OREM, Utah, July 10, 2025 /PRNewswire/ — Dymicron®, a privately held medical device company pioneering advanced spinal technologies, today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to begin a pivotal clinical study of the Triadyme®–C cervical artificial disc. This achievement marks a critical milestone in the company’s mission to bring the next-generation cervical artificial disc to patients suffering from degenerative disc disease.
The IDE approval enables Dymicron to initiate a multi-center, prospective, historically controlled clinical trial comparing the safety and effectiveness of Triadyme-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of symptomatic cervical disc disease (SCDD). The trial will enroll patients across several leading U.S. spine centers, with the first implantations expected in Q4 2025.
“This FDA approval is a value-defining achievement for Dymicron,” said Alan S. Layton, Chief Executive Officer and Chairman of the Board at Dymicron. “It reflects both the strength of our technology and the disciplined execution of our regulatory roadmap. We are now poised to generate high-quality clinical data that will support a future PMA submission and lay the groundwork for commercialization in the U.S. market.”
According to Richard Guyer, MD, Co-director, Center for Disc Replacement, Texas Back Institute, Plano, TX, co-primary investigator for the Triadyme-C IDE clinical trial, “The Triadyme-C represents a remarkable advancement in cervical disc technology. Its revolutionary polycrystalline diamond bearing surfaces dramatically reduce wear debris generation, while the tri-lobed design is engineered to closely replicate normal spinal kinematics—two factors that could improve long-term outcomes for patients.”
Groundbreaking Material Technology: Adymite
The Triadyme–C device features bearing surfaces made from Adymite™, Dymicron’s proprietary medical grade polycrystalline diamond material. Adymite was developed specifically for high-stress load-bearing environments and is engineered to dramatically reduce wear debris generation compared to conventional implant materials such as titanium, cobalt-chromium, and polyethylene – an issue linked to long-term device complications and revision surgeries. The result is a construct with exceptional hardness, low friction, and long-term articulation performance, optimized for the lifetime demands of spinal motion preservation.
“We believe Adymite represents a platform technology with long-term strategic value across multiple medical applications,” added Mr. Layton. “Our core IP portfolio, proprietary manufacturing capabilities, and strong clinical positioning give us a powerful foundation for growth. We look forward to validating our technology in this pivotal U.S. trial.”
Study Design
- Prospective, historically controlled trial comparing Triadyme–C to ACDF.
- Conducted across top, world-renowned U.S. spine centers.
- Composite clinical success primary endpoint defined by:
- Improvement in Neck Disability Index (NDI) Score
- Maintenance or improvement in neurological status
- No secondary surgical interventions
Data from this trial will support a future Premarket Approval (PMA) submission to the FDA.
“IDE approval for the Triadyme-C marks a pivotal milestone in advancing this next-generation cervical disc toward the U.S. market,” said Pierce Nunley, MD, founder and Medical Director of the Spine Institute of Louisiana and Triadyme-C co-primary investigator. “A key factor distinguishing spine arthrodesis products is wear debris, which can trigger varying degrees of osteolysis and potential implant failure. With its proprietary polycrystalline diamond material designed to virtually eliminate wear debris, and a tri-lobed geometry engineered to restore natural motion, Triadyme-C stands to set a new benchmark in long-term implant performance and market differentiation.”
About the Triadyme–C
The Triadyme-C is a next-generation, motion-preserving cervical artificial disc made of Adymite (polycrystalline diamond), one of the most wear-resistant materials known to man. As a result, the Triadyme-C produces virtually no detectable wear debris, minimizing the risk of any wear debris-related complications, and optimizing performance for the lifetime of the patient. The Triadyme-C’s patented Tri-Lobe design mimics the natural kinematics and motion of a normal disc.
About Dymicron
Dymicron is a privately held, innovative medical device company based in Orem, Utah. The Company has developed a revolutionary, next-generation total disc replacement system for the cervical spine engineered from Adymite, their proprietary medical-grade polycrystalline diamond material. To learn more, visit http://www.dymicron.com/.
For more information, please contact:
Curt Ence
Chief Financial Officer
1186 South 1680
West Orem, UT 84058
Email: IR@dymicron.com
SOURCE Dymicron Inc.