Polyganics said today it won CE Mark approval in the European Union for its absorbable, implantable Neurocap device designed to reduce neuroma formation and facilitate tissue repair.
Neuromas, also known as pinched nerves or nerve tumors, are benign growths of nerve tissue that can cause pain, burning sensation, tingling or numbness, according to the company.
“CE regulatory approval is a key milestone for our nerve capping device. We strongly believe Neurocap represents an important addition to the surgeons’ tool-box in the treatment of peripheral nerve injuries enhancing surgical outcomes and patient recovery. Furthermore, if Neurocap shows effectiveness in terms of preventing pain symptoms to return over a one-year period, the device could be used in the prevention of painful neuroma formation following amputations. This is an additional, even more significant population which is steadily increasing due to the growing prevalence of diseases such as diabetes,” CEO Rudy Mareel said in a press release.
The company said it has begun enrollment in its Stop Neuroma study which looks to examine the long-term effectiveness of the Neurocap for reducing painful neuroma formation, and that the 1st patients have been enrolled at the MC Groep hospital in Emmeloord, The Netherlands.
Polyganics won FDA 510(k) clearance for the Neurocap in January. A week earlier, the company said it signed an exclusive distribution deal with strategic partner MicroAire Surgical Instruments that will put it in charge of distributing Polyganics peripheral nerve repair portfolio in the U.S., Canada and Puerto Rico.