WEST CHESTER, Pa., May 2, 2023 /PRNewswire/ — Centinel Spine®, LLC, (“the Company”) a leading global medical device company addressing cervical and lumbar spinal disease by providing the most robust and clinically-proven total disc replacement (TDR) technology platform in the world (prodisc®), today announced record full-year 2022 performance and a top position in the TDR market. These achievements were propelled by full-year growth in the prodisc L lumbar TDR business and the late-year limited launch of the new prodisc C Vivo and prodisc C SK cervical TDR system.
According to spine surgeon William D. Bradley, M.D., of Meridian, Idaho, “With the addition of prodisc C Vivo to my practice, I can now tailor a cervical arthroplasty implant to patient anatomy and expand indications when clinically relevant.”
“2022 was a transformational year for Centinel Spine. We were able to drive strong financial performance—resulting in record revenue for the year—and also achieve significant milestones that will further accelerate our growth going forward. This included the FDA approval of three new cervical prodisc implant options and the subsequent launch of two of these devices,” said Centinel Spine CEO Steve Murray.
Full-Year 2022 Performance
Global full-year 2022 revenue for the Company’s Motion Preservation business approached $45 million (a record for the Company)—driven by the late-year limited release in the US of the new prodisc C Vivo and prodisc C SK cervical TDR system. Launch of the new TDR system along with continued expansion in the prodisc L lumbar business contributed to 12% growth in total surgeon users in the U.S. in 2022 versus the prior year.
A major contributor to the Company’s 2022 Motion Preservation success was 26% growth in the U.S. prodisc L lumbar TDR business. Acceleration of the business came as a result of broader one- and two-level prodisc L adoption, the full release of the novel prodisc L anatomic implant designs, increasing patient awareness of total disc replacement as an alternative to fusion, and broader reimbursement coverage.
Strong commercial cervical and lumbar prodisc TDR traction in the U.S. was bolstered by a broad customer base of over 500 surgeon users, across almost 600 hospitals and ambulatory surgery centers (ASC). The number of U.S. facilities utilizing the Company’s Motion Preservation products increased almost 10% and revenue growth in the rapidly expanding ASC market grew by 80% in 2022 versus the prior year. New surgeon users were added through global company medical educational programs that trained over 600 surgeons on TDR techniques and the prodisc technology.
The Company continues to lead the industry-wide transition from fusion to TDR for the treatment of patients suffering from Degenerative Disc Disease, and achieved the second-highest total disc replacement market share position in the U.S. in 2022—both in terms of revenue and units sold (source: iData Research, US Artificial Disc Market Has Seen Exceptional Growth in 2022, Driven by Zimvie, Centinel Spine, and Orthofix).
Impact of Key 2022 Accomplishments
- FDA Approval for Three Additional prodisc Cervical TDR Technologies
In July 2022, the Company received approval from the Food and Drug Administration (FDA) of one-level indications for three additional cervical TDR devices: prodisc C Vivo, prodisc C SK, and prodisc C Nova. The prodisc C Vivo product has keel-less endplates—including a convex, superior endplate—while the prodisc C SK and prodisc C Nova implant designs have flat endplates with low-profile keels. All of these products incorporate prodisc CORE technology, the basis behind the predictable clinical outcomes of every prodisc device after 30 years and over 240,000 implantations worldwide. - Launch of Multiple Cervical TDR Technologies and the Match-the-Disc™ System
Limited commercial launches of the prodisc C Vivo and prodisc C SK technologies were initiated in September and October 2022, respectively. Along with the currently available prodisc C implant, which continues to be widely used throughout the U.S., Centinel Spine became the first and only company in the world with a system of multiple cervical TDR solutions that allows matching the disc to the preferences of the surgeon and to the patient’s anatomy. - Advancement of Two-level Cervical TDR IDE Clinical Trial
The Company made significant advancements towards completing enrollment in a two-level Investigational Device Exemption (IDE) study monitored by the FDA. The two-level IDE clinical trial is a prospective, randomized, multi-center clinical study evaluating two different cervical prodisc C TDR devices at multiple sites across the U.S.
The IDE clinical trial is the first and only of its kind that compares two different investigational devices (prodisc C Vivo and prodisc C SK), using an approved TDR product as a control. Two-level approval of the prodisc C Vivo and prodisc C SK devices in the U.S. will extend the Company’s Match-the-Disc™ platform and uniquely position Centinel Spine as the only company with multiple cervical TDR solutions for one- and two-level indications. - Strengthening of Manufacturing Supply Chain
The Company strengthened long-term manufacturing partnerships and overall throughput capacity for cervical and lumbar TDR implants and instruments. Expanding and strengthening vendor partnerships in key supply chain steps progressed according to plans.
About Centinel Spine, LLC
Centinel Spine®, LLC is a leading global medical device company addressing cervical and lumbar spinal disease through anterior surgical access. The Company offers a continuum of trusted, brand-name, solutions backed by over 30 years of clinical success—providing the most robust and clinically-proven technology platforms in the world.
Centinel Spine continues to advance its pioneering culture and corporate mission to become a catalyst of change in the spine industry and alter the way spine surgery is perceived. Centinel Spine’s prodisc platform remains the only technology with multiple motion-preserving solutions for both cervical and lumbar anterior column reconstruction.
For more information, please visit the company’s website at www.CentinelSpine.com or contact:
Centinel Spine
Varun Gandhi
Chief Financial Officer
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: [email protected]
Media
Elizabeth Coleman
ICR Westwicke
Phone: 203-682-4783
Email: [email protected]
SOURCE Centinel Spine, LLC
