AVITA Medical shares surged on Thursday after the company’s RECELL System used for the treatment of burn patients, received a key US government funding approval.
Avita is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs.
AVITA Medical’s first U.S. product, the RECELL System, was approved by the U.S. FDA in 2018. The system is used to prepare Spray-On Skin Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required.
The pivotal studies leading to the FDA premarket approval demonstrated that the RECELL System treated burns using 97.5% less donor skin when used alone in second-degree burns, and 32% less donor skin when used with autograft for third-degree burns. This significant reduction in donor skin required produced healing comparable to the standard of care while providing a significant reduction in donor site pain.
The company announced that the Centers for Medicare & Medicaid Services approved Avita’s application for a Transitional Pass-Through Payment device category code that will provide separate payment for RECELL Devices used in procedures that are performed in hospital outpatient facilities and ambulatory surgical centers (ASC).
The new payments effective from January 1, 2022, will be used by facilities to bill for RECELL Systems used in the hospital outpatient and ASC settings. The pass-through payment is intended to facilitate the adoption of new technology for Medicare beneficiaries by offsetting the cost of the device to facilities.
The approval will expand access to the RECELL System as a critical treatment option for burn patients and will enable health care providers to treat burn patients with RECELL in various care settings, especially during the pandemic.
Dr Mike Perry, AVITA Medical Chief Executive Officer. “In addition to expanding burn treatment to a new care setting with existing customers, this device code lays the reimbursement foundation for the soft tissue repair indication we are working towards which has a serviceable addressable market valuation of $450M.”