BlueWind wins CE mark for overactive bladder neurostimulator

Israeli startup BlueWind Medical has won a CE mark for its miniature wireless neurostimulation device to treat overactive bladder. The first-of-its-kind device is inserted using a minimally invasive procedure and could help improve the quality of life for patients with overactive bladder.

The OAB-1000 System is implanted in the leg close to the tibial nerve. It is 90% smaller than neurostimulators currently on the market and takes about 30 minutes to implant, BlueWind Medical said. Currently, overactive bladder patients must undergo invasive surgery to implant a neurostimulator and its lead close to the pelvis.

The BlueWind device is powered wirelessly by an external unit that the patient wears. It treats the condition by electrically stimulating the tibial nerve. Being batteryless, it spares the patient from future surgeries to replace the device.

"Today, neurostimulators that treat OAB are large, bulky, and require complex and expensive surgery," said Guri Oron, Bluewind CEO, in the statement. "BlueWind's implantable microstimulators are significantly smaller, allow for a simple implant procedure and are easier for patients to use at home. This is the first product out of many in our pipeline that will transform Neurostimulation and by that, will enable the treatment of millions of additional patients."

BlueWind Medical completed a 36-patient clinical trial in the Netherlands and the U.K. earlier this year. The study participants liked having the "flexibility and sense of control by treating themselves at home," Dr. Sohier Elneil of the University College London and National Hospital for Neurology and Neurosurgery Hospitals said. The company plans to present its findings later this year. It did not disclose plans for a U.S. trial.

While its first CE mark is for overactive bladder, the company focuses on wireless neurostimulators for a number of indications. Rainbow Medical's portfolio includes 12 medical device startups that address various chronic indications, including heart disease, uterine fibroids and chronic neuropathic pain.

BlueWind Medical was founded in 2010 by Rainbow Medical. Rainbow Medical was founded in 2003 by GlenRock Israel, a private equity group focusing on technology in life sciences. GlenRock founder Leon Recanati, Yossi Gross, a medical device entrepreneur, and Efi Cohen-Arazi, a medical industry exec, co-founded it.

Just a week earlier, Irvine, CA-based Axonics won a CE mark for its own neurostimulator for overactive bladder and fecal dysfunction. The device is 60% smaller than the FDA-approved InterStim SNM implant, marketed by Medtronic. Axonics' device is rechargeable and has a 15-year life span, an improvement over the surgeries patients with nonrechargeable neurostimulators must undergo every four to 5 years.

- here's the statement