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Brain Scientific Announces CE Mark Approval for NeuroCap™ Device

Brain Scientific Announces CE Mark Approval for NeuroCap™ Device

大脑科学宣布NeuroCap™ 设备获得CE标志批准
GlobeNewswire ·  2022/08/24 10:25

LAKEWOOD RANCH, Fla., Aug. 24, 2022 (GLOBE NEWSWIRE) -- via InvestorWire -- –– Brain Scientific (OTCQB:BRSF), a Florida-based medical device technology company, today announces receiving the Conformité Européenne (CE) Mark for the NeuroCap™. The CE mark confirms that Brain Scientific meets all European Medical Device Directive requirements to begin commercializing its innovative neurological devices across the European Continent and other CE mark geographies.

佛罗里达州莱克伍德牧场,2022年8月24日(环球通讯社)通过InvestorWire----总部位于佛罗里达州的医疗设备技术公司Brain Science(场外交易市场代码:BRSF)今天宣布,获得了NeuroCap™的ConformitéEuropéenne(CE)标志。CE标志确认Brain Science满足所有欧洲医疗器械指令的要求,开始在欧洲大陆和其他CE标志地区将其创新的神经设备商业化。

"The CE mark approval is yet another certification proving the effectiveness of Brain Scientific's technologies," said Daniel Cloutier, CEO of LOK Corporation. "We have seen strong demand from European neurologists and distributors for the NeuroCap™, and now with the CE mark Brain Scientific can start selling to medical facilities in Europe."

乐氏公司首席执行官Daniel·克劳蒂埃表示:“CE标志的批准是证明Brain Science技术有效性的又一认证。”我们已经看到欧洲神经科医生和分销商对NeuroCap™的强劲需求,现在有了CE标志,Brain Science就可以开始向欧洲的医疗机构销售产品。“

"Our neurology products are accelerating access to EEG testing both in hospitals and in the field," said Hassan Kotob, chairman and CEO of Brain Scientific. "The CE mark is a vital step forward as we increase our market penetration in Europe."

Brain Science董事长兼首席执行官哈桑·科托布表示:“我们的神经学产品正在加快医院和现场脑电测试的速度。”随着我们增加在欧洲的市场渗透率,CE标志是向前迈出的重要一步。“

Brain Scientific has developed two distinct devices to streamline EEG prep, testing, and diagnosis. NeuroCap™ has 22 pre-gelled electrodes making it a suitable option for most clinical EEG tests, including routine EEGs that are often used for stroke and epilepsy patients. The fixed electrode placement is in accordance with the international 10-20 system. NeuroEEG™ is a 21-channel amplifier that provides clinicians with the same quality as traditional EEG equipment.

Brain Science已经开发了两种不同的设备来简化EEG准备、测试和诊断。NeuroCap™有22个预凝胶电极,这使其成为大多数临床脑电测试的合适选择,包括经常用于中风和癫痫患者的常规脑电检查。固定电极位置按照国际10-20系统。神经脑电™是一款21通道放大器,为临床医生提供与传统脑电设备相同的质量。

The NeuroCap™ is an FDA 510k cleared, pre-gelled disposable EEG headset for clinical use. The NeuroCap™ allows any clinician to prepare a patient for an EEG exam in a fraction of the time normally spent applying individual electrodes. The NeuroCap™ can be used in nearly any environment, including rural hospitals, ambulances, private practices, and athletic events, vastly expanding access to EEG testing. It is currently available in four sizes, including pediatric sizes.

NeuroCap™是一款FDA 510k透明、预凝胶的临床使用的一次性脑电耳机。NeuroCap™允许任何临床医生在正常情况下使用单个电极的一小部分时间就可以为患者的脑电检查做好准备。NeuroCap™几乎可以在任何环境中使用,包括乡村医院、救护车、私人诊所和体育赛事,极大地扩大了脑电测试的范围。它目前有四种尺寸可供选择,包括儿科尺寸。

About Brain Scientific

关于脑科学

Brain Scientific (brainscientific.com) is a medical technology company with multiple patents and FDA-cleared products. Brain Scientific is committed to developing next-gen solutions that advance the future of neurodiagnostic and OEM medical devices. Brain Scientific has two product lines covering neurology and precision motion. The NeuroCap™ and NeuroEEG™ are smart neurological diagnostic devices that simplify administration, shorten scan time, and cut costs. The Piezo Motion product line consists of ultra-efficient compact precision motors that will drive the next generation of medical devices. To learn more about Brain Scientific's corporate strategy, products, or investor relations, please visit brainscientific.com.

Brain Science是一家拥有多项专利和FDA批准产品的医疗技术公司。Brain Science致力于开发下一代解决方案,以推动神经诊断和OEM医疗设备的未来。Brain Science有两个产品线,涵盖神经学和精密运动。NeuroCap™和NeuroEEG™是智能神经诊断设备,可简化管理、缩短扫描时间并降低成本。Piezo Motion产品线由超高效紧凑型精密电机组成,将驱动下一代医疗设备。欲了解有关Brain Science公司的公司战略、产品或投资者关系的更多信息,请访问BrainScience网站。

Forward-Looking Statements

前瞻性陈述

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of EEG products and services and piezo motor technology; (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items; (iii) the company's future financial performance; (iv) the successful integration of Piezo Motion with and into Brain Scientific; and (v) the assumptions underlying or relating to any statement described in points (i), (ii), (iii) or (iv) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the company's current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, over many of which the company has no control. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the company's inability to obtain additional financing; the significant length of time and resources associated with the development of products and related insufficient cash flows and resulting illiquidity; the company's inability to expand its business; significant government regulation of medical devices and the healthcare industry; lack of product diversification; volatility in the price of the company's raw materials; and the failure to implement the company's business plans or strategies. Some of these and other factors are identified and described in more detail in the company's filings with the SEC. The company does not undertake to update these forward-looking statements.

本新闻稿中包含的任何不描述历史事实的陈述都可能构成前瞻性陈述。前瞻性陈述可能包括但不限于以下陈述:(I)未来业务的管理计划和目标,包括与脑电产品和服务以及压电电机技术的设计、开发和商业化有关的计划或目标;(Ii)收入(包括收入/亏损)、每股收益(包括收益/亏损)、资本支出、股息、资本结构或其他财务项目的预测;(Iii)公司未来的财务表现;(Iv)Piezo Motion与Brain Science的成功整合;以及(V)以上第(I)、(Ii)、(Iii)或(Iv)点所述任何陈述所依据的或与之有关的假设。此类前瞻性陈述不是为了预测或保证实际结果、业绩、事件或情况,也可能无法实现,因为它们是基于公司目前的预测、计划、目标、信念、预期、估计和假设,受许多风险、不确定性和其他影响的影响,其中许多是公司无法控制的。由于这些风险和不确定性,某些事件和情况的实际结果和时间可能与前瞻性陈述中描述的大不相同。可能影响或导致前瞻性陈述不准确或导致实际结果与预期或期望结果大不相同的因素可能包括但不限于, 该公司无法获得更多融资;与开发产品和相关产品相关的时间和资源过长;现金流不足和由此导致的流动性不足;该公司无法扩大其业务;政府对医疗器械和医疗保健行业的监管力度较大;缺乏产品多元化;该公司原材料价格波动;以及未能实施该公司的业务计划或战略。在该公司提交给美国证券交易委员会的文件中,对其中一些因素以及其他一些因素进行了识别和更详细的描述。该公司不承诺更新这些前瞻性陈述。

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