Bioness Receives Health Canada Approval for StimRouter Neuromodulation System

Device for chronic pain management now approved to market in Canada

VALENCIA, Calif., Jan. 29, 2018 /PRNewswire/ -- Bioness, Inc., the leading provider of cutting edge, clinically supported rehabilitation therapies, today announced it has received a medical device license from Health Canada for its StimRouter Neuromodulation System for the treatment of chronic peripheral nerve pain (excluding the cranial facial region). The Canadian medical device license provides approval to commercialize StimRouter and begin sales throughout Canada. Building upon the StimRouter's successful launch in the United States and Europe, this Health Canada approval supports Bioness' objective to expand the availability of StimRouter to more clinicians and patients seeking long-term pain relief. 

Designed to reduce pain by specifically targeting the affected peripheral nerve and delivering gentle stimulating pulses to disrupt pain signals before they reach the brain, StimRouter is intended to be a cost-effective and long-term alternative to prescription opioids, temporary nerve block injections, and more invasive options such as spinal cord stimulation. The StimRouter implant procedure requires just two small incisions and is often completed in under 30 minutes using only local anesthesia. A small, externally-worn patch generates power to the implanted lead. Patients control the system using a wireless, handheld programmer.

"For years, Canada has had limited solutions to help patients who are living in constant pain," shared Dr. Michael Gofeld, Chronic Pain Management Physician at the University of Toronto. "I'm very pleased to be able to provide a non-opioid, neuromodulation option for my patients in response to the growing opioid crisis. I am confident that StimRouter will help a wide range of Canadian pain patients and I personally look forward to assisting those who are suffering from neuropathic pain by making this technology available." 

"As we continue to see impressive clinical results in the US and Europe, we are excited to begin marketing StimRouter in Canada to further our mission of supporting clinicians looking to improve the lives of chronic pain patients," said Todd Cushman, President and CEO of Bioness. "The opioid epidemic continues to impact people across the world in high numbers. Patients and their loved ones are searching for less-addictive alternatives for true relief of chronic pain and we are proud to expand StimRouter to other countries in an effort to bring alternative pain management options to those who care for patients."

StimRouter is the first minimally-invasive, long-term neuromodulation medical device cleared by the FDA, CE and now Health Canada to treat chronic pain of a peripheral nerve origin, excluding the cranial facial region. The technology is currently being implanted at prestigious clinical institutions across the United States and Europe. The patient controlled medical device is an adjunct to other modes of therapy and is being well received by patients and clinicians alike. To date, more than 20 nerve locations have been targeted, signaling the broad application of this technology.

For more information on the StimRouter as well as videos of real patients sharing their StimRouter experience, please visit www.stimrouter.com.

About the StimRouter^™ Neuromodulation System
The StimRouter™ Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat 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. Precautions, Warnings and Contraindications can be found at www.StimRouter.com.

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 solution.  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.

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StimRouter^® and Bioness^® are trademarks of Bioness, Inc. | www.bioness.com | 800.211.9136 | Rx Only | Additional information about StimRouter can be found at www.stimrouter.com

SOURCE Bioness, Inc.

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