Mark H. Stouffer, MD and team from Zion Surgery Center perform first case in St George, UT.
This clinical study will assess patient pain scores, fusion as well as other patient reported outcomes out to 24 months
LOS GATOS, CA / ACCESSWIRE / November 15, 2022 / Tennon Medical, Inc. ("Tenon" or the "Company") (NASDAQ:TNON), a company transforming care for patients suffering with certain sacroiliac joint disorders, today announced completion of the first patient treated in the Company's Catamaran SI Joint Fusion System clinical study. Mark H. Stouffer, MD, an orthopedic spine surgeon from St. George Orthopedic Spine in St George, UT. successfully treated the first study patient at Zion Surgery Center on November 14, 2022.
The study is 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 goal of SI joint fusion is to stabilize the joint by reducing associated micromotion that is creating pain. The ability to facilitate a true fusion of the SI joint long term can be a key component to favorable patient outcomes, "states Mark Stouffer, MD. "The Catamaran, with its ability to transfix the joint and potentially facilitate bony in-growth through the SI joint is one of the more novel implant designs that we have available to treat patients with SI joint disruption. I look forward to the results of this study which will allow us to continue to assess the clinical effectiveness of this implant and its radiographic profile."
"We are extremely appreciative to Dr Stouffer and the team at Zion Surgery Center for completing the first study patient with our Catamaran SI Joint Fusion System. We look forward to our additional study centers and investigators beginning their enrollment as well." states Steven M. Foster, President and CEO of Tenon Medical. "This study represents our continued commitment in validating and differentiating patient outcomes and radiographic assessment with the Catamaran system. It is our strong belief that the Catamaran's single, titanium implant design, that transfixes the ilium and sacrum to stabilize the SI Joint, as well as an optimized surgical approach, will have a positive impact on patients suffering with sacroiliac joint disruptions or degenerative sacroiliitis."
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. Tenon is underway with 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.
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SOURCE: Tenon Medical, Inc.