First presentation of U.S. IDE clinical data shows statistically significant improvements in pain and function at 24 months compared with fusion surgery
BEVERLY HILLS, CA / ACCESS Newswire / November 7, 2025 / Todd H. Lanman, MD, FACS, FAANS, founder of Lanman Spinal Neurosurgery and ADR Spine, presented the first public results today from the Synergy Disc® 1-Level Investigational Device Exemption (IDE) Clinical Trial (NCT 04469231) during the DOCS Health 7th Annual Spine Arthroplasty Summit in Beverly Hills, CA. The pivotal study demonstrated that arthroplasty with Synergy Disc® was statistically superior to anterior cervical discectomy and fusion (ACDF) in both pain and function at 24 months.*Dr. Lanman served as the study's Principal Investigator.
The multicenter, prospective pivotal trial enrolled 175 patients with one-level symptomatic cervical degenerative disc disease and was conducted at 20 leading spine centers across the United States. The study compared the safety and effectiveness of the Synergy Disc® with ACDF and is designed to support a pre-market approval (PMA) submission to the U.S. Food and Drug Administration. Synergy Spine Solutions submitted the PMA earlier this year and anticipates potential FDA approval in the first half of 2026. Together, the Synergy 1-Level and 2-Level IDE programs now involve more than 40 clinical trial sites across the United States.
At the conference, Dr. Lanman reported that the Synergy Disc® achieved statistically significant improvements in neck pain, arm pain, and Neck Disability Index (NDI) scores at 24 months compared with ACDF. These findings represent the first publicly presented clinical data from the U.S. IDE study.
"The Synergy Disc® represents an important evolution in motion restoration," said Dr. Lanman. "Traditional disc replacements aim to preserve spinal movement. Synergy was engineered to restore motion and alignment, reflecting a more physiological approach to cervical spine function. These early results suggest the potential for meaningful advances in treating degenerative cervical disc disease and reducing the need for fusion."
The Synergy Disc® features a 6-degree lordotic core specifically engineered for alignment restoration and multi-plane stability, with safety stops in every motion plane to prevent hypermobility. Its semi-constrained, soft-on-hard design employs time-validated titanium and ultra-high-molecular-weight polyethylene (UHMWPE) materials, which are compatible with MRI imaging. Unlike traditional disc replacements, Synergy Disc® was designed to address the alignment and load-bearing challenges encountered in patients with prior cervical fusion-a population that made up nearly 40 percent of participants in the trial.
From a biomechanical standpoint, motion at spinal levels adjacent to a fusion can increase by as much as 35 percent, amplifying shear forces and implant stresses. The disc's built-in motion stops are designed to limit these forces while maintaining physiologic movement, reducing the potential for hypermobility and adjacent segment strain.
Long-term follow-up through 48 months demonstrated maintained range of motion and lordosis correction with no observed heterotopic ossification, subsidence, or osteolysis, which supports the device's durability and safety profile.
The Spine Arthroplasty Summit, hosted by DOCS Health, showcased complex case studies and clinical advances in motion-preserving cervical and lumbar arthroplasty. Dr. Lanman's presentation drew significant interest from surgeons nationwide for its implications in reducing adjacent segment disease and optimizing spinal alignment without fusion.
Investigational Use Disclaimer
* CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use. The Synergy Disc® is not yet approved by the U.S. Food and Drug Administration. Safety and effectiveness have not been established.
About ADR Spine
ADR Spine is a leading authority in spinal care, dedicated to providing innovative and comprehensive solutions for patients with spine-related conditions. With a team of highly skilled and experienced physicians, ADR Spine is committed to delivering the highest standard of care, utilizing leading-edge technologies and patient-centric approaches. Learn more at www.adrspine.com.
About Lanman Spinal Neurosurgery
Lanman Spinal Neurosurgery, based in Beverly Hills, California, has been at the forefront of motion restoration and spine health for over 25 years. The practice specializes in artificial disc replacement and complex fusion revision surgery to relieve pain, restore movement, and help patients live their best lives. Learn more at www.spine.md.
About Synergy Spine Solutions
The vision of Synergy Spine Solutions is to identify and commercialize innovative spine technologies that help surgeons improve their patients' quality of life and advance the standard of care. The company's flagship product, the Synergy Disc®, is the only device designed to restore both motion and alignment to the spine. For more information, visit www.synergyspinesolutions.com.
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SOURCE: Lanman Spinal Neurosurgery
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