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FDA approves Centinel Spine's prodisc C Nova for two-level cervical disc replacement
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FDA approves Centinel Spine's prodisc C Nova for two-level cervical disc replacement

Oct 7, 2026

Centinel Spine receives FDA approval for two-level use of its prodisc C Nova cervical total disc replacement device, joining prodisc C Vivo and prodisc C SK in its portfolio. The decision expands surgical motion-preserving options for cervical spine conditions. Concurrently, Centinel Spine files for a U.S. IPO on the NYSE under symbol CNTL after reporting a 42% revenue increase to $85.2 million and $10.2 million in net income for first-half 2026.

FDA approval and device details

  • ▪The prodisc C Nova device features flat endplates with low-profile keels designed for specific vertebral anatomy and incorporates prodisc CORE kinematic technology.
  • ▪The prodisc C Nova joins prodisc C Vivo and prodisc C SK as Centinel Spine's three distinct cervical total disc replacement devices approved for both one- and two-level use.
  • ▪Centinel Spine received U.S. Food and Drug Administration approval for two-level use of its prodisc C Nova cervical total disc replacement device.
  • ▪Centinel Spine's prodisc C Vivo and prodisc C SK devices received U.S. Food and Drug Administration approval for two-level use in October 2025.
  • ▪The prodisc C Nova device has been in clinical use outside the U.S. since 2009 and is available on a limited-release basis in the U.S.

Prodisc platform track record

  • ▪Centinel Spine's prodisc technology remains the only total disc replacement platform in the U.S. approved for one- and two-level use in both the cervical and lumbar spine.
  • ▪Centinel Spine's prodisc platform has been used in more than 300,000 implantations worldwide and is supported by over 590 peer-reviewed clinical papers.

Initial public offering plans

  • ▪Centinel Spine filed for a U.S. initial public offering to list its shares on the New York Stock Exchange under the ticker symbol CNTL.
  • ▪Centinel Spine plans to use its initial public offering proceeds to repay debt and invest in sales infrastructure, patient-awareness programs, and clinical trials.

First-half financial results

  • ▪Centinel Spine reported a 42 percent increase in first-half revenue in its U.S. initial public offering disclosure on October 7, 2026.
  • ▪Centinel Spine posted net income of $10.2 million on revenue of $85.2 million for the six months ended June 30, 2026, compared to a net loss of $503,000 on revenue of $60.1 million a year earlier.

4 sources

Biospace
Centinel Spine® Receives FDA Approval for Two-Level Use of prodisc® C Nova, Further Expanding the Match-The-Disc™ Cervical Portfolio
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Healio
FDA approves prodisc C Nova device for two-level use for cervical total disc replacement
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