Polyganics Announces Enrollment of the First Patient in its PROTECT NEURO Study
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 it has enrolled the first patient in its international PROTECT NEURO study to treat and prevent symptomatic neuroma. The first patient was treated at Stanford Medicine by Catherine Curtin, MD, associate professor of surgery.
The PROTECT NEURO (Prospective Cohort Evaluation Of NEUROCAP® in the Treatment of Symptomatic Neuroma) study is aimed to collect additional evidence for the long-term effectiveness of NEUROCAP®, in the reduction of symptomatic nerve pain in patients with a history of having painful neuroma. PROTECT is a prospective cohort evaluation of NEUROCAP®’s performance in the surgical management of peripheral nerve-ends in both upper and lower extremities including amputation. 92 patients will be enrolled for the study which will run in 17 leading medical centres in both Europe and the United States. Completion of the study enrolment is due to take place in Q4 2017 and final results including two year patient follow-up are expected in 2019.
Polyganics’ NEUROCAP® is a transparent tubular device with a sealed end, a first-in-kind transparent nerve capping device that combines synthetic and bioresorbable qualities. NEUROCAP® is currently the only regulatory cleared dedicated device for the surgical management of symptomatic neuromas.
The Principal Investigator of this study is Professor L. Scott Levin, MD, FACS, from the University of Pennsylvania School of Medicine, a renowned surgeon in orthopaedic, plastic and reconstructive surgery.
Professor Levin said; “NEUROCAP is a promising solution for the treatment of neuromas, a peripheral nerve problem where there are currently limited effective treatment options available. NEUROCAP has the potential to positively impact the quality of life of many patients that suffer from neuromas. This study could provide evidence that this novel treatment is effective in reducing long term neuroma pain and disability.”
Rudy Mareel, CEO of Polyganics said, “Demonstration of long term efficacy is a key milestone for the global recognition of our game changing nerve capping device. NEUROCAP is now being accepted by the clinical community as a solution for the surgical management of symptomatic neuroma. Following the publication of the highly promising interim data of our STOP NEUROMA study in March, which showed an average pain reduction of 84% after three months following surgery using the NEUROCAP, we are focused on continuing our efforts to obtain additional evidence for the prevention of neuroma after nerve injury”.