~ Feasibility and CT scan studies will assess patient pain scores, fusion as well as other patient reported outcomes out to 12 and 24 months ~
~ Studies represent Tenon's continued commitment in validating and differentiating patient outcomes with Catamaran System~
LOS GATOS, CA / ACCESSWIRE / October 25, 2022 / Tenon Medical, Inc. ("Tenon" or the "Company") (NASDQ:TNON), a company transforming care for patients suffering with certain sacroiliac joint disorders, today announced Institutional Review Board ("IRB") approval from WCG IRB for two separate Tenon-sponsored post market clinical studies of the Company's Catamaran SI Joint Fusion System (the "Catamaran"). The approval by WCG represents a milestone for Tenon, which allows designated Catamaran study centers to begin recruiting and enrolling patients into the respective studies.
The first approval from WCG IRB will support a prospective, multi-center, single arm post market study that will evaluate the clinical outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis treated with the Catamaran SI Joint Fusion System. Patients will be followed out to 24 months assessing various patient reported outcomes, radiographic assessments, and adverse events.
The second prospective, multi-center, Catamaran study will evaluate 6-to-12-month radiographic outcomes to assess fusion of patients that have already undergone treatment with the Catamaran SI Joint Fusion System. In addition, retrospective and prospective clinical outcomes will be evaluated.
"We are both pleased and excited to have received IRB approvals from WCG IRB for our Catamaran clinical study protocols. This approval allows selected centers to move efficiently to enrollment initiation." states Steven M. Foster, President, and CEO of Tenon. "Our investment in these two important studies shows our continued commitment in validating and differentiating patient outcomes and radiographic assessment when utilizing a single, titanium Catamaran fixation device from an Inferior-Posterior approach to treat SI joint disruption and degenerative sacroilitis."
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 Inferior-Posterior approach to the SI joint using a single, robust titanium implant. The system features the Catamaran™ Trans-Fixation Device which passes through both the axial and sagittal planes of the ilium and sacrum, transfixing the SI joint along its longitudinal axis. With an entry that mimics SI joint injection, the surgical approach is direct to the joint and inferior to the wide and variable dorsal recess. The angle and trajectory of the Inferior-Posterior approach is designed to provide a pathway away from critical neural and vascular structures and into the strongest cortical bone. Tenon is preparing a national launch of this system to address the greatly underserved market opportunity that exists in this space. For more information, please visit https://www.tenonmed.com/.
The Tenon Medical logo and Tenon Medical, are registered trademarks of Tenon Medical, Inc. Catamaran is a trademark 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 contain 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 Registration Statement on Form S-1 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: 203-741-8811
MZ North America
[email protected]
SOURCE: Tenon Medical, Inc.