Centinel Spine's Leadership in Lumbar Total Disc Replacement Fueled Through Rapidly Expanding Market and Long-Term Survivability Data

• Centinel Spine remains the clear worldwide leader in the lumbar total disc replacement (LTDR) market¹, and its prodisc L device is the only LTDR system in the U.S. approved for one- and two-level use in the lumbar spine.
  
  
• The LTDR market remains one of the fastest growing segments in all of orthopedics, exhibiting a compound annual growth rate (CAGR) of over 25% in the U.S. over the last 5 years.¹
  
  
• A landmark 20-year consecutive-series retrospective study with over 2,000 patients supports the durability and reliability of LTDR devices, demonstrated through a low 1.26% revision rate.²
  
  
• Strong sustained growth in the LTDR market is expected to continue as more long-term data is published, the reimbursement landscape strengthens, and patient demand for the procedure continues to increase.

WEST CHESTER, Pa., Aug. 22, 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 data supporting strong market growth and the long-term durability and reliability of the lumbar total disc replacement (LTDR) procedure.

Data from a landmark long-term LTDR study out of the Texas Back Institute (Plano, Texas) supports the durability and reliability of the LTDR procedure, demonstrated through a low 1.26% removal/revision rate across 20 years.² The study collected data beginning in the year 2000 for a consecutive series of 2,141 LTDR patients, with a mean follow-up of 78.6 months. Of the 258 patients with greater than or equal to 15-year follow-up, only one patient underwent removal/revision. The study concluded that the low removal/revision rate over a 20-year period supports the safety of LTDR.

According to Dr. Richard Guyer, orthopedic spine surgeon with the Center for Disc Replacement, Texas Back Institute, and lead author of the study, "The purpose of this study was to investigate the survival rates for lumbar total disc replacement. When we began to utilize this procedure in the early 2000s, there were questions regarding long-term efficacy—particularly the need for future device removal or revision. The incredibly low removal/revision rate in this data across thousands of patients far exceeded our expectations and, we believe, is significantly better than knee and hip replacement revision rates over the same period of time. Lumbar total disc replacement has been an extremely effective procedure in our practice."

Centinel Spine is the fastest growing company of scale in the spine industry³ and is dedicated exclusively to cervical and lumbar total disc replacement. The LTDR market is one of the fastest growing segments in orthopedics, exhibiting a compound annual growth rate (CAGR) of more than 25% in the U.S. over the last five years.¹ Further, the Company has outperformed the overall LTDR market growth for over five years and expects strong sustained future LTDR growth due to:

• Continued publication of long-term LTDR data: More and more data with positive long-term implant survivorship—such as the 20-year LTDR study out of the Texas Back Institute—is expected to be published, now that almost two decades have passed since the prodisc L U.S. IDE trial was completed. Equally positive data from an international long-term prodisc L study of up to 21 years, across a large patient cohort, has been reported.⁴ The prodisc technology is the most studied total disc replacement device and has been validated across 540 published papers during its almost 35 years of clinical usage.
  
  
• Strengthening reimbursement coverage: With several recent favorable payor coverage decisions, it is estimated that commercial coverage in the U.S. for one-level LTDR has grown to nearly 95% today.⁵ A similar trend towards universal coverage for two-level LTDR is expected as more commercial payers consider the positive long-term clinical data that continues to be published.
  
  
• Increasing patient demand: As public awareness of the potential benefits of LTDR builds and patients naturally seek motion-preserving surgical solutions, demand for the LTDR procedure is expected to be driven at the patient level. Based on internal patient search data from the Company, patients seeking LTDR surgical care has increased by over 70% in 2024 versus 2023.⁶ Dr. Richard Guyer adds, "Patients undergoing the lumbar total disc replacement procedure are among our most grateful and happiest patients."

Centinel Spine CEO Steve Murray concludes, "We see ongoing growth in the lumbar total disc replacement market for years to come, with prodisc L leading the way. Increasingly, patients are sharing the life-changing impact this procedure has on their welfare and quality of life. Furthermore, the clinical evidence and long-term success of the lumbar total disc replacement procedure and technology speaks for itself versus spinal fusion and many other joint replacement surgeries."

The first-generation of the prodisc technology was invented as a motion-sparing alternative to interbody fusion and, in 1990, the first prodisc L LTDR device was implanted. After almost 35 years and over 120,000 prodisc L LTDR devices implanted worldwide, the prodisc technology has been validated with a reported reoperation rate of less than 1%.⁷ The prodisc L LTDR technology portfolio now includes FDA approvals for one-level indications, two-level indications and, most recently, for the Anatomic Endplate™ version of prodisc L.

¹ Q4'23 ADR MedSKU Update, iData Research and Data on File.
² Richard D. Guyer MD, Scott L. Blumenthal MD, Jessica L. Shellock MD, Jack E. Zigler MD, and Donna D. Ohnmeiss PhD. Lumbar Total Disk Replacement Device Removals and Revisions Performed During a 20-Year Experience with 2141 Patients. Spine. 2024;49(10):671-676. Note: Centinel Spine's prodisc L device is approved in the U.S. for one- and two-level use in the lumbar spine and is not indicated for all procedures overviewed in the study.
³ Based on publicly available information.
⁴ Marnay, Thierry. "7 to 21 year clinical outcomes of 1,187 patients treated with one and two level lumbar total disc arthroplasty", ISASS 2021 Annual Meeting, May 14, 2021, Miami, FL.
⁵ Data on File, estimate based on combined positive and neutral policies.
⁶ Data on File, based on Centinel Spine Surgeon Locator search data in 1H-2024 vs 1H-2023.
⁷ 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: [email protected]

SOURCE Centinel Spine, LLC