FDA Grants Chronic Tibial Nerve IDE Approval for World’s Smallest Wireless System to Alleviate OAB Symptoms

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, percutaneously implantable device for the treatment of urgency urinary incontinence resulting from refractory overactive bladder (OAB) syndrome. The StimGuard device utilizes wireless technology and is placed through a needle at the tibial nerve to activate the afferent micturition (neural urinary) pathways. The clinical trial of this novel approach will launch this winter.

“Physicians have been anticipating the evolution of tibial nerve stimulation with the potential to provide a minimally invasive, long-term implant neuromodulation treatment option for OAB,” said Tufts University Associate Professor David Staskin, MD, a recognized authority on incontinence and one of the committee members of the 5th International Consultation on Incontinence. StimGuard’s technology has the potential to be that innovation. Dr. Staskin serves as one of the data safety monitors for the StimGuard tibial study.

More than 37 million Americans – one out of every six adults – live with some level of OAB. OAB treatment varies depending on the severity of the symptoms, with the modality estimated to cost the U.S. healthcare system more than $60 billion per year.

This clinical trial will focus on implanting a small neurostimulator at the tibial nerve under ultrasound and utilizing a discreetly worn external transmitter to provide energy and therapy to the implanted device. The clinical trial will assess the effectiveness of delivering pulsed electrical energy to surrounding tibial nerves that travel to the sacral nerves to regulate bladder function. Should the results prove successful, StimGuard plans to develop a commercial product solution that would enable clinicians to treat urinary urgency incontinence associated with OAB in an office based procedure through a needle using ultrasound guidance.

“If successfully trialed, the StimGuard technology would allow neuromodulation to be offered to patients in an office setting, which has never been the case before for a permanent, long-term treatment of urinary urge incontinence associated with OAB,” said Laura Tyler Perryman, managing director and co-founder of the StimGuard. “Should the study results show effectiveness, StimGuard will have the ability to treat an underserved OAB patient population with a solution that is simple and not intimidating. We look forward to positive results from the study on the path to bring this technology to the urology market.”

For more information about the StimGuard clinical trials, please visit www.clinicaltrials.gov.

About StimGuard

StimGuard is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, 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.

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