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Devices Neurology Urology Regulatory

 News Release - February 19, 2019

Bioness StimRouter(R) Neuromodulation System Receives European CE Mark Approval for the Treatment of Overactive Bladder (OAB)

FDA-Approved StimRouter Continues to Improve the Lives of Chronic Pain Patients in the United States

VALENCIA, Calif., Feb. 19, 2019 -- (Healthcare Sales & Marketing Network) -- Bioness, Inc., the leading provider of state-of-the-art, clinically supported rehabilitation and pain management medical devices, announced today its StimRouter® Neuromodulation System has received CE Mark Approval in Europe for the treatment of Overactive Bladder (OAB). Through this approval, StimRouter is proving to be a versatile solution in multiple therapeutic areas. In the US, the StimRouter currently has FDA approval for the treatment of chronic pain of a peripheral nerve origin as an adjunct to other non-drug therapeutic options. The system is now a viable option to clinicians looking to help their patients who are living with OAB. At this time, Bioness is enrolling patients for a U.S. FDA IDE study to support the use of the system for the treatment of OAB in the U.S.

OAB affects an estimated 33 million people in the US and 526M people worldwide. It is a chronic condition that involves a problem with bladder-storage function that causes a sudden urge to urinate. The urge may be difficult to stop and may lead to the involuntary loss of urine (incontinence). Unlike traditional treatments that include invasive sacral nerve stimulation systems and externalized percutaneous needle stimulation procedures requiring frequent clinic visits, the StimRouter provides patients with a minimally invasive, permanent treatment that puts the patient in control of their therapy at home.

"Traditional treatments for overactive bladder can put an added burden on patients who are already experiencing symptoms that are disruptive to daily life," said Eric Grigsby, MD, Chief Medical Officer at Bioness. "Putting the patient in charge of their OAB management instead of requiring them to come to the office on a regular basis will make treatment more streamlined and less invasive."

The StimRouter is already an effective therapeutic treatment to help reduce or eliminate chronic pain of a peripheral nerve origin for patients seeking to return to normal, daily activities and can now extend its benefits to patients with OAB. The StimRouter procedure requires only one small incision and is completed in about 30 minutes while the patient is awake under local anesthesia. A hand-held remote allows patients to control their symptoms by delivering gentle stimulating pulses to the Tibial Nerve to reduce the chronic urge to urinate.

"The StimRouter has been helping patients in the US, Europe, and Canada manage their chronic pain to move forward with their lives and can now improve quality of life for patients in Europe that suffer from overactive bladder (OAB)," says Todd Cushman, President and CEO at Bioness. "The effects of OAB can cause embarrassment and isolation from work and activities of daily living. The StimRouter has the potential to meet a significant unmet medical need with a unique solution by putting the patient in charge of their customized therapy without having to travel to the doctor's office for multiple visits."

For more information about the StimRouter, visit www.stimrouter.com.

About StimRouter® Neuromodulation System

StimRouter is approved by the FDA to treat chronic pain of peripheral nerve origin, excluding pain in the craniofacial region. StimRouter is a minimally invasive neuromodulation medical device consisting of a thin, implanted lead with conductive electrode, external pulse transmitter (EPT), and hand-held wireless patient programmer. Electrical signals are transmitted transdermally from the EPT through the electrode, down the lead to the target nerve. StimRouter is programmed at the direction of the physician to meet patient requirements but is controlled by the patient to address the patients' specific, changing pain management needs.

About Bioness, Inc.

Bioness is the leading provider of innovative technologies helping people regain mobility and independence. Bioness solutions include implantable and external neuromodulation systems, robotic systems, and software based therapy programs providing functional and therapeutic benefits for individuals affected by pain, central nervous system disorders, and orthopedic injuries. Currently, Bioness offers six medical devices within its commercial portfolio which are distributed and sold on five continents and in over 25 countries worldwide. Our technologies have been implemented in the most prestigious and well-respected institutions around the globe with approximately 90% of the top rehabilitation hospitals in the United States currently using one or more Bioness solutions. Bioness has a singular focus on aiding large, underserved customer groups with innovative, evidence-based solutions and we will continue to develop and make commercially available new products that address the growing and changing needs of our customers. Individual results vary. Consult with a qualified physician to determine if this product is right for you. Contraindications, adverse reactions and precautions are available online at www.bioness.com.


Source: Bioness

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