#Australia #Gold Coast #Clinical Trial #TYBR Health #B3 GEL™

TYBR Health Initiates Clinical Trial of B3 GEL™ System for Tendon Surgery

In a significant advancement for tendon surgery, TYBR Health has enrolled its first patients in an Australian clinical trial evaluating the efficacy of the B3 GEL™ System in flexor and extensor tendon tenolysis procedures. As part of a broader strategy aimed at generating substantial clinical evidence, this trial aims to support the wider use of the B3 GEL™ after its recent clearance by the U.S. FDA.

The B3 GEL™ System is a state-of-the-art bio-gel barrier that has been specifically designed to prevent post-surgical tissue tethering, a common issue that can severely hinder recovery following tendon and ligament surgery. By forming a protective barrier, it minimizes the formation of restrictive scar tissue while promoting optimal healing. This innovative solution can be applied through both conventional and minimally invasive surgical procedures, addressing a critical post-surgical challenge faced by many patients.

The Clinical Approach

In tenolysis operations, which aim to release tendons that have become bound by scar tissue, the B3 GEL™ is utilized to maintain the freed tendon's ability to glide freely during the crucial early phases of recovery. This technique is designed to significantly reduce the risk of re-adhesion, therefore supporting better rehabilitation progress and restoring motion and function more effectively for patients.

The clinical trial is being led by Professor Randy Bindra at the Gold Coast University Hospital, an authority in hand and wrist surgery with considerable experience in clinical research. Professor Bindra remarked, "Adhesions remain a leading cause of stiffness and the need for reoperation following flexor tendon repair. This study will investigate the potential of a flowable extracellular matrix barrier to prevent tethering and enhance early range of motion, thus simplifying the rehabilitation process. I eagerly anticipate monitoring the recovery outcomes of these patients as the trial unfolds."

Commitment to Innovation

TYBR Health's Co-Founder and CEO, Tim Keane, emphasized the importance of this trial in establishing a solid evidence base for the B3 GEL™ System. He stated, "The introduction of the B3 GEL™ System into clinical trials represents a crucial milestone in building the evidence that surgeons seek when evaluating new surgical technologies. The Australian study is just the first in a series planned to assess the real-world effectiveness of this product in tendon and ligament repairs. The insights gained will significantly influence future development and may reveal avenues for improving recovery outcomes across various surgical interventions."

What to Expect from the Study

The ongoing study will meticulously evaluate both the safety and effectiveness of the B3 GEL™ in flexor and extensor tendon tenolysis procedures. With promising outcomes anticipated, the trial results are expected to play an influential role in aiding surgeons' decision-making processes as they integrate this innovative technology into clinical practice.

About TYBR Health

TYBR Health is dedicated to developing solutions that enhance post-surgical tissue recovery. The company focuses on pioneering technologies such as the B3 GEL™ System, which has been FDA-cleared to support the healing of soft tissues in the aftermath of surgery. For further details, interested parties can visit www.tybrhealth.com.

This clinical trial not only marks a pivotal moment for TYBR Health but also sets a promising precedent for the future of surgical recovery methods, offering new hope to patients recovering from tendon surgeries.