02.24.15
Valencia, Calif.-based Bioness Inc. has earned 510(k) clearance from the U.S. Food and Drug Administration for the Stimrouter, an implantable neuromodulation device designed to treat chronic, intractable pain of peripheral nerve origin. The device is cleared with a specific indication for peripheral nerve stimulation.
With an estimated 50 million people suffering from chronic pain and burdening the United States healthcare system with $150 billion in annual costs, there is a demonstrable need need for pain management options. As a minimally invasive implantable device designed to reduce pain by specifically targeting the affected peripheral nerve, the Stimrouter is designed to be a cost-effective alternative to injections, ongoing medication regiments, and complex surgeries.
“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,” said Bioness founder Alfred Mann. “Furthermore, the Stimrouter represents a less invasive and more cost-effective treatment method when compared to commercially available pain management implanted devices.”
“The FDA clearance of Stimrouter represents a monumental development for Bioness,” said President and CEO Todd Cushman. “The Stimrouter builds on the success of our external neuromodulation systems and allows us to expand into the pain management market as well as other future applications. The positive clinical results, ease of use and a specific indication for use that targets peripheral nerve pain, make the Stimrouter a unique and compelling alternative to spinal cord stimulation and opiates.”
Bioness makes technologies to help people regain mobility and independence and improve quality of life.
With an estimated 50 million people suffering from chronic pain and burdening the United States healthcare system with $150 billion in annual costs, there is a demonstrable need need for pain management options. As a minimally invasive implantable device designed to reduce pain by specifically targeting the affected peripheral nerve, the Stimrouter is designed to be a cost-effective alternative to injections, ongoing medication regiments, and complex surgeries.
“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,” said Bioness founder Alfred Mann. “Furthermore, the Stimrouter represents a less invasive and more cost-effective treatment method when compared to commercially available pain management implanted devices.”
“The FDA clearance of Stimrouter represents a monumental development for Bioness,” said President and CEO Todd Cushman. “The Stimrouter builds on the success of our external neuromodulation systems and allows us to expand into the pain management market as well as other future applications. The positive clinical results, ease of use and a specific indication for use that targets peripheral nerve pain, make the Stimrouter a unique and compelling alternative to spinal cord stimulation and opiates.”
Bioness makes technologies to help people regain mobility and independence and improve quality of life.