Avita Medical (ASX:AVH) said today that it successfully finished multiple production runs for its Recell device at its newly-acquired manufacturing facility in Ventura, California. Avita acquired the facility last month from a manufacturer that previously assembled the Recell device on a contract basis. The components being made at the Ventura facility will be used to support the […]
Avita Medical wins expanded FDA compassionate use IDE for Recell
Avita Medical (ASX:AVH) said today it won expanded coverage under the FDA’s compassionate use investigational device exemption program for its Recell autologous cell harvesting device. The ReCell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, Avita said. With […]
ViewRay picks up ex-Spectranetics CEO Drake, COO Matin | Personnel Moves – July 25, 2018
ViewRay (NSDQ:VRAY) said yesterday it tapped former Spectranetics head Scott Drake as its new chief executive officer and former Spectranetics COO Shar Matin as its new COO. Before joining ViewRay, Drake served as CEO and prez of Spectranetics, which was acquired by Royal Philips (NYSE:PHG) in a deal that closed last August. Drake also serves as board chair […]
Avita Medical touts publication of pivotal ReCell trial data
Avita Medical (ASX:AVH) today released results from a pivotal clinical trial of its ReCell autologous cell harvesting device in treating deep partial-thickness second-degree burns. The ReCell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, Avita said. Results from […]
Avita raises $12m for US debut of Recell device
Avita Medical (ASX:AVH) said yesterday that it raised $12.3 million to back the U.S. launch of its Recell wound treatment. Melbourne- and Valencia, Calif.-based Avita said the A$16 million round, raised from a consortium of institutional and “sophisticated” investors led by Bell Potter, consists of two tranches: $9.8 million (A$12.8 million) that’s slated to close June […]
Avita Medical touts pivotal trial of ReCell burn injury device
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. Get the full story at […]
Avita touts ReCell use in treating flesh eating bacteria, announces Chinese trial
Avita Medical (ASX:AVH) this week announced that its ReCell technology had been used to treat a patient with necrotizing fasciitis, and that it launched a Chinese trial of the device exploring its use treating second-degree burns. The ReCell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of […]
RenovaCare touts win in patent spat with Avita Medical
RenovaCare today touted a win in a patent spat with Avita Medical (ASX:AVH) after the US Patent Office dismissed a challenge to RenovaCare’s patents and denied a trial that Avita was seeking. RenovaCare said that the USPTO specifically noted that Avita’s arguments “were based on old claims and technologies which had already been considered and rejected,” […]
Avita wins expanded FDA compassionate use for ReCell device
Avita Medical (ASX:AVH) said today the FDA approved an expansion to the number of patients treatable by its ReCell device under the compassionate use investigational device exemption program by 20 individuals. The ReCell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and […]
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. Get the full story at […]
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