The US Food and Drug Administration (FDA) has granted 510(k) clearance to TYBR Health’s bioresorbable B3 GEL system, a barrier intended for protecting healing tissues and preserving mobility post-surgery, which involves ligaments, tendons, and skeletal muscle.
This gel temporarily separates tissues during the early healing phase, without hindering the natural healing process, while maintaining surgical precision.
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Composed of a naturally derived extracellular matrix, B3 GEL is applied using the company’s integrated mixer-applicator system.
Its flowable nature allows it to conform to complex anatomical structures and is suitable for both open and minimally invasive surgeries.
The blue gel ensures visibility during placement and is fully resorbable, leaving no residual material.
According to the company, the gel stays in place during the first week post-surgery, safeguarding tissues through the acute inflammation and fibroblast proliferation phases.
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By GlobalDataIt metabolises naturally over two to three weeks, ensuring protection when necessary and full clearance once healing is done.
TYBR noted that the B3 GEL System’s protective capabilities extend across various tendon and ligament complexes in the body, offering consistent performance from hand to foot and ankle surgeries.
It forms a protective barrier, preventing restrictive scar tissue while aiding in healing.
The company anticipates commercial sales to begin by the end of this year.
TYBR Health CEO and co-founder Tim Keane said: “When we started TYBR, it was with a clear purpose: to solve a real, overlooked problem in surgical recovery.
“Too often, healing goes unprotected once the procedure ends. B3 GEL is designed to fill that gap—working with the body’s biology to protect tissue planes and give surgeons a way to safeguard patient outcomes during the critical early phase of recovery.”
