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. Get the full story at our sister site, Drug Delivery Business News.
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US Dept of HHS pulls the trigger on $24m contract option with Avita Medical
Avita Medical (ASX:AVH) said today it is executing a $24.3 million expanded contract option with the US Department of Health and Human Services to support development and procurement of its ReCell devices. The option is related to an original contract between Avita Medical and the Biomedical Advanced Research and Development Authority division of the HHS, and […]
Mainstay Medical taps ex-NuVasive COO Hannon for CEO | Personnel Moves, Sept. 7, 2017
Mainstay Medical (EPA:MSTY) said this week that it tapped former NuVasive Inc. (NSDQ:NUVA) president & COO Jason Hannon to succeed Peter Crosby as CEO, effective Oct. 9. Crosby, recruited in 2009 to lead the company and its development of the Reactiv8 neurostimulation device for treating chronic pain, is slated to act as a consultant for Mainstay through […]
Avita to seek PMA for ReCell burn indication, considers making US operations hub
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 […]
Avita Medical touts ReCell skin graft study data
Avita Medical (ASX:AVH) today released data from a trial of its ReCell device used to treat skin graft patients, touting hastened healing and improved final outcomes. 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. Results from the […]
Avita Medical taps ex-Novartis exec Perry for CEO as it shifts focus to US | Personnel Moves June 9, 2017
Avita Medical (ASX:AVH) said last week it tapped former Novartis (NYSE:NVS) global biz dev & licensing chief scientific officer Dr. Michael Perry as its new chief executive officer, replacing resigning CEO Adam Kelliher. Dr. Perry served as a non-exec director of Avita since Feb 2013, according to the company, and held positions with Novartis including chief scientific […]
Avita ReCell pivotal meets endpoints, shares jump
Avita Medical (ASX:AVH) saw shares rise over 5% today after announcing that the pivotal clinical trial of its regenerative ReCell device for treating severe burns met both co-primary endpoints. 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 Cambridge, U.K.-based […]
Avita Medical seeks IP review of Renovacare patent
Avita Medical (ASX:AVH) said yesterday it filed an Inter Partes review petition against a patent held by RenovaCare. The company said it filed the IPR challenge with the US Patent Trial and Appeal Board for US Patent No. 9,610,430 owned by Renovacare. “We believe we have presented a very strong rationale to the PTAB as to why […]
Avita shares rise on FDA nod for expanded ReCell trial
Avita Medical (ASX:AVH) today saw shares jump as much as 7% after the FDA approved an expansion to the number of patients that can be treated in a trial of its ReCell regenerative device. The ReCell device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and […]
7 medtech stories we missed this week: March 17, 2017
The FDA awarded 510(k) clearance to a couple of medtech companies this week while others received tax breaks and incentives, including a local tax break for a $154 million Stryker R&D facility planned in Michigan. Here are 7 medtech stories we missed this week but thought were worth mentioning. 1. FirstRay wins FDA 510(k) clearance […]
Avita inks Iranian distro deal
Avita Medical (ASX:AVH) said today it will be entering the Iranian market after inking a distribution deal with Iran-based Teb Sanaat Lotus and its Iranian partner company Zikad International Aesthetics Supplier. As part of the deal, a dedicated clinic using Avita’s regenerative medical devices will open in Tehran, the company said. “Using our strong distribution network […]