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Tenon Medical’s Catamaran(TM) SI Joint Fusion System Receives Institutional Review Board Approval for Two Strategic Post Market Studies
~ 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
About this update from Tenon Medical, Inc.
[{"type":"text","content":"~ 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 titaniu...