BioCircuit Technologies, a National Institutes of Health (NIH)-funded medical device company focused on tissue repair and neuromodulation, has received FDA 510(k) clearance for its nerve repair device, Nerve Tape.
The product’s patented design is the first FDA cleared, sutureless solution for surgical repair of transected nerves.
“The development and clearance of Nerve Tape represents a significant advancement in the treatment of nerve injuries,” said Jonathan Isaacs, MD, Professor and Chair, Division of Hand Surgery, Virginia Commonwealth University Medical Center. “This product has the potential to offer surgeons a faster, simpler method for achieving a precise, reliable repair of injured nerves. As a co-inventor with several years of experience using the device in animal models, I look forward to having Nerve Tape available for clinical use.”
“We are very pleased to have completed this critical milestone on our path towards providing a new solution for the treatment of peripheral nerve injuries,” said Michelle Jarrard, CEO of BioCircuit Technologies. “As BioCircuit’s first FDA cleared medical device, Nerve Tape exemplifies our commitment to equipping surgeons with powerful, practical tools to improve the treatment of injuries, and we are excited to be entering the commercial phase of development as we prepare to bring this solution to market.”
Nerve Tape was developed in partnership with the Orthopedic Microsurgery Laboratory at Virginia Commonwealth University, Richmond, VA. As previously announced, BioCircuit is working with supply partners in preparation for launch of Nerve Tape in the United States. The company anticipates the product will be available for first human use in 2023.