Bioness Announces First European Implants for StimRouter Neuromodulation System

VALENCIA, Calif., Feb. 22, 2017 /PRNewswire/ -- Bioness, Inc., the leading provider of cutting edge, clinically supported rehabilitation therapies, today announced the first series of successful StimRouter Neuromodulation System implantations in Europe at Radboud University Medical Center (Nijmegen, Netherlands), South Victoria University (Cork, Ireland), and Kliniek Park Leopold Chirec (Brussels, Belgium). With the successful launch continuing, Bioness plans to further support clinicians across the continent who are looking to support patients seeking minimally-invasive, long-term pain relief.

Erkan Kurt, MD (The Netherlands), Dominic Hegarty, MD (Ireland), and Jean Pierre van Buyten, MD (Belgium) implanted the StimRouter to manage chronic pain conditions originating from varied peripheral neuralgias. With an estimated 100 million Europeans suffering from chronic pain, there has never been a greater need for innovative pain management options.

"For many years we have had limited solutions to help our patients manage their debilitating pain," shared Dominic Hegarty, MD, a trained Interventional Neuromodulation and Pain Management Specialist. "I'm very pleased to be able to provide the best neuromodulation options for my patients. I am confident that the StimRouter technology will be suitable for a greater range of patients in the future." 

"The StimRouter promises to be a breakthrough in neurostimulation because it is a much smaller device to implant and therefore easier to target pain at its origin," stated Jean Pierre van Buyten, MD, an internationally renowned Pain Anesthesiologist. "Another advantage is that it minimizes cost and recovery time when compared to other more invasive treatments."

"Peripheral neuropathy is a very common and often painful disorder. As a neurosurgeon with more than 20 years of neuromodulation experience, the StimRouter provides a unique opportunity to deliver patients relief from chronic pain, especially among those with peripheral nerve damage and scar tissue around the targeted nerve," explained Erkan Kurt, MD. "Where percutaneous implantation might be a difficult procedure, the StimRouter is a small device that takes a minimally invasive approach that is easy to perform. Another great advantage is the transdermal electrical stimulation which makes implantation of an implantable pulse generator unnecessary."

As a minimally invasive device designed to reduce pain by specifically targeting the affected peripheral nerve, the StimRouter is intended to be a cost-effective and long-term alternative to immobilization, injections, and prescription opioids. The implant procedure is usually completed in less than 30 minutes and uses only local anesthesia.

"As we continue to see impressive clinical results in the US and now Europe we are excited to further our mission of supporting clinicians looking to improve the lives of patients," said Todd Cushman, President and CEO of Bioness. "Patients and their loved ones are looking for true relief from the downward spiral of chronic pain. With greater awareness of opioid addiction, alternative choices which deliver life improving results are needed. We are thrilled to be bringing expanded treatment options to those who care for patients."

StimRouter was the first FDA cleared minimally-invasive, long-term, minimally invasive neuromodulation medical device indicated to treat chronic pain of a peripheral nerve origin. The StimRouter System then received CE mark in February of 2014 and the Company began expanding its focus into the European Union. The patient controlled medical device is an adjunct to other modes of therapy and is being well received by patients and clinicians alike.

The StimRouter is currently being implanted at prestigious clinical institutions across the United States to treat chronic peripheral nerve pain, with specific focus on the following conditions or areas:

• Axillary nerve (e.g. post-stroke shoulder pain)
• Ulnar nerve (e.g. cubital tunnel syndrome)
• Suprascapular
• Superior Cluneal nerve (e.g. lower back neuralgia)
• Genicular nerve
• Median nerve
• Peroneal nerves

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

About StimRouter^™ Neuromodulation System

StimRouter is cleared by the FDA to treat chronic pain of peripheral nerve origin. 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. Bioness innovations have been implemented in the most prestigious and well-respected institutions around the globe with 17 of the top 20 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 | Rx Only | Additional information about StimRouter can be found at www.stimrouter.com

SOURCE Bioness, Inc.

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