Infiniti Research is the world's leading independent provider of strategic market intelligence solutions. Our market intelligence services are designed to connect your organizations goals with global opportunities. Today's competitive business environment demands in-depth, accurate, and reliable business information to ensure that companies gain a strong foothold in domestic or foreign markets. Our global industry specialist teams ensure the international consistency of our research, enabling powerful access to the real story behind market changes. Request a free brochure for more insights into our solutions portfolio.

Regenerative medicine is currently the hive of innovation in modern science with far-reaching benefits for big pharma, healthcare systems, and patient outcomes. The rapid pace of development is expected in the US regenerative medicine market over the next decade. Some of the key factors fueling demand include the increasing investments in R&D activities and the rising incidence of chronic diseases in the country. Leading vendors have enhanced their R&D investments to develop innovative medical therapies, which is driving the overall growth of the market. Furthermore, M&A and strategic alliances among vendors will have a significant impact on the overall market growth and innovation. Nevertheless, the actual delivery of regenerative medicines has proven to be rather challenging with several roadblocks to commercially viable therapies that are capable of catering to unmet clinical needs.

The promise of regenerative medicines requires an innovative look at the complete product lifecycle, including the development of an efficient distribution network. Planning to venture into this space? Request a free proposal for comprehensive insights about the market.

Experts at Infiniti Research outline some of the most relevant and pressing manufacturing challenges in regenerative medicine products:

Manufacturing expense: Cell therapy manufacturing processes are generally highly expensive. Scaling up from limited laboratory facilities to automated systems for bulk production will largely be based on cost, therefore impeccable financial and time planning become vital.

Design quality: In the case of automation, robots manually reproduce the existing inefficient manual processes due to which the products are often based on obsolete technologies. As a result, the manufacture of regenerative medicines sometimes misses the opportunity to improve their quality by innovating process design.

Biomaterials challenges: Challenges relating to biomaterials are mostly concerned with their selection than the manufacturing process. The trends in material selection will eventually have a major impact on the manufacturing process.

Supply chain challenges: The clinical supply chains required to deliver regenerative medicines therapies are arguably the most complex the industry has seen so far, even more so than for biologic medicine.

Read the complete article for comprehensive insights on the key regenerative medicine manufacturing challenges.

The personalization and unique requirements of regenerative medicines require manufacturers to provide an increased focus on the precision and accuracy of processes. Get in touch with an industry expert from Infiniti research to identify gaps in your existing processes and bridge them with viable business strategies.

About Infiniti Research

Established in 2003, Infiniti Research is a leading market intelligence company providing smart solutions to address your business challenges. Infiniti Research studies markets in more than 100 countries to help analyze competitive activity, see beyond market disruptions, and develop intelligent business strategies. To know more, visit: https://www.infinitiresearch.com/about-us

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Regenerative Medicine: The Future of Medicine is Here but Not Without Challenges | Infiniti Research - Business Wire

DUBLIN--(BUSINESS WIRE)--The "Global Regenerative Medicine Market: Size & Forecast with Impact Analysis of COVID-19 (2020-2024)" report has been added to ResearchAndMarkets.com's offering.

This report provides an in-depth analysis of the global regenerative medicine market with description of market sizing and growth. The analysis includes market by value, by product, by material and by region. Furthermore, the report also provides detailed product analysis, material analysis and regional analysis.

Moreover, the report also assesses the key opportunities in the market and outlines the factors that are and would be driving the growth of the industry. Growth of the overall global regenerative medicine market has also been forecasted for the years 2020-2024, taking into consideration the previous growth patterns, the growth drivers and the current and future trends.

Regenerative medicines emphasise on the regeneration or replacement of tissues, cells or organs of the human body to cure the problem caused by disease or injury. The treatment fortifies the human cells to heal up or transplant stem cells into the body to regenerate lost tissues or organs or to recover impaired functionality. There are three types of stem cells that can be used in regenerative medicine: somatic stem cells, embryonic stem cells (ES cells) and induced pluripotent stem cells (iPS cells).

The regenerative medicine also has the capability to treat chronic diseases and conditions, including Alzheimer's, diabetes, Parkinson's, heart disease, osteoporosis, renal failure, spinal cord injuries, etc. Regenerative medicines can be bifurcated into different product type i.e., cell therapy, tissue engineering, gene therapy and small molecules and biologics. In addition, on the basis of material regenerative medicine can be segmented into biologically derived material, synthetic material, genetically engineered materials and pharmaceuticals.

The global regenerative medicine market has surged at a progressive rate over the years and the market is further anticipated to augment during the forecasted years 2020 to 2024. The market would propel owing to numerous growth drivers like growth in geriatric population, rising global healthcare expenditure, increasing diabetic population, escalating number of cancer patients, rising prevalence of cardiovascular disease and surging obese population.

Though, the market faces some challenges which are hindering the growth of the market. Some of the major challenges faced by the industry are: legal obligation and high cost of treatment. Whereas, the market growth would be further supported by various market trends like three dimensional bioprinting , artificial intelligence to advance regenerative medicine, etc.

Market Dynamics

Growth Drivers

Challenges

Market Trends

Companies Profiled

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

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Global Regenerative Medicine Market (2020 to 2024) - Size & Forecast with Impact Analysis of COVID-19 - ResearchAndMarkets.com - Business Wire

Overview: Regenerative medicine is an interdisciplinary field that applies life science and engineering principles for the regeneration or repair of injured/diseased tissues or organs resulting from various causes including, disease, defects, trauma and aging. The field includes the generation and use of tissue engineering, therapeutic stem cells and the production of artificial organs. It also allows scientists to grow organs or tissues in the lab and implant them in the body safely when the body fails to heal itself. Notably, it has great potential to solve the problem of organ shortage.

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According to the estimation of World Health Organization, there is an increasing prevalence of diabetes among adults over the age of 18 years, that has increased to 8.5% in 2014 compared to 4.5% in 1980 across the globe. As per the estimation of Arthritis Foundation, the number of people expected to be diagnosed from arthritis will be more than 78 million, by 2040.

The market for regenerative medicine is driven by increasing prevalence of neuronal disease, cancer and genetic disease, emerging application of regenerative medicine, and advancement in technology. Huge number of ongoing clinical trails and strong product pipeline are providing market growth oppurtunity. High cost of the treatment, regulatory issues and ethical issuesare hampering the market growth.

Market Analysis: The Global Regenerative Medicine market is estimated to witness a CAGR of 16.6% during the forecast period 20182024. The global market is analyzed based on three segments Therapy, Application and regions.

Regional Analysis: The regions covered in the report are the North America, Europe, Asia Pacific, and Rest of the World (ROW). North America is the major shareholder in the global regenerative medicine market, followed by Europe. Asia-Pacific region is expected to have the fastest growth rate with the market growth centered at Japan, China and India. This is mainly due to increasing funding in healthcare research, rising research activities, growing patient pool, flexible regulatory environment for clinical trials, and rising healthcare expenditure.

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Therapy Analysis:Immunotherapy occupied major market share of global regenerative medicine market in 2017, and is expected to remain same during the forecasted period. Increasing product approvals, emerging technological advancements in cell and gene therapy, flexible regulatory for stem cell based research, and growing awareness regarding the benefits of stem cell therapies.

Application Analysis: The market by application is segmented into cancer, central nervous system, orthopedic and musculoskeletal, diabetes, dermatology, cardiovascular and others. Among various application, dermatology occupied the largest share in 2017 and cancer segment is expected to grow at fastest rate during the forecasted period. Growing aging population, changing lifestyle, increasing disease prevalence makes cancer, the fastest growing application segment during the forecasted period.

Key Players: Allergan plc, Integra lifesciences, Mimedx Group, Inc., Medtronic plc, Organogenesis Inc., Zimmer Biomet, Acelity L.P. Inc., Nuvasive, Inc., Stryker Corporation, Japan Tissue Engineering Co., Ltd. (Fujifilm Holdings Corporation subsidiary), Osiris Therapeutics, Inc., Vericel Corporationand other predominate and niche players.

Competitive Analysis: Currently dermatology segment dominates the global regenerative medicine segment. A lot of researches are going on cancer, CNS, cardiovascular, orthopedic & musculoskeletal applications. The increasing importance of regenerative medicine has resulted in the launch of new products and also increased acquisition, approvals, funding to develop new product.

For instance, in August 2017, Tissue Regenix Group plc completed the acquisition of acquisition of CellRight Technologies, an US based specialist in regenerative osteoinductive bone scaffolds. In April 2018, Roche acquired a program named Inception 5, focused on regenerative therapies for multiple sclerosis. In May 2018, Novartis received second FDA approval for Kymriah, CAR-T cell therapy for B-cell acute lymphoblastic leukemia (ALL)

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Benefits: The report provides complete details about the usage and adoption rate of regenerative medicine in various therapeutic verticals and regions. With that, key stakeholders can know about the major trends, drivers, investments, and vertical players initiatives. Moreover, the report provides details about the major challenges that are going to impact on the market growth. Additionally, the report gives the complete details about the key business opportunities to key stakeholders to expand their business and capture the revenue in the specific verticals to analyze before investing or expanding the business in this market.

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Regenerative Medicine Market to Record a Robust Growth Rate for the COVID-19 Period - Cole of Duty

PHILADELPHIA, June 23, 2020 /PRNewswire/ --Graham Company, one of the country's largest insurance brokerages, today announced a new partnership with Regenexx, a network of leading interventional orthopedics clinics. The partnership gives Graham Company's self-insured clients the option to offer alternative non-surgical orthopedic treatment methods, provided by Regenexx through its expansive network of physicians, as a benefit enhancement for employees. In addition, the partnership will help Graham Company's clients control and reduce overall costs of orthopedic surgery procedures for employees.

According to data from Regenexx, its procedures have effectively intervened on 70% of elective orthopedic injuries and conditions where surgery was previously the only solution.* Regenexx offers a unique approach to treating orthopedic injuries non-surgically through stem cell therapy and other regenerative medicine. Procedures performed by Regenexx's specially trained physician network involve injections of custom orthobiologics, derived from the patient's own cells and natural healing agents, to treat approximately 40 orthopedic conditions. This interventional approach enables employers to save up to 70% of orthopedic costs by reducing the number of unnecessary surgeries performed annually.

"At Graham Company, we are committed to identifying solutions to help our clients control escalating health care costs while also enhancing their benefits offerings for employees," said Debra Montella, Graham Company's Vice President of the Employee Benefits Division. "Through this partnership with Regenexx, we are now able to present our self-insured clients with a unique approach that is transforming orthopedic care and driving down costs associated with surgical procedures."

This partnership also benefits the employees of clients with self-funded plans, providing them with alternative non-surgical treatment options to address orthopedic injuries or conditions. Regenexx company data found that when employees are given the choice between an invasive orthopedic surgery or its non-invasive procedure to treat orthopedic conditions, employees chose Regenexx's procedure a majority of the time. Compared to traditional orthopedic surgeries, Regenexx procedures require less downtime for patients and are considered less costly, less invasive and less risky.

"Regenexx is looking forward to expanding our mission of producing the best possible patient outcomes for Graham Company and their clients through our innovative alternative to orthopedic surgery," said Regenexx CEO Jason Hellickson. "Our patented regenerative approach to treating common orthopedic conditions is transforming the care pathway of an orthopedic patient who can now avoid a surgical encounter with less risk and less downtime."

*This data applies only to elective orthopedic surgery without fracture-related care and acute care trauma.

About Graham CompanyGraham Company is one of the largest insurance and employee benefits brokers in the country, committed to enhancing employee safety and business viability through an action-oriented approach to risk management. In business for nearly 60 years, Graham Company designs customized and effective property and casualty, surety and employee benefits programs for its clients to protect employees and prevent losses. With offices in Philadelphia, New York City and Washington, D.C., Graham Company became 100 percent employee-owned through an employee stock ownership plan in 2017. Through its innovative insurance and safety training programs, Graham Company is redefining what it means to be an insurance broker. To learn more, visit http://www.grahamco.com.

GRAHAM COMPANY IS AN INSURANCE BROKER AND NOT A MEDICAL CARE PROVIDER. ANY QUESTIONS CONCERNING THIS PROCEDURE SHOULD BE REFERRED TO REGENEXX OR YOUR MEDICAL CARE PROVIDER.

About RegenexxRegenexx is a nationwide network of physicians who practice Interventional Orthopedics, a new specialty that focuses on using the most advanced regenerative protocols available as an alternative to many orthopedic surgeries. Regenexx has published roughly half of the research worldwide on the use of orthobiologics for treating orthopedic injuries, and our patented treatment lab-processing and treatment protocols allow us to achieve unmatched results. Our procedures use your body's natural healing agents including blood platelets and bone marrow concentrate to repair damaged bone, muscle, cartilage, tendons and ligaments. We believe in educating patients, offering options and encouraging people to take an active role in their own treatment. For more information on Regenexx Corporate, visit http://www.regenexxcorporate.com or call 888-547-6667. For more information on the Regenexx procedures, visit http://www.regenexx.com.

SOURCE Regenexx

http://www.regenexx.com

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Graham Company and Regenexx Announce Innovative Partnership to Reduce Orthopedic Surgical Spend for Employers - PRNewswire

Premium market insights delivers well-researched industry-wide information on the Regenerative Medicine market. It studies the markets essential aspects such as top participants, expansion strategies, business models, and other market features to gain improved market insights. Additionally, it focuses on the latest advancements in the sector and technological development, executive tools, and tactics that can enhance the performance of the sectors.

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Scope of the Report

The global regenerative medicine market was valued at $5,444 million in 2016, and is estimated to reach $39,325 million by 2023, registering a CAGR of 32.2% from 2017 to 2023. Regenerative medicines repair, replace, and regenerate tissues and organs affected due to injury, disease, or natural ageing process. These medicines help restore the functionality of cells & tissues and are applicable in numerous degenerative disorders such as dermatology, neurodegenerative diseases, cardiovascular, and orthopedic applications. Researchers focus on developing technologies based on biologics, genes, somatic as well as stem cells. Stem cells are capable of proliferation and differentiation and hence, are critical in this field.

The major factors that boost the market growth include technological advancements in tissue and organ regeneration, increase in prevalence of chronic diseases and trauma emergencies, prominent potential of nanotechnology, and emergence of stem cell technology. In addition, rise in degenerative diseases and shortage of organs for transplantation are expected to fuel the growth of the market. Moreover, utilization of nanomaterials in wound care, drug delivery, and immunomodulation has opened numerous growth avenues for the regenerative medicines market. However, stringent regulatory barriers and high cost of the treatment are likely to hinder the market growth.

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Top Key Players:

KEY MARKET BENEFITS FOR STAKEHOLDERS

This report offers a detailed quantitative analysis of the market trends from 2016 to 2023 to identify the prevailing opportunities.

The market estimations provided in this report are based on a comprehensive analysis of the key developments in the industry.

An in-depth analysis based on geography facilitates the study of the regional market to assist in strategic business planning.

The development strategies adopted by the key manufacturers are enlisted in the report to understand the competitive scenario of the market.

KEY MARKET SEGMENTS

By Product Type

Cell Therapy

Gene Therapy

Tissue Engineering

Small Molecule & Biologic

By Material

Synthetic Material

Biodegradable Synthetic Polymer

Scaffold

Artificial Vascular Graft Material

Hydrogel Material

Biologically Derived Material

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Geographically, this report focuses on product sales, value, market share, and growth opportunity in key regions such as United States, Europe, China, Japan, Southeast Asia, and India.

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Regenerative Medicine Market Key Trends, Growth, Share, Size, Analysis and Forecast to 2023 - 3rd Watch News

VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--AVITA Medical Limited ACN 058 466 523 (Company) is pleased to announce that the Federal Court of Australia (Court) has today approved the scheme of arrangement to effect a redomiciliation of the Company and its subsidiaries (Avita Group) from Australia to the United States of America (Scheme), under which AVITA Therapeutics, Inc. ARBN 641 288 155 (Avita US), a company incorporated in the State of Delaware in the United States of America, will become the parent company of the Avita Group.

The Company expects to lodge a copy of the Court orders with the Australian Securities and Investments Commission (ASIC) tomorrow (Tuesday, 23 June 2020). Once the orders are registered with ASIC, the Scheme will become effective.

The Companys shares will be suspended from trading on the ASX from close of trading on Tuesday, 23 June 2020.

The expected timetable for implementation of the Scheme is set out below:

Event

Indicative Date

Effective Date for the Scheme

Last day of trading of the Companys shares on the ASX

23 June 2020

Listing of Avita US on the ASX

Trading of Avita US Chess Depositary Interests (CDIs) commences on the ASX on a deferred settlement basis

24 June 2020

Record Date (for determining the entitlements of shareholders of the Company to Avita US shares or Avita US CDIs)

7.00pm (AEST) on 25 June 2020

Last day of trading of the Companys American Depositary Shares (ADSs) on NASDAQ

Last day of trading of Avita US CDIs on the ASX on a deferred settlement basis

29 June 2020

Implementation Date

Issue of Avita US shares or Avita US CDIs to eligible shareholders of the Company

29 June 2020

Listing of Avita US on NASDAQ

Trading of Avita US Shares commences on NASDAQ

Promptly following the Implementation Date

Trading of Avita US CDIs commences on the ASX on a normal basis

30 June 2020

Any changes to the above dates will be announced to the ASX and NASDAQ and via news release, and will also be notified on the Companys website (www.avitamedical.com).

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 - Court Approves Scheme of Arrangement - Business Wire

By now, most of us in the manufacturing world are familiar with the steady stream of news describing organizations, large and small, providing medical equipment using 3D printers. Face masks, face shields, swabs, and parts for ventilators are the most commonand neededas the frontline medical community struggles to heal patients while protecting themselves. What could be simpler than to create a design, prep the data, ship it to a printer and send the finished part to a happy user or manufacturer?

It is not as simple as it sounds.

There are literally hundreds of 3D printing designs to support the current COVID-19 response. Some work, others dont. Some look great but do not work, explained Dr. Jenny Chen, M.D., founder and CEO of 3DHEALS, a company focusing on education and industrial research in bioprinting, regenerative medicine, and healthcare applications using 3D printing. She was a moderator for a webinar panel titled 3D Printing Design for COVID-19, presented April 22.

Some of the most relevant highlights from the 90-minute webinar were discussions about liability, best choice of materials, and dealing with material shortages as demand spikes for the raw materials needed to make the products that are in such high demand.

In March, four people started a non-profit group called MAKE4COVID and [as of April 22] we are over 2,000 people making needed personal protective equipment (PPE) for the greater Colorado area, said Nicholas Jacobson in the webinar. He is an architect and designer focused on biomedical 3D printing. MAKE4COVID is a coalition formed by the maker community, with small providers as well as larger companies.

Jacobson stressed the need to work directly with surgeons using PPE to develop the best designs possible. We had a trauma surgeon who literally flipped our design [for a face shield] upside down to make it work better for her, he said. We had high hopes when we started, but we would come up with a design and [the sources for] materials dried up, he said, a caution echoed by others in the webinar. He explained how they made do with substitutes, constantly shifting designs to accommodate the materials they could actually get.

He also shared concerns about liability. Face shields were easy because there was no liability attached, at least in Colorado, he said. But, as we get into producing medical devices, the territory gets a lot trickier. He noticed that there was much initial skepticism of taking equipment from such a coalition, until the pandemic progressed and the need became greater. Still, liability is a real concern for the future.

Beyond face shields, MAKE4COVID also went through a process of designing face masks, which as of April 22 were in production. Again, as in face shields, Jacobson stressed it was a process that required input from end users to create an acceptable face mask design.

Dr. Kevin Yoder, D.D.S., is a practicing dentist who also provides software for dentists to employ 3D printers in their practices. He stressed the need to use biocompatible resins from 3D printers. If you are using 3D printing for face masks and other PPE, one should ask if there is any harm in doing that, such as allergic reactions, he said. Using biocompatible resins would reduce that, among other considerations. He also stressed that when using FDM for PPE, avoid using ABS since it produces a harmful off-gas. The FDM materials he recommended were TPU, PLA and PETG.

Yoder also noted that even among the 3D-printed masks they were one-size-fits-all designs. Adapting designs to the unique anatomy [of patients] and creating one-off designs is what dentists do all the time, he said. In response, he adapted his dental software to create MeshMask, a free and semi-automated software tool to create a custom-fitted mask based on 3D face scans.

As expected, it is not just in the U.S. that people are finding source materials difficult to get. If you are looking for straight plastic PETG right now, you will have to wait at least 15 weeks, said Dr. Stephanie Willerth. She has been working with a group in British Columbia using an open-source approach to 3D printing for PPE. She has the technical credentials, holding a Canada Research Chair in Biomedical Engineering at the University of Victoria, Canada with dual appointments in the Department of Mechanical Engineering and the Division of Medical Sciences as a Full Professor.

By converting what had been her biomedical laboratory into a temporary facility for inspecting and sterilizing the parts, the lab has been able to ship out 100 to 200 face shields per day for use in B.C. We did consult with the Health Canada authorities to ensure our designs were suitable and we did have some disclaimers on our packaging, she said.

She expressed a sentiment most ad hoc providers can relate to. A month ago we werent doing this and now we are making large quantities and shipping them every day, she said.

As Dr. Chen noted in the conversation afterwards, there is a possibility that liability can be an issue after all of this is over; the risk is not zero. However, if you have gone through various processes to vet your design, vet your final manufactured product, you have tried your best, and demonstrated a process or obtained your design from an official website, the risk may be decreased.

To listen and watch the entire webinar go to: https://3dheals.com/3d-printing-design-for-covid-19-show-notes-and-recordings

To learn more about 3DHEALS, go to https://3dheals.com/

Read this article:
Practices and Pitfalls of 3D Printing for COVID-19 - Advanced Manufacturing

"When COVID came along we really weren't sure how things would pan out ... but we were less impacted than we thought we'd be ... in that sense there is ongoing demand, but we will have some lumpiness."

Aroa filed its prospectus to list this week, intending to start trading on July 30. The float is being managed by brokers Wilsons and Bell Potter.

We've been able to provide a leading biologic that's 20-60 per cent less expensive.

Brian Ward, Aroa Biosurgery CEO

The New Zealand company has created a biological scaffold from sheep forestomachs, which helps the body to grow new tissue that's been lost due to disease or injury.

The business gets access to the forestomachs from sheep that have been killed for food and the product would have otherwise gone to waste.

Its Endoform products are already in use in more than 600 hospitals and have been used in 4 million surgeries to date.

At the moment the company has scaffolds on the market that can be used to help heal diabetic ulcers, hernias and wounds.

In the year to March 31, the business recorded $NZ25 million ($23.4 million) of revenue and a loss after tax of $NZ6 million.

Mr Ward said the product's advantage over other biological scaffolds on the market was that they were cheaper but just as effective, if not more.

"We have a very efficient large-scale process that's able to produce the material very cost-effectively and in doing that, it's also just a really high-quality product," he said.

Mr Ward says Aroa's biological scaffolds are cheaper and at least as effective as any others on the market.

"We purify it in a gentle way that preserves the biology of the material, having invested significant time and resource into that process in the past 11 years.

"To date, other biologic materials have been limited because they're very expensive, but we've been able to provide a leading biologic that's 20-60 per cent less expensive, letting more patients get access to it."

To date the company has raised about $NZ30 million from venture capitalists and wealthy investors in New Zealand and Australia.

As part of the float, the company will issue 40 million new shares at 75 a share, raising $30 million, while existing shareholders will sell $15 million worth of shares.

After the float, Mr Ward will retain an 11 per cent stake.

Mr Ward started his career as a veterinary surgeon before moving into the life sciences sector, taking on roles with Baxter and SmithKline Beecham. He has also managed investments into New Zealand technology companies for the Foundation for Research Science and Technology.

After becoming interested in regenerative medicine, Mr Ward spent eight years developing the Endoform product before launching commercially in 2016.

Its products have been peer-reviewed and have regulatory approval in 37 countries. Its biggest market is the US, where it sells its products directly as well as through NASDAQ-listed TELA Bio.

The total addressable market for its current products is estimated to be $US1.5 billion ($2.2 billion), but it has more products in its pipeline targeted at things such as complex wounds and breast surgery that it expects will grow this by an additional $US1 billion.

Aroa competes with fellow ASX-listed biotech company PolyNovo, which in early 2019 traded at only 60, but now fetches about $2.45 a share and has a market capitalisation of $1.6 billion.

Mr Ward said the capital raised through the IPO would help it expand its commercial team in the US.

"We see a great opportunity for us to really develop a leadership position at the advanced end of this market," he said. "We believe we can be the leading regenerative medicine company."

Read this article:
Why Aroa is pushing ahead with its IPO despite pandemic - The Australian Financial Review

NEW YORK, June 23, 2020 /PRNewswire/ --BrainStorm Cell Therapeutics Inc. (NasdaqCM: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that its shares will join the Russell 2000 Index and the broad-market Russell 3000 Index at the conclusion of the 2020 Russell indexes annual reconstitution, effective after the US stock market opens on June 29, 2020.

Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of May 8, ranking them by total market capitalization. Membership in the US all-cap Russell 3000 Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

For more information on the Russell 3000 Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

About FTSE Russell

FTSE Russell is a leading global index provider creating and managing a wide range of indexes, data and analytic solutions to meet client needs across asset classes, style and strategies. Covering 98% of the investable market, FTSE Russell indexes offer a true picture of global markets, combined with the specialist knowledge gained from developing local benchmarks around the world.

FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $16 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create investment funds, ETFs, structured products and index-based derivatives. FTSE Russell indexes also provide clients with tools for asset allocation, investment strategy analysis and risk management.

A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on index innovation and customer partnership applying the highest industry standards and embracing the IOSCO Principles. FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit http://www.ftserussell.com/.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.

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Safe-Harbor Statement

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

CONTACTS

Investor Relations:Michael RiceLifeSci Advisors, LLCPhone: +1 646 889 1200mrice@lifesciadvisors.com

Public Relations:Paul TyhalaSmithSolve973.442.1555paul.tyahla@smithsolve.com

View original content:http://www.prnewswire.com/news-releases/brainstorm-cell-therapeutics-to-join-the-russell-2000-index-and-russell-3000-index-301081791.html

SOURCE Brainstorm Cell Therapeutics Inc

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BrainStorm Cell Therapeutics to Join the Russell 2000 Index and Russell 3000 Index - Yahoo Finance