HOUSTON, Sept. 4, 2025 /PRNewswire/ -- TYBR Health today announced the enrollment of the first patients in an Australian clinical trial evaluating the B3 GEL™ System in flexor and extensor tendon tenolysis procedures. The study is part of the company's evidence-generation strategy to support broader clinical adoption of the technology following its U.S. FDA clearance.
The B3 GEL™ System is a proprietary flowable bio-gel barrier designed to reduce post-surgical tissue tethering, a complication that can restrict motion and prolong rehabilitation after tendon and ligament surgery. In tenolysis procedures—performed to surgically release tendons from scar tissue—the system is applied to help maintain the freed tendon's ability to glide during the critical early healing phase. This approach aims to reduce re-adhesion, support rehabilitation progress, and ultimately restore motion and function for patients.
Multi-Center Clinical Study
The multi-center trial is being conducted under the leadership of principal investigator Professor Randy Bindra of Gold Coast University Hospital, an expert in hand and wrist surgery with extensive experience in clinical research.
"Adhesions remain a major driver of stiffness and reoperation after flexor tendon repair," said Prof. Bindra. "This study will assess whether a flowable extracellular matrix barrier can reduce tethering and improve early range of motion, potentially simplifying rehabilitation. I look forward to tracking these patients' recovery outcomes as the study progresses."
Addressing a Critical Post-Surgical Challenge
TYBR Health Co-Founder and CEO Tim Keane said the launch of the study reflects the company's commitment to building a strong evidence base for the technology. "Advancing the B3 GEL™ System into clinical evaluation marks an important step in building the evidence surgeons value when considering new surgical tools," Keane said. "This Australian study is the first in a planned series designed to assess real-world performance in tendon and ligament repair. The findings will help guide future development and explore opportunities to improve recovery across a range of surgical procedures."
About the Clinical Trial
The study will evaluate the safety and performance of the B3 GEL™ System in flexor and extensor tendon tenolysis procedures, with results intended to support surgeon decision-making and optimal clinical integration.
About TYBR Health
TYBR Health develops solutions for post-surgical tissue recovery, focusing on technologies that support optimal healing and functional restoration after surgical repair. 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. For more information, visit www.tybrhealth.com
Media Contact:
Tim Keane
Co-Founder and CEO
TYBR Health
[email protected]
www.tybrhealth.com
SOURCE TYBR Health
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