Polyganics, a privately held medical technology company focused on the commercialization of proprietary products and technologies for peripheral nerve reconstruction and regeneration, has received the CE mark for NEUROCAP, a nerve capping device. Polyganics intends to launch the device in several European countries later this year.
NEUROCAP is an absorbable implant for the treatment and reduction of symptomatic neuroma in peripheral nerves. It was cleared for sales in the United States and introduced during the Annual Meeting of the American Society of Surgery of the Hand in Phoenix in January.
In February, the European STOP NEUROMA study started to gather evidence for the long-term effectiveness of NEUROCAP in the reduction of painful neuroma formation. The first patients have been successfully enrolled at the MC Groep hospital in Emmeloord, The Netherlands, by coordinating investigator Mariëtta Bertleff, MD.
Through the study, Polyganics is collecting more data on the clinical performance of device’s ability to isolate the nerve end, and the product’s effectiveness with respect to the reduction of pain from the symptomatic neuroma and prevention of pain reoccurrence.
If it shows effectiveness in terms of preventing a return of pain symptoms over a one-year period, the device could be used in the prevention of painful neuroma formation following amputations, according to the company.