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Dymicron was granted Investigational Device Exemption (IDE) approval to begin a pivotal clinical study of the Triadyme-C cervical artificial disc.
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) in the treatment of symptomatic cervical disc disease. The trial will enroll patients across several U.S. spine centers, with the first implantations expected in 4Q25.
Triadyme-C features bearing surfaces made from Adymite, Dymicron’s proprietary polycrystalline diamond material. Adymite was developed specifically for high-stress load-bearing environments and is engineered to dramatically reduce wear debris generation vs. conventional implant materials. The result is a construct with exceptional hardness, low friction and long-term articulation performance, optimized for the lifetime demands of spinal motion preservation. Triadyme-C’s Tri-Lobe design mimics the natural kinematics and motion of a normal disc.
Data from this trial will support a future Premarket Approval (PMA) submission to FDA.
“This FDA approval is a value-defining achievement for Dymicron,” said Alan S. Layton, Chief Executive Officer 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.”
Source: Dymicron
Dymicron was granted Investigational Device Exemption (IDE) approval to begin a pivotal clinical study of the Triadyme-C cervical artificial disc.
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...
Dymicron was granted Investigational Device Exemption (IDE) approval to begin a pivotal clinical study of the Triadyme-C cervical artificial disc.
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) in the treatment of symptomatic cervical disc disease. The trial will enroll patients across several U.S. spine centers, with the first implantations expected in 4Q25.
Triadyme-C features bearing surfaces made from Adymite, Dymicron’s proprietary polycrystalline diamond material. Adymite was developed specifically for high-stress load-bearing environments and is engineered to dramatically reduce wear debris generation vs. conventional implant materials. The result is a construct with exceptional hardness, low friction and long-term articulation performance, optimized for the lifetime demands of spinal motion preservation. Triadyme-C’s Tri-Lobe design mimics the natural kinematics and motion of a normal disc.
Data from this trial will support a future Premarket Approval (PMA) submission to FDA.
“This FDA approval is a value-defining achievement for Dymicron,” said Alan S. Layton, Chief Executive Officer 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.”
Source: Dymicron
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
