10 May 2016
Polyganics Announces Enrollment of First Patients in Multicenter Study for NEUROCAP Nerve Capping Device
Groningen, The Netherlands, 9 May 2016, Polyganics, a privately held medical technology company focused on the commercialization of proprietary products and technologies for peripheral nerve reconstruction and regeneration, announced today that the first four patients have been enrolled in the “STOP NEUROMA” study.
The STOP NEUROMA study (Surgical Treatment Of symPtomatic Neuroma) will examine the effectiveness of the company’s device NEUROCAP® in the reduction of painful neuroma formation. NEUROCAP® is a transparent tubular device with a sealed end, and is the first and only synthetic nerve capping device cleared for the treatment of symptomatic neuromas. The patients have been enrolled at the MCGroep hospital in Emmeloord, The Netherlands, by Coordinating Investigator, Marietta Bertleff, MD.
Dr Bertleff said, “Neuropathic pain caused by symptomatic neuromas is an important problem following peripheral nerve injury. The treatment of such disabling neuropathic pain following nerve injury is a topic that is of timeless interest to surgeons but an entirely effective treatment remains elusive. The STOP NEUROMA study is designed to support surgeons with clinical evidence about NEUROCAP for the much needed management of symptomatic neuroma pain to improve patients’ daily life and functioning.”
Rudy Mareel, CEO a.i. of Polyganics said, “Our active recruitment to the STOP NEUROMA study, which uses our nerve stump barrier NEUROCAP, is another significant milestone for Polyganics. This work helps us to gain traction in an important market: in the US alone there are approximately 600,000 nerve repair procedures per year. We strongly believe NEUROCAP represents an important addition to our peripheral nerve repair portfolio of products designed to enhance patient recovery and surgical outcomes.”
About the STOP NEUROMA study
To examine the effectiveness of NEUROCAP®, Polyganics is working with several European hospitals in an open non-randomized clinical investigation (STOP NEUROMA study: Surgical Treatment Of symPtomatic Neuroma), which is due to recruit 30 patients. The study has been designed to obtain data on the clinical performance of NEUROCAP®’s ability to isolate the nerve end, and its effectiveness in both reducing pain from the symptomatic neuroma and prevention of its reoccurrence. For more information on the STOP NEUROMA study visit www.clinicaltrials.gov (identifier: NCT02528266).
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 3-5% of all patients involved in peripheral nerve injury develop a symptomatic neuroma. In the US alone there are approximately 600,000 nerve repair procedures per year. It is estimated that around 185,000 persons in the US undergo amputations of a limb each year of which around 20% 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 leading 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, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including HEMOPORE®, SINUPORE® and OTOPORE®) to US Company Stryker, one of the world’s leading medical technology companies. NASOPORE®, a reliable, easy-to-use, nasal wound care dressing made of biodegradable foam, has been used in over 2.5m procedures globally.
Polyganics is profitable and privately held. The Company is based in Groningen, The Netherlands, a center of biomedical engineering excellence, in an ISO 13485-certified manufacturing facility. The Company’s polymer platform technologies are protected by a broad portfolio of patents and its products have received clearance from the US FDA, CE-approval, and approval from CFDA and other international authorities.
For more information, visit: www.polyganics.com