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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

治疗阿尔茨海默病的新疾病改良药物已获美国食品药品管理局全面批准,凸显了认知性在早期发现和监测中的关键作用
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批准为全球阿尔茨海默氏症患者带来重大突破;Cognetivity NeuroSciences的AI CognICA技术将在全球早期检测和监测中发挥关键作用

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.

温哥华,不列颠哥伦比亚省-(Newsfile Corp.-2023年7月7日)-认知神经科学有限公司。(CSE:CGN)(OTCQB:CGNSF)(FSE:1UB)(“公司”或“认知性”)Eisai(TYO:4523)Leqembi公司欣喜地注意到,Eisai(TYO:4523)的治疗阿尔茨海默病的药物已获得FDA的全面批准,这一消息为全球数千万患者和高危人群带来了希望。

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月加速获得FDA的批准,这要归功于它能够清除淀粉样斑块-大脑中与阿尔茨海默病相关的有害蛋白质块。此前,美国政府针对65岁及以上老年人的医疗保险计划仅限于临床试验中的患者。这是首个针对阿尔茨海默氏症的标准批准,这意味着Leqembi现在将覆盖所有患者,尽管医疗保险和医疗补助服务中心(CMS)正在医疗机构数据库中将报销与患者的参与联系起来,该数据库被称为登记表。由于阿尔茨海默氏症是一种老年性疾病,大多数美国患者都有医疗保险。CMS署长Chiquita Brooks-LaSure在一份声明中说:“有了FDA的决定,CMS将广泛覆盖这种药物,同时继续收集数据,帮助我们了解药物是如何起作用的。”

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."

在一份新闻稿中,阿尔茨海默氏症协会在回应这一声明时表示:“有了这一批准,早期检测和诊断更加关键,以确保个人尽早获得最大好处。”

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的突破性人工智能(AI)驱动产品CognICA已经证明了其在检测早期认知障碍、跟踪使用卫材合作伙伴Biogen的Aduhelm(Aducanumab)治疗阿尔茨海默病患者认知功能方面的有效性,该药于2021年6月获得FDA的部分批准。CognICA正被成功地用于筛查有轻度认知障碍风险的个人群体,并可靠地识别那些显示出认知问题的早期迹象并需要进一步评估的人。临床诊断后,该技术平台用于监测每月接受治疗的患者的认知功能变化,展示提供CMS强制报告患者进展的能力。CognICA的速度、精度和规模化能力使其在大规模检测和监测患有早期阿尔茨海默病和其他大脑健康问题的个人方面处于独特的市场地位。

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."

认知神经科学公司首席执行官新娜·哈比比评论道:“对于全世界患有这种令人衰弱和残忍的疾病的患者,以及在神经变性领域工作的每个人来说,这是一个巨大的突破和杰出的消息。这突显了在人群层面进行早期诊断的关键重要性。目前有一半的阿尔茨海默氏症患者根本没有得到诊断,当涉及到疾病的早期阶段时,情况就更糟了。”他补充道:“我们对早期疾病的敏感度非常高,能够有效地监控患者的病情进展,能够在不占用专家时间的情况下远程定期使用,这些都是为阿尔茨海默氏症的治疗带来变革性变化的关键因素,我们鼓励从事护理规划和提供工作的人与我们联系,因为我们今天已经准备好提供帮助。”

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仍致力于利用其人工智能平台技术来改变全球大脑健康的格局,提高向患者提供的护理质量,并减轻提供者和付款人的负担和成本,实现公司为富勒生活提供更光明心灵的愿景。

About Cognetivity Neurosciences

关于认知神经科学

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是一家技术公司,它开发了一种认知测试平台,用于医疗、商业和消费环境。认知性的认知ICATM使用人工智能和机器学习技术来测试大脑大片区域的表现,以帮助检测认知功能障碍的早期迹象。CognICA目前可在美国、英国、欧洲和中东用于临床,预计2023年将在其他地区获得监管批准。

On behalf of the Board of Directors

我谨代表董事会

"Sina Habibi"
Sina Habibi

《新浪哈比比》
新浪哈比比

Chief Executive Officer and Director

董事首席执行官兼首席执行官

Forward-looking statements:

前瞻性陈述:

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.

本新闻稿中包含的某些陈述,包括“预期”、“假设”、“相信”、“计划”、“估计”、“预期”、“打算”、“可能”、“应该”以及类似的表述,在与公司或其管理层有关的范围内,构成前瞻性信息或陈述(统称为“前瞻性陈述”)。这些前瞻性陈述不是历史事实,反映了对未来结果或事件的当前预期。本新闻稿包含前瞻性陈述。这些前瞻性陈述不是对未来业绩的保证,涉及难以预测的风险、不确定性和假设。此类陈述基于当前预期和各种估计、因素和假设,涉及已知和未知的风险、不确定性和其他因素。这些陈述和信息是基于对我们当前和未来的业务战略以及我们所处的经营环境的一些假设。除法律要求外,我们不承担更新或修改前瞻性信息以反映新事件或新情况的责任。告诫读者不要过度依赖我们的前瞻性陈述。

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

加拿大证券交易所不对本新闻稿的充分性或准确性负责。

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

如需更多信息,请访问:网站:或联系方式:info@cognetivity.com;媒体查询可发送至pr@cognetivity.com。

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

要查看本新闻稿的源版本,请访问

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