FDA approval relevant to us - in time!16 Dec 2020 20:12
This has just been published by the FDA this evening. It's a reminder of the size of the opportunity in just one of TRX's assets, OrthoPure, as we move from European to add full US approval, too. As someone observed recently on this chat - Patience is KEY.
FDA Authorizes Marketing of New Implant to Repair a Torn ACL
Today, the U.S. Food and Drug Administration granted marketing authorization—under the De Novo premarket review pathway—for an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of ACL rupture.
“Torn ACLs are among the most common knee injuries in the U.S., but for years, treatment has been limited to ACL reconstruction, which can be quite invasive and typically requires using tendon or a combination of tendon and bone from other parts of the body, or obtained from a tissue bank, to complete the reconstruction,” said Capt. Raquel Peat, Ph.D., MPH, USPHS, director of the Center for Devices and Radiological Health’s Office of Orthopedic Devices, “Today’s marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.”
The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. Despite being a very common injury, until today, the only surgical treatment available for...