TYBR Health has received US Food and Drug Administration (FDA) 510(k) clearance for its B3 GEL System for enhancing functional recovery in musculoskeletal surgeries.
B3 GEL is a bioresorbable, flowable gel barrier, designed to safeguard healing tissue planes and maintain mobility post-surgery
The system temporarily separates tissues during the early healing phase, ensuring surgical precision without disrupting the natural healing process.
Composed of a naturally derived extracellular matrix, the gel is applied using TYBR’s proprietary integrated mixer-applicator system.
Its flowable nature allows it to adapt to complex anatomical structures, suitable for both open and minimally invasive procedures.
The gel’s blue hue facilitates visual confirmation of placement, and it fully resorbs over time, leaving no residual bulk.
Preclinical studies showed that the B3 GEL System reduced tissue binding and improved range of motion in treated models, enhancing flexion and extension compared to controls.
TYBR Health plans to begin commercial sales of the B3 GEL System by the end of 2025.
TYBR Health cofounder and CEO 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.”
Founded in 2020 and based in Houston, Texas, TYBR Health focuses on improving surgical recovery through innovative solutions.
The company aims to address significant unmet needs in musculoskeletal surgery, where recovery complications can affect function and increase healthcare costs.
TYBR Health is poised for a commercial launch, supported by established manufacturing and a proprietary delivery system designed for precise intraoperative use.
