Polyganics' NEUROCAP receives FDA 510(k)
Friday 29 January 2016
- Life Cooperative
Polyganics announced it has received FDA 510 (K) clearance for NEUROCAP. This is an innovative device, designed to reduce painful neuroma formation. Thereby it facilitates tissue repair and regenaration.
Rudy Mareel, CEO a.i. of Polyganics said, “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. 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 US FDA 510(k) clearance for NEUROCAP is another major milestone for Polyganics.”
Polyganics, a privately held medical technology company focused on the commercialization of proprietary products and technologies for peripheral nerve repair, neurosurgery, general surgery, as well as ear, nose & throat surgery.
NEUROCAP is available in the USA through MicroAire Surgical Instruments LLC (www.microaire.com), the exclusive distribution partner of Polyganics’ PNR portfolio for the USA, Canada and Puerto Rico.
Focus areasLife Cooperative
Tuesday 16 April 2019
New building Polyganics on Zernike Campus
Wednesday 13 March 2019
Enthusiastic crowd Beta Business Days 2019
Tuesday 26 February 2019
Ofichem in TV program ZEMBLA
Wednesday 6 February 2019
High presence talent at Meet&Greets 2019
Wednesday 30 January 2019
LIFE Cooperative: ‘An important ecosystem in the field of ..
Tuesday 15 January 2019
InnoCore Pharmaceuticals will develop contraceptive micron..
Tuesday 4 December 2018
Welcome to new start up EV Biotech
Monday 5 November 2018
Worldwide market at LIFE Cooperatives feet
Monday 3 September 2018
Lode Holding: initiator, participant and part of the Campu..
Tuesday 28 August 2018
A goldmine in Groningen: business in biobanking