TYBR Health’s B3 GEL System Receives the US FDA’s 510(k) Clearance to Protect Healing Tissue and Preserve Function
Shots:
- The US FDA has granted 510(k) clearance to the B3 GEL System to protect healing tissue planes and preserve mobility; launch is anticipated at the end of 2025
- Preclinical studies supporting clearance showed that B3 GEL reduced tissue binding and improved range of motion, with greater flexion and extension in treated models compared to controls
- B3 GEL is a bioresorbable gel barrier designed to protect healing tissues and preserve mobility after tendon, ligament, or muscle surgeries. It’s made from natural extracellular matrix and applied using TYBR’s proprietary mixer-applicator system
Ref: Prnewswire | Image: Tybr Health | Press Release
Related News:- Aytu BioPharma Collaborates with Fabre-Kramer Pharmaceuticals to Commercialize Exxua (Gepirone) in the US for Major Depressive Disorder
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com