Avita Medical (ASX:AVH) said today that the FDA put its ReCell autologous cell harvesting device on the fast track, granting expedited access pathway status to the burn treatment. The decision accelerates the timeline for ReCell’s approval, which Avita had expected to occur in the 3rd quarter of 2017, the company said. “The FDA’s decision that we […]
Avita Medical (ASX:AVH) said yesterday it won FDA approval to expand the Investigational Device Exemption trial of its ReCell wound treatment, which sent shares of the company up nearly 12%. The expansion will allow the trial to cover twice as many patients and extend it to patients to patients with larger, more serious defects than […]
Avita Medical (ASX:AVH) said yesterday it won $53.9 million in contracts from the Biomedical Advanced Research and Development Authority for development and procurement of Avita’s ReCell autologous cell harvesting device. The 5-year contract will provide an initial $16.9 million to support the company’s pursuit of FDA premarket approval for its ReCell device, and to procure more […]
The National Venture Capital Assn. is spearheading a drive to get a bill through the U.S. Senate that would make it easier for small companies to raise money by going public.
The "IPO On Ramp" measure would ease the regulatory requirements for IPOs and temporarily reduce the reporting burdens imposed by the Sarbanes-Oxley Act.
Urologix Inc. (NSDQ:ULGX) is heralding the results of a long-term study on its enlarged prostate treatment device.
Data from a study published in The Journal of Urology show that the Minneapolis-based medical device manufacturer’s Cooled ThermoTherapy (CTT) is safe and effective at treating both symptoms and obstruction associated with benign prostatic hyperplasia (BPH), the company reported.