Avita Medical (ASX:AVH) said today that a pivotal trial of its ReCell autologous cell harvesting device met its co-primary endpoints. The device, designed to help heal deep, full-thickness burns, demonstrated a statistically significant reduction in donor skin requirements compared to the standard of care and achieved comparable wound closure, Avita touted. “Treatment with the ReCell device […]
Tandem’s finance chief to retire at year’s end | Personnel Moves – Dec. 8, 2017
Tandem Diabetes Care (NSDQ:TNDM) announced today that its EVP and chief financial exec, John Cajigas, will retire at the end of 2017. The company’s SVP of finance, Leigh Vosseller, is slated to take his place effective Jan. 1. Tandem noted that Cajigas’ retirement is not due to any disagreement or problem with the company’s accounting or […]
Avita Medical aims for $13m to bring ReCell burn injury device to U.S.
Avita Medical (ASX:AVH) said today that it hopes to raise $13.2 million to fund its efforts to bring its ReCell autologous cell harvesting device for treatment of burn injuries to the U.S. The Australia-based company said it received commitments from investors for a $3.5 million private placement. Avita added that it plans to undertake a rights […]
FDA expands protocol for investigational ReCell burn injury device
Avita Medical (ASX:AVH) said today that the FDA approved a supplement to the company’s investigational device exemption for its ReCell autologous cell harvesting device. The approved treatment protocol for burn injuries has been simplified, according to the company, and the number of approved investigational sites has grown from eight to 15. Up until now, treatment using […]
Avita Medical submits PMA app for ReCell burn injury treatment
Avita Medical (ASX:AVH) said today that it submitted its pre-market approval application to the FDA for its ReCell autologous cell harvesting device. The company’s system is designed to reduce the amount of skin harvesting needed to treat burn injuries compared to conventional treatments. The PMA application is supported by clinical data from two trials. The […]
