share_log

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

Tenon(R)医疗宣布推出Catamaran(R) SE SI关节融合系统
Accesswire ·  20:56

~ 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 关节固定装置可将植入体尺寸缩小 30%,使用双体船技术为医生提供不同的解剖和治疗策略的选择 ~

~The SE System Can Also Be Utilized with a Manual Drilling Option During Implant Preparation~

~在种植体准备过程中,SE系统也可以与手动钻孔选项一起使用〜

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.

加利福尼亚州洛斯加托斯/ACCESSWIRE/2024年9月12日/Tenon Medical, Inc.(纳斯达克股票代码:TNON)(“Tenon” 或 “公司”)是一家为患有某些Sacroiliac关节(SIJ)疾病的患者提供护理服务的公司,今天宣布为该公司计划于第四季度初首次推出新的Catamaran SE SI关节融合系统做准备。Catamaran SE 固定装置为在进行 SI 关节融合手术时更倾向于使用较小双体船植入物的医生扩展了种植体产品线。与最初的双体船固定装置相比,新的植入物宽度减少了30%,为医生提供了缩小SI关节解剖结构的选择,或者在空间有限的情况下使用失败的替代性SI关节植入物修复先前治疗过的SI关节。对于那些喜欢在植入物准备期间进行手动钻孔或治疗部位没有现成电源的医生,SE植入物还提供了手电钻选项。

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版发布将为特定医生用户群体提供重要的初始用户反馈,以支持未来几个月更广泛的市场推出。双体船SE的这一消息是在该公司最近宣布双体船SI联合聚变系统MAINSAIL研究的积极中期结果发布之际发布的。点击此处查看完整出版物。

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 关节固定装置是坚固耐用、完全兼容 MRI 的钛制植入物,由两个浮桥组成,由成骨桥连接,该桥旨在沿纵轴将 SI 关节固定在纵轴上,从而立即固定和稳定关节,目的是实现成功的长期融合。双体船植入物是根据关节置换术的AO原则开发的,包括1)适当的关节准备,2)刚性固定和稳定,以及3)适当的骨移植增强。通过微创的下后路方法,Catamaran & Catamaran SE 植入物被输送到骶骨和的密集皮质骨内,用于固定和稳定 SI 关节,以治疗 SIJ 功能障碍。迄今为止,已经植入了700多台双体船固定装置,用于治疗原发性SI关节功能障碍和骶鞘炎,并用失败的替代性SI关节植入物修复了先前治疗过的SI关节。

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."

犹他州普罗沃市西南脊柱与疼痛中心介入性疼痛医生兼医学主任布莱恩·霍尔泽博士评论说:“随着最近双体船MAINSAIL研究的发表,证实下后路治疗SI关节疾病的安全性和有效性的临床证据持续增加。从较小的Catamaran SE固定设备中可以看出,植入技术的持续进步令人兴奋,它将为我自己和我的患者在治疗和管理他们痛苦的SI关节疾病方面提供更多更好的选择。”以及整个介入性疼痛社区。”

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总裁兼首席执行官Steven m. Foster表示:“作为SI关节融合市场的领导者,我们必须不断听取客户的意见,并采用使患者受益的创新技术做出回应。Catamaran SE SI 关节融合系统的开发和引入将为我们的医生用户提供更多选择,以治疗他们的 SI 关节疾病患者。我们期待成功推出限量版 alpha 版,然后迅速全面推向市场。”

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 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. 是一家成立于2012年的医疗器械公司,开发了Catamaran SI关节融合系统,该系统使用单个坚固的钛植入物为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,它穿过和骶骨的轴向和矢状面,沿其纵轴稳定和固定 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推出以来,Tenon专注于其系统在SI关节市场的两个商业机会,其中包括:1) 初级SI接头手术,以及2) 失败的SI关节植入物的修订程序。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. MAINSAIL is a trademark of Tenon Medical

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

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," "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”、“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

香农·迪瓦恩/Rory Rumore
203-741-8811
MZ 北美
tenon@mzgroup.us

SOURCE: Tenon Medical, Inc.

来源:Tenon Medical, Inc.


声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
    抢沙发