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Aurora Spine Corporation Celebrates Second Anniversary of Initial Implantation of the World's First Bone Density Matched DEXA-C Cervical Interbody Fusion Device

Aurora Spine Corporation Celebrates Second Anniversary of Initial Implantation of the World's First Bone Density Matched DEXA-C Cervical Interbody Fusion Device

Aurora Spine Corporation 庆祝全球首款骨密度匹配型 DEXA-C 颈椎体间融合设备首次植入两周年
GlobeNewswire ·  03/20 07:30

CARLSBAD, Calif., March 20, 2024 (GLOBE NEWSWIRE) -- Aurora Spine Corporation ("Aurora Spine" or the "Company") (TSXV: ASG) (OTCQB: ASAPF), a manufacturer of innovative spinal implants announced today that it has completed the second full year of implantation of the world's first patient-bone-density matched interbody device, the cervical interbody DEXA-C.

加利福尼亚州卡尔斯巴德,2024年3月20日(GLOBE NEWSWIRE)——创新脊柱植入物制造商Aurora Spine Corporation(“Aurora Spine” 或 “公司”)(TSXV:ASG)(OTCQB:ASAPF)今天宣布,它已经完成了世界上第一款患者骨密度匹配的椎间器械——颈椎间体间DEXA-C的第二整年植入。

Trent Northcutt, CEO and President at Aurora Spine said, "It's a significant milestone for Aurora to celebrate the second anniversary of the world's first surgical implantations of the DEXA-C patient-bone-density matched interbody devices. The DEXA-C implants, a line of cervical cages for anterior cervical discectomy with fusion (ACDF) procedures, are the first of its kind in the world offering an implant based upon a patient's bone density. It is also the first color-coded implant on the marketplace and will help doctors match against the color-coding of a DEXA score."

Aurora Spine首席执行官兼总裁特伦特·诺斯卡特表示:“对于奥罗拉来说,庆祝世界上首次手术植入DEXA-C患者骨密度匹配的体间设备两周年,这是一个重要的里程碑。DEXA-C 植入物是一系列用于前颈椎间盘切除术融合术 (ACDF) 手术的宫颈笼,是世界上首款根据患者骨密度提供植入物的植入物。它也是市场上第一种颜色编码的植入物,将帮助医生与DEXA分数的颜色编码相匹配。”

Dr. Sebastian Koga, Neurosurgeon at Koga Neurosurgery in Covington, Louisiana said, "After two years and over 200 levels with the DEXA-C cage, I could never go back to standard cages or structural allograft. My colleagues who have implanted the device, also feel the same. I am able to confidently offer multilevel anterior fusions to patients who likely could not have benefitted from other existing implants because of their bone density. The interface between the woven lattice of the cage and the endplate images very clearly on x-ray and CT and causes reduced artefact on MRI."

位于路易斯安那州卡温顿的Koga神经外科的神经外科医生塞巴斯蒂安·科加博士说:“在使用DEXA-C笼子两年和超过200个水平之后,我再也无法回到标准笼子或结构性同种异体移植了。植入该设备的同事也有同样的感受。我能够放心地为那些由于骨密度而可能无法从其他现有植入物中受益的患者提供多层前融合术。在X射线和CT上,笼子的编织晶格与端板图像之间的界面非常清晰,从而减少了核磁共振成像上的伪影。”

Aurora announced in March 2023 that it had received Institutional Review Board (IRB) approval for its new multicenter study of its DEXA-C Cervical Interbody System, which is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1.

Aurora 于 2023 年 3 月宣布,其新的 DEXA-C 颈椎体间系统多中心研究已获得机构审查委员会 (IRB) 的批准,该系统适用于与 C2-T1 相隔一到两个连续水平的颈椎退行性椎间盘疾病 (DDD) 骨骼成熟患者的前颈椎椎间盘融合术,伴有神经根症状。

In June 2023, Aurora announced that the first patient has been enrolled for its multicenter study of DEXA-CTM Cervical Interbody System. The commencement of the enrollment of patients indicates that the company has received all necessary approvals to launch the study, with initial plans to include data from 40 single level and 40 multiple level subjects.

2023年6月,奥罗拉宣布,其DEXA-CTM宫颈椎体间系统的多中心研究已入组首位患者。患者入组的开始表明,该公司已获得启动该研究的所有必要批准,初步计划纳入来自40个单层和40个多层次受试者的数据。

Dr. Koga continued, "We are reviewing the first one hundred patients in a retrospective clinical study now, while also collecting prospective longitudinal data for the DEXA study. Preliminarily, we have seen both in radiographs and surgical exploration that patients have incipient bone fusion by 90 days after surgery. This technology is now ripe for duplication in more challenging areas of the spine. I continue to believe that that progress is contingent on new biomaterials, and that such personalized implants will revolutionize spine surgery."

Koga博士继续说:“我们现在正在审查回顾性临床研究中的前一百名患者,同时还为DEXA研究收集前瞻性的纵向数据。最初,我们在X光片和手术探索中都看到,患者在手术后90天内已经开始进行骨融合。这项技术现在已经成熟,可以在更具挑战性的脊柱区域进行复制。我仍然相信,这种进展取决于新的生物材料,而这种个性化植入物将彻底改变脊柱手术。”

In February 2024, Aurora announced the issuance of its second United States Patent No: 11,850,162 entitled "Body Density Scan Result-Matched Orthopedic Implants and Methods of Use" for The World's First DEXA Technology Patient-Matched Implant Technology.

2024年2月,Aurora宣布发布其第二项美国专利号:11,850,162,标题为 “人体密度扫描结果匹配的骨科植入物和使用方法”,该专利涉及世界上第一项DEXA技术的患者匹配植入技术。

Aurora is focused on the release of other devices utilizing the patented DEXA Technology. Northcutt stated, "These patents will allow us to create DEXA implants for use anywhere in the human body where bone fixation is needed providing patients with previously non-existing new treatment possibilities."

Aurora专注于使用专利DEXA技术发布其他设备。Northcutt表示:“这些专利将使我们能够制造出DEXA植入物,用于人体任何需要骨固定的地方,为患者提供以前不存在的新治疗可能性。”

About Aurora Spine

关于奥罗拉脊柱

Aurora Spine is focused on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies. Additional information can be accessed at or .

Aurora Spine专注于通过一系列创新的、微创的再生脊柱植入技术为脊柱植入市场带来新的解决方案。可以在或访问其他信息。

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

多伦多证券交易所风险投资交易所及其监管服务提供商(该术语在多伦多证券交易所风险交易所的政策中定义)均不对本新闻稿的充分性或准确性承担责任。

Forward-Looking Statements

前瞻性陈述

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Information" in Aurora Spine's final prospectus (collectively, "forward-looking information"). Forward-looking information in this news release includes information concerning the proposed use and success of the company's products in surgical procedures. Aurora Spine cautions investors of Aurora Spine's securities about important factors that could cause Aurora Spine's actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward-looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

本新闻稿包含前瞻性信息,涉及大量已知和未知的风险和不确定性,其中大多数是Aurora Spine无法控制的,包括但不限于Aurora Spine最终招股说明书中 “风险因素” 和 “关于前瞻性信息的警示声明” 中列出的信息(统称为 “前瞻性信息”)。本新闻稿中的前瞻性信息包括有关公司产品在外科手术中的拟议用途和成功的信息。Aurora Spine提醒Aurora Spine证券的投资者注意一些重要因素,这些因素可能导致Aurora Spine的实际业绩与本新闻稿中包含的任何前瞻性陈述中的预测存在重大差异。任何表达预期、信念、计划、目标、假设或未来事件或业绩或涉及讨论的陈述都不是历史事实,可能是前瞻性的,可能涉及估计、假设和不确定性,可能导致实际结果或结果与此类前瞻性陈述中表达的结果或结果存在单方面差异。无法保证此处提出的预期会被证明是正确的,因此,潜在投资者不应过分依赖这些前瞻性陈述。这些声明仅代表截至本新闻稿发布之日,Aurora Spine 不承担任何更新或修改声明以反映新事件或情况的义务。

Contact:

联系人:

Aurora Spine Corporation
Trent Northcutt
President and Chief Executive Officer
(760) 424-2004

奥罗拉脊柱公司
特伦特·诺斯卡特
总裁兼首席执行官
(760) 424-2004

Chad Clouse
Chief Financial Officer
(760) 424-2004

查德·克劳斯
首席财务官
(760) 424-2004


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