Data Safety Monitoring Board Determines SynerFuse™ Proof-of-Concept Study Meets Safety Expectations

--Recommends Study Should Continue with No Protocol Modifications

EDEN PRAIRIE, Minn., Oct. 18, 2022 /PRNewswire/ -- SynerFuse, Inc., an Eden Prairie, Minnesota-based medical device company, announced today that an independent Data Safety and Monitoring Board (DSMB) completed its pre-specified safety review of the first five implanted subjects in the company's ongoing proof-of-concept study.

The SynerFuse proof-of-concept study is an early feasibility study being conducted under an Investigational Device Exemption (IDE) approved by the FDA. Per the protocol, an independent DSMB was to meet after five subjects were followed through 10-20 days post-study surgery.

The independent DSMB, which met on October 11, is comprised of a neurosurgeon, an interventional pain medicine physician, and a biostatistician. The DSMB reviewed all safety and efficacy data collected to date and determined that the study procedure met safety expectations and recommended to continue the study with no protocol modifications or changes to the study procedures. The DSMB will continue to monitor subject safety data until the study is completed.

The SynerFuse proof-of-concept study involves combining spinal fusion with the implant of a neurostimulator to provide stimulation of the DRG, a key nerve structure along the spine that can be targeted with neuromodulation to address chronic neuropathic pain. The study is evaluating the safety and tolerability of the integrated therapy. Patients undergoing an initial spinal fusion, among other criteria, are eligible for the study. Up to 20 patients are expected to be enrolled in the proof-of-concept study.

"Gaining validation from the DSMB for what we have done in our proof-of-concept study so far is a significant milestone for SynerFuse, and we are thrilled about it." said co-founder and CEO Justin Zenanko.

"Getting the green light from the DSMB to continue our proof-of-concept study with no changes to the protocol or procedures is a testament to the excellent collaboration we have experienced within our company and with our surgeon and staff partners at the University of Minnesota Medical School and M Health Fairview University of Minnesota Medical Center," said SynerFuse co-founder and Chief Scientific Officer Greg Molnar, PhD.

cLBP is defined as lower back pain that continues for 12 weeks or longer, even after an initial injury or underlying cause of acute lower back pain has been treated.¹ With more than 500,000 procedures performed annually, spinal fusion remains a common treatment for spinal instability, albeit with a high incidence of residual neuropathic pain.² Up to 40% of patients who undergo spinal fusion end up with Failed Back Surgery Syndrome (FBSS), a condition resulting in significant, lingering neuropathic pain, costing the U.S. healthcare system $20B per year and significantly affecting the quality of life of patients.³

SynerFuse is a Delaware corporation based in Minnesota—the heart of Medical Alley and the cradle of neuromodulation and medical device innovation. SynerFuse believes that individuals with cLBP/FBSS and their providers deserve an alternative option other than spinal fusion alone. Even when spinal fusion is successful, it can often result in residual chronic neuropathic pain and use of addictive opioids. The company is working to create a non-narcotic pain management for chronic low back pain with a patented therapy that integrates spinal fusion hardware and an active neuromodulation system. For more information on the company, please visit www.synerfuse.com.

This communication contains information about an investigational product. This product is limited by Federal (U.S.) law to investigational use only. SynerFuse makes no claims regarding the safety or effectiveness of the unapproved investigational product. The intent of providing this information is to convey research and development initiatives underway at SynerFuse.

¹ See "Low Back Pain Fact Sheet." National Institute of Neurological Disorders and Stroke, https://www.ninds.nih.gov/low-back-pain-fact-sheet#:~:text=Chronic%20back%20pain%20is%20defined, back%20pain%20has%20been%20treated, accessed October 17, 2022.

² Karen L. Saban et al., "Health-Related Quality of Life of Patients Following Selected Types of Lumbar Spinal Surgery: A Pilot Study," Health and Quality of Life Outcomes 5 (2007), https://doi.org/10.1186/1477-7525-5-71.

³ Farber SH, Han JL, Elsamadicy AA, Hussaini Q, Yang S, Pagadala P, Parente B, Xie J, Lad SP. Long-term Cost Utility of Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome. Pain Physician. 2017 Sep;20(6):E797-E805. PMID: 28934786; PMCID: PMC8358894.

SOURCE SynerFuse

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