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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

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