For the first time in the history of spine surgery, an abundance of motion-preserving options compels US surgeons to consider alternatives to fusion.
A quick history FDA approvals in artificial discs.
- Lumbar:
- Charite – Approved on October 26, 2004, for one level at L4-S1.
- ProDisc-L – First approval on August 14, 2006, for one level at L3-S1, and a subsequent approval on April 10, 2020, for one or two levels at L3-S1.
- activL – Approved on June 11, 2015, for one level at L4-S1.
- Cervical:
- Prestige – Approved on July 16, 2007, for one level at C3-C7, with a variant, Prestige LP, receiving approval on July 24, 2014, for one level at C3-C7, and on July 7, 2016, for one or two levels at C3-C7.
- Prodisc TM-C – Approved on December 17, 2007, for one level at C3-C7.
- Bryan – Approved on May 12, 2009, for one level at C3-C7.
- Nuvasive PCM – Approved on October 26, 2012, for one level at C3-C7.
- Mobi-C – Approved on August 7, 2013, for one level at C3-C7, and on August 23, 2013, for two levels at C3-C7.
- M6-C – Approved on February 6, 2019, for one level at C3-C7.
- Simplify – Approved twice, first on April 1, 2020, for one level at C3-C7, and then on September 18, 2020, for one or two levels at C3-C7.
Graphic provided by Ted Bird
Exhibit A in the motion trend is Centinel Spine’s recent outstanding performance.
Centinel Spine® Record prodisc® Total Disc Replacement Growth of 55% in 2023 Sets the Foundation for Continued Growth in 2024 and Beyond (SPINEMarketGroup)
- Full year 2023 prodisc® Total Disc Replacement (TDR) revenue of nearly $70 million in sales, representing record growth of 55% over prior year.
- Full-year 2023 prodisc TDR sales broke records by geography and by product segment—with U.S. prodisc sales growing 60% and International sales growing 38% YOY, in addition to global cervical prodisc sales growth of 69% and lumbar growth of 36% YOY.
- Cervical prodisc TDR growth in 2023 continued to be driven by the launch of the new Match-the-Disc™ prodisc C Vivo and prodisc C SK cervical TDR system, with an almost 90% increase in the U.S. over prior year.
- Strong global revenue growth and operational performance in the fourth quarter 2023 resulted in Centinel Spine’s third consecutive adjusted EBITDA-positive quarter*.
WEST CHESTER, Pa., Jan. 31, 2024 /PRNewswire/ — Centinel Spine®, LLC, (“the Company”) the leading global medical device company focused exclusively on treating cervical and lumbar spinal disease with the most complete and clinically-proven total disc replacement (TDR) technology platform in the world (prodisc®), today announced achievement of record full-year 2023 TDR business results, setting the stage for continued accelerated growth in 2024.
Based on publicly available information, Centinel Spine is the fastest growing company in the spine industry, focused on the fastest growing segment in orthopedic implants: total disc replacement. The Company is also uniquely positioned from a profitability perspective, achieving its third consecutive adjusted EBITDA positive quarter in Q4 2023*.
Full-Year 2023 Highlights
- Record worldwide prodisc TDR revenue of nearly $70 million, representing 55% growth over full-year 2022.
- Record worldwide prodisc Cervical revenue of nearly $43 million—with year-over-year (YOY) growth of 69%—and prodisc Lumbar revenue of nearly $27 million, up 36% YOY.
- Record U.S. prodisc TDR revenue over $54 million, representing 60% YOY growth.
- Record U.S. prodisc total surgeon user-base of nearly 800 surgeons, representing 44% YOY growth.
- Record of nearly 350 new prodisc users in the U.S., representing an almost 70% increase YOY.
- U.S. healthcare facilities utilizing prodisc approached 800, a 38% YOY increase, with sales in ASC/outpatient facilities growing 56% YOY.
- Record International prodisc TDR revenue of nearly $15 million, representing growth of 38% YOY.
Highlights on the New Match-the-Disc™ prodisc Cervical TDR System
- Fully launched the Match-the-Disc Cervical system of prodisc C Vivo and prodisc C SK, which was released on a limited basis in Q3 2022.
- Nearly 3,700 procedures were completed with the new system through the end of 2023.
- The new system drove a nearly 90% YOY increase in full-year U.S. prodisc Cervical revenue.
- Added an average of nearly 100 new surgeons using the Match-the-Disc system per quarter in 2023, increasing the total number of system users to 480.
- Strong majority of surgeon users came from competitive conversions and remain repeat users.
Key 2023 Highlights Setting the Foundation for 2024 Growth
- Completed the divestment of the fusion business in Q4 2023, allowing the Company to exclusively focus on its rapidly expanding prodisc Cervical and Lumbar global TDR business.
- In Q2 2023, achieved the first adjusted EBITDA-positive quarter since the December 2017 prodisc acquisition—and remained EBITDA positive in Q3 and Q4 2023*.
- Reached a significant milestone of more than 250,000 prodisc devices implanted worldwide**, validated across 30 years of clinical use and a reported reoperation rate of less than 1%***.
- Expanded the commercial launch of the new prodisc C Vivo and prodisc C SK technologies released in late 2022, uniquely positioning Centinel Spine as the 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.
- Advanced first-of-its-kind 2-level IDE trial evaluating prodisc C Vivo and prodisc C SK Match-the-Disc™ cervical TDR system:
- Completed study enrollment in June 2023.
- Food and Drug Administration (FDA) accepted the filing of Premarket Approval (PMA) study application in September 2023.
- Patient access to the prodiscL Lumbar Total Disc Replacement system significantly expanded—with one-level coverage now nearly 95% and two-level coverage over 30%:
- New Category I Current Procedural Terminology (CPT®) code added for a second level of lumbar TDR.
- 22 million covered lives added through Aetna® medical necessity guideline update to include a positive coverage policy recommendation for one-level lumbar TDR.
- Over 20 million covered lives added through positive policy updates in the states of Illinois, Michigan, New Mexico, North Carolina, Oklahoma and Texas.
- Continued expansion of prodisc L Lumbar surgeon usage through adoption of Match-the-Disc Anatomic Endplates, a lumbar TDR system that uniquely allows surgeons to better match patient anatomy at one- or two-levels.
- Trained over 800 surgeons through the Company’s global Medical Education program.
- Expanded and strengthened long-term manufacturing supply chain partnerships.
Centinel Spine CEO Steve Murray adds, “The Centinel team reached many major milestones and accomplishments in 2023, setting the company up for continued success and growth-acceleration in 2024. With the divestiture of the fusion business, we are exclusively focused on leading the rapidly expanding total disc replacement market—as we appreciate the surgeon response and support of our full commitment to the total disc replacement clinical space.”
Murray continues, “Our advanced technology platform along with the key foundational elements established this past year uniquely position us in the market. The performance results in 2023 speak for themselves and, as an organization, we believe that we are just getting started.”
* Q4 2023 adjusted EBITDA is based on unaudited financials, adjusting for one-time costs related to the fusion divestiture.
** Data on file.
*** Based upon U.S. complaint handling units for prodisc since launch in 2006.
About Centinel Spine, LLC
Centinel Spine®, LLC is the leading global medical device company exclusively focused on addressing cervical and lumbar spinal disease with prodisc®, the most complete total disc replacement (TDR) technology platform in the world.
The Company’s prodisc technology is the most studied and clinically-proven TDR system across the globe, validated by over 540 published papers and more than 250,000 implantations. Centinel Spine’s prodisc is the only TDR technology with multiple motion-preserving anatomic solutions allowing the surgeon to Match-the-Disc™ to each patient’s anatomy for both cervical and lumbar total disc replacement.
For more information, please visit the company’s website at www.CentinelSpine.com or contact:
Varun Gandhi
Chief Financial Officer
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: v.gandhi@centinelspine.com
SOURCE Centinel Spine, LLC