Texas Back Institute

Centinel Spine remains the clear worldwide leader in the lumbar total disc replacement (LTDR) market1, and its pro disc 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 (pro disc®), today announced data supporting strong market growth and the long-term durability and reliability of the lumbar total disc replacement (LTDR) procedure. Continue Reading prodisc L for 2-Level Use. 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 pro disc L U.S. IDE trial was completed. Equally positive data from an international long-term pro disc L study of up to 21 years, across a large patient cohort, has been reported.4 The pro disc 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 pro disc 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 pro disc technology was invented as a motion-sparing alternative to interbody fusion and, in 1990, the first pro disc L LTDR device was implanted. After almost 35 years and over 120,000 pro disc L LTDR devices implanted worldwide, the pro disc technology has been validated with a reported reoperation rate of less than 1%.7 The pro disc L LTDR technology portfolio now includes FDA approvals for one-level indications, two-level indications and, most recently, for the Anatomic Endplate™ version of pro disc 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 pro disc 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 pro disc 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 pro disc®, the most complete total disc replacement (TDR) technology platform in the world. The Company's pro disc 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 pro disc 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 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

MISGAV, Israel, May 6, 2024 /PRNewswire/ -- ZygoFix Ltd. a portfolio company of The Trendlines Group Ltd. ("Trendlines") announced that it received regulatory clearance from the United States Food and Drug Administration (FDA clearance) for its zLOCK Lumbar Facet Fixation System. This achievement was supported by compelling clinical evidence from the company's ongoing European clinical study, marking a significant advancement in spinal fusion technology. Spinal fusion, a common surgical procedure performed for degenerative spinal conditions such as Spondylolisthesis, Spinal Stenosis, and degenerative disc disease, traditionally requires placement of 4 screws and 2 rods, creating an artificial bridge, to stabilize the segment. The conventional invasive approach requires precise placement and building of bridges intraoperatively. ZygoFix's revolutionary zLOCK system harnesses the spine's innate bone structure to securely lock its connecting joints. Unlike traditional methods, the company's innovative implant adapts to the joint's anatomy during insertion, offering unparalleled stability with a minimally invasive, simple procedure that can be performed in outpatient and ASC environments. With CE certification and six years of clinical utilization yielding long-term pain reduction and bone growth, ZygoFix's zLOCK Lumbar Facet Fixation System is positioned to revolutionize spinal fusion surgery. ZygoFix CEO Ofer Levy remarked, "Receiving FDA clearance for our zLOCK Lumbar Stabilization System is an exciting milestone, and I am very proud of the team that has worked hard to achieve this goal. The system has garnered significant interest in the US market and this clearance paves the way for us to introduce our transformative solution to the US market, fostering collaboration with leading surgeons and enhancing patient care." Dr. Nicholas Pachuda, ZygoFix Chair, added: "Obtaining 510(k) clearance is a testament to ZygoFix's commitment to innovation and addressing the unmet needs of patients suffering from degenerative spinal conditions. We eagerly anticipate offering patients our minimally invasive, life-changing solution in the United States." Dr. Isador Lieberman, Orthopedic & Spine Surgeon at Texas Back Institute, commented: "The simplicity and minimally invasive nature of the zLOCK system provides a new tool in the surgeon's offering. For the right patients, zLOCK can provide a great alternative to pedicle screws." About ZygoFix ZygoFix Ltd. is a spine device company, a portfolio company of the Trendlines Group (SGX: 42T) (OTCQX: TRNLY), and has been supported by the Israel Innovation Authority and the European EIC program, alongside The Trendlnes Group and investors worldwide. The Company's inventions enable internal joint stabilization while conforming to the joint's anatomy. Contact Information Ofer Levy, CEO ZygoFix [email protected] SOURCE ZygoFix

SUNRISE, FL / ACCESSWIRE / October 17, 2023 / SURE Retractors Inc. a medical device company that has developed a range of industry-disruptive, sterile retractors for orthopaedic, trauma and spinal surgery, has announced the first use of their latest product line addition, a new sterile anterior and posterior cervical retractor with Dr. Richard Guyer of Texas Back Institute and Dr. D Fossett of Howard University Hospital in Washington, D.C. Richard Guyer, MD, Co-Director, Center for Disc Replacement, Texas Back Institute, commented, "I have been aware of the unique, innovative SURE Retractors technology over the last few months and finally got a chance to use their new high performance polymer cervical system on a 2 level Cervical Disc Replacement case on Thursday 5thOctober. The retractor comes in a sterile pack, which the staff loved, and has everything you need in one small box. Normally I would have to remove my usual retractor for the AP shots to check the centering of the distraction pins, however, as the SURE retractor is radiolucent, this was not necessary, and it provided visualization unlike anything else I have ever seen. This probably savedaround 5-7mins of OR time. The intra-operative images, with no artifact from traditional retractor blades, allow you to see exactly where the disc replacement is during insertion. It also reduces the amount of fluoro used, which is beneficial to the patient and surgical team. I will continue using the SURE retractor on all my future cervical cases and believe this will become the standard of care for retractors moving forward." SURE radiolucent retractors are single-use, surgery-ready, sterile-packed, and easy to use.These retractors allow an ASC/Hospital to: Maximize Surgical Volume Improve OR Efficiency Improve Profitability Reduce Infection Risk Dr. Fossett, Chair of Neurosurgery at Howard University in Washington, D.C., commented, "Earlier this month, I performed a 5-level posterior cervical laminectomy and fusion for central cord syndrome. For this case, I used the new SURE A/P Cervical Retractor. I've previously used SURE retractors for posterior cervical, thoracic, and lumbar procedures as well as ACDF. I found the new retractor was as easy to place as my usual retractor. Since I had a long incision, I placed 3 blades on each arm of the SURE retractor. I had excellent visualization throughout the case. Since the retractors are radiolucent, I didn't have to remove/manipulate the retractors when using x-ray/Fluoroscopy during the case - saving time and radiation exposure for the patient and OR personnel. I'm happy to use the SURE retractor with any future cases without reservation." With SURE Retractors you can maximize your operational and logistical efficiency, which also helps more cases to be planned with certainty. The increase in throughput, reduced OR time, mitigated risks and eliminated sterilization costs can help to unlock substantial additional profit for each surgery undertaken. "I am delighted with the progress we have made in the U.S. in the last six months with our cervical, mini-open, lumbar, SURE Fire, and now our new A/P cervical retractor systems. Many Physicians, ASC owners and stakeholders are becoming aware of and adopting our technology. Our aim is to make sterile, single-use retractor systems the standard of care for hospitals and Ambulatory Surgery Centers," said Forbes Butterfield, CEO, SURE Retractors Inc. SURE has filed patents for its technology around the world. Media Contact: Nick Goebel, 248-767-6276, NGoebel@PerceptionPRLLC.com SOURCE: Sure Retractors Ltd. View source version on accesswire.com: