TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System, a Flowable Bio-Gel to Protect Healing Tissue and Preserve Function

HOUSTON, June 9, 2025 /PRNewswire/ -- TYBR Health, a medical device and regenerative medicine company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the B3 GEL™ System. B3 GEL™ is a bioresorbable, flowable gel barrier designed to protect healing tissue planes and preserve mobility following surgeries involving tendons, ligaments, and skeletal muscle.

This clearance marks a significant milestone for TYBR Health, enabling a new approach to support functional recovery in musculoskeletal surgery. B3 GEL™ helps maintain surgical precision by temporarily separating tissues during the early healing phase—without impeding the natural healing process.

"When we started TYBR, it was with a clear purpose: to solve a real, overlooked problem in surgical recovery," said Tim Keane, PhD, Cofounder and CEO of TYBR Health. "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."

B3 GEL™ is composed of a naturally derived extracellular matrix and is applied via TYBR's proprietary integrated mixer-applicator system. Its flowable format conforms to complex anatomy and can be used in both open and minimally invasive procedures. The blue-colored gel allows for visual confirmation of placement and resorbs completely over time without leaving residual bulk.

Preclinical studies submitted to support clearance demonstrated that B3 GEL™ reduced tissue binding and supported improved range of motion in treated models, with enhanced flexion and extension compared to controls (data on file).

TYBR Health plans to begin commercial sales of the B3 GEL™ System by the end of 2025.

About TYBR Health
Founded in 2020, TYBR Health is a medical device and regenerative medicine company focused on improving surgical recovery. Headquartered in Houston, Texas, TYBR develops solutions that help surgeons protect healing tissues and preserve function after surgery. Its lead product, the B3 GEL™ System, is a bioresorbable gel barrier cleared by the FDA to aid in the protection of soft tissues during post-surgical healing. TYBR is targeting a significant unmet need in musculoskeletal surgery, where recovery complications impact function and healthcare costs. With FDA clearance secured, manufacturing in place, and a proprietary delivery system developed for precise, intraoperative use, TYBR is preparing for commercial launch in late 2025.

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SOURCE TYBR Health