BlueWind posts positive follow-up study results

Neurostim developer BlueWind Medical reported positive results from a follow-up study of patients using its implantable tibial nerve stimulator for overactive bladder (OAB).

Renova iStim is a leadless, miniature, wireless neurostimulation platform designed for the treatment of multiple clinical indications. Three years after implantation of the BlueWind’s Renova iStim device, 75% of patients experienced at least a 50% long-term reduction in symptoms. Patients experienced a durable, long-term, effect of urinary urge incontinence relief in “leaks” (50% of patients) and in “large leaks” (80% of patients). No severe adverse events were reported throughout the follow-up study, according to the Herzliya, Israel-based company.

In June, the FDA approved the company’s pivotal study design to support its marketing application for Renova iStim in the U.S. The OASIS pivotal trial analysis will focus on the proportion of responders to tibial therapy at six months post-implant based on the reduction in urinary urgency incontinence episodes from the patient’s baseline diary. Safety and durability of the effect will be assessed 12 months post-implantation.

The prospective OPTIMIST study was conducted in four clinical centers in the U.K. and the Netherlands. It is an extension of the previously published OPTIMIST six-month pilot study and included 20 of the 36 pilot study patients.

BlueWind Medical is the only company today with long-term positive clinical data for implantable tibial stimulation for the treatment of overactive bladder, the company said in a prepared statement. An estimated 66 million people in the E.U. and 43 million in the U.S. suffer from overactive bladder, a disease that adversely affects patients’ quality of life.

“We are very encouraged by the sustained long-term results of the Renova system,” said Dr. John Heesakkers, the study’s principal investigator. “The study provides assurance that BlueWind’s Renova iStim stimulation of the tibial nerve can lead to meaningful symptoms improvement, without the clinical risks associated with sacral device implantation.”

The study also demonstrated that the Renova iStim system provided long-term improvement in all health-related quality of life aspects of patients, with 70% of the patients showing a meaningful improvement as assessed by an overactive bladder quality-of-life questionnaire, the company said.

“The 36-month study results confirm that the Renova iStim system provides robust and effective long-term performance, that could help millions of patients in the management of OAB,” said Efi Cohen Arazi, CEO of parent company Rainbow Medical and chairman of BlueWind Medical. “We believe BlueWind has highly differentiated wireless neuromodulation, and this data provides strong evidence of the potential for this technology in OAB and other indications.”