AVITA Medical Achieves Milestone with First Case Using RECELL GO
AVITA Medical has achieved a significant milestone with the first use of its FDA-approved RECELL GO System at the Joseph M. Still Burn Center. The RECELL GO System is an advanced cell harvesting device designed to treat thermal burn wounds and full-thickness skin defects using a patient's own skin cells. This next-generation device enhances healing, reduces pain, and minimizes the need for donor skin. AVITA plans to roll out RECELL GO to top U.S. burn centers in June, with a full deployment throughout the year. The device promises to streamline medical procedures and improve patient outcomes.
- First successful use of RECELL GO at a major U.S. burn center.
- FDA approval of the RECELL GO System.
- Plans for widespread rollout to top U.S. burn centers in June.
- RECELL GO reduces the need for donor skin and minimizes patient pain.
- Enhanced features streamline the preparation of Spray-On Skin Cells.
- Device simplifies user interface and improves workflow efficiency.
- Faster healing and reduced hospital stay for patients.
- Positive clinical feedback from the Joseph M. Still Burn Center.
- Potential high costs associated with adopting new technology.
- Uncertain long-term efficacy and safety data.
- Dependency on early adoption by major burn centers for widespread success.
- Initial rollout to top burn centers, potentially slow adoption elsewhere.
Insights
AVITA Medical's FDA approval and the first case use of their RECELL GO System represent significant advancements in wound care technology. The use of a patient's own skin cells to treat thermal burns and full-thickness skin defects can substantially enhance healing, reduce donor site morbidity and improve patient outcomes. This development is particularly noteworthy because it leverages the body's natural regenerative capabilities, reducing the need for extensive skin grafts and multiple surgical procedures.
Short-term impact: Given the substantial benefits in patient outcomes, hospitals and burn centers are likely to adopt this technology quickly, leading to a potential increase in sales and market penetration for AVITA Medical. The speed of technology deployment and positive patient stories could drive investor confidence and positively affect stock performance.
Long-term impact: As more burn centers adopt this technology, AVITA Medical could set a new standard in the industry. This innovation might spur further advancements in regenerative medicine and attract more investments in this field. However, success will depend on consistent clinical outcomes and widespread adoption among healthcare providers.
AVITA Medical’s successful implementation of the RECELL GO System at the Joseph M. Still Burn Center marks a milestone in the commercial deployment of this technology. Market potential is promising given the large number of burn cases annually in the United States. The faster recovery times and improved outcomes offered by RECELL GO could sway hospitals to transition from traditional skin grafting methods to this innovative solution, enhancing AVITA’s market share.
Short-term implications: Immediate deployment to other top burn centers, as planned, will likely drive initial revenue growth. Investors should watch for follow-up reports on sales performance and further clinical case studies to assess the rate of adoption and market penetration.
Long-term outlook: If RECELL GO gains traction, AVITA Medical may see a steady revenue stream and establish a competitive edge. However, market competition and regulatory challenges could pose risks. Monitoring market responses and adaptation rates will be important in gauging the long-term financial success of this product.
Joseph M. Still Burn Center at Doctors Hospital of Augusta first to treat a patient using AVITA Medical’s FDA-Approved RECELL GO System for thermal burn wounds and full-thickness skin defects
VALENCIA, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that the Joseph M. Still Burn Center at Doctors Hospital of Augusta is the first U.S. burn center to treat a patient using its RECELL GO™ System. Recently FDA-approved, RECELL GO is a next-generation autologous cell harvesting device that harnesses the regenerative properties of a patient’s own skin to treat thermal burn wounds and full-thickness skin defects.
“Completing the first case with RECELL GO at the Joseph M. Still Burn Center is a defining moment for AVITA Medical,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “Following FDA approval, our swift product deployment ensured prompt delivery to the center. The center embraced our initiative, and together with our team, their clinicians successfully completed the first case last Friday, with additional cases completed over the past three days. With the integration of RECELL GO, we believe their clinicians will be empowered to expand treatment capabilities, reaching more patients and achieving optimal outcomes, thus setting a new standard of care in wound care management. We eagerly await the success stories of patients treated at this facility in the coming months.”
AVITA Medical will continue to rollout RECELL GO to top U.S. burn treatment centers in June, while other existing accounts will be converted throughout the year. New accounts will receive RECELL GO with their first order, eliminating the need for conversion.
"As the largest U.S. burn center, we are committed to adopting technology that provides the best possible care for our patients," said Dr. Zaheed Hassan, President of Joseph M. Still Burn Centers, Inc. and Chairman of Burn Reconstruction Center of America. "By integrating RECELL GO into our hospital, we are providing our clinical staff with cutting-edge technology that allows us to focus more on our patients. Our team is proud to be the first in the U.S. to use this innovative device, and we are eager to see the positive impact it will have on our patients' lives."
RECELL technology offers clinicians and their patients a range of benefits compared to traditional skin grafting. The innovative device allows for improved healing using significantly less donor skin1, leading to reduced pain, faster closure, and enhanced aesthetic appearance.2 Additionally, patients often require fewer procedures for definitive closure and experience a reduced length of stay for burns covering less than
RECELL GO introduces enhanced features that streamline the preparation of Spray-On Skin™ Cells. This next-generation device significantly reduces the training burden on medical staff, improves workflow efficiency in the operating room, and controls the RECELL Enzyme™ incubation time to ensure optimal cell yield and viability. These advancements simplify the user interface, enabling medical teams to provide quality care readily and consistently to their patients.
About AVITA Medical, Inc.
AVITA Medical® is a commercial-stage regenerative medicine company transforming the standard of care in wound care management and skin restoration with innovative devices. At the forefront of our platform is the RECELL® System, approved by the U.S. Food and Drug Administration for the treatment of thermal burn wounds and full-thickness skin defects, and for repigmentation of stable depigmented vitiligo lesions. RECELL harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin™ Cells, delivering a transformative solution at the point-of-care. This breakthrough technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes. AVITA Medical also holds the exclusive rights to market, sell, and distribute PermeaDerm®, a biosynthetic wound matrix, in the United States.
In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including burns, full-thickness skin defects, and vitiligo. The RECELL System is TGA-registered in Australia, has received CE-mark approval in Europe and has PMDA approval in Japan.
To learn more, visit www.avitamedical.com.
Forward-Looking Statements
Statements in this announcement may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements generally may 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,” and similar words or expressions, and the use of future dates. Forward-looking statements in this announcement include but are not limited to statements concerning our product development activities, regulatory approval of our products, the potential for future growth of our business, and our ability to achieve financial goals. These statements are made as of the date of this announcement, and the Company undertakes no obligation to publicly update or revise any of these statements, except as required by law. For additional information and other important factors that may cause actual results to differ materially from forward-looking statements, please see the “Risk Factors” section of the Company’s latest Annual Report on Form 10-K and other publicly available filings for a discussion of these and other risks and uncertainties.
Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.
1 Instructions for Use. RECELL® Autologous Cell Harvesting Device.
2 Holmes JH, Molnar JA, Carter JE, et al. A comparative study of the RECELL® device and autologous split-thickness meshed skin graft in the treatment of acute burn injuries. J Burn Care Res. 2018;39(5):694-702.
3 Kowal S, Kruger E, Bilir P, et al. Cost effectiveness of the use of autologous cell harvesting device compared to standard of care for treatment of severe burns in the United States. Adv Ther. Published online May 7, 2019. doi:10.1007/s12325-019-00961-2.
4 Holmes JH, Molnar JA, Carter JE, et al. A comparative study of the RECELL® device and autologous split-thickness meshed skin graft in the treatment of acute burn injuries. J Burn Care Res. 2018;39(5):694-702.
FAQ
What is the RECELL GO System?
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