The FDA has given the green light to BioCircuit Technologies’ latest innovation in tissue repair and neuromodulation. A 501(k) clearance has been granted for Nerve Tape, the company’s nerve repair device, making it the first sutureless surgical repair solution for transected nerves to have earned FDA approval. The product stemmed from a team-up between BioCircuit and the Orthopedic Microsurgery Laboratory at Virginia Commonwealth University in Richmond, Virginia.
“The development and clearance of Nerve Tape represents a significant advancement in the treatment of nerve injuries,” said Dr. Jonathan Isaacs, a professor and chair of the Division of Hand Surgery at VCU 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.”
BioCircuit’s Chief Executive Officer, Michelle Jarrard, said that the agency’s approval of Nerve Tape represents a significant step forward in the company’s journey toward introducing effective new solutions for peripheral nerve injury treatment. FDA clearance will advance the product into the commercialization pipeline with the help of several supply partners, with Nerve Tape expected to be made available for human use as soon as 2023.