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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(环球通讯社)--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个与患者骨密度匹配的椎间装置颈椎椎间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.
Aurora Spine首席执行官兼总裁特伦特·诺思卡特(TrentNorthcutt)说,“庆祝世界上第一台DEXA-C患者骨密度匹配椎间装置手术植入两周年,对Aurora来说是一个重要的里程碑。DEXA-C植入物是用于颈椎前路椎间盘切除术(ACDF)手术的一系列颈椎笼,是世界上第一种基于患者骨密度提供植入物的植入物。
It is also the first color-coded implant on the marketplace and will help doctors match against the color-coding of a DEXA score.”.
它也是市场上第一个颜色编码的植入物,将帮助医生与DEXA评分的颜色编码相匹配。”。
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.
路易斯安那州科文顿市科加神经外科(Koga Neurosurgery)的神经外科医生塞巴斯蒂安·科加(SebastianKoga)博士(Dr.SebastianKoga)说,“使用DEXA-C笼子两年多,达到200多个水平后,我再也无法回到标准笼子或结构性同种异体移植物了。植入该设备的同事也有同样的感受。我能够自信地为那些由于骨密度可能无法从其他现有植入物中受益的患者提供多级前路融合。
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.'.
笼的编织晶格和终板之间的界面在x射线和CT上非常清晰,并导致MRI上的伪影减少。”。
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,已获得机构审查委员会(IRB)的批准,对其DEXA-C颈椎椎间系统进行新的多中心研究,该系统适用于骨骼成熟的颈椎退行性椎间盘疾病(DDD)患者的颈椎前路椎间融合手术,伴有C2-T1一个或两个连续水平的神经根症状。。
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,Aurora宣布第一名患者已被纳入其DEXA-CTM颈椎椎间系统的多中心研究。患者登记的开始表明,该公司已获得启动该研究的所有必要批准,初步计划包括来自40个单水平和40个多水平受试者的数据。。
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.
Koga博士继续说:“我们现在正在回顾性临床研究中回顾前100名患者,同时也为DEXA研究收集前瞻性纵向数据。初步而言,我们在X光片和手术探查中都发现患者在手术后90天内有早期骨融合。
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.”.
这项技术现在已经成熟,可以在脊柱更具挑战性的区域进行复制。我仍然相信,这一进展取决于新的生物材料,这种个性化的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11850162,题为“体密度扫描结果匹配的骨科植入物和使用方法”,这是世界上第一项DEXA Technology™患者匹配植入物技术。
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专注于利用专利DEXA技术发布其他设备。Northcutt表示,“这些专利将使我们能够创建DEXA植入物,用于需要骨固定的人体任何地方,为患者提供以前不存在的新治疗可能性。”。
About Aurora Spine
关于Aurora Spine
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 www.aurora-spine.com or www.aurorapaincare.com.
Aurora Spine专注于通过一系列创新的微创再生脊柱植入技术为脊柱植入市场带来新的解决方案。其他信息可访问www.aurora-spine.com或www.aurorapaincare.com。
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.
TSX风险交易所及其监管服务提供商(该术语在TSX风险交易所的政策中定义)均不对本版本的充分性或准确性承担责任。
Forward-Looking Statements
前瞻性声明
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').
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,其中大多数不受Aurora Spine的控制,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”(统称“前瞻性信息”)中列出的信息。
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.
本新闻稿中的前瞻性信息包括有关该公司产品在外科手术中的拟议使用和成功的信息。Aurora Spine提醒Aurora Spine证券的投资者注意可能导致Aurora Spine的实际结果与本新闻稿中任何前瞻性声明中预测的结果存在重大差异的重要因素。
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.
任何表达或涉及对期望、信念、计划、目标、假设或未来事件或表现的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单方面不同。
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..
无法保证本文所述的预期将被证明是正确的,因此,潜在投资者不应过度依赖这些前瞻性声明。这些声明仅在本新闻稿发布之日有效,Aurora Spine没有义务更新或修订这些声明以反映新的事件或情况。。
Contact:
联系人:
Aurora Spine Corporation
极光脊柱公司
Trent Northcutt
特伦特·诺斯卡特
President and Chief Executive Officer
总裁兼首席执行官
(760) 424-2004
(760) 424-2004
Chad Clouse
查德·克劳斯
Chief Financial Officer
首席财务官
(760) 424-2004
(760) 424-2004
www.aurora-spine.com
www.aurora-spine.com