Synergy Spine Solutions® Announces PERFORM International Real-World Study Results for Synergy Disc® at North American Spine Society 2026 Annual Meeting

• The PERFORM study evaluated 120 patients treated with the Synergy Disc across five sites in the United Kingdom, European Union, and Australia, providing evidence from routine clinical practice.

• Mean Neck Disability Index scores decreased from 43.4 before surgery to 7.8 at two years and remained low at three years. Mean neck pain scores decreased from 5.8 before surgery to 0.8 at two years.

• No device-related adverse events, explants, or supplemental fixation were reported during follow-up. Kaplan–Meier analysis estimated 100% device survival through up to four years.

• The findings add to the clinical evidence supporting the Synergy Disc, a cervical disc replacement designed to preserve motion while addressing sagittal alignment.

LOUISVILLE, Colo., Oct. 20, 2026 /PRNewswire/ -- Synergy Spine Solutions, a medical device company focused on improving the quality of life for patients undergoing spine surgery, today announced results from PERFORM, an international real-world clinical study evaluating the Synergy Disc, presented at the North American Spine Society (NASS) 2026 Annual Meeting in San Antonio.

The multicenter study found that patients treated with the Synergy Disc experienced sustained improvements in neck pain and disability, with no device-related adverse events or explants observed during follow-up. The findings provide additional evidence on the device's performance across international clinical settings and support continued evaluation of its longer-term outcomes.

PERFORM is an ongoing, international, multicenter, open-label, pragmatic clinical study with prospective and retrospective cohorts. It evaluates the Synergy Disc in a routine, real-world evidence setting, with safety data collected for all patients and patient-reported outcomes assessed according to each participating site's standard of care.

The study included 120 patients across five sites in the United Kingdom, the European Union, and Australia. All patients underwent cervical disc replacement at a single level, and 30% also underwent anterior cervical discectomy and fusion (ACDF) during the same surgery.

"Reducing pain and disability is central to helping patients regain function after cervical disc replacement," said Neil Duggal, Chief Medical Officer and Founder at Synergy Spine Solutions. "PERFORM shows sustained improvements in these outcomes across international clinical settings, with no device-related adverse events reported during follow-up. These results give surgeons additional real-world evidence and confidence to inform treatment decisions as we continue to evaluate the Synergy Disc's long-term performance."

Among the study's findings:

• Mean Neck Disability Index (NDI) scores decreased from 43.4 before surgery to 16.4 at six weeks, 9.5 at one year, and 7.8 at two years. At three years, the mean score remained low at 10.8.

• Mean neck pain scores decreased from 5.8 before surgery to 1.2 at one year and 0.8 at two years.

• No device-related adverse events, explants, or supplemental fixation were reported during follow-up.

• Kaplan–Meier analysis estimated 100% device survival through up to four years of follow-up, with patients censored at their last completed follow-up visit.

Patient-reported outcome data were available for 78% of patients who had reached one- and two-year follow-up and 63% of those who had reached three-year follow-up. One patient underwent disc replacement at an adjacent level following an acute disc prolapse. Follow-up is ongoing to assess long-term safety and clinical outcomes.

The Synergy Disc is designed to preserve motion while supporting sagittal alignment, or the natural curvature of the cervical spine. The device evaluated in PERFORM features a nickel-free titanium alloy and ultra-high molecular weight polyethylene articulation, a mobile center of rotation, and options with 0 or 6 degrees of lordosis. The Synergy Disc received U.S. FDA Premarket Approval in February 2026 for single-level use from C3 to C7 and is now commercially available in the U.S., following more than a decade of clinical use outside the U.S.

At NASS 2026, Ashvin Patel, M.D., also presented two-year clinical outcomes from the Synergy Spine Solutions U.S. Investigational Device Exemption (IDE) 1-Level clinical trial. Among patients with evaluable data, the Synergy Disc achieved an 87.1% composite clinical success rate compared with 56.6% for historical ACDF controls, meeting the study criteria for non-inferiority and superiority (p < 0.0001).

The company also sponsored and participated in the non-CME special session at NASS 2026, "Debate on the Role of Arthroplasty in Spine Surgery," with Roland S. Kent, M.D., who represented Synergy Spine Solutions and presented the case for arthroplasty. Moderated by Brian Perri, D.O., and James Harrop, M.D., the session examined current evidence, patient selection considerations, and long-term outcomes for cervical and lumbar disc replacement compared with fusion.

For more information about Synergy Spine Solutions, visit synergyspinesolutions.com.

About Synergy Spine Solutions

Synergy Spine Solutions® is a medical device company focused on improving the quality of life for patients undergoing spine surgery. The company develops motion-preserving technologies designed to treat degenerative disc disease while supporting the spine's natural curvature. Its flagship product, the FDA-approved Synergy Disc®, features a built-in 6-degree lordotic core designed to not only preserve motion but also improve sagittal alignment.

Media Contact:
AM Public Relations for Synergy Spine Solutions
synergy@ampublicrelations.com

SOURCE Synergy Spine Solutions