Polyganics Receives FDA 510(k) Clearance for Nerve Capping Device

Polyganics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Neurocap, a device designed to reduce painful neuroma formation and thereby facilitate tissue repair and regeneration.

“Neuroma-induced neuropathic pain and morbidity can seriously affect the quality of a patient’s daily life. Neurocap, a transparent tubular device with a sealed end, is the first and only synthetic nerve capping device cleared for the management of symptomatic neuromas,” said Rudy Mareel, CEO of Polyganics. “Current approaches are based on surgical removal of the neuroma and surrounding scar tissue, then placing the nerve stump in tissue subjected to minimal mechanical stimulation. However, these approaches have in many cases unsatisfactory outcomes. With our bioresorbable medical device Neurocap we offer orthopedic and hand surgeons a valuable new tool that contributes to the clinical management of neuromas and that can improve the daily life of patients. Receiving U.S. FDA 510(k) clearance for Neurocap is another major milestone for Polyganics.”

Neurocap is available in the United States through MicroAire Surgical Instruments LLC, the exclusive distribution partner of Polyganics’ PNR portfolio.

A neuroma is a painful condition, also referred to as a “pinched nerve” or a nerve tumor. It is a benign growth of nerve tissue. It brings on pain, a burning sensation, tingling, or numbness. Approximately 3 percent to 5 percent of all patients involved in peripheral nerve injury develop a symptomatic neuroma. In the United States alone there are approximately 600,000 nerve repair procedures annually. It is estimated that around 185,000 Americans undergo amputations of a limb each year, of which around 20 percent will develop symptomatic neuromas. Neurocap is intended to be used for neuromas that occur after nerve repair and for amputation stump neuromas.

Polyganics is a medical technology company with multiple versatile polymer platforms. The company develops, manufactures and commercializes innovative bioresorbable medical devices that facilitate tissue repair and regeneration.

Polyganics’ portfolio includes products developed in-house and in collaboration with medical technology companies and academic centers of excellence. In the peripheral nerve repair (PNR) and neurosurgery field, the portfolio includes three marketed products: Vivosorb for minimizing unwanted tissue adhesions after surgery; Neurolac for supporting PNR following hand surgery; and Neurocap for the management of symptomatic neuromas. Products in development include a sealant for the dural membrane, for use post brain surgery.

In 2014, the company sold its Ear, Nose & Throat (ENT) surgery business unit (the Nasospore product family including Hemopore, Sinupore and Otopore) to Stryker Corp. Nasopore, a reliable, easy-to-use, nasal wound care dressing made of biodegradable foam, has been used in more than 2.5 million procedures globally, the company claims.

Polyganics has a supportive shareholder base, including the investment agency of the Northern Netherlands (NOM), and the University of Groningen. The company also has a research partnership with the non-profit organization the Brain Technology Institute, an international group of neurosurgeons.

Based in Groningen, The Netherlands, Polyganics is privately held.