BioCircuit’s Nerve Tape Earns FDA Nod

BioCircuit Technologies, an NIH-funded company focused on tissue repair and neuromodulation, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Nerve Tape nerve repair device.
 
According to the company, Nerve Tape is the first FDA-cleared, sutureless tool to surgically repair transected nerves.
 
“The development and clearance of Nerve Tape represents a significant advancement in the treatment of nerve injuries,” Jonathan Isaacs, MD, Professor and Chair, Division of Hand Surgery, Virginia Commonwealth University Medical Center, told the press. “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,” added 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.”
 
The technology was co-developed with the Orthopedic Microsurgery Laboratory at Virginia Commonwealth University. BioCircuit is working with supply partners to prepare Nerve Tape’s U.S. launch. The company expects it to be commercially available for first human use in 2023.