VALENCIA, Calif. and MELBOURNE, Australia, Sept. 01, 2022 (GLOBE NEWSWIRE) — AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a leading regenerative medicine company in the development and commercialization of cellular devices and therapies autologous for skin restoration, today announced that COSMOTEC, an M3 Group company, has received insurance coverage in Japan for the RECELL® System for the treatment of acute burns.
“We are very pleased that the Japanese MHLW (Ministry of Health, Labor and Welfare) has granted marketing approval for the RECELL system with favorable reimbursement that will be aligned with prices in the United States,” said said Dr. Mike Perry, CEO of AVITA Medical. “We look forward to continuing to work with our partner, COSMOTEC, as they launch and promote RECELL in the Japanese market.”
The RECELL System is used to prepare Spray-On Skin™ cells using a small amount of patient skin, to treat severe burns, while greatly reducing the amount of donor skin needed. 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.
“We will utilize the capabilities of our strong team to support the successful launch of RECELL in Japan,” said Mr. Tatsuro Tsutsumi, CEO of COSMOTEC. “With this product on the market, we look forward to contributing to the treatment of burn patients with the goal of returning them to their daily lives as soon as possible.”
M3 Inc. is a publicly traded company on the Tokyo Stock Exchange (TYO:2413) with subsidiaries in major markets including the United States, United Kingdom, Japan, South Korea and China. M3 Inc. provides services to the healthcare and life sciences industry. In addition to market research, these services include medical education, ethical drug promotion, clinical development, recruitment, and clinical appointments. M3 Inc. operates in the United States, Asia and Europe with more than 4.5 million physician members worldwide through its portals, including MDLinx.com, m3.com, Doctors.net.uk, medigate.net and medlive.cn. M3 has offices in Tokyo, Washington DC, Fort Washington, Pennsylvania, Oxford, London, Beijing and Seoul. Please visit https://corporate.m3.com/en/ for more information.
COSMOTEC Co., Ltd., established in 1992, specializes in the sale and consulting of medical devices focusing on cardiac surgery, general surgery and endovascular treatment. COSMOTEC holds 98% of the market for institutions performing cardiovascular surgery in Japan. COSMOTEC has offices in Tokyo, Sapporo, Sendai, Nagoya, Osaka, Okayama and Fukuoka across Japan. COSMOTEC is an M3, Inc. group company. Please visit http://cosmotec.com/english/ for more information.
About AVITA Medical, Inc.
AVITA Medical is a leading regenerative medicine company in the development and commercialization of autologous cell therapy and devices for skin restoration. The RECELL® The system’s platform technology, FDA-cleared for the treatment of acute thermal burns in adults and children, harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin™ cells. Delivered at the point of care, RECELL helps improve clinical outcomes and validate cost savings. RECELL is the catalyst for a new treatment paradigm and AVITA Medical is leveraging its proven and differentiated capabilities to develop best-in-class cell therapies for multiple indications, including acute traumatic wounds and repigmentation of stable vitiligo lesions.
AVITA Medical’s 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 approved for acute partial-thickness thermal burns in patients 18 years of age and older or for application in combination with mesh autograft for acute full-thickness thermal burns in pediatric and adult patients. In February 2022, the FDA reviewed and approved the PMA Supplement for RECELL Autologous Cell Harvesting Device, an improved RECELL system aimed at providing clinicians with a more efficient user experience and streamlined workflow.
The RECELL System is used to prepare Spray-On Skin™ cells using a small amount of patient skin, providing a new way to treat severe burns, while greatly reducing the amount of donor skin needed. 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. Compelling data from randomized, controlled clinical trials conducted at leading burn centers in the United States and real-world use in over 15,000 patients worldwide confirms that the RECELL System is a significant advance over the current standard of care for burn patients and offers benefits in terms of clinical outcomes and cost savings. Healthcare professionals should read INSTRUCTIONS FOR USE – RECELL Autologous Cell Collection Device (https://recellsystem.com) for a full description of indications for use and important safety information, including contraindications. directions, warnings and precautions.
In international markets, our products are approved under the RECELL System brand to promote skin healing in a wide range of applications including burns, acute traumatic wounds, vitiligo and aesthetics. The RECELL system is registered with the TGA in Australia, has received CE Mark approval in Europe and has received PMDA approval in Japan. To learn more, visit www.avitamedical.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. These forward-looking statements can generally be identified by the use of words such as “anticipate”, “expect”, “intend”, “could”, “may”, “will”, “believe”, “estimate”, “look”. before”, “forecast”, “goal”, “target”, “project”, “continue”, “outlook”, “direction”, “future”, other words of similar meaning and use of future dates. Forward-looking statements in this press release include, but are not limited to, statements regarding, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, growth potential future of our business and our ability to achieve our primary strategic, operational and financial objective. Forward-looking statements, by their nature, address matters that are, to varying degrees, uncertain. Each forward-looking statement contained in this press release 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 and achievement of regulatory approvals of our products; physician acceptance, approval and use of our products; failure to obtain the expected benefits from the approval of our products; the effect of regulatory measures; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industrial, economic or political conditions beyond the company’s control. Investors should not place substantial reliance on the forward-looking statements contained in this press release. Investors are encouraged to read our publicly available documents for a discussion of these and other risks and uncertainties. The forward-looking statements contained in this press release speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.
This press release has been cleared by the review board of AVITA Medical, Inc.
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