Dymicron, Inc., Receives ISO 13485 Certification and CE Mark for its Triadyme-C TM Cervical Total Disc Replacement

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Announcement of Dymicron's CE mark for Triadyme-C

Dymicron, Inc., (dymicron.com) announced that their Triadyme-C Cervical Total Disc Replacement (cTDR) device (previously the Tri-Lobe cTDR) has earned its CE mark. The company has also completed ISO13485 certification of its Quality Management System. Achieving these benchmarks allows for the marketing and commercialization of their next generation Orthopedic DiamondTM cervical disc in the European Union countries and other countries around the world that recognize the CE mark approval process.

“This is tremendous news not just for medical professionals, but for patients suffering from degenerative disc disease,” said Jeffrey Bennett, President of Dymicron, Inc. “Dymicron’s Triadyme-C is highly differentiated from other discs on the market due to its material composition, superior durability and wear characteristics, and unique emulation of natural spinal motion.”

Triadyme-C will address two immediate areas of concern in the total disc replacement field – minimizing wear debris generation and emulation of natural constrained motion in the spine.

Dymicron’s biocompatible Orthopedic Diamond material is made of polycrystalline diamond compact (PDC), one of the hardest and most durable substances known to man. With extreme durability and a low coefficient of friction, Triadyme-C resists the structural breakdown that can release dangerous wear debris into the body.

The proprietary tri-lobe technology developed by Dymicron features an articulation mechanism made of three spherical lobes seated within three non-congruent, spherical pockets. The motion of the three lobes within their associated pockets generates a smooth, gentle centering force that emulates the natural motion of the spine.

“With its natural motion design and Orthopedic Diamond material, we feel like Dymicron can make an immediate impact in the cervical disc replacement market. Based on our technology and design, we’re confident we can provide a great option to patients suffering from degenerative disc disease and become the leader among the next generation of cervical disc replacement devices,” added Bennett.

Dymicron recently confirmed the successful implantation of the Triadyme-C in two patients. The surgeries, performed by Dr. William Smith at the American Institute of Minimally Invasive Surgery, were the first in-vivo placement of Dymicron’s unique cTDR.

Founded in 1997, Dymicron, Inc. is a privately-held company located in Orem, Utah. They are an innovation-based medical device company that focuses on the design, development, manufacturing and marketing of a new generation of orthopedic implant devices utilizing their proprietary biocompatible Orthopedic Diamond material. For additional information about Dymicron, their products or to arrange an interview with a member of Dymicron management, please contact Angela Bailey, Vice President of Marketing at (801) 580-4049 or at abailey(at)dymicron(dot)com.

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Angela Bailey
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