Benzinga | Nov 3, 2021 09:19AM EDT

AVITA Medical Announces Expanded Medicare Reimbursement To Outpatient Hospital And Ambulatory Surgical Centers

AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH))), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today that the Centers for Medicare & Medicaid Services (CMS) has approved AVITA Medical's application for a Transitional Pass-Through Payment device category code that will provide separate payment for RECELL(r) Autologous Cell Harvesting Devices (RECELL(r) System) used in procedures that are performed in hospital outpatient facilities and ambulatory surgical centers (ASC).

The new Healthcare Common Procedure Coding System (HCPCS) device category C code will be effective January 1, 2022 and 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.

"We are pleased with yesterday's CMS approval, which will expand access to the RECELL System as a critical treatment option for Medicare burn patients treated in the hospital outpatient and ambulatory surgical settings. The new code will enable health care providers to treat burn patients with RECELL in various care settings especially during the pandemic, and over the long run, help foster adoption of RECELL in small burns as well as in future indications," said 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."

"The autologous skin cell suspension procedure is a long-awaited, major technological improvement in the treatment of burns that significantly reduces the patient's donor site pain due to the substantial reduction in donor skin requirements," said Dr. William Hickerson, current Coding Committee Chair and former President of the American Burn Association. "CMS is to be commended for taking these steps that will directly improve Medicare patient access to innovative treatments for burns."

The pivotal studies leading to the RECELL System's FDA premarket approval for the treatment of acute thermal burns demonstrated that the RECELL System treated burns using 97.5i percent less donor skin when used alone in second-degree burns, and 32 percent less donor skin when used with autograft for third-degree burns.ii This statistically significant reduction in donor skin required to treat burn patients with the RECELL System produced healing comparable to the standard of care while providing a significant reduction in donor site pain and improved donor site healing.i In the three years since FDA approval, more than 85% of burn surgeons throughout the United States have been certified to use the RECELL System, which is used in 77% of major burn centers.

For more information about the RECELL System, please visit www.RECELLSystem.com.

This press release was authorized by the review committee of AVITA Medical, Inc.