Tenon(R) Medical Announces the Introduction of the Catamaran(R) SE SI Joint Fusion System
Tenon(R) Medical Announces the Introduction of the Catamaran(R) SE SI Joint Fusion System
The alpha launch of the Catamaran SE will provide important initial user feedback from a select group of physician users to support a broader market launch in the coming months. This news of the Catamaran SE comes on the recent announcement by the Company of the Catamaran SI Joint Fusion System MAINSAIL Study's positive interim outcomes publication. Click here to view the publication in its entirety.~ New SI Joint Fixation Device Offers a 30% Reduction in Implant Size Providing Physicians Choices for Varying Anatomy and Treatment Strategies with the Catamaran Technology ~
~ 全新 SI 關節固定裝置可將植入體尺寸縮小 30%，使用雙體船技術爲醫生提供不同的解剖和治療策略的選擇 ~
~The SE System Can Also Be Utilized with a Manual Drilling Option During Implant Preparation~
~在種植體準備過程中，SE系統也可以與手動鑽孔選項一起使用〜
LOS GATOS, CA / ACCESSWIRE / September 12, 2024 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering from certain Sacroiliac Joint (SIJ) disorders, today announced preparation for the initial alpha launch of the Company's new Catamaran SE SI Joint Fusion System targeted for the beginning of Q4. The Catamaran SE Fixation Device extends the line of implant offerings for physicians preferring a smaller Catamaran implant when performing a SI joint fusion procedure. The new implant offers a 30% reduction in implant width as compared to the original Catamaran fixation device, providing physicians options for smaller SI joint anatomy or revising previously treated SI joints with failed alternative SI joint implants where space is limited. The SE implant also comes with a hand drill option for those physicians who prefer to manually drill during implant preparation or do not have power sources readily available in their treating sites of care.
加利福尼亞州洛斯加託斯/ACCESSWIRE/2024年9月12日/Tenon Medical, Inc.（納斯達克股票代碼：TNON）（「Tenon」 或 「公司」）是一家爲患有某些Sacroiliac關節（SIJ）疾病的患者提供護理服務的公司，今天宣佈爲該公司計劃於第四季度初首次推出新的Catamaran SE SI關節融合系統做準備。Catamaran SE 固定裝置爲在進行 SI 關節融合手術時更傾向於使用較小雙體船植入物的醫生擴展了種植體產品線。與最初的雙體船固定裝置相比，新的植入物寬度減少了30％，爲醫生提供了縮小SI關節解剖結構的選擇，或者在空間有限的情況下使用失敗的替代性SI關節植入物修復先前治療過的SI關節。對於那些喜歡在植入物準備期間進行手動鑽孔或治療部位沒有現成電源的醫生，SE植入物還提供了手電鑽選項。
The alpha launch of the Catamaran SE will provide important initial user feedback from a select group of physician users to support a broader market launch in the coming months. This news of the Catamaran SE comes on the recent announcement by the Company of the Catamaran SI Joint Fusion System MAINSAIL Study's positive interim outcomes publication. Click here to view the publication in its entirety.
Catamaran SE的Alpha版發佈將爲特定醫生用戶群體提供重要的初始用戶反饋，以支持未來幾個月更廣泛的市場推出。雙體船SE的這一消息是在該公司最近宣佈雙體船SI聯合聚變系統MAINSAIL研究的積極中期結果發佈之際發佈的。點擊此處查看完整出版物。
The Catamaran and Catamaran SE SI Joint Fixation devices are single robust fully MRI compatible titanium implants 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 & Catamaran SE implant are 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 over 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.
Catamaran 和 Catamaran SE SI 關節固定裝置是堅固耐用、完全兼容 MRI 的鈦制植入物，由兩個浮橋組成，由成骨橋連接，該橋旨在沿縱軸將 SI 關節固定在縱軸上，從而立即固定和穩定關節，目的是實現成功的長期融合。雙體船植入物是根據關節置換術的AO原則開發的，包括1）適當的關節準備，2）剛性固定和穩定，以及3）適當的骨移植增強。通過微創的下後路方法，Catamaran & Catamaran SE 植入物被輸送到骶骨和的密集皮質骨內，用於固定和穩定 SI 關節，以治療 SIJ 功能障礙。迄今爲止，已經植入了700多臺雙體船固定裝置，用於治療原發性SI關節功能障礙和骶鞘炎，並用失敗的替代性SI關節植入物修復了先前治療過的SI關節。
Bryan Hoelzer, MD, Interventional Pain Physician and Medical Director of Southwest Spine and Pain Center, in Provo, UT., commented, "The clinical evidence validating the safety and efficacy of the inferior-posterior approach to treat SI Joint disease continues to grow with the recent Catamaran MAINSAIL Study publication. Continued advancement in implant technology as seen in the smaller Catamaran SE Fixation Device is exciting and will provide more improved options for myself and, my patients in treating and managing their painful SI joint disorders."and the entire interventional pain community."
猶他州普羅沃市西南脊柱與疼痛中心介入性疼痛醫生兼醫學主任布萊恩·霍爾澤博士評論說：「隨着最近雙體船MAINSAIL研究的發表，證實下後路治療SI關節疾病的安全性和有效性的臨床證據持續增加。從較小的Catamaran SE固定設備中可以看出，植入技術的持續進步令人興奮，它將爲我自己和我的患者在治療和管理他們痛苦的SI關節疾病方面提供更多更好的選擇。」以及整個介入性疼痛社區。”
Steven M. Foster, President and CEO of Tenon Medical, stated, "As a leader in the SI joint fusion market it is critical that we continually listen to input from our customers and respond with innovative technology that benefits their patients. The development and introduction of the Catamaran SE SI Joint Fusion System will provide our physician users with more choices to treat their patients with SI Joint disease. We look forward to a successful limited alpha launch and then move rapidly to a full market introduction."
Tenon Medical總裁兼首席執行官Steven m. Foster表示：「作爲SI關節融合市場的領導者，我們必須不斷聽取客戶的意見，並採用使患者受益的創新技術做出回應。Catamaran SE SI 關節融合系統的開發和引入將爲我們的醫生用戶提供更多選擇，以治療他們的 SI 關節疾病患者。我們期待成功推出限量版 alpha 版，然後迅速全面推向市場。」
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 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 .
Tenon Medical, Inc. 是一家成立於2012年的醫療器械公司，開發了Catamaran SI關節融合系統，該系統使用單個堅固的鈦植入物爲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，它穿過和骶骨的軸向和矢狀面，沿其縱軸穩定和固定 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推出以來，Tenon專注於其系統在SI關節市場的兩個商業機會，其中包括：1) 初級SI接頭手術，以及2) 失敗的SI關節植入物的修訂程序。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. MAINSAIL is a trademark of Tenon Medical
Tenon Medical 徽標 Tenon Medical 和 Catamaran 是 Tenon Medical, Inc. 的註冊商標。MAINSAIL 是 Tenon Medical 的商標
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," "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.
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」、「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
香農·迪瓦恩/Rory Rumore
203-741-8811
MZ 北美
tenon@mzgroup.us
SOURCE: Tenon Medical, Inc.
來源：Tenon Medical, Inc.
譯文內容由第三人軟體翻譯。
