Cognetivity Neurosciences Announces Successful Registration With Health Canada for Clinical Use of CognICA(TM) AI-Powered Brain Health Technology in Canada
Cognetivity Neurosciences Announces Successful Registration With Health Canada for Clinical Use of CognICA(TM) AI-Powered Brain Health Technology in Canada
Approval opens up a new major market for CognICA, providing a solution to the urgent requirement for large-scale early detection and monitoring for the rollout of incoming Alzheimer's disease drugs
批准為CognICA打開了一個新的主要市場，為即將推出的阿爾茨海默病藥物的大規模早期檢測和監測的迫切需求提供瞭解決方案
Vancouver, British Columbia--(Newsfile Corp. - August 2, 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 announce that it has completed registration for its groundbreaking CognICA cognitive assessment system with Health Canada under Medical Devices Regulations (SOR/98-282). This registration allows the company to market the medical device commercially for clinical use in Canada.
溫哥華，不列顛哥倫比亞省-(Newsfile Corp.-2023年8月2日)-認知神經科學有限公司(CSE：CGN)(OTCQB：CGNSF)(FSE：1UB)(“公司”或“認知”)，一家創建了用於醫療、商業和消費環境的獨特的人工智慧(AI)驅動的大腦健康篩查和監測平臺的科技公司高興地宣佈，它已經根據醫療器械法規(SOR/98-282)完成了其突破性的CognICA認知評估系統在加拿大衛生部的註冊。這一註冊允許該公司將該醫療設備在加拿大進行商業銷售，用於臨床使用。
Commenting on the announcement, Dr Sina Habibi, Cognetivity's CEO, said, "We are pleased to announce our Health Canada registration, in particular as it is not just a major healthcare market but also one of our home jurisdictions and one where there is a significant unmet need for early detection of brain health issues. This is part of our ongoing strategy to expand our access to new high-value healthcare markets, where, sadly, there is much work to be done to tackle the public health crisis in dementia. Given the urgent and huge need for early detection in the light of new drugs for Alzheimer's disease coming to market, and CognICA's unique capabilities to do this at scale, we would welcome contact from potential collaborators in Canada who share the same ambitions and interests."
Cognetivity首席執行官Sina Habibi博士在評論這一聲明時表示：“我們很高興宣佈我們的加拿大健康註冊，特別是因為它不僅是一個主要的醫療保健市場，也是我們的本土司法管轄區之一，在那裡有一個巨大的未得到滿足的需求，即早期發現大腦健康問題。這是我們正在進行的戰略的一部分，目的是擴大我們進入新的高價值醫療保健市場的機會。遺憾的是，在這些市場，要解決痴呆症的公共衛生危機，還有很多工作要做。鑑於治療阿爾茨海默病的新藥即將上市，以及CognICA公司在規模上實現這一目標的獨特能力，對早期發現的迫切和巨大需求，我們歡迎在加拿大有相同抱負和興趣的潛在合作者與我們聯繫。“
CognICA is a five-minute, computerized cognitive assessment, incorporating artificial intelligence (AI) delivered via Apple iPad devices. It offers numerous benefits to clinicians and patients, particularly in comparison to traditional, pen-and-paper-based tests. These include high sensitivity to early-stage cognitive impairment which allows reliable detection of patients at the early stages of diseases such as Alzheimer's, lack of cultural or educational bias and absence of learning effect upon repeat testing, enabling reliable monitoring of patient progress. CognICA is also capable of supporting remote, self-administered testing at scale and is geared towards seamless integration with existing electronic health record (EHR) systems.
CognICA是一種五分鐘的電腦化認知評估，納入了通過蘋果iPad設備提供的人工智慧(AI)。它為臨床醫生和患者提供了許多好處，特別是與傳統的紙筆測試相比。這些包括對早期認知障礙的高度敏感性，使患者能夠在阿爾茨海默氏症等疾病的早期階段可靠地檢測到患者，沒有文化或教育偏見，在重複測試時沒有學習效果，從而能夠可靠地監測患者的進展。CognICA還能夠支持大規模的遠端自我管理測試，並致力於與現有的電子健康記錄(EHR)系統無縫集成。
The prevalence of Mild Cognitive Impairment (MCI) for people aged above 60 is around 10%, a rate which doubles every additional 10 years of life. Currently, the majority of the MCI population within the 7 million Canadians aged 60 and above have not been detected or received any formal diagnosis. Regular screening of the population allows for early stage detection of MCI, diagnosis and intervention, which is only effective at the early stage of impairment. For example Leqembi, a disease modifying drug for Alzheimer's developed by Eisai, which recently received full FDA approval has been shown to slow down disease progression by 27% if applied at the early stage of disease. Similarly, another upcoming drug for Alzheimer's, Donanemab, developed by Eli Lilly reported a 35% decline in rate of impairment, but again only if applied at the MCI stage. CognICA's ease of use and sensitivity allows for regular mass scale detection programs to identify patients at the early stage required for effective intervention, and furthermore the platform's AI enables powerful monitoring and population health management. Forecasts for annual sales for Alzheimer's treatment drugs by 2032 range from $6.5 billion to $17 billion, dependent on a significant improvement in detection and diagnosis at the early stage, according to a Visible Alpha report.
在60歲以上的人群中，輕度認知障礙(MCI)的患病率約為10%，這個比率每增加10年就會翻一番。目前，在700萬60歲及以上的加拿大人中，大多數MCI人口尚未被髮現或接受任何正式診斷。定期對人群進行篩查，可以對MCI進行早期檢測、診斷和幹預，這只在損害的早期階段有效。例如，衛材開發的治療阿爾茨海默氏症的疾病修改藥物Leqembi最近獲得了FDA的全面批准，已被證明如果在疾病的早期使用，可以減緩27%的疾病進展。同樣，由禮來公司開發的另一種治療阿爾茨海默氏症的藥物Donanemab報告稱，損傷率下降了35%，但同樣只有在MCI階段使用。CognICA的易用性和敏感性允許定期進行大規模檢測計劃，以便在有效幹預所需的早期階段識別患者，此外，該平臺的人工智慧能夠實現強大的監測和人口健康管理。根據一份可見的Alpha報告，到2032年，阿爾茨海默氏症治療藥物的年銷售額預測在65億美元到170億美元之間，這取決於早期階段檢測和診斷的顯著改善。
CognICA has already been registered for clinical use in the USA, as well as having European regulatory approval as a CE-marked medical device, and has been deployed for primary and specialist clinical care and to give early warning of brain health issues both in the clinic and at home in the USA, Middle East, UK, Singapore and Japan. This announcement enables access to Canada, a major market for digital heath, the market size for which was valued at c. $17 billion in 2022 and is estimated to expand annually at 18.6% from 2022 to 2030, reaching $66 billion in 2030. The rising popularity of remote patient monitoring services is a major driving factor in this Canada home healthcare market growth, a key capability of Cognetivity's CognICA platform.
CognICA已在美國註冊用於臨床，並已獲得歐洲監管機構的CE認證醫療設備批准，並已被部署用於初級和專科臨床護理，並在美國、中東、英國、新加坡和日本的診所和家庭中對大腦健康問題提供早期預警。這一聲明使加拿大得以進入數位健康的主要市場，其市場規模在2022年價值170億加元，預計從2022年到2030年每年以18.6%的速度增長，2030年達到660億美元。遠端患者監護服務的日益流行是加拿大家庭保健市場增長的主要推動因素，這是Cognetivity的CognICA平臺的一項關鍵功能。
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 CognICA 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, Canada and the Middle East, with regulatory approval in other regions expected later 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。Cognetivity的CognICA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目前在美國、英國、歐洲、加拿大和中東可用於臨床，其他地區的監管部門預計將於2023年晚些時候批准。
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
譯文內容由第三人軟體翻譯。