logo
Plus   Neg
Share
Email

AVITA Gets FDA IDE Approval Of Soft Tissue Reconstruction Pivotal Clinical Trial

AVITA Medical (AVMXY.OB) on Monday announced that the FDA has approved the company's Investigational Device Exemption (IDE) application to conduct a study of the Autologous Cell Harvesting Device RECELL in combination with meshed autografting for the treatment of acute soft tissue injuries, defects, and reconstruction.

The study is expected to start in 6 months.

The RECELL System was approved by the U.S. FDA in September 2018, for use in the treatment of acute thermal burns in patients 18 years and older.

The total product sales of RECELL System in the year ended June 30, 2019, were
A$7.7 million compared to A$1.19 million in the prior year.

AVMXY.OB closed Monday's trading at $7.12, unchanged from the previous day's close.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Polaris Industries Inc. is recalling certain Ranger and General Utility, as well as All-Terrain vehicles citing risks of crash, the U.S. Consumer Product Safety Commission said in a statement. The Medina, Minnesota-based company has called back about 26,730 units of Model Year 2019 - 2020 Ranger XP 1000 & Model Year 2020 General XP 1000 Utility vehicles. Gilead Sciences Inc. (GILD) said Friday that the European Commission has granted conditional marketing authorization for Veklury or remdesivir as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19. FedEx is asking NFL team Washington Redskins to change its name for its racist connotations. The delivery services company, which is a major sponsor for the team, made the suggestion following increasing pressure from its investors amid the ongoing protests against racial injustice and inequality that arose from the killing of African-American George Floyd.
Follow RTT