Dymicron: Advancing the Next Generation of Artificial Cervical Disc Replacement
Alan Layton, Chairman and CEO Since its development in the 1950s, the anterior cervical discectomy and fusion (ACDF) procedure has long been the standard surgical treatment for degenerative cervical disc disease. In this procedure, the affected disc is removed, and the vertebrae of the spine are fused together with metal plates, screws, cages, or biologic bone growth materials to stiffen the particular segment. Unfortunately, the loss of motion imposed by the fusion accelerates the degeneration of adjacent discs. Thus, at some point in the future, patients who undergo fusion might need additional fusion surgeries on adjacent spinal segments due to pain from degeneration, instability, or nerve compression.
This is why surgeons and patients have increasingly started to rely on cervical disc arthroplasty or cervical total disc replacement (cTDR) today. An alternative to fusion treatment, cTDR is an innovative process of surgically removing the damaged disc from the spinal column and replacing it with an artificial disc. While this is an improvement over the standard ACDF treatment, most of the leading first-generation artificial cervical disc devices—that are currently available on the market today—leverage ball-in-socket or ball-in-trough designs that only enable a pivot rotation and not the complex coupled motion of the spine. Hence, these designs do not facilitate natural movement between the vertebrae and can also result in undue stress, leading to various complications. The materials with which these devices are made (metal-on-metal, metal-on-plastic, ceramic-on-plastic, or viscoelastic plastic) can also create wear debris, which can induce inflammation and lead to osteolysis and implant loosening. This may require a secondary revision operation for some patients.
However, Dymicron—an innovative medical technology company—finally has a solution for these problems. Dymicron’s next-generation Triadyme-C Artificial Cervical Disc solves the domain’s two greatest challenges: the replication of natural spine motion and the elimination of wear debris. To enable this, the Triadyme-C device relies on two of Dymicron’s powerful inventions—the company’s patented tri-lobe technology and a patented biomedical grade of polycrystalline diamond (PCD) material.
A Peerless Technology Coupled with Next-Gen Orthopedic Implant Material
Triadyme-C’s tri-lobe technology—three spherical lobes that mate with three non-congruent spherical pockets—allows it to emulate natural spinal motion with its unique design. The movement of the three lobes within their corresponding pockets makes Triadyme-C a self-centering device. This allows a controlled range of motion in a variety of directions and provides the progressive resistance that prevents hypermobility and protects surrounding structures, like that of a natural spinal disc.
At the same time, the state-of-the-art implant is made from Dymicron’s patented biomedical grade of PCD, which is one of the hardest and most durable substances known to humans. PCD exhibits more than 1000 times greater wear resistance than cobalt-chrome, the most commonly-used alloy in orthopedic applications. “Thanks to the material’s unrivaled hardness and extreme wear resistance, Triadyme-C doesn’t create any detectable wear debris,” states Alan Layton, Chairman and CEO of Dymicron. With exclusive properties, like extreme wear resistance, unparalleled toughness, an excellent biocompatibility profile, and an extraordinarily low coefficient of friction, Dymicron’s PCD variant indeed is providing Triadyme-C physiological characteristics very similar to the natural spine, and is ushering in a new era in orthopedic implants.
The Genesis of a Unique Product
Dymicron was founded in 1997 by Dr. Bill Pope, a professor of chemical engineering at Brigham Young University and founder of several successful synthetic diamond companies for industrial mining applications.
Dymicron’s next-generation Triadyme-C Artificial Cervical Disc solves the domain’s two greatest challenges: the replication of natural spine motion and the elimination of wear debris
When one of Dr. Pope’s friends had to undergo revision hip surgery, he became aware of the limitations of materials commonly used in orthopedic joint replacements. He realized that artificial implants create wear debris, potentially leading to implant failure. Dr. Pope decided that using synthetic diamond—of which he was an expert—in orthopedic applications could eliminate this debilitating failure mode, due to the material’s hardness and very low coefficient of friction, which resists the creation of wear debris.
Around this time, Dr. Pope became acquainted with Dr. Bao Nguyen from the University of Utah, who was researching the motion of artificial cervical discs. When comparing the motion of artificial discs with that of cadaveric specimens, Dr. Nguyen discovered that single-lobe, ball-in-socket artificial discs do not replicate the natural movement of the human spine. So, to reproduce the complex coupled motion of the spine more closely, Dr. Nguyen developed a tri-lobe design.
“Where Dr. Pope found an answer for the durability and wear debris issue, Dr. Nguyen discovered a solution to replicate natural spinal motion,” notes Jeff Bennett, president and COO of Dymicron. “Their combined efforts led to the invention of Triadyme-C,” adds Bennett. The rest, as they say, is history.
Making Implantation Intuitive and Retaining Imagibility
Today, Triadyme-C is offered in a variety of sizes to accommodate any patient’s anatomy. The device has three heights and four separate footprints for each height, for a total of 12 different sizes. When describing its implantation, Ted Bird, chief strategy officer at Dymicron, comments, “The surgical technique is very simple with just four key steps. After removing the degenerated disc and preparing the spinal segment for an implant, the proper size is determined with the use of trial instruments. Keel cuts are then made with a chisel, and the implant, which comes sterile-packed and already attached to the inserter, is placed into the proper position under fluoroscopic control. The Triadyme-C has two end plates with two keels each to provide immediate fixation and a titanium microtextured surface that promotes bone in-growth for long-term stability.”
Because of its material properties, the Triadyme-C retains its compatibility with modern imaging tools after implantation. Almost all first-generation devices create large artifacts or are incompatible with CT or MRI imaging, which removes a key tool for surgeons if further diagnosis is required. However, Triadyme-C’s material is fully compatible with CT and MRI imaging, allowing clear visualization at the treatment level with little artifact.
Expanding the Footprint on the Back of Excellent Patient Feedback
Triadyme-C has received the CE Mark, allowing the commercialization of the product in the European Union, and Dymicron is currently conducting a limited release of the product in Germany and Spain.
Ted Bird, Chief Strategy Officer, Jeff Bennett, President and COOThe device has been consequently garnering very positive anecdotal reviews from patients and surgeons alike, owing to its peerless capabilities. “Today, about 350 devices have been implanted in patients, and we have had outstanding post-surgical results,” mentions Layton. “The company will soon start another clinical trial in Europe to gather more data,” he adds.
Concurrently, Dymicron is well positioned to begin the FDA approval process and venture into the U.S. market, which is also the world’s largest medical device market. “As Triadyme-C is a Class III medical device, our immediate priority is to initiate investigational device exemption (IDE) studies that require two years of follow-up from all enrolled patients,” states Bennett. The company is hoping to receive full FDA commercial approval by 2026.
Triadyme-C’s material is fully compatible with CT and MRI imaging, allowing clear visualization at the treatment level with little artifact
Leaning on Vast Expertise
Converting an industrial-grade diamond into a biocompatible material in shapes and surface finishes for orthopedic implants and then applying this technology to a device like the Triadyme-C has required extensive R&D effort. The credit for this success extends to a vast pool of contributors at Dymicron, whose expertise varies from material science to orthopedics. In particular, the late Richard Dixon, manufacturing engineer; Dr. Jeffery Taylor, Chief Medical Officer; Dr. Clayton Gardinier, lead scientist; Dean Blackburn, R&D and manufacturing engineer; Dr. David Harding, principal engineer; Stan Despres, R&D leader; Troy Medford, manufacturing technology; and Stephen Ulmer, manufacturing manager are some of the key figures at Dymicron who have played a role in developing and maintaining the manufacturing and production processes, transforming this revolutionary diamond material into an orthopedic implant with unique benefits for patients.
At the same time, Dymicron has added well-known leaders from the orthopedics space in recent years. Dr. Armen Khachatryan, who was recently appointed to Dymicron’s board of directors, is an internationally renowned orthopedic surgeon who specializes in minimally invasive microsurgery and treatment of cervical and lumbar spinal diseases. Similarly, Ted Bird, the Chief Strategy Officer at the company, has three decades of expertise in the spinal device industry. Bird, along with other experts in the industry, like Eric Lange, vice president of regulatory strategy, and Gunther Peeters, senior vice president of commercial operations, are currently spearheading Dymicron’s efforts to gain U.S. FDA approval and expand international commercialization efforts for Triadyme-C under President/ COO Bennett’s leadership.
To support these endeavors, Dymicron is embarking on a fundraising campaign. Layton comments that an exciting journey is ahead for Dymicron and Triadyme-C in the burgeoning artificial disc replacement market. He reiterates Dymicron’s vision on that front, “Our mission statement is simple: replace, restore, and revitalize. Triadyme-C is looking to replace the debilitating soreness that patients get from degenerative disc diseases by restoring the natural motion of the spine, ultimately revitalizing their lives,” Layton concludes.
Management Alan Layton, Chairman and CEO and Ted Bird, Chief Strategy Officer, Jeff Bennett, President and COO
Description Dymicron’s next-generation Triadyme®-C Artificial Cervical Disc solves the domain’s two greatest challenges: the replication of natural spine motion and the elimination of wear debris. And to enable this, Triadyme-C leans on two of Dymicron’s powerful inventions—the company’s patented tri-lobe technology and a patented biomedical grade of polycrystalline diamond (PCD) material. Notably, tri-lobe technology makes Triadyme-C effectively emulate natural spinal motion with its unique design—three spherical lobes that mate with three non-congruent spherical pockets. The movement of the three lobes within their corresponding pockets makes Triadyme-C a self-centering device that allows a controlled range of motion in a variety of axes and gives it the progressive resistance (like a natural spinal disc) that prevents hypermobility and protects surrounding structures. At the same time, the state-of-the-art implant is made from Dymicron’s patented biomedical grade of PCD, which is one of the hardest and most durable substances known to humans. Thanks to the material’s unrivaled hardness and extreme wear resistance, Triadyme-C doesn’t produce any detectable wear debris.
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