~ Interim Patient Outcomes Demonstrate Significant Improvements in Pain (VAS) and Disability (ODI), Along with High Patient Satisfaction and Safety Profile at Primary 6-month Analysis ~
~ Preliminary SI Joint Fusion Results Based on Independent Radiologist Review Indicate Evidence of Fusion at 12-Months Post-Procedure ~
LOS GATOS, CA / ACCESSWIRE / September 4, 2024 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering with certain Sacroiliac Joint (SIJ) disorders, today announced the first publication of the Catamaran SI Joint Fusion System® MAINSAIL™ study. This study is an ongoing prospective, single-arm, multi-center, post-market study evaluating clinical and radiographic outcomes of adult patients with sacroiliac joint disruptions or degenerative sacroiliitis treated with the Catamaran SI Joint Fusion System. The target enrollment for this study is up to 50 patients with up to 24-month follow-up.
Literature estimates that the sacroiliac joint contributes to 15%-38% of lower back pain cases, a leading cause of global disability [1,2,3,4]. Non-surgical treatment options for SI joint dysfunction include physical therapy, pain management and therapeutic pain injections. However, when these treatments fail to provide relief, minimally invasive SI joint surgery can be a viable option to relieve painful symptoms and improve patient quality of life.
This interim analysis presents early experiences of the first 33 consecutive patients treated with the Catamaran SI Joint Fusion System across six US clinical sites, with primary and secondary clinical endpoint analysis at 6 months and radiographic CT fusion assessment, performed by an independent radiologist.
Notable outcomes from this interim analysis include the following:
Statistically Significant Reduction in SIJ Pain (VAS) and Disability (ODI) Scoring at 6 months:
Mean VAS SIJ pain intensity scores (0-100) significantly decreased from pre-operative levels of 80.9mm to 31.1mm (p<0.001).
ODI scores, measuring a patient's perceived disability, showed a significant improvement from pre-operative values of 51.9% to 29.6% (p<0.01).
66.6% of subjects demonstrated an improvement in ODI by more than 15%.
Robust Safety Profile:
No serious adverse events, no reoperations, and no reinterventions reported.
No vascular or nerve injuries associated with the use of the inferior-posterior surgical approach used to deliver the Catamaran implant.
High Patient Satisfaction Throughout All Follow-Up Timepoints:
93.3% of patients reported high satisfaction with their treatment at 6 months.
Definitive Evidence of Fusion Response at 12 months:
6 patients have reached 12 months follow-up with CT radiographic imaging.
4 of the 6 patients showed unequivocal evidence of fusion with bridging bone as identified by an independent radiology reviewer.
Efficient Surgical Technique and Procedural Workflow:
55% of procedures were completed in under 45 minutes, with the shortest procedural time recorded as 24 minutes.
50% of procedures utilized < 1 minute of fluoroscopy time.
All procedures were performed in an outpatient setting.
The Catamaran SI Joint Fixation device is a single robust titanium implant comprised of two pontoons, connected by an osteotome bridge, which is designed to transfix the SI joint along its longitudinal axis providing immediate fixation and stabilization of the joint, with the aim of achieving a successful long-term fusion. The Catamaran implant was developed with respect to AO principles of arthrodesis including 1) adequate joint preparation, 2) rigid fixation and stabilization, and 3) adequate bone graft augmentation. Via a minimally invasive inferior-posterior approach the Catamaran implant is delivered within the dense cortical bone of the sacrum and ilium, to transfix and stabilize the SI joint for the treatment of SIJ dysfunction. To date, there have been 700 Catamaran fixation devices implanted to treat primary SI Joint dysfunction and sacroiliitis, as well as revise previously treated SI joints with failed alterative SI joint implants.
These interim outcomes from the MAINSAIL study provide early evidence of the clinical safety and efficacy of the Catamaran SI Joint Fusion System as a promising minimally invasive treatment option for patients suffering from painful SI joint dysfunction.
Matthew Davies, MD, a board-certified Neurosurgeon at Orthopaedic Associates of Duluth in Duluth, MN. and Principal Investigator and lead author of the publication, commented, "The interim results of the Catamaran MAINSAIL study are extremely promising as it provides early evidence of the safety and efficacy of the inferior posterior approach with use of the Catamaran SI Joint Fusion System. Patients are reporting high satisfaction with this procedure, and we are achieving significant improvement in pain (VAS) and function (ODI) scores, along with evidence of fusion on 12-month CTs. We look forward to additional patient follow up as we work towards the assessment of long-term clinical safety and efficacy of the Catamaran System and its radiographic profile."
Steven M. Foster, President and CEO of Tenon Medical, stated, "We are very encouraged by the interim outcomes reported in this publication and are appreciative to all our Catamaran MAINSAIL study investigators and their clinical research teams in helping us execute this study. This clinical data continues to validate our ongoing conviction that the Catamaran's novel transfixing design, less invasive inferior-posterior approach and utilization of AO principles to promote true fusion position it as one of the most innovative implants available to safely and effectively reduce pain and disability in patients suffering with SI joint disease."
The Catamaran MAINSAIL study is on-going and further analysis will be performed upon study completion up to 24-month follow-up. Additionally, this study was designed to allow for future longitudinal comparative analysis, to further assess the safety and efficacy of the inferior posterior approach and Catamaran SI Joint Fusion System against other comparative surgical approach techniques of varying system design and materials.
To read the full study publication please click the following link to the Catamaran MAINSAIL Study.
References
1 Chen L-YM, Liang H-DM, Qin Q-NMT, et al. Sacroiliac joint fusion VS conservative management for chronic low back pain attributed to the sacroiliac joint
A protocol for systematic review and meta analysis [RESEARCH ARTICLE: STUDY PROTOCOL SYSTEMATIC REVIEW]. Medicine. 2020 November 13, 2020.
2 Yoshihara H. Sacroiliac joint pain after lumbar/lumbosacral fusion: current knowledge
Review Article. European spine journal. 2012 May 13, 2012;21:1788-1796.
3 Lee DW, Patterson DG, Sayed D. Review of Current Evidence for Minimally Invasive Posterior Sacroiliac Joint Fusion. International Journal of Spine Surgery. 2021;15(3):514-524.
4 Cher D, Polly D, Berven S. Sacroiliac joint pain: burden of disease. Medical Devices: Evidence and Research. 2014:73-81.
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 two commercial opportunities with its System in the SI Joint market which includes: 1) Primary SI Joint procedures, and 2) Revision procedures of failed SI Joint implants. For more information, please visit https://www.tenonmed.com/.
The Tenon Medical logo Tenon Medical, and Catamaran are registered trademarks of Tenon Medical, Inc. MAINSAIL is a trademark of Tenon Medical
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," "aims," 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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