BlueWind Medical
Charting New Territories in Neurostimulation

We all have at least one friend who often feels the recurring need to make a trip to the washroom, irrespective of whether they are at home, in a supermarket, or even traveling. Otherwise known as overactive bladder (OAB) syndrome, this is a common affliction affecting almost 35 percent of the adult population worldwide. A person with OAB displays symptoms that include a frequent urge to urinate many times during the day and night, and also unintentional loss of urine (urgency incontinence) in some instances.

Even though some treatment options are available for OAB, the only successful candidates are Botox injections, Sacral Nerve Stimulation (SNS), and Percutaneous Tibial Nerve Stimulation (TNS) therapies. And although effective, they also have considerable complications associated with the treatment processes. For instance, SNS involves implanting a large stimulator device and leads placed near the sacral nerve. There can be pain and infection at the stimulation or lead site. In certain cases, leads even migrate from their designed location and require reintervention. While Botox injections can deaden nerves on the surface of the bladder and is relatively effective, roughly 70-80 percent of patients stop therapy after four years due to the need for recurrent touch-ups and other side effects. And while Percutaneous TNS successfully addresses the limitations of SNS, the therapy can only be administered at a physician’s clinic—for 12 consecutive weeks with frequent treatments required thereafter. Given the limitations of other therapies, is there an effective and hassle-free alternative to these conventional treatments for OAB? Enter BlueWind Medical.

An innovative medical device manufacturer from Israel, BlueWind Medical, has developed a breakthrough wireless neurostimulation device called RENOVA™ based on the core tenets of TNS therapy, but only better. “We are improving tibial nerve modulation with a miniature wireless implant, powered by a wearable device to treat pelvic floor disorders, particularly over-active bladder,” states Daniel Lemaitre, chairman and CEO of BlueWind. Notably, the medical device company has successfully completed pilot clinical studies with excellent results and is now focused on bringing its novel neuromodulation device to the market.

But how does the RENOVA neuromodulation device work?

To elaborate, Lemaitre first explains the basic premise of TNS. Nerve stimulation to the tibial nerve would effectively travel up the nervous system and affect the sacral nerve that controls the bladder. Chinese acupuncturists were the first to understand this relation and used the knowledge to treat OAB by mechanically stimulating the tibial nerve.

However, what sets BlueWind’s approach to TNS apart in the marketplace is RENOVA’s unique design.

RENOVA comes with a 3cm long implantable wireless stimulator and a wearable device. The physician implants the electrode in the patient’s ankle with a simple cut down procedure and can also calibrate the stimulator’s exact position using ultrasound or active stimulation guidance. This entire process can be completed within 20-30 minutes. Besides, physicians can further minimize any untoward incidents by placing the device in the vicinity of the tibial neurovascular bundle without exposing them.

We are improving tibial nerve modulation with a miniature wireless implant, powered by a wearable device to treat pelvic floor disorders, particularly over-active bladder

Once the entire implantation process is completed, RENOVA facilitates simple and personalized treatment in the comfort of the patient’s home without frequently visiting the clinic. Patients use the wearable device around their ankle to stimulate the tibial nerve on a daily basis for 30 minutes up to two hours per day. And because it’s wearable, patients can carry out their daily activities even during the treatment duration. “The rechargeable wearable device that powers the implant eliminates the need to reintervene to replace batteries and the device design minimizes complications, which is the main benefit as compared to existing devices,” underscores Lemaitre.

What substantiates these benefits is a pilot clinical study wherein BlueWind has successfully demonstrated the RENOVA device’s safety and performance. The study was conducted in four prominent clinical centers in the UK and the Netherlands. 36 patients suffering from OAB were enrolled in the research for six months to evaluate RENOVA. 71 percent of the study candidates experienced at least a 50 percent decline in OAB symptoms within six months of starting the treatment. They witnessed a reduction in the number of urine leaks per day and a significant decrease in the severity of leaks. Besides, 28 percent of patients suffering from urge incontinence became “dry,” meaning they had stopped experiencing any leaking episodes. All in all, the trial results suggest that BlueWind’s miniature implant negates the side effects and inconveniences of the traditional SNS or TNS and paves the way for a safer and more accessible reality. The study also demonstrated that the BlueWind RENOVA system improved all quality of life aspects of the patients, including coping with symptoms, symptom concern, sleep disturbances, and problems with social interactions. A 200 patient pivotal study is now being conducted at roughly 30 centers in the US, Europe, and Israel, which the company hopes will lead to FDA marketing clearance.

With these clinical studies highlighting the value of BlueWind’s RENOVA neuromodulation device, the company is now laser-focused on transforming the traditional modes of neurostimulation further by eliminating the need for complex and invasive surgeries. “And as RENOVA continues to enable a safer and easier treatment procedure, more patients will have the opportunity to benefit from this advanced therapy,” concludes Lemaitre.