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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 慶祝全球首款骨密度匹配型 DEXA-C 頸椎體間融合設備首次植入兩週年
GlobeNewswire ·  03/20 19:30

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.

加利福尼亞州卡爾斯巴德,2024年3月20日(GLOBE NEWSWIRE)——創新脊柱植入物製造商Aurora Spine Corporation(“Aurora Spine” 或 “公司”)(TSXV:ASG)(OTCQB:ASAPF)今天宣佈,它已經完成了世界上第一款患者骨密度匹配的椎間器械——頸椎間體間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首席執行官兼總裁特倫特·諾斯卡特表示:“對於奧羅拉來說,慶祝世界上首次手術植入DEXA-C患者骨密度匹配的體間設備兩週年,這是一個重要的里程碑。DEXA-C 植入物是一系列用於前頸椎間盤切除術融合術 (ACDF) 手術的宮頸籠,是世界上首款根據患者骨密度提供植入物的植入物。它也是市場上第一種顏色編碼的植入物,將幫助醫生與DEXA分數的顏色編碼相匹配。”

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."

位於路易斯安那州卡溫頓的Koga神經外科的神經外科醫生塞巴斯蒂安·科加博士說:“在使用DEXA-C籠子兩年和超過200個水平之後,我再也無法回到標準籠子或結構性同種異體移植了。植入該設備的同事也有同樣的感受。我能夠放心地爲那些由於骨密度而可能無法從其他現有植入物中受益的患者提供多層前融合術。在X射線和CT上,籠子的編織晶格與端板圖像之間的界面非常清晰,從而減少了核磁共振成像上的僞影。”

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 於 2023 年 3 月宣佈,其新的 DEXA-C 頸椎體間系統多中心研究已獲得機構審查委員會 (IRB) 的批准,該系統適用於與 C2-T1 相隔一到兩個連續水平的頸椎退行性椎間盤疾病 (DDD) 骨骼成熟患者的前頸椎椎間盤融合術,伴有神經根症狀。

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,奧羅拉宣佈,其DEXA-CTM宮頸椎體間系統的多中心研究已入組首位患者。患者入組的開始表明,該公司已獲得啓動該研究的所有必要批准,初步計劃納入來自40個單層和40個多層次受試者的數據。

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博士繼續說:“我們現在正在審查回顧性臨床研究中的前一百名患者,同時還爲DEXA研究收集前瞻性的縱向數據。最初,我們在X光片和手術探索中都看到,患者在手術後90天內已經開始進行骨融合。這項技術現在已經成熟,可以在更具挑戰性的脊柱區域進行復制。我仍然相信,這種進展取決於新的生物材料,而這種個性化植入物將徹底改變脊柱手術。”

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宣佈發佈其第二項美國專利號:11,850,162,標題爲 “人體密度掃描結果匹配的骨科植入物和使用方法”,該專利涉及世界上第一項DEXA技術的患者匹配植入技術。

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專注於使用專利DEXA技術發佈其他設備。Northcutt表示:“這些專利將使我們能夠製造出DEXA植入物,用於人體任何需要骨固定的地方,爲患者提供以前不存在的新治療可能性。”

About Aurora Spine

關於奧羅拉脊柱

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專注於通過一系列創新的、微創的再生脊柱植入技術爲脊柱植入市場帶來新的解決方案。可以在或訪問其他信息。

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.

多倫多證券交易所風險投資交易所及其監管服務提供商(該術語在多倫多證券交易所風險交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。

Forward-Looking Statements

前瞻性陳述

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.

本新聞稿包含前瞻性信息,涉及大量已知和未知的風險和不確定性,其中大多數是Aurora Spine無法控制的,包括但不限於Aurora Spine最終招股說明書中 “風險因素” 和 “關於前瞻性信息的警示聲明” 中列出的信息(統稱爲 “前瞻性信息”)。本新聞稿中的前瞻性信息包括有關公司產品在外科手術中的擬議用途和成功的信息。Aurora Spine提醒Aurora Spine證券的投資者注意一些重要因素,這些因素可能導致Aurora Spine的實際業績與本新聞稿中包含的任何前瞻性陳述中的預測存在重大差異。任何表達預期、信念、計劃、目標、假設或未來事件或業績或涉及討論的陳述都不是歷史事實,可能是前瞻性的,可能涉及估計、假設和不確定性,可能導致實際結果或結果與此類前瞻性陳述中表達的結果或結果存在單方面差異。無法保證此處提出的預期會被證明是正確的,因此,潛在投資者不應過分依賴這些前瞻性陳述。這些聲明僅代表截至本新聞稿發佈之日,Aurora Spine 不承擔任何更新或修改聲明以反映新事件或情況的義務。

Contact:

聯繫人:

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

奧羅拉脊柱公司
特倫特·諾斯卡特
總裁兼首席執行官
(760) 424-2004

Chad Clouse
Chief Financial Officer
(760) 424-2004

查德·克勞斯
首席財務官
(760) 424-2004


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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