I think you may need to brush up on the new FDA approved Recell Go and soon to be Mini version. I know you're a PNV fan and me too but AVH the way i see it is around 12/18 months behind PNV in terms of traction and application. AVH has much higher sales from the old-world way of treating patients with the same spray on skin.
Have a read of the new clinical trial results and applying over BTM from June and July this year.......... The data and rollout is gaining pace as are the results benefiting both patient/hospitals and insurance saving costs, time of recovery and hospital stay.
Do yourself a Favour and buy some post some research on the trial results, the sales will come and i also believe minimum a PNV agreement of some description....
AVITA Medical Announces FDA Approval of RECELL GOVALENCIA, Calif., May 30, 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 U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for the RECELL GO™ System, its 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.When choosing RECELL, clinicians and patients can realize several significant advantages over traditional skin grafting:• Improved healing is achieved using significantly less donor skin1• Pain is reduced, closure is faster, and the aesthetic appearance at the RECELL-harvested donor site is improved2• Fewer procedures are required for definitive closure3• There's a reduction in the length of stay for burns covering less than 50% Total Body Surface Area (TBSA)2,3,4RECELL 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."FDA approval of RECELL GO marks a paradigm shift in the treatment of partial-thickness and full-thickness wounds,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “By streamlining processes and enhancing operational efficiency with the use of RECELL GO, clinicians can now treat a greater number of patients and more broadly experience the proven benefits of RECELL technology. We believe that this transformative shift will empower more clinicians to achieve optimal outcomes for their patients, driving greater adoption, and fundamentally redefining wound care management. It's GO time for a new era in wound care."In the United States, the Company will launch RECELL GO in its top burn treatment centers in June, and other existing accounts will be converted to RECELL GO throughout the year. New accounts will receive RECELL GO with their first order, eliminating the need for conversion.
The supplement follows the original PMA of RECELL Autologous Cell Harvesting Device and subsequent PMA supplements.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.
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