Avita Medical (ASX:AVH) said yesterday that the FDA approved an investigational device exemption for a pivotal trial of its Recell autologous cell harvesting device. The Valencia, Calif.-based company said the 65-patient study is designed to compare conventional skin grafting with and without Recell system. Each patient is slated for a control wound treated with a conventional […]
‘Berkmorgazon’ health play Haven COO Stoddard steps away | Personnel Moves – May 17, 2019
Healthcare joint venture Haven, started by Amazon (NSDQ:AMZN), Berkshire Hathaway and J.P. Morgan, has lost its COO Jack Stoddard at just nine months post-hiring, according to a CNBC report. The former digital health general manager for Comcast told the news channel that he is departing the healthcare play due to personal reasons, including the distance between […]
Avita says EU sales temporarily interrupted, inks Japanese distro deal for Recell
Avita Medical (ASX:AVH) said yesterday that sales of its Recell device in the European Union were temporarily interrupted due to an administrative issue with its notified body and announced a new Japanese marketing and distribution deal. The Valencia, Calif.-based company said that the sales interruption occurred after its EU-based notified body “reported open items related to […]
Avita Medical raises $14m
Avita Medical (ASX:AVH) has raised approximately $14.4 million in a new round of equity financing, according to a recently posted SEC filing. Funds in the round came from a single unnamed source, with the first sale noted as having occurred on December 7, 2018. The company paid approximately $1.3 million in finders fees for the offering, […]
Avita Medical raises $9m, wins $1m R&D tax credit
Avita Medical (ASX:AVH) has raised $8.9 million in a new round of equity financing and obtained an approximately $1 million (AUD $1.4 million) research and development tax credit from the Australian Tax Office, according to recently released documents from the company. The $8.9 million funding round included participation from a single anonymous investor, according to an […]
Senseonics CFO Elsey to retire | Personnel Moves – December 4, 2018
Senseonics (NYSE:SENS) said yesterday that its CFO R. Elsey is retiring for the company, and that it has begun searching for a permanent replacement. The Germantown, Md.-based company said that Elsey will stay on until a replacement is appointed, and remain on in an advisory role through to the completion of the company’s 2018 fiscal […]
Avita launches pediatric burn trial
Avita Medical (ASX:AVH) said today that it launched a new trial of its Recell autologous cell harvesting device exploring its use treating pediatric patients. 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, the Valencia, Calif.-based company […]
Avita Medical lands tax credit Down Under
Avita Medical (ASX:AVH) said today that it received a $730,000 (AUD $1 million) Research and Development Tax cash rebate from the Australian Tax Office for its year ending June 30, 2017. The Valencia, Calif.-based company said the incentive program is designed to provide a cash rebate to support companies in Australia undertaking R&D projects. Avita said […]
Avita Medical wins FDA PMA for Recell severe burn treatment device
Avita Medical (ASX:AVH) said today that it won FDA premarket approval for its Recell autologous cell harvesting device, now cleared for use in treating severe thermal burns in patients 18 and older, and that it plans to launch the device in the fourth quarter. The Recell autologous cell harvesting device is designed to use the patient’s […]
Avita begins Recell manufacturing in new facility
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 […]
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