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Brain Scientific Announces CE Mark Approval for NeuroCap™ Device

Brain Scientific Announces CE Mark Approval for NeuroCap™ Device

大腦科學宣佈獲得神經 CAP™ 設備的 CE 標誌批准
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.

佛羅裏達州萊克伍德牧場,2022年8月24日(環球通訊社)通過InvestorWire----總部位於佛羅裏達州的醫療設備技術公司Brain Science(場外交易市場代碼:BRSF)今天宣佈,獲得了NeuroCap™的ConformitéEuropéenne(CE)標誌。CE標誌確認Brain Science滿足所有歐洲醫療器械指令的要求,開始在歐洲大陸和其他CE標誌地區將其創新的神經設備商業化。

"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."

樂氏公司首席執行官Daniel·克勞蒂埃表示:“CE標誌的批准是證明Brain Science技術有效性的又一認證。”我們已經看到歐洲神經科醫生和分銷商對NeuroCap™的強勁需求,現在有了CE標誌,Brain Science就可以開始向歐洲的醫療機構銷售產品。“

"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董事長兼首席執行官哈桑·科託布表示:“我們的神經學產品正在加快醫院和現場腦電測試的速度。”隨着我們增加在歐洲的市場滲透率,CE標誌是向前邁出的重要一步。“

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已經開發了兩種不同的設備來簡化EEG準備、測試和診斷。NeuroCap™有22個預凝膠電極,這使其成為大多數臨牀腦電測試的合適選擇,包括經常用於中風和癲癇患者的常規腦電檢查。固定電極位置按照國際10-20系統。神經腦電™是一款21通道放大器,為臨牀醫生提供與傳統腦電設備相同的質量。

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、預凝膠的臨牀使用的一次性腦電耳機。NeuroCap™允許任何臨牀醫生在正常情況下使用單個電極的一小部分時間就可以為患者的腦電檢查做好準備。NeuroCap™幾乎可以在任何環境中使用,包括鄉村醫院、救護車、私人診所和體育賽事,極大地擴大了腦電測試的範圍。它目前有四種尺寸可供選擇,包括兒科尺寸。

About Brain Scientific

關於腦科學

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是一家擁有多項專利和FDA批准產品的醫療技術公司。Brain Science致力於開發下一代解決方案,以推動神經診斷和OEM醫療設備的未來。Brain Science有兩個產品線,涵蓋神經學和精密運動。NeuroCap™和NeuroEEG™是智能神經診斷設備,可簡化管理、縮短掃描時間並降低成本。Piezo Motion產品線由超高效緊湊型精密電機組成,將驅動下一代醫療設備。欲瞭解有關Brain Science公司的公司戰略、產品或投資者關係的更多信息,請訪問BrainScience網站。

Forward-Looking Statements

前瞻性陳述

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.

本新聞稿中包含的任何不描述歷史事實的陳述都可能構成前瞻性陳述。前瞻性陳述可能包括但不限於以下陳述:(I)未來業務的管理計劃和目標,包括與腦電產品和服務以及壓電電機技術的設計、開發和商業化有關的計劃或目標;(Ii)收入(包括收入/虧損)、每股收益(包括收益/虧損)、資本支出、股息、資本結構或其他財務項目的預測;(Iii)公司未來的財務表現;(Iv)Piezo Motion與Brain Science的成功整合;以及(V)以上第(I)、(Ii)、(Iii)或(Iv)點所述任何陳述所依據的或與之有關的假設。此類前瞻性陳述不是為了預測或保證實際結果、業績、事件或情況,也可能無法實現,因為它們是基於公司目前的預測、計劃、目標、信念、預期、估計和假設,受許多風險、不確定性和其他影響的影響,其中許多是公司無法控制的。由於這些風險和不確定性,某些事件和情況的實際結果和時間可能與前瞻性陳述中描述的大不相同。可能影響或導致前瞻性陳述不準確或導致實際結果與預期或期望結果大不相同的因素可能包括但不限於, 該公司無法獲得更多融資;與開發產品和相關產品相關的時間和資源過長;現金流不足和由此導致的流動性不足;該公司無法擴大其業務;政府對醫療器械和醫療保健行業的監管力度較大;缺乏產品多元化;該公司原材料價格波動;以及未能實施該公司的業務計劃或戰略。在該公司提交給美國證券交易委員會的文件中,對其中一些因素以及其他一些因素進行了識別和更詳細的描述。該公司不承諾更新這些前瞻性陳述。

CONTACTS

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