StimGuard Receives Positive Trial Results in Wireless Treatment for Overactive Bladder

Miami Beach, Fla.-based StimGuard LLC, a medical device manufacturer and independent research institute, has received positive long-term results from clinical trials held in Europe for its wireless micro-technology injectable tibial stimulator for the relief of overactive bladder (OAB). The device was placed last year in Zurich, Switzerland by leading urology pioneer Karl-Dietrich Sievert, M.D., chairman of urology at the University of Salzburg. Patient outcomes show ongoing reduction of voiding episodes and more than 80 percent relief with a therapy that is administered only at night.

To date, patients have had to make office visits routinely or undergo a surgery in the operating room to use neuromodulation for relief of their OAB symptoms. The StimGuard technology, developed by scientists and engineers led by co-inventor and StimGuard Chairman Laura Tyler Perryman, uses a tiny injectable microchip device placed through a small needle that delivers small pulses of energy to electrodes near surrounding nerves, triggering a reaction designed to enable the brain to remap specific urge signals.

“The therapy is utilized for just eight hours a day, so it can be conveniently administered using only a sock worn during the evening or overnight,” said StimGuard Director James McGivern. “Chronic tibial stimulation affects multiple afferent paths to the micturition centers, possibly better serving patients than classic sacral neurostimulation over the long term.”

Sievert conducted the procedures live at the 2014 Swiss Continence Foundation Conference in Zurich, Switzerland last August. “I am pleased to report that our two patients who presented with OAB and a variety of other medical complications had long term positive outcomes and a reduction in incontinence episodes of greater than 80 percent on average, positively affecting their quality of life,” he said. “The procedure was simple to perform, and I look forward to treating many patients with this novel therapy, which can be administered in a less costly way than other neuromodulation options.”

“I am extremely excited about this new technology developed by StimGuard. Now people with overactive bladder will have additional options, including the ability to receive a permanent implant with a far less invasive and complicated surgery in an office setting,” said Chris Winters, M.D., chairman of the department of urology, Louisiana State University. “The StimGuard tibial system is well positioned to revolutionize the urology industry with an interventional method that most urologists will be able to easily integrate into their practices.”

While neuromodulation has been used for the treatment of OAB since 1997 with expensive systems and numerous large implanted parts and batteries, StimGuard’s novel tibial placement procedure requires just one implanted component: a microsized neurostimulator that can be implanted non-surgically by using only a needle and without the need for imaging equipment. According to the company, this treatment offers a minimally-invasive, outpatient office procedure resulting in a lower cost option for the industry and a patient option that is widely accepted since it is similar to acupuncture, but permanent.

StimGuard conducted short-term pilot studies in 2013 with encouraging results for the chronic tibial neurostimulation concept. The company plans to complete regulatory studies for CE mark in 2015 and to seek U.S. Food and Drug Administration approval in 2016.