NEUROCAP® 3-month interim data show an average pain reduction of 84%
- Final patient recruited in "STOP NEUROMA" clinical study, full data due to be reported by Q3 2018.
Polyganics, a privately held medical technology company, announced today that interim results show a sharp improvement in pain reduction observed across patients currently enrolled within the "STOP NEUROMA" study.
Enrolment was recently completed for the European "STOP NEUROMA" (Surgical Treatment Of symPtomatic Neuroma) which was designed to gather evidence for the long-term effectiveness of NEUROCAP® in the reduction of painful neuroma formation. The patients that have reached the 3 month endpoint show an average pain reduction of 84% on the Visual Analogue Scale (VAS), where each patient reports a score between 1 and 100 for the experienced pain. The first patients that reached the 12 month endpoint show that the pain relief is maintained together with a significant improvement in daily functioning and quality of life.
Polyganics’ unique proprietary technology 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 approved dedicated device for the surgical management of symptomatic neuromas.
Mariëtta Bertleff, MD PhD, Principal Investigator of the STOP NEUROMA trial said: "Symptomatic neuroma may develop after a nerve dissection or bruising of a nerve following any blunt or sharp trauma to a peripheral nerve, whether accidental or during planned surgery. Neuroma-induced neuropathic pain and morbidity seriously affect the patient’s daily life and socioeconomic functioning. Currently, there is no effective treatment for this extremely disabling condition which may affect over 300,000 patients worldwide. Several patients enrolled in the trial have undergone prior neuroma surgery without beneficial results. Our promising interim data could indicate a breakthrough in the treatment and future prevention of peripheral end-neuroma."
Rudy Mareel, CEO of Polyganics, commented: "The STOP NEUROMA study was designed to provide surgeons with clinical evidence about NEUROCAP®’s benefits in the much needed management of symptomatic neuroma pain. Over 12 months, the interim data shows the effectiveness of NEUROCAP® in terms of reducing pain symptoms, improving patients’ daily life and functioning. We are confident that our first-in-kind device can be used in prevention of neuroma pain in the long term, following amputations or accidental damage."
Please click here to go to Polyganics’ website for more information about NEUROCAP®.
About NEUROCAP®
NEUROCAP® is intended to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic end-neuroma. NEUROCAP® is a tubular device with one open end and one closed end. Dislocation of the nerve stump is prevented by suturing the nerve end into the cap. A hole at the sealed end of the tube allows easy fixation of the nerve stump with a suture to the surrounding tissue. This allows an effective capping technique without the necessity of drilling a hole into bones, or sacrificing other tissue.
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 has recruited 10 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).
About Neuromas
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 alon...
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