SynerFuse™ Announces IDE Proof of Concept Study Data Presented at Minnesota Neuromodulation Symposium

--Study to Evaluate Safety and Tolerability of Simultaneous Implant of Spinal Fusion and Neuromodulation Devices in Chronic Lower Back Pain Patients

EDEN PRAIRIE, Minn., April 24, 2023 /PRNewswire/ -- Justin Zenanko, CEO of SynerFuse™, is proud to announce that Michael Park, M.D., associate professor of neurosurgery at the University of Minnesota, SynerFuse IDE Proof of Concept study PI, presented data from the Proof of Concept study's first eight patients at the 10^th annual Minnesota Neuromodulation Symposium, April 21, 2023. (See abstract, page 68: https://drive.google.com/file/d/1GPhWsox60OVzCRBxcJWkp_EQAeSpklUp/view?pli=1).

"This presentation showcased the promising surgical procedure results to date of the world's first SynerFuse^® implants integrating spinal fusion with neuromodulation of the dorsal root ganglia (DRG) in patients with chronic neuropathic pain of the low back or leg," said Zenanko.

Spine surgeons Rohan Lall, M.D., Department of Neurosurgery, M Health Fairview, and Jonathan Sembrano, M.D., associate professor of orthopedic surgery, University of Minnesota, performed the implants with Park and Lall also performing the world's first solo SynerFuse^® implant.

"The study surgical procedure data presented today showed that in these eight patients—average followup 7.8 months—there were no infections, device failures with loss of stimulation therapy, or lead migrations associated with the novel integrated implant offering surgeons visual and direct access in placing leads on the DRG," said Zenanko.

Enrollment in the study is ongoing.

More information about SynerFuse is available at www.synerfuse.com.

About Chronic Lower Back Pain (cLBP)

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 pain². 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 patients³.

About SynerFuse

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 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