MIAMI — (BUSINESS WIRE) — StimGuard, a privately-held, pre-commercial stage medical device company, today announced that it has received FDA Investigational Device Exemption (IDE) approval to launch a clinical trial of the world’s first passive microsize implantable device for the treatment of Overactive Bladder Syndrome (OAB), utilizing wireless technology and placed completely through a needle. The clinical trial will launch in summer 2015.
StimGuard has just one implanted component: a microsize neurostimulator that can be implanted non-surgically by using only a needle. A small external transmitter is easily and discreetly worn and attached to underwear and not directly in contact with the skin at anytime. With no internal batteries, StimGuard’s wireless technology eliminates the need for extra surgeries to replace batteries or upgrade components and is compatible with MRI scans, unlike the existing commercial options.More than 33 million Americans live with some level of OAB and treatments vary depending on the severity of the symptoms. Over 200,000 patients have received Sacral Nerve Stimulation (SNS) to alleviate severe symptoms. Conventional SNS treatment for OAB involves surgically implanting an electrode and an implantable pulse generator, a relatively bulky device with a non-rechargeable battery requiring future surgical replacement.
“StimGuard has the potential to revolutionize the treatment of OAB and dramatically improve the lives of millions of people,” said James McGivern, MBA, StimGuard’s Managing Director and a renowned medical device specialist with over 30 years experience in the industry. “We are excited to be at this stage of testing the efficacy of this next generation medical treatment for indications including urinary urge incontinence. We anticipate very promising outcomes.”
StimGuard utilizes Stimwave’s revolutionary electroceutical device – a tiny, injectable microchip that delivers small pulses of energy to electrodes near surrounding nerves. Sacral Nerve Stimulation (SNS) has been a proven, FDA-approved treatment for severe OAB since 1997. However, conventional treatments are expensive and invasive, requiring multiple surgeries to implant and replace components. StimGuard is revolutionary because of the small size of the device – 1.3 mm in diameter – that can be implanted in an outpatient procedure through a standard needle with no need for a large surgical incision.
“We are thrilled about using this innovative technology to help patients manage the chronic and debilitating issue of overactive bladder,” said Kenneth Peters, MD, Professor and Chairman of Urology at Oakland University William Beaumont School of Medicine and a recognized authority on neuromodulation. “The majority of issues with the conventional SNS treatments have to do with the relatively large size of the devices and the need to replace the very expensive implantable pulse generators. StimGuard has the potential to eliminate those barriers through microtechnology.”
“StimGuard introducing a completely percutaneous method for sacral stimulation is going to have a major impact on the field and open up many options for urologists,” said Laura Tyler Perryman, Managing Director and Co-Founder of the StimGuard device. “With a product that eliminates the need for invasive and expensive surgery, we have the ability to access underserved OAB patients with a proven neurostimulation treatment. We look forward to positive results from the study and bringing forward this technology to the urology market.”
StimGuard’s wireless technology is already being used by Stimwave, another medical device company, to successfully provide relief of chronic back and leg pain in Europe and the United States. The Stimwave Freedom Spinal Cord Stimulation (SCS) SystemTM – the smallest neuromodulation device on the market – represents a life-changing technological breakthrough for people who endure daily chronic pain and may otherwise need to rely on pain medications.
For more information about the StimGuard clinical trials, which will test OAB-related indications including urinary urge incontinence, starting in summer 2015, please visit www.stimguard.com or www.clinicaltrials.gov.
StimGuard is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, injectable, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective urological solution that is easily incorporated into their daily lives. StimGuard’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of urinary management. www.stimguard.com.
Glodow Nead Communications
Evan Nicholson or Sonia Meyer, 415-394-6500