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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

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

Tenon (R) Medical宣佈在IRB批准的使用Catamaran (R) SI關節融合系統的多中心上市後研究中,首批接受12個月隨訪的患者獲得陽性融合結果
Accesswire ·  03/26 08:00

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

基於獨立放射科醫生審查的初步SI關節融合結果表明,術後12個月的融合效果良好
初步的患者結果顯示,疼痛評分和殘障程度顯著改善,患者滿意度評分也很高

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.

加利福尼亞州洛斯加託斯/ACCESSWIRE/2024年3月26日/Tenon Medical, Inc.(納斯達克股票代碼:TNON)(“Tenon” 或 “公司”)是一家爲某些骶關節疾病患者提供護理服務的公司,今天宣佈,利用該公司雙體船SI關節融合系統的上市後研究取得了重大進展。該研究是一項前瞻性、多中心、單臂的上市後研究,評估了使用Catamaran SI關節融合系統治療的骶關節破裂或退行性骶尾炎患者的臨床療效。將對患者進行長達24個月的評估,審查患者報告的各種結果、射線照相評估和不良事件。研究招生預計將在下個季度完成。

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.

根據獨立放射科醫生對已達到12個月隨訪的100%的初始治療患者SI關節的計算機斷層掃描(CT)的審查,初步結果表明,術後12個月的融合反應強勁。此外,這些初步結果表明,疼痛評分和殘疾明顯改善。這些初步結果還反映了針對手術和結果的高患者滿意度評級。

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."

肯塔基州路易斯維爾恢復性疼痛研究所的介入性疼痛醫生、FASA醫學博士蒂莫西·比查姆評論說:“我對患者療效感到非常滿意,因爲這與使用雙體船植入物減輕疼痛症狀和提高患者滿意度有關。同樣令人印象深刻的是,在12個月的隨訪期內,所有初始研究患者的明確CT成像均顯示出明確的融合。如果這一結果在整個研究人群中保持一致,那麼Tenon Medicalan的雙體船植入物將成爲推進SI關節疾病治療的重要差異化因素。”

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."

明尼蘇達州德盧斯Orthopaedic Associates的董事會認證神經外科醫生、研究調查員馬修·戴維斯醫學博士補充說:“有效穩定並最終融合SI關節是每位治療SI關節疼痛疾病患者的目標。Catamaran的新穎設計及其沿其縱軸固定SI關節的能力旨在優化有效融合關節並最大限度地提高患者預後的機會。我讚揚Tenon Medical爲這項上市後研究撥出時間和投資,以獲得對雙體船植入物的臨床和放射療效的寶貴見解。”

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."

Tenon Medical總裁兼首席執行官史蒂芬·福斯特表示:“這個初步研究隊列的初步結果令我們感到鼓舞。我們堅信,Catamaran的迷人設計和侵入性較小的下後路方法旨在通過短期穩定和長期融合SI關節來優化患者的預後。我們非常感謝我們所有的研究人員及其臨床研究團隊幫助我們實現入組目標,同時也關注他們的患者完成研究的結論。我們期待更多的術後數據來支持這些初步結果。”

About Tenon Medical, Inc.

關於 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

成立於2012年的醫療器械公司Tenon Medical, Inc. 開發了雙體船SI關節融合系統,該系統使用單一堅固的鈦植入物爲SI關節提供了一種新穎的、侵入性較小的方法。該系統採用雙體船固定裝置,該裝置穿過髂骨和骶骨的軸向和矢狀面,沿其縱軸穩定和穿過SI關節。雙體船手術方法的角度和軌跡還旨在提供一條遠離關鍵神經和血管結構並進入最強皮質骨的途徑。自2022年10月雙體船SI關節融合系統在全國上線以來,Tenon一直專注於其系統在SI關節市場的三個商業機會,其中包括:1) 初級SI關節手術,2) 失敗的SI關節植入物的修訂程序以及3) 脊柱融合結構的輔助SI關節融合術。欲了解更多信息,請訪問

The Tenon Medical logo Tenon Medical, and Catamaran are registered trademarks of Tenon Medical, Inc.

Tenon Medical 徽標 Tenon Medical 和 Catamaran 是 Tenon Medical, Inc. 的註冊商標。

Safe Harbor

安全港

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.

本新聞稿包含 “前瞻性陳述”,即與Tenon預期、相信或預期未來將或可能發生的事件、業績、活動或發展相關的陳述。前瞻性通常包含 “打算”、“估計”、“預期”、“希望”、“項目”、“計劃”、“期望”、“尋求”、“相信”、“看見”、“應該”、“將”、“目標” 等詞語以及類似的表達方式及其否定版本。此類聲明基於Tenon的經驗和對當前狀況、趨勢、預期未來發展及其認爲在特定情況下適當的其他因素的看法,僅代表截至公佈之日。前瞻性陳述本質上是不確定的,由於各種因素,實際結果可能與前瞻性陳述中反映或包含的假設、估計或預期存在重大差異。有關可能導致我們的實際業績與前瞻性陳述中表達的業績存在重大差異的不確定性的詳細信息,請查看我們在美國證券交易委員會存檔的10-K年度報告(網址爲www.sec.gov),特別是標題爲 “風險因素” 的部分中包含的信息。除非法律要求,否則我們沒有義務公開更新或修改任何前瞻性陳述以反映新信息或未來事件或其他方面。

IR Contact:

投資者關係聯繫人:

Shannon Devine/Rory Rumore
203-741-8811
MZ North America
tenon@mzgroup.us

Shannon Devine/Rory Rumore
203-741-8811
MZ 北美
tenon@mzgroup.us

SOURCE: Tenon Medical, Inc.

來源:Tenon Medical, Inc.


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