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May 04, 2015 11:18 AM ET

Healthcare Equipment and Supplies

Company Overview of Bioness Inc.

Company Overview

Bioness Inc. designs, develops, and distributes medical devices for people with stroke, multiple sclerosis, traumatic brain injury, cerebral palsy, and spinal cord injury. It offers L300, a foot drop system for people with various neurological conditions; L300 Plus for foot drop and thigh weakness, which delivers programmed, low-level electrical stimulation to activate the nerves controlling the muscles of the leg; H200, a wireless hand rehabilitation system for reaching, grasping, opening, and closing the hand; and StimRouter, an implantable neuromodulation device designed to treat intractable pain of peripheral nerve origin. The company was founded in 2004 and is based in Valencia, Califor...

25103 Rye Canyon Loop

Valencia, CA 91355

United States

Founded in 2004

Phone:

661-362-4850

Fax:

877-362-4855

Key Executives for Bioness Inc.

Chief Executive Officer and President
Founder and Chairman
Age: 88
Chief Medical Officer
Compensation as of Fiscal Year 2014.

Bioness Inc. Key Developments

Bioness Inc. Initiates Pilot Study of StimRouter Neuromodulation System for Overactive Bladder

Bioness Inc. announced 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.

Bioness Announces FDA 510K Clearance of StimRouter System

Bioness Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the StimRouter, an implantable neuromodulation device designed to treat chronic, intractable pain of peripheral nerve origin. The StimRouter is the only implanted device to be cleared by the FDA with a specific indication for peripheral nerve stimulation. According to Bioness, The StimRouter is a disruptive technology that presents an opportunity to change the way healthcare professionals treat chronic peripheral pain by targeting and neuromodulating the affected nerve. Furthermore, the StimRouter represents a less invasive and more cost-effective treatment method when compared to commercially available pain management implanted devices. StimRouter is approved 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 the origin of pain. Each system is programmed at the direction of the physician to meet the requirements of the patient.

Bioness, Inc. Launches Bioness Integrated Therapy System (BITS(TM))

Bioness Inc. announced the launch of the Bioness Integrated Therapy System (BITS(TM)), a touch-screen based clinical rehabilitation platform designed to evaluate and improve abilities for individuals with disabilities resulting from traumatic injuries and neurological disorders and to improve performance in competitive athletes. BITS is a clinical nexus that allows current and future Bioness technologies to be integrated on a single platform. The system consists of a touchscreen display (up to 65") mounted on a highly portable stand and is designed to support a series of software programs for optimizing patient outcomes. The system is being launched with a Visuomotor software program covering seven main therapy categories including eye-hand, rotator, rapid eye movement, memory recall, metronome, letter chart and visual-motor programs. These therapy categories provide unique programs for visual-motor integration, improving reaction time, improving visual and auditory memory, visual-vestibular integration and improving hand speed and field attention.

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