Checkpoint Surgical today said it received FDA breakthrough device designation for its brief electrostimulation therapy system.
The Cleveland-based company’s brief electrostimulation therapy (BEST) system is designed to stimulate peripheral nerves to promote nerve regeneration when used with surgical intervention following a nerve injury, according to the company.
“We are pleased to receive the Breakthrough Device designation from the FDA as it will allow Checkpoint Surgical to deliver this important innovation in nerve regeneration for patients much sooner,” president and CEO Len Cosentino said in a press release. “Based on the recently published research by our clinical partners Dr. Susan Mackinnon and Dr. Amy Moore at Washington University in St. Louis, we believe the Checkpoint BEST system will be transformational for the treatment of nerve injuries. We are actively enrolling patients in a clinical study of the Checkpoint BEST technology at Washington University in St. Louis and working to add additional surgeon collaborators and study sites.”
“The Checkpoint BEST technology represents a paradigm shift in the treatment algorithm of nerve injuries if proven successful in our clinical trial. As clinicians we will be able to proactively deliver a therapeutic intervention which augments the current care and counters the inefficient initiation of nerve regrowth,” Dr. Amy Moore, associate professor of surgery at Washington University School of Medicine, said. “I look forward to continuing my collaboration with Checkpoint Surgical to develop both the science and technology of the Checkpoint BEST system.”
The breakthrough device designation comes after Checkpoint Surgical raised $9 million in September 2018 for its handheld neurostimulation device.