PNV Media Thread, page-3223

Exclusive development and distribution agreement with Regenity Biosciences provides AVITA Medical with the commercialization rights to a unique collagen-based dermal matrix following 510(k) clearanceVALENCIA, Calif., July 31, 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 it has entered into an exclusive multi-year development and distribution agreement with Regenity Biosciences (“Regenity”), a leading regenerative medical product developer and manufacturer of bioresorbable technologies. Through this agreement, following 510(k) by the FDA, AVITA Medical will hold the exclusive marketing, sales and distribution rights to a unique collagen-based dermal matrix, which will be manufactured by Regenity.“This strategic collaboration significantly strengthens our portfolio and advances our long-term growth objectives,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “Regenity’s proven expertise in developing and manufacturing bioresorbable materials aligns with our vision. By integrating their innovative collagen-based solutions with our existing RECELL technology, we believe we also have the potential to establish a new standard of care with a one-stage closure, thereby improving patient outcomes.”As part of the exclusive development and distribution agreement, Regenity expects to secure 510(k) clearance for a collagen-based dermal matrix developed in collaboration with AVITA Medical in the fourth quarter of 2024. Once 510(k) clearance is obtained, Regenity will manufacture and supply this product to AVITA Medical. AVITA Medical will then hold its exclusive rights to market, sell, and distribute the product, including any future enhancements or modifications, under the AVITA Medical brand name within the U.S., and potentially in countries in the European Union, as well as in Australia and Japan.Alongside the use of RECELL for the treatment of thermal burn wounds and full-thickness skin defects, our new product will generate a dermal-like tissue in full-thickness wounds through rapid cell repopulation and revascularization of the dermal collagen matrix. Immediately following 510(k) clearance and commercialization, AVITA Medical plans to initiate multiple clinical studies to establish the unique synergies between the new dermal matrix and RECELL. These studies will include the evaluation of the new dermal matrix and other commercially available dermal matrices in full-thickness wounds, followed by delayed treatment with a split-thickness skin graft plus RECELL in a two-stage procedure (the current standard of care), to demonstrate improved time to grafting and wound closure. Additional clinical studies will evaluate the use of the new dermal matrix in full-thickness wounds with immediate grafting together with RECELL in a single procedure, aiming to establish a new standard of care. AVITA Medical anticipates completing these studies in 2025.

Not good news for PNV.
Must be the reason BP see sales for PNV stalling.

Aloha.