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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宣布在IRB批准的使用Catamaran (R) SI关节融合系统的多中心上市后研究中,首批接受12个月随访的患者获得阳性融合结果
Accesswire ·  03/26 20:00

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

基于独立放射科医生审查的初步SI关节融合结果表明,术后12个月的融合效果良好
初步的患者结果显示,疼痛评分和残障程度显著改善,患者满意度评分也很高

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.

加利福尼亚州洛斯加托斯/ACCESSWIRE/2024年3月26日/Tenon Medical, Inc.(纳斯达克股票代码:TNON)(“Tenon” 或 “公司”)是一家为某些骶关节疾病患者提供护理服务的公司,今天宣布,利用该公司双体船SI关节融合系统的上市后研究取得了重大进展。该研究是一项前瞻性、多中心、单臂的上市后研究,评估了使用Catamaran SI关节融合系统治疗的骶关节破裂或退行性骶尾炎患者的临床疗效。将对患者进行长达24个月的评估,审查患者报告的各种结果、射线照相评估和不良事件。研究招生预计将在下个季度完成。

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.

根据独立放射科医生对已达到12个月随访的100%的初始治疗患者SI关节的计算机断层扫描(CT)的审查,初步结果表明,术后12个月的融合反应强劲。此外,这些初步结果表明,疼痛评分和残疾明显改善。这些初步结果还反映了针对手术和结果的高患者满意度评级。

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."

肯塔基州路易斯维尔恢复性疼痛研究所的介入性疼痛医生、FASA医学博士蒂莫西·比查姆评论说:“我对患者疗效感到非常满意,因为这与使用双体船植入物减轻疼痛症状和提高患者满意度有关。同样令人印象深刻的是,在12个月的随访期内,所有初始研究患者的明确CT成像均显示出明确的融合。如果这一结果在整个研究人群中保持一致,那么Tenon Medicalan的双体船植入物将成为推进SI关节疾病治疗的重要差异化因素。”

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."

明尼苏达州德卢斯Orthopaedic Associates的董事会认证神经外科医生、研究调查员马修·戴维斯医学博士补充说:“有效稳定并最终融合SI关节是每位治疗SI关节疼痛疾病患者的目标。Catamaran的新颖设计及其沿其纵轴固定SI关节的能力旨在优化有效融合关节并最大限度地提高患者预后的机会。我赞扬Tenon Medical为这项上市后研究拨出时间和投资,以获得对双体船植入物的临床和放射疗效的宝贵见解。”

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总裁兼首席执行官史蒂芬·福斯特表示:“这个初步研究队列的初步结果令我们感到鼓舞。我们坚信,Catamaran的迷人设计和侵入性较小的下后路方法旨在通过短期稳定和长期融合SI关节来优化患者的预后。我们非常感谢我们所有的研究人员及其临床研究团队帮助我们实现入组目标,同时也关注他们的患者完成研究的结论。我们期待更多的术后数据来支持这些初步结果。”

About Tenon Medical, Inc.

关于 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

成立于2012年的医疗器械公司Tenon Medical, Inc. 开发了双体船SI关节融合系统,该系统使用单一坚固的钛植入物为SI关节提供了一种新颖的、侵入性较小的方法。该系统采用双体船固定装置,该装置穿过髂骨和骶骨的轴向和矢状面,沿其纵轴稳定和穿过SI关节。双体船手术方法的角度和轨迹还旨在提供一条远离关键神经和血管结构并进入最强皮质骨的途径。自2022年10月双体船SI关节融合系统在全国上线以来,Tenon一直专注于其系统在SI关节市场的三个商业机会,其中包括:1) 初级SI关节手术,2) 失败的SI关节植入物的修订程序以及3) 脊柱融合结构的辅助SI关节融合术。欲了解更多信息,请访问

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

Tenon Medical 徽标 Tenon Medical 和 Catamaran 是 Tenon Medical, Inc. 的注册商标。

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.

本新闻稿包含 “前瞻性陈述”,即与Tenon预期、相信或预期未来将或可能发生的事件、业绩、活动或发展相关的陈述。前瞻性通常包含 “打算”、“估计”、“预期”、“希望”、“项目”、“计划”、“期望”、“寻求”、“相信”、“看见”、“应该”、“将”、“目标” 等词语以及类似的表达方式及其否定版本。此类声明基于Tenon的经验和对当前状况、趋势、预期未来发展及其认为在特定情况下适当的其他因素的看法,仅代表截至公布之日。前瞻性陈述本质上是不确定的,由于各种因素,实际结果可能与前瞻性陈述中反映或包含的假设、估计或预期存在重大差异。有关可能导致我们的实际业绩与前瞻性陈述中表达的业绩存在重大差异的不确定性的详细信息,请查看我们在美国证券交易委员会存档的10-K年度报告(网址为www.sec.gov),特别是标题为 “风险因素” 的部分中包含的信息。除非法律要求,否则我们没有义务公开更新或修改任何前瞻性陈述以反映新信息或未来事件或其他方面。

IR Contact:

投资者关系联系人:

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.

来源:Tenon Medical, Inc.


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