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Bioness Initiates Pilot Study of StimRouter™ Neuromodulation System for Overactive Bladder (OAB)Bioness, Inc. announced today that four (4) patients have successfully been implanted with the StimRouter Neuromodulation System, for an ongoing Canadian pilot study to evaluate device use in the treatment of overactive bladder symptoms. The StimRouter is already FDA cleared as a treatment for chronic, intractable pain of peripheral nerve origin. Now, this minimally invasive technology is being studied as an alternative treatment for the 35 million people in the United States who suffer from overactive bladder symptoms and the 10 million who receive treatment for it, which contributes $66 billion in annual cost to the U.S. healthcare system. In the pilot study, subjects with documented refractory overactive bladder will receive tibial nerve stimulation via the StimRouter implantable lead and external pulse transmitter. The subjects will manage their treatment at home in accordance with the defined protocol, with periodic in-clinic outcome visits. The device is equipped with a feature to track usage and compliance during the 6-month trial. While the StimRouter has demonstrated efficacy in relieving peripheral nerve pain, the technology has the potential to be leveraged for even more applications. According to Bioness President and CEO Todd Cushman, "The StimRouter is a platform technology with a design that we believe has applications outside of its current indication, chronic periheral pain. This pilot study demonstrates the first of several investigations with the goal of expanding StimRouter use in markets of unmet need or existing markets that seek the appropriate neuromodulation solution." About StimRouter™ StimRouter is cleared by the FDA to treat chronic pain of peripheral nerve origin. StimRouter is a minimally invasive neuromodulation medical device consisting of an implanted lead, external pulse transmitter (EPT) and conductive electrode, controlled by a small hand-held wireless control unit. Electrical signals are transmitted transdermally from the EPT through the electrode, down the lead to target nerve. Each system is programmed at the direction of the physician to meet patient requirements. About Bioness Inc. Bioness is the leading provider of innovative technologies to help people regain mobility and independence and improve quality of life. The company provides neurological solutions for people suffering from hand and lower extremity paralysis, including the L300® Foot Drop System, L300® Plus System and the H200® Wireless Hand Rehabilitation System, all of which utilize functional electrical stimulation (FES). Patients may also benefit from the Vector Gait and Safety System®, a state-of-the-art, over-ground gait rehabilitation system that uses dynamic body weight support. Individual results vary. Would-be patients should consult with a qualified physician to determine product suitability. Contraindications, Adverse Reactions and Precautions are available online at www.bioness.com StimRouter™, L300®, L300® Plus, H200®, Vector Gait & Safety System®, BITS™ and Bioness® are trademarks of Bioness Inc. | www.bioness.com | Rx Only Additional information about Bioness can be found at www.bioness.com.
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