Some nice words from...

Some nice words from BARDA

https://medicalcountermeasures.gov/newsroom/2023/avita/

Treatment for full thickness skin defects becomes 78th FDA approval for a BARDA-supported product

BARDA is pleased to announce the 78th approval, licensure or clearance for a medical product developed with BARDA support. The product, the RECELL System from partner AVITA Medical, received U.S. Food and Drug Administration (FDA) approval for an expanded indication to include full-thickness skin defects.

The RECELL System is a point-of-care, regenerative technology that significantly reduces the amount of donor skin required to treat deep wounds using skin grafting (autografting) and RECELL Spray-on Skin cell suspension. In 2018, FDA approved RECELL for the treatment of thermal burn wounds. The 2023 FDA approval expands the previous indication to treat a broad range of full-thickness skin defects, such as those resulting from traumatic injuries, surgical excision due to necrotizing soft tissue infection that can destroy the skin tissue or resection for skin cancer patients.

Currently, autografting (transplanting) a patient’s tissue to another part of the person’s body is the standard of care for full-thickness skin defects, including post-trauma and post-surgical skin reconstruction. This procedure results in an additional injury to the patient and poses risks, such as significant pain, delayed healing, infection, discoloration, scarring, and the need for multiple procedures. The RECELL System isolates the patient’s skin cells from a small skin sample that is immersed in an enzyme solution to produce Spray-on Skin cells for immediate application. The widely meshed autografts used with Spray-on-Skin cells significantly reduce the amount of donor skin needed. The RECELL System thus helps improve patient outcomes and reduces potential morbidity and mortality.

Approximately 80% of acute wounds that require skin grafting are not burn related injuries. The expanded indication represents a significant opportunity to deliver an innovative, earlier treatment method for definitive wound closure in patients with limited donor skin available. Furthermore, in a mass casualty incident that may limit the capacity to deliver care to a large number of patients, products such as RECELL can reduce the duration of hospital stays, improving the treatment capacity within the U.S. burn and trauma care system. FDA approval of such products with broad indications for use in burns and trauma also helps build national preparedness.

This most recent FDA approval is a critical step in BARDA’s overarching strategy, outlined in the 2022-2026 Strategic Plan, to support the development of medical countermeasures built on versatile platforms that can be adapted rapidly to address new or different threats. By supporting the development of medical interventions, such as the RECELL device, that are available in routine care and during mass casualty emergencies, BARDA helps mitigate severe patient outcomes.

We are honored to work with private sector partners to help make the world healthier and safer. For us, number 78 illustrates what government and industry can accomplish together. With novel medicines, diagnostics, and vaccines, we can save lives, protect the American people and enhance global health security.