Tenon(R) Medical Announces Positive Fusion Results in First Patients Reaching 12-Month Follow Up in an IRB Approved, Multi-Centered, Post-Market Study Utilizing the Catamaran(R) SI Joint Fusion System
Preliminary SI Joint Fusion Results Based on Independent Radiologist Review Indicate Robust Fusion at 12-Months Post-Procedure
Initial Patient Results Demonstrate Marked Improvements in Pain Scores and Disability, Along with High Patient Satisfaction Ratings
LOS GATOS, CA / ACCESSWIRE / March 26, 2024 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering with certain sacroiliac joint disorders, today announced significant progress in the post-market study utilizing the Company's Catamaran® SI Joint Fusion System. The study is a prospective, multi-center, single-arm post market study evaluating the clinical outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis treated with the Catamaran SI Joint Fusion System. Patients will be evaluated for a period of up to 24 months reviewing various patient reported outcomes, radiographic assessments, and adverse events. Study enrollment is expected to be finalized in the coming quarter.
The preliminary results demonstrate a robust fusion response at 12-months post-procedure based on the independent radiologist review of computed tomography (CT) scans of the SI joint in 100% of the initial cohort of treated patients that have reached the 12-month follow-up. Additionally, these initial results demonstrate marked improvements in pain scores and disability. These preliminary results also reflect high patient satisfaction ratings specific to the procedure and outcomes.
Timothy Beacham, MD, FASA, Interventional Pain physician at Restorative Pain Institute in Louisville, KY and study investigator, commented, "I am extremely pleased with my patient outcomes as it pertains to reduction in pain symptoms and positive patient satisfaction utilizing the Catamaran implant. Equally impressive is that there is definitive CT imaging of all initial study patients showing unequivocal fusion at the 12-month follow-up period. If this outcome remains consistent across the study population, Tenon Medical's Catamaran implant represents a considerable differentiating factor to advance the treatment of SI joint disease."
Matthew Davies, MD, a board-certified Neurosurgeon at Orthopaedic Associates of Duluth in Duluth, MN and study investigator, added, "Effective stabilization and ultimately fusing the SI joint should be the goal of every physician treating patients with painful SI joint disorders. The Catamaran's novel design and its ability to transfix the SI joint along its longitudinal axis is designed to optimize the opportunity to effectively fuse the joint and maximize patient outcomes. I applaud Tenon Medical for the time and investment they have allocated to this post-market study to gain valuable insight into the clinical and radiographic efficacy of the Catamaran implant."
Steven M. Foster, President and CEO of Tenon Medical, stated, "We are encouraged by the preliminary results from this initial study cohort. We remain steadfast in our conviction that the Catamaran's transfixing design and less-invasive inferior-posterior approach is intended to optimize patient outcomes through short term stabilization and long-term fusion of the SI joint. We are extremely appreciative to all our study investigators and their clinical research teams in helping us fulfill our enrollment targets while also following their patients through the conclusion of the study. We look forward to additional post-procedure data to support these initial results."
About Tenon Medical, Inc.
Tenon Medical, Inc., a medical device company formed in 2012, has developed The Catamaran SI Joint Fusion System that offers a novel, less invasive approach to the SI joint using a single, robust titanium implant. The system features the Catamaran™ Fixation Device which passes through both the axial and sagittal planes of the ilium and sacrum, stabilizing and transfixing the SI Joint along its longitudinal axis. The angle and trajectory of the Catamaran surgical approach is also designed to provide a pathway away from critical neural and vascular structures and into the strongest cortical bone. Since the national launch of the Catamaran SI Joint Fusion System in October 2022 Tenon is focused on three commercial opportunities with its System in the SI Joint market which includes: 1) Primary SI Joint procedures, 2) Revision procedures of failed SI Joint implants and 3) SI Joint fusion adjunct to a spine fusion construct. For more information, please visit https://www.tenonmed.com/.
The Tenon Medical logo Tenon Medical, and Catamaran are registered trademarks of Tenon Medical, Inc.
Safe Harbor
This press release contains "forward-looking statements," which are statements related to events, results, activities, or developments that Tenon expects, believes, or anticipates will or may occur in the future. Forward-looking often contains words such as "intends," "estimates," "anticipates," "hopes," "projects," "plans," "expects," "seek," "believes," "see," "should," "will," "would," "target," and similar expressions and the negative versions thereof. Such statements are based on Tenon's experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances, and speak only as of the date made. Forward-looking statements are inherently uncertain and actual results may differ materially from assumptions, estimates or expectations reflected or contained in the forward-looking statements as a result of various factors. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, please review our Annual Report on 10-K on file with the Securities and Exchange Commission at www.sec.gov, particularly the information contained in the section entitled "Risk Factors". We undertake no obligation to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise unless required by law.
IR Contact:
Shannon Devine/Rory Rumore
203-741-8811
MZ North America
tenon@mzgroup.us
SOURCE: Tenon Medical, Inc.
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