Company remains optimistic on the potential for this pioneering healthcare solutionPLEASANTON, Calif., Nov. 4, 2024 /PRNewswire/ -- Movano Health (NASDAQ: MOVE) announced today that it has submitted a complete response package to the FDA as part of the final phase of the Company's 510(k) application review of the EvieMED Ring. The Company remains optimistic on EvieMED's potential for 510(k) clearance."Our team has worked diligently to provide a thorough response to the Agency's questions," said John Mastrot ...

公司调查交易操纵情况 - 公司继续与证券监管机构、法律顾问和其他合作伙伴合作以保护股东利益[1] - 初步调查显示2024年10月25日宣布反向股票分割到10月29日生效期间有大量单股交易疑似利用四舍五入惯例获利公司在增发股票前发现此活动反向分割后流通股预计约660万股[2] 公司态度 - 公司总裁兼首席执行官表示致力于透明性和保护公司与股东利益并提到近期多支小盘股反向分割后有类似操纵公司正与多方沟通积极处理此问题[3] 公司概况 - 公司成立于2018年旗下有Evie Ring正在开发医疗保健解决方案将医疗级数据引入可穿戴设备为客户和企业提供创新数据服务[4] - 公司正在开发专有技术和可穿戴医疗设备解决方案以便未来利用数据主动监测和管理健康结果[5] 前瞻性陈述 - 新闻稿包含前瞻性陈述基于当前假设受已知和未知风险与不确定性影响实际结果可能与预期不同不应过度依赖[6]

Company Communicating with Securities Regulators, Legal Advisors and Other Partners to Protect Interests of Shareholders PLEASANTON, Calif., Oct. 31, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE) (the "Company") announced today that it has opened an investigation to expose apparent manipulation in trading of the Company's common shares, following the recent announcement of a shareholder approved reverse stock split."We are committed to transparency and protecting the interests of our Company and shareho ...

文章核心观点 - 公司与社交媒体名人Heidi D'Amelio建立品牌合作关系,以扩大Evie智能戒指在女性群体中的知名度 [1][2][3] - Evie是专为女性设计的智能戒指,具有多项创新功能,如适应手指尺寸变化的开放式设计、AI分析提供个性化健康洞见等 [3][4] - 公司计划通过此次合作,进一步扩大Evie的用户群,并计划在今年11月推出Android版本 [4] 公司概况 - 公司成立于2018年,是一家专注于开发医疗级可穿戴设备的公司 [5][6] - 公司正在开发自有技术和可穿戴医疗设备解决方案,以推动数据在预防性健康管理中的应用 [6] 产品信息 - Evie智能戒指具有4+天续航、60分钟快充等特点,售价269美元无需订阅 [4] - Evie提供睡眠跟踪、运动记录、目标设置等功能,帮助用户更好地了解和管理自身健康 [3]

Shares Expected to Begin Trading on Split-Adjusted Basis on October 29, 2024PLEASANTON, Calif., Oct. 25, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE) announced today that it will implement a 1-for-15 reverse stock split of the issued shares of its common stock (the "Reverse Stock Split"), effective at 12:01 a.m. Eastern time on October 29, 2024. The Company's common stock is expected to begin trading on a split-adjusted basis when the market opens on Tuesday, October 29, 2024, and will continue to trad ...

A successful response to requests for additional information would bring the Company one step closer to introducing this pioneering healthcare product to the marketPLEASANTON, Calif., Oct. 24, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE) announced today that it plans to submit updated responses next week to all clarifying questions that it recently received from the FDA as part of the final phase of the Company's 510(k) application review. The Company secured a positive resolution this summer after res ...

The Company continues to work closely with the FDA to bring this pioneering healthcare product to market PLEASANTON, Calif., Oct. 10, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE) announced today that the Company recently received additional clarifying questions from the FDA related to medical aspects of the EvieMED Ring, as part of the final phase of the Company's 510(k) application review process. The Company secured a positive resolution this summer after responding to initial FDA questions related t ...

Orders Reopen with Enhancements to AI Powered Health Insights, Sleep and Heart Rate Measurements and More PLEASANTON, Calif., Sept. 17, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE) today announced the immediate availability of its Evie Ring, the first smart ring designed specifically for women. The ring features the same industry-first, award-winning open design that accommodates fluctuations in finger size, and is accompanied by an updated app that enhances users' ability to track and understand key m ...

Following the positive outcome of a recent agency meeting, the Company will continue to work closely with the FDA to bring this pioneering healthcare product to market PLEASANTON, Calif., Sept. 3, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE) announced today that a productive in-person meeting with the FDA on August 15, 2024, resulted in a positive outcome regarding the EvieMED Ring's wellness features and metrics. Following this development, the Company will be working with the agency to move forward w ...

财务数据和关键指标变化 - 公司在第二季度发货了1,837个Evie Ring,此前在第一季度发货约5,300个 [37] - 公司在第二季度没有报告任何收入,因为之前的递延收入抵消了退款 [37] - 公司在第二季度的经营亏损为640万美元,去年同期为740万美元 [40] - 公司在6月30日的现金及现金等价物为1,690万美元,这包括了4月增发2,410万美元的影响 [39][40] 各条业务线数据和关键指标变化 - 公司正在为9月17日重新开始接受Evie Ring订单和发货做准备 [24][30] - 公司正在与FDA合作,争取获得EV Med Ring的510(k)认证 [11][12][13] - 公司已经与两家全球制药公司和一家大型医疗保险公司达成了三个新的B2B商业合作机会 [14][15] 各个市场数据和关键指标变化 - 公司预计FDA认证的可穿戴设备在临床试验市场的总地址市场规模可达50亿美元 [18][19] - 远程患者监护(RPM)市场在过去4年中才刚刚起步,但COVID-19疫情推动了这一市场的发展 [20][21][22] 公司战略和发展方向以及行业竞争 - 公司正在开发多种生理指标传感技术,包括血压、体温和睡眠等,并计划进行相关临床试验 [33][34][35] - 公司认为EV Med Ring是一种"变革性"的解决方案,在当前市场上还没有类似的产品 [15] - 公司正在加强后端运营能力,以满足合作伙伴的要求,包括提高生产效率、改善客户服务等 [23][24][27][28] 管理层对经营环境和未来前景的评论 - 公司对即将与FDA会面并获得EV Med Ring认证持乐观态度 [50][51][52] - 公司对D2C业务的扩张、EV Med在B2B市场的机遇以及射频芯片技术的潜力感到兴奋和乐观 [41] 其他重要信息 - 公司与MIT Tal研究小组合作,将使用Evie Ring参与针对莱姆病和肺部COVID-19长期健康影响的MAESTRO临床研究 [16] - 公司最近举办了题为"B2B,下一个可穿戴设备热潮"的虚拟活动,探讨了可穿戴设备在临床试验和远程患者监护领域的广阔前景 [17][18][19][20][21] 问答环节重要的提问和回答 问题1 **Bruce Jackson 提问** 新版Evie Ring是否具有自动活动检测功能,与新开发的心率和运动算法有何关系? [43][45] **Michael Leabman 回答** 公司开发了基于机器学习的新心率算法,可以更准确地检测步行、慢跑等活动。自动活动检测功能可以识别用户的活动类型,并在用户未手动启动的情况下开始记录数据。这两项功能相结合可以提供更好的运动数据。 [45] 问题2 **Bruce Jackson 提问** 公司与医疗服务提供商的合作关系有何深度,是否有最低订单要求? [46][48] **Michael Soule 回答** 公司正在与多个渠道合作伙伴进行beta测试和初步协议谈判,包括医疗服务提供商、医疗保险公司和远程患者监护公司。这些合作旨在为EV Med Ring的上市做好准备,具体合作细节还在商议中。 [48] 问题3 **Bruce Jackson 提问** 公司与FDA的会面是否有任何变动? [49] **John Mastrototaro 回答** 公司仍计划在8月中旬与FDA会面,公司对此持乐观态度。公司拥有经验丰富的内部监管团队,并聘请了业内顶级的监管咨询公司提供支持。此外,EV Med Ring的核心是基于强大的临床数据,这也增加了公司获得认证的信心。 [50][51][52]