Avita Medical (ASX:AVH) today released an update on its future plans, saying it it intends to submit an application to the FDA for Premarket Approval for its ReCell device for use in patients with severe burns and that it’s considering making the US its center of operations.
The ReCell device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the company said.
Avita said that the decision to pursue FDA approval for the device under the indication came after it completed a US pivotal trial of the device for treating burns, which it said “demonstrated positive results,”
The company said it would also be considering making the US its main operational hub, while “still maintaining key strategic R&D efforts in Australia and other influential geographies,” according to the press release.
“To this end, Avita will be conducting a strategic review to assess the long-term positioning of the company and its operations as it increasingly looks to the US markets for growth of product sales. Within this framework, we also intend to review the best location for Avita’s administration and head office and to concurrently evaluate future capital requirements as we grow the company. This strategic review may include a proposal for moving our administration and head office functions to the US in context of a re-domicile of the group,” CEO Mike Perry said in a press release.
Last month, Avita released data from a trial of its ReCell device used to treat skin graft patients, touting hastened healing and improved final outcomes.