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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 21:00

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

衛材獲得 Leqembi FDA 批准,爲全球阿爾茨海默氏症患者帶來重要突破;Cognetivity Neurosciences 的 AI Cognica 技術有望在全球早期發現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.

不列顛哥倫比亞省溫哥華--(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 “Cognetivity”)是一家科技公司,它創建了由人工智能(AI)提供支持的獨特的大腦健康篩查和監測平臺,用於醫療、商業和消費環境。我們很高興地注意到,衛材(TYO:4523)的Leqembi已獲得美國食品藥品管理局對阿爾茨海默氏病的治療的全面批准,這一消息爲全球數千萬患者和高危人羣帶來了希望。

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月獲得了美國食品藥品管理局的加速批准,這要歸功於其能夠清除澱粉樣蛋白斑塊,澱粉樣蛋白斑塊是大腦中與阿爾茨海默氏病相關的有害蛋白質團塊。此前,美國政府針對65歲及以上人羣的Medicare健康計劃僅限於臨床試驗中的患者。儘管醫療保險和醫療補助服務中心(CMS)正在將報銷與患者參與名爲註冊表的衛生機構數據庫聯繫起來,但標準批准是阿爾茨海默氏病的首個此類批准,這意味着Leqembi現在將爲所有患者提供保險。由於阿爾茨海默氏症是一種衰老疾病,因此大多數美國患者都有Medicare的保險。CMS管理員Chiquita Brooks-LaSure在一份聲明中說:“根據美國食品藥品管理局的決定,CMS將廣泛涵蓋這種藥物,同時繼續收集數據,幫助我們瞭解該藥物的作用原理。”

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."

阿爾茨海默氏症協會在一份新聞稿中回應這一宣佈時說:“有了這項批准,早期發現和診斷對於確保個人儘早獲得最大的益處就顯得尤爲重要。”

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由人工智能(AI)驅動的開創性產品Cognica已經證明了其在早期認知障礙檢測方面的有效性,使用衛材的合作伙伴Biogen的Aduhelm(aducanumab)追蹤阿爾茨海默病患者的認知功能治療,該產品於2021年6月獲得美國食品藥品管理局的部分批准。CogniCa已成功用於篩查有輕度認知障礙風險的人羣,並可靠地識別出那些表現出認知問題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認知功能的變化,這表明能夠提供CMS規定的患者進展報告。CogniCa的速度、精度和擴展能力使其在大規模檢測和監測患有早期阿爾茨海默氏病和其他大腦健康問題的個體方面佔據了獨特的地位。

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."

Cognetivity Neurosciences首席執行官Sina Habibi評論說:“對於全球患有這種使人衰弱而殘酷的疾病的患者以及所有在神經變性領域工作的人來說,這是一個巨大的突破,也是個好消息。這凸顯了早期診斷在人羣層面的至關重要性。目前,一半的阿爾茨海默氏症患者根本沒有被診斷出來,而在疾病的早期階段,情況要糟糕得多。”他補充說:“我們對早期疾病的出色敏感性、有效監測患者進展以及在不佔用專家時間的情況下遠程定期使用的能力,是爲阿爾茨海默氏症治療帶來變革性變革的關鍵要素,我們鼓勵參與規劃和提供護理的人與我們聯繫,因爲我們今天準備提供幫助。”

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仍然致力於利用其人工智能平臺技術來改變全球大腦健康的格局,提高爲患者提供的護理質量,減輕提供者和付款人的負擔和成本,實現公司的願景,爲更美好的生活創造更美好的心靈。

About Cognetivity Neurosciences

關於 Cognetivity 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 是一家科技公司,開發了用於醫療、商業和消費環境的認知測試平臺。康耐力的 CogniCaTM 使用人工智能和機器學習技術來測試大腦大面積區域的表現,以幫助檢測認知功能障礙的早期跡象。Cognica目前已在美國、英國、歐洲和中東上市,預計將於2023年在其他地區獲得監管部門的批准。

On behalf of the Board of Directors

代表董事會

"Sina Habibi"
Sina Habibi

“Sina Habibi”
Sina Habibi

Chief Executive Officer and Director

首席執行官兼董事

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,包括以 “預期”、“假設”、“相信”、“計劃”、“估計”、“期望”、“打算”、“可能”、“應該” 等詞和類似表達方式確定的陳述,如果與公司或其管理層有關,則構成前瞻性信息或陳述(統稱爲 “前瞻性陳述”)。這些前瞻性陳述不是歷史事實,反映了當前對未來業績或事件的預期。本新聞稿包含前瞻性陳述。這些前瞻性陳述不能保證未來的表現,涉及難以預測的風險、不確定性和假設。此類陳述基於當前的預期和各種估計、因素和假設,涉及已知和未知的風險、不確定性和其他因素。此類陳述和信息基於有關我們當前和未來業務戰略以及我們運營環境的許多假設。除非法律要求,否則我們不承擔更新或修改前瞻性信息以反映新事件或情況的責任。提醒讀者不要過分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.

加拿大證券交易所對本新聞稿的充分性或準確性不承擔任何責任。

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

欲瞭解更多信息,請訪問: 網站:或聯繫方式:info@cognetivity.com;媒體諮詢可以發送至 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

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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