Dymicron’s Triadyme-C IDE Clinical Trial is Underway

The first patient has been enrolled and treated in Dymicron’s Triadyme-C Investigational Device Exemption (IDE) clinical trial, which aims to evaluate the safety and effectiveness of the company’s Triadyme-C cervical artificial disc.

The first procedure was performed by Armen Khachatryan, M.D., a board-certified spine surgeon and founder/director of The Disc Replacement Center in South Jordan, Utah. “The first U.S. procedure with the Triadyme-C was performed successfully, and the patient is doing well,” Dr. Khachatryan said. “The Triadyme-C disc is a cervical artificial disc with a polycrystalline diamond surface that enables its unique tri-lobe design to mimic the natural motion of a spinal segment. I look forward to evaluating clinical and radiographic outcomes as enrollment in the IDE study continues.”

The Triadyme–C device features bearing surfaces made from Adymite, Dymicron’s proprietary, medical-grade polycrystalline diamond technology. Adymite 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 device with exceptional hardness, low friction, and long-term articulation performance, optimized for the lifetime demands of spinal motion preservation, according to the company.

“Enrollment of the first patient in our Triadyme-C IDE trial represents a significant milestone for Dymicron, and underscores years of focused innovation and validation,” Dymicron Chairman/CEO Alan S. Layton stasted. “This achievement reflects the dedication of our team and clinical partners, and it moves us one step closer to providing U.S. surgeons and patients with a next-generation cervical artificial disc designed to preserve motion while addressing the limitations of existing technologies.”

The IDE trial was designed to assess clinical and radiographic outcomes in patients with cervical degenerative disc disease who need surgery. The Triadyme-C IDE clinical trial will enroll patients across multiple investigational U.S. sites. Data from the study will support Dymicron’s evaluation of Triadyme-C as a cervical artificial disc aimed at preserving motion and supporting long-term function.

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 humans. 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 patient’s lifetime. The Triadyme-C’s patented tri-lobe articulation surfaces are designed to mimic the natural kinematics and motion of a spinal disc.

Dymicron is a privately held medical device company based in Orem, Utah, that has developed a next-generation total disc replacement system for the cervical spine engineered from Adymite, a proprietary, medical-grade polycrystalline diamond material.