BlueWind Medical Announces Successful Completion of Patients' Follow-Up for Its Peripheral Neuropathic Pain (PNP) Study Toward a CE Mark
The study evaluates the "Reprieve System”, a miniature wireless leadless neuro-stimulation platform to treat multiple indications
Herzliya, Israel November 12, 2015 – Bluewind Medical, developer of the “Reprieve” wireless neuro-stimulation device to treat multiple clinical indications, such as pain management, incontinence (OAB), epilepsy, sleep-apnea and more, announced today the completion of patient follow up for a peripheral neuropathic pain (PNP) study for its CE submission.
The study was successfully performed in four centers in Belgium and Poland with up to six months follow-up. Study results will be presented next month at the North American Neurostimulation Society (NANS) annual meeting in Las Vegas.
Peripheral neuropathy is a debilitating condition that is caused by damage to the peripheral nervous system, typically as a result of diabetes. It is estimated that approximately 20 million people are affected by peripheral neuropathy in the US alone.
"Approximately 50% of patients with diabetic peripheral neuropathic pain cannot be sufficiently treated with pain medication alone and are therefore condemned to a life of unbearable suffering," said Dr Van Buyten, the primary investigator of the study and Chairman of the Multidisciplinary Pain Centre at the AZ Niklaas Medical Center. "The Reprieve system enables us to treat many of these patients and provide them with immediate relief".
The Reprieve neurostimulator electrically stimulates the tibial nerve, supressing the patient’s painful sensations. The Reprieve unit is a miniature leadless device that can be implanted in a minimally invasive procedure under local anaesthesia. The novel device empowers patients to take control of their therapy and decide when to use stimulation, based on actual pain.
“The future of neurostimulation is in miniaturization and patient empowerment,” said Guri Oron, Bluewind's CEO. “Today, Neurostimulators that treat pain are large and require complex and expensive surgery. We believe that in order to treat most patients, devices that are significantly smaller and simpler to implant will be required.”
“We are very pleased with this achievement that can significantly improve the quality of life of many patients suffering from debilitating peripheral neuropathic pain, and are planning on making this product available for physicians and patients as soon as possible” said Efi Cohen Arazi, CEO of Rainbow Medical and chairman of the board of BlueWind Medical.
About Bluewind Medical
Bluewind Medical, based in Herzliya, Israel, is developing a novel wireless neuro-stimulation device for the treatment of multiple potential clinical applications in the human body, including peripheral neuropathic pain (PNP), incontinence (OAB), epilepsy and more.
The company was founded in 2010 by Rainbow Medical (www.rainbowmd.com ), a unique private operational investment company that seeds and grows start-up companies developing breakthrough medical devices invented by Yossi Gross, in a diverse range of medical fields. By addressing significant unmet market needs, Rainbow Medical seeks to improve people’s lives and generate exceptional returns for its shareholders.