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TYBR Health Enrolls First Patients in Clinical Trial of B3 GEL™ System in Tendon Surgery

TYBR Logo (PRNewsfoto/TYBR Health)

News provided by

TYBR Health

Sep 04, 2025, 08:00 ET

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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.

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The B3 GEL™ System is a proprietary flowable bio-gel barrier designed to prevent post-surgical tissue tethering, a common complication that can limit functional recovery after tendon and ligament surgeries. By creating a protective barrier that minimizes restrictive scar tissue formation while supporting optimal healing, the system aims to improve rehabilitation outcomes and enhance patient recovery. It can be applied using open and more minimally invasive procedures.
The B3 GEL™ System is a proprietary flowable bio-gel barrier designed to prevent post-surgical tissue tethering, a common complication that can limit functional recovery after tendon and ligament surgeries. By creating a protective barrier that minimizes restrictive scar tissue formation while supporting optimal healing, the system aims to improve rehabilitation outcomes and enhance patient recovery. It can be applied using open and more minimally invasive procedures.

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

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

TYBR Health, a medical device and regenerative medicine company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the B3...

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