SynerFuse™, a developer of a novel implantable neurostimulator intended to treat chronic low-back pain without the use of addictive opioids, announced a strategic development and manufacturing relationship with Cirtec Medical Corporation to support their current investigational and future commercial technology needs.
MINNEAPOLIS, March 4, 2021 /PRNewswire/ -- SynerFuse™, a developer of a novel implantable neurostimulator intended to treat chronic low-back pain without the use of addictive opioids, today announced a strategic development and manufacturing relationship with Cirtec Medical Corporation to support their current investigational and future commercial technology needs.
The partnership is focused on the development of the NeuroFuse™ DRG therapy, which uniquely integrates spinal fusion and neuromodulation in order to attack the problem of chronic low-back pain with a preemptive, drug-free pain management solution.
SynerFuse™ is currently investigating its therapy in a pilot trial at the University of Minnesota in Minneapolis, MN. The study is being led by neurosurgeons Dr. Matthew Hunt and Dr. Michael Park. More information is available at www.synerfuse.com.
There are approximately 500,000 low-back fusion procedures performed annually in the United States. Spinal fusion does not always relieve pain as intended; residual neuropathic pain after successful spinal fusion occurs after as many as 50% of spinal surgeries and severely reduces the quality of life for patients. Patients are often prescribed opioids to combat residual pain, which are not effective for long term use or targeting neuropathic pain but have contributed to the current opioid epidemic.
“SynerFuse™ aims to make traditional spine implants more successful by embedding active neuromodulation therapy at the time surgeons are performing fusion back surgery,” said Justin Zenanko, CPA/MACS, SynerFuse™ co-founder and CEO. “We are pleased to be able to work with the outstanding team at Cirtec to develop the NeuroFuse™ DRG system to support future clinical trials and bring long term back relief to back surgery patients.”
According to Dr. Greg Molnar, PhD, SynerFuse™ co-founder, CSO and board director “Pain is not Pain is not Pain” further, “There are many types of pain with different biological mechanisms involved in lower back pain and in the residual pain after lumbar fusion. Some pains called nociceptive / mechanical pain are often addressed by the surgery whereas neuropathic pain can only be effectively addressed by neuromodulation. Our ongoing clinical trial will work to provide evidence for proactive, preemptive pain management and holds the promise of a more desirable solution to long-term pain relief.”
“Cirtec is excited to partner with SynerFuse™ to develop and commercialize this innovative life changing therapy. The ability for SynerFuse™ to leverage our neuromodulation platform technology to bring their therapy to market quickly and cost effectively validates the investments we have made over the past several years to support this very exciting market,” said Brian Highley, Cirtec’s CEO.
Cirtec is a leading provider of outsourced medical device design, engineering, and manufacturing. For over 25 years, Cirtec has offered outsourced solutions for complex medical devices by providing a uniquely comprehensive range of resources and expertise that includes the design and manufacture of neuromodulation, drug delivery, cardiac rhythm management, mechanical circulatory support, and interventional devices.
About SynerFuse™
SynerFuse™ is a Delaware corporation based in Minnesota—the heart of Medical Alley. SynerFuse™ believes that individuals with chronic back pain and their providers deserve a better option than spinal fusion alone. Even when spinal fusion is successful, it can often result in residual chronic pain and use of addictive opioids. The company is working to create a new future of non-narcotic pain management for lower back pain with a patented therapy that integrates spinal fusion hardware, an active neuromodulation system, and sensors in a novel “smart” device.
About Cirtec Medical Corporation
Cirtec is headquartered in Brooklyn Park, Minnesota, and has been in operation for over 25 years. It operates nine facilities across the United States, Costa Rica and Germany and has over 1,000 employees. Cirtec has been providing design, development, manufacturing, and product transfer services for the medical device industry. With facilities in Los Gatos CA, Chandler, AZ, Brooklyn Park, MN, Enfield CT, Lowell, MA, Birkenfeld, Germany and Costa Rica, the company specializes in outsourced solutions for active implantable devices in the areas of neuromodulation, drug delivery, cardiac rhythm management, ventricular assist, and minimally invasive devices. Companies rely on Cirtec expertise throughout the entire development cycle to bring life-enhancing therapies to market. More information is available at http://cirtecmed.com.
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SOURCE SynerFuse
