Synergy Spine Solutions® Highlights Superior Two-Year Clinical Outcomes for FDA-Approved Synergy Disc® at Society for Minimally Invasive Spine Surgery

Two-year primary endpoint data from U.S. IDE clinical trial demonstrates statistical superiority in composite clinical success and improvements in cervical alignment for first-of-its-kind lordotic cervical disc

• Clinical data presented at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum demonstrated that the Synergy Disc achieved an 87.1% composite clinical success (CCS) rate, demonstrating statistical superiority over anterior cervical discectomy and fusion (ACDF) at 56.6% (p<0.0001).
• Synergy Disc patients experienced a 92% Neck Disability Index (NDI) responder rate and significantly greater reductions in neck and arm pain compared to those in the fusion group at 24 months.
• The study demonstrates improvements in cervical alignment, with global C2–C7 lordosis increasing by 27% and overall mean disc angle increasing by 8.6 degrees at 24 months.
• Unlike conventional ball-and-socket cervical disc replacement designs that focus primarily on motion preservation, the Synergy Disc combines a 6-degree lordotic core with a design that supports controlled motion, alignment correction, and migration resistance, along with nickel-free titanium alloy endplates for patients with nickel sensitivities.

LOUISVILLE, Colo., Sept. 16, 2026 /PRNewswire/ -- Synergy Spine Solutions, a medical device company focused on improving the quality of life for patients undergoing spine surgery, presented its two-year primary endpoint results from the U.S. Investigational Device Exemption (IDE) 1-Level clinical trial during a podium presentation at SMISS.

The presentation, delivered by Amir Vokshoor, MD, FAANS, presenting author and a board-certified neurosurgeon with the Neurosurgery & Spine Group in Santa Monica, California and investigator in the study, highlighted that the Synergy Disc  achieved superior composite clinical success compared with anterior cervical discectomy and fusion (ACDF) at 24 months, with rates of 87.1% versus 56.6%, respectively. Patients treated with the Synergy Disc also experienced greater functional improvement, reduced neck and arm pain scores, and higher overall satisfaction. In addition to the clinical outcomes, researchers observed improvements in segmental and global cervical alignment among Synergy Disc patients. The findings support the device's differentiated design, which combines motion preservation with a built-in 6-degree lordotic core intended to restore alignment at the treated level.

"The clinical results presented at the SMISS Annual Forum give us a clear picture of what this technology means for patients, from pain relief and excellent clinical outcomes to restored motion and improved spinal alignment," said Josh Butters, CEO of Synergy Spine Solutions. "The data reflects years of surgeon-led innovation and clinical validation, showing that the Synergy Disc successfully addresses both motion preservation and sagittal alignment in a single, reliable device."

The prospective, multicenter study evaluated 175 patients treated with the Synergy Disc across 20 U.S. sites, comparing outcomes with those of a propensity-score matched historical control of 192 ACDF patients. At 24 months, the study met its primary endpoint and demonstrated statistical superiority over ACDF (p < 0.0001), supporting the safety and effectiveness of the motion-preserving, alignment-restoring disc.

Among the study's findings at 24 months:

• Composite Clinical Success (CCS): 87.1% of Synergy Disc patients achieved composite clinical success, compared with 56.6% of ACDF control patients, meeting the study criteria for superiority with a high degree of statistical significance (p < 0.0001).
• Neck Disability Index (NDI) Improvement: 92% of patients in the Synergy Disc group achieved a clinically meaningful improvement in Neck Disability Index scores (NDI responder rate) at 24 months, compared to 75% of fusion patients.
• Neck and Arm Pain Relief: Mean neck pain scores were 15.6 for Synergy Disc patients versus 30.2 for fusion patients, while worst arm pain scores were 15.0 versus 32.2, respectively, on a 100-point visual analog scale.
• Patient Satisfaction: 92.3% of patients were very satisfied or satisfied with the Synergy Disc, compared with 61.6% for fusion patients.
• Cervical Alignment: Global C2–C7 lordosis increased by 27% among Synergy Disc patients. Patients with preoperative segmental kyphosis also achieved an average 8.6-degree correction, improving from −3.5 degrees before surgery to +5.1 degrees at 24 months.

"While traditional cervical disc replacements preserve motion, many available devices are designed primarily to maintain preoperative alignment rather than actively restore segmental lordosis or optimize sagittal balance," said presenting author Amir Vokshoor, MD, FAANS, of the Neurosurgery & Spine Group in Santa Monica, California. "The two-year results from the ALIGN-1L trial demonstrate that the Synergy Disc's unique lordotic core improves spinal alignment, especially in patients presenting with baseline kyphotic segments, while delivering superior pain and disability relief compared to fusion. These findings demonstrate the value of addressing alignment as part of motion-preserving cervical disc replacement."

The Synergy Disc received premarket approval from the U.S. Food and Drug Administration in February 2026 for single-level use from C3 to C7. The approval was supported by the IDE study results, including superiority over the fusion control on the primary endpoint of composite clinical success.

Unlike conventional cervical disc replacements designed to maintain motion, the Synergy Disc incorporates a 6-degree lordotic core designed to preserve motion while improving sagittal alignment. The device was designed with migration resistance as an explicit goal, rather than a secondary effect of the implant design. Nickel-free titanium alloy endplates and an ultra-high molecular weight polyethylene core support durability and improved postoperative imaging while expanding access for patients with nickel sensitivities. Nickel allergy is among the most common metal allergies, with published estimates suggesting that up to 17% of women and 3% of men are allergic to nickel.

The Synergy Disc has more than a decade of clinical use outside the United States and has been implanted in thousands of patients across more than 10 countries. It is now commercially available in the United States.

For more information, visit https://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

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