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New Disease Modifying Drug for Alzheimer's Disease Fully Approved by FDA, Highlighting the Crucial Role for Cognetivity in Early Detection and Monitoring

New Disease Modifying Drug for Alzheimer's Disease Fully Approved by FDA, Highlighting the Crucial Role for Cognetivity in Early Detection and Monitoring

治療阿爾茨海默病的新疾病改良藥物已獲美國食品藥品管理局全面批准,凸顯了認知性在早期發現和監測中的關鍵作用
newsfile ·  2023/07/07 09:00

Vital breakthrough for Alzheimer's patients worldwide with Eisai's Leqembi FDA approval; Cognetivity Neurosciences' AI CognICA technology poised to play pivotal role in early detection and monitoring globally

Eisai的Leqembi FDA批准為全球阿爾茨海默氏症患者帶來重大突破;Cognetivity NeuroSciences的AI CognICA技術將在全球早期檢測和監測中發揮關鍵作用

Vancouver, British Columbia--(Newsfile Corp. - July 7, 2023) - Cognetivity Neurosciences Ltd. (CSE: CGN) (OTCQB: CGNSF) (FSE: 1UB) ("the Company" or "Cognetivity"), a technology company that has created a unique Artificial Intelligence (AI) powered brain health screening and monitoring platform for use in medical, commercial and consumer environments, is delighted to note that Eisai's (TYO: 4523) Leqembi has achieved full FDA approval for the treatment of Alzheimer's disease, news that brings hope to tens of millions of sufferers and at-risk individuals worldwide.

溫哥華,不列顛哥倫比亞省-(Newsfile Corp.-2023年7月7日)-認知神經科學有限公司。(CSE:CGN)(OTCQB:CGNSF)(FSE:1UB)(“公司”或“認知性”)Eisai(TYO:4523)Leqembi公司欣喜地注意到,Eisai(TYO:4523)的治療阿爾茨海默病的藥物已獲得FDA的全面批准,這一消息為全球數千萬患者和高危人群帶來了希望。

Leqembi received accelerated FDA approval in January 2023 thanks to its ability to clear amyloid plaques - harmful clumps of protein in the brain associated with Alzheimer's disease. Previously, the U.S. government's Medicare health plan for people aged 65 and over had restricted coverage only to patients in a clinical trial. Standard approval, the first of its kind for Alzheimer's disease, means that Leqembi will now be covered for all patients, although the Centers for Medicare and Medicaid Services (CMS) is linking reimbursement to patient participation in a health agency database, known as a registry. Since Alzheimer's is a disease of aging, most U.S. patients are insured by Medicare. "With FDA's decision, CMS will cover this medication broadly while continuing to gather data that will help us understand how the drug works," CMS Administrator Chiquita Brooks-LaSure said in a statement.

Leqembi在2023年1月加速獲得FDA的批准,這要歸功於它能夠清除澱粉樣斑塊-大腦中與阿爾茨海默病相關的有害蛋白質塊。此前,美國政府針對65歲及以上老年人的醫療保險計劃僅限於臨床試驗中的患者。這是首個針對阿爾茨海默氏症的標準批准,這意味著Leqembi現在將覆蓋所有患者,儘管醫療保險和醫療補助服務中心(CMS)正在醫療機構資料庫中將報銷與患者的參與聯繫起來,該資料庫被稱為登記表。由於阿爾茨海默氏症是一種老年性疾病,大多數美國患者都有醫療保險。CMS署長Chiquita Brooks-LaSure在一份聲明中說:“有了FDA的決定,CMS將廣泛覆蓋這種藥物,同時繼續收集數據,幫助我們瞭解藥物是如何起作用的。”

Responding to the announcement in a press release, the Alzheimer's Association stated, "With this approval, early detection and diagnosis are even more critical to ensure individuals receive the most benefit at the earliest point possible."

在一份新聞稿中,阿爾茨海默氏症協會在回應這一聲明時表示:“有了這一批准,早期檢測和診斷更加關鍵,以確保個人儘早獲得最大好處。”

Cognetivity's groundbreaking Artificial Intelligence (AI) driven product, CognICA, has already demonstrated its effectiveness in the detection of early stage cognitive impairment, tracking of cognitive function treatment of Alzheimer's disease patients using Eisai's partner Biogen's Aduhelm (aducanumab), which was given partial approval by the FDA in June 2021. CognICA is being used successfully to screen populations of individuals at risk of mild cognitive impairment, and reliably identifies those who show early signs of cognitive problems and require further assessment. Following clinical diagnosis, the technology platform is used to monitor changes in cognitive function among patients receiving monthly treatment, demonstrating the ability to deliver the CMS mandated reporting on patient progress. The speed, precision and ability to scale of CognICA give it a unique position in the market for the large-scale detection and monitoring of individuals with early stage Alzheimer's disease and other brain health issues.

Cognetivity的突破性人工智慧(AI)驅動產品CognICA已經證明瞭其在檢測早期認知障礙、跟蹤使用衛材合作夥伴Biogen的Aduhelm(Aducanumab)治療阿爾茨海默病患者認知功能方面的有效性,該藥於2021年6月獲得FDA的部分批准。CognICA正被成功地用於篩查有輕度認知障礙風險的個人群體,並可靠地識別那些顯示出認知問題的早期跡象並需要進一步評估的人。臨床診斷後,該技術平臺用於監測每月接受治療的患者的認知功能變化,展示提供CMS強制報告患者進展的能力。CognICA的速度、精度和規模化能力使其在大規模檢測和監測患有早期阿爾茨海默病和其他大腦健康問題的個人方面處於獨特的市場地位。

Sina Habibi, CEO of Cognetivity Neurosciences, commented, "This is a huge breakthrough and outstanding news for sufferers worldwide of this debilitating and cruel disease, and for everyone working in the area of neurodegeneration. What this highlights is the critical importance of early stage diagnosis at population level. Currently half of patients with Alzheimer's are not diagnosed at all, and the situation is much worse when it comes to the earlier stages of the disease." He added "Our outstanding sensitivity to early-stage disease, ability to effectively monitor patient progress and to be used remotely and regularly without taking up specialists' time are key elements in bringing transformational change to the treatment of Alzheimer's, and we encourage people working on the planning and delivery of care to get in touch with us as we are ready to help today."

認知神經科學公司首席執行官新娜·哈比比評論道:“對於全世界患有這種令人衰弱和殘忍的疾病的患者,以及在神經變性領域工作的每個人來說,這是一個巨大的突破和傑出的消息。這突顯了在人群層面進行早期診斷的關鍵重要性。目前有一半的阿爾茨海默氏症患者根本沒有得到診斷,當涉及到疾病的早期階段時,情況就更糟了。”他補充道:“我們對早期疾病的敏感度非常高,能夠有效地監控患者的病情進展,能夠在不佔用專家時間的情況下遠端定期使用,這些都是為阿爾茨海默氏症的治療帶來變革性變化的關鍵因素,我們鼓勵從事護理規劃和提供工作的人與我們聯繫,因為我們今天已經準備好提供幫助。”

Cognetivity Neurosciences remains dedicated to utilizing its AI platform technology to transform the landscape of brain health globally, enhance the quality of care provided to patients and to reduce the burden and cost to providers and payers, delivering the company's vision of A Brighter Mind for a Fuller Life.

Cognetivity NeuroSciences仍致力於利用其人工智慧平臺技術來改變全球大腦健康的格局,提高向患者提供的護理質量,並減輕提供者和付款人的負擔和成本,實現公司為富勒生活提供更光明心靈的願景。

About Cognetivity Neurosciences

關於認知神經科學

Cognetivity is a technology company that has developed a cognitive testing platform for use in medical, commercial, and consumer environments. Cognetivity's CognICATM uses artificial intelligence and machine learning technology to test the performance of large areas of the brain to help detect early signs of cognitive dysfunction. CognICA is currently available for clinical use in the United States, United Kingdom, Europe, and the Middle East, with regulatory approval in other regions expected in 2023.

Cognetivity是一家技術公司,它開發了一種認知測試平臺,用於醫療、商業和消費環境。認知性的認知ICATM使用人工智慧和機器學習技術來測試大腦大片區域的表現,以幫助檢測認知功能障礙的早期跡象。CognICA目前可在美國、英國、歐洲和中東用於臨床,預計2023年將在其他地區獲得監管批准。

On behalf of the Board of Directors

我謹代表董事會

"Sina Habibi"
Sina Habibi

《新浪哈比比》
新浪哈比比

Chief Executive Officer and Director

董事首席執行官兼首席執行官

Forward-looking statements:

前瞻性陳述:

Certain statements contained in this news release, including those identified by the words "anticipate," "assume," "believe," "plan," "estimate," "expect," "intend," "may," "should" and similar expressions, to the extent they relate to the Company or its management, constitute forward-looking information or statements (collectively, the "Forward-Looking Statements"). These forward-looking statements are not historical facts and reflect current expectations regarding future results or events. This news release contains forward-looking statements. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Such statements are based on current expectations and various estimates, factors and assumptions, and involve known and unknown risks, uncertainties and other factors. Such statements and information are based on a number of assumptions regarding our current and future business strategies and the environment in which we operate. We assume no responsibility to update or revise forward-looking information to reflect new events or circumstances, except as required by law. Readers are cautioned not to place undue reliance on our forward-looking statements.

本新聞稿中包含的某些陳述,包括“預期”、“假設”、“相信”、“計劃”、“估計”、“預期”、“打算”、“可能”、“應該”以及類似的表述,在與公司或其管理層有關的範圍內,構成前瞻性資訊或陳述(統稱為“前瞻性陳述”)。這些前瞻性陳述不是歷史事實,反映了對未來結果或事件的當前預期。本新聞稿包含前瞻性陳述。這些前瞻性陳述不是對未來業績的保證,涉及難以預測的風險、不確定性和假設。此類陳述基於當前預期和各種估計、因素和假設,涉及已知和未知的風險、不確定性和其他因素。這些陳述和資訊是基於對我們當前和未來的業務戰略以及我們所處的經營環境的一些假設。除法律要求外,我們不承擔更新或修改前瞻性資訊以反映新事件或新情況的責任。告誡讀者不要過度依賴我們的前瞻性陳述。

The Canadian Securities Exchange is not responsible for the adequacy or accuracy of this release.

加拿大證券交易所不對本新聞稿的充分性或準確性負責。

For more information, please visit: website: or contact: info@cognetivity.com; media inquiries can be sent to pr@cognetivity.com.

如需更多資訊,請訪問:網站:或聯繫方式:info@cognetivity.com;媒體查詢可發送至pr@cognetivity.com。

To view the source version of this press release, please visit

要查看本新聞稿的源版本,請訪問

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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