MyndTec Receives FDA 510(k) Clearance for MyndMove 2.0, its Second Generation Neuromodulation Device, for Clinical and Home Use
MyndTec Receives FDA 510(k) Clearance for MyndMove 2.0, its Second Generation Neuromodulation Device, for Clinical and Home Use
Mississauga, Ontario--(Newsfile Corp. - March 8, 2022) - MyndTec Inc. (CSE: MYTC) ("MyndTec" or the "Company"), an emerging trailblazer in neurological rehabilitation, today announced that it has received from the U.S. Food and Drug Administration (the "FDA") 510(k) clearance for MyndMove 2.0, its second generation neuromodulation MyndMove System.
安大略省密西索加-(Newsfile Corp.-2022年3月8日)-MyndTec Inc.(CSE：MYTC)(“MyndTec“或”公司)，一家新興的神經康復的先驅，今天宣佈，它已經從美國食品和藥物管理局(the U.S.Food and Drug Administration，簡稱FDA)獲得了林業局)510(K)批准其第二代神經調節MyndMove系統MyndMove 2.0。
"This is a very exciting time for the Company as we advance into the strategic re-launch of MyndMove devices in the United States through our distribution partner, LBB Applied Technology, LLC to offer clinicians a device that delivers effective therapy at clinic or home environments, without compromising patient comfort, through our proprietary design," stated Craig Leon, CEO of MyndTec.
MyndTec首席執行官克雷格·利昂説：“對於公司來説，這是一個非常令人興奮的時刻，因為我們通過我們的分銷合作伙伴LBB應用技術有限責任公司進入了在美國重新推出MyndMove設備的戰略階段，通過我們的專有設計，為臨牀醫生提供一種在診所或家庭環境中提供有效治療的設備，而不會影響患者的舒適度。”
The MyndMove System is a touch screen, eight-channel neuromodulation device that delivers short electrical pulses to stimulate muscle contractions and enhance motor recovery following stroke or spinal cord injury. The MyndMove System includes a stimulator unit, electrodes, hand and foot switches, an optional cart, and integrated software that allows the user to choose from a number of pre-programmed stimulation protocols, to customize the stimulation intensities for each patient and document the treatments provided.
MyndMove系統是一種觸摸屏、八通道神經調節設備，可提供短電脈衝來刺激肌肉收縮，並在中風或脊髓損傷後增強運動恢復。MyndMove系統包括刺激器單元、電極、手腳開關、可選手推車和集成軟件，允許用户從多個預先編程的刺激方案中進行選擇，以定製每個患者的刺激強度並記錄所提供的治療。
About MyndTec
關於MyndTec
Co-founded in 2008 by Dr. Milos Popovic, MyndTec is a Canadian medical technology company dedicated to the development and commercialization of innovative products that improve function, maximize independence and enhance the quality of life for individuals who have suffered injury to the central nervous system as a result of stroke, spinal cord injury and certain traumatic brain injuries. The Company develops non-invasive neurological and nervous system electrical stimulation therapeutics for the treatment of neurological diseases and injury specifically targeted to markets with large, growing and global patient populations. The Company's flagship product MyndMove™ is a non-invasive functional electrical stimulation-based intervention. MyndMove™ uses neuroplasticity mechanisms to stimulate development of new neural efferent and afferent pathways allowing patients to re-establish voluntary movement and improve independence in their activities of daily living. The MyndMove™ system offers trained therapists the ability to assist individuals affected with paralysis to improve voluntary control of their limbs. The MyndMove™ therapy system offers a broad spectrum of sophisticated functional electrical stimulation software protocols which therapists customize to patient needs to enable meaningful controlled movements via proprietary stimulation technology.
MyndTec由米洛斯·波波維奇博士於2008年聯合創立，是一家加拿大醫療技術公司，致力於創新產品的開發和商業化，這些產品可以改善功能，最大限度地提高獨立性，並提高因中風、脊髓損傷和某些創傷性腦損傷而遭受中樞神經系統損傷的個人的生活質量。該公司開發非侵入性神經和神經系統電刺激療法，專門針對擁有大量、不斷增長的全球患者羣體的市場，治療神經系統疾病和損傷。該公司的旗艦產品Myndmove™是一種基於電刺激的非侵入性功能性幹預產品。MyndMove™使用神經可塑性機制刺激新的神經傳出和傳入通路的發展，使患者能夠重新建立自願運動，並提高他們日常生活活動的獨立性。MyndMove™系統為訓練有素的治療師提供了幫助癱瘓患者改善對肢體的自願控制的能力。MyndMove™治療系統提供了一系列複雜的功能性電刺激軟件協議，治療師根據患者需要定製這些協議，以便通過專有刺激技術實現有意義的可控運動。
Contact Information
聯繫信息
Craig Leon
Chief Executive Officer
Investor.relations@myndtec.com
(416) 569-0430
克雷格·利昂
首席執行官
郵箱：Investor.relationship@myndtec.com
(416) 569-0430
Cautionary Note Regarding Forward-Looking Statements
有關前瞻性陳述的注意事項
This news release contains forward-looking statements that constitute "forward-looking information" within the meaning of applicable Canadian securities laws (collectively, "forward-looking statements"). All statements in this news release that are not historical facts are forward-looking statements, including, but not limited to, all statements regarding: events, performance or results of operations that the Company believes, expects or anticipates will or may occur in the future; and its strategic re-launch of MyndMove devices in the United States. Forward-looking statements are typically, but not always, identified by words such as: "believes", "expects", "aim", "anticipates", "intends", "estimates", "plans", "may", "should", "could", "continue", "would", "will", "potential", "scheduled", "goal", "target", or variations of such words and phrases and similar expressions, which, by their nature, refer to future events or results that may, could, would, might or will occur or be taken or achieved.
本新聞稿包含前瞻性陳述，構成適用的加拿大證券法(統稱為“前瞻性信息”)所指的“前瞻性信息”。前瞻性陳述“)。本新聞稿中所有非歷史事實的陳述均為前瞻性陳述，包括但不限於以下所有陳述：公司相信、預期或預期未來將會或可能發生的事件、業績或經營結果；以及公司在美國重新推出MyndMove設備的戰略。前瞻性陳述通常(但並非總是)由以下詞語來標識：“相信”、“預期”、“目標”、“預期”、“打算”、“估計”、“計劃”、“可能”、“應該”、“可能”、“繼續”、“將”、“將”、“潛在”、“預定”、“目標”、“目標”或此類詞語和短語的變體以及類似的表述，這些詞語和短語的本質是指可能、可能、將、可能或將會發生、被採取或實現。
Forward-looking statements are necessarily based on a number of estimates and assumptions that include, but are not limited to: expected future development; general economic conditions; the ability of the Company to execute on its business objectives; and other estimates and assumptions described in the Company's Listing Statement dated February 18, 2022 (the "Listing Statement"), a copy of which is available under the Company's profile on SEDAR at . Forward-looking statements are inherently subject to a number of significant risks and uncertainties that could cause the actual results or events to differ materially from those described in the forward-looking statements. Important risks and uncertainties that could cause actual results or events to differ materially from expectations include, but are not limited to: the Company's ability to continue as a going concern, the Company's research, development and commercialization of its products could be stopped or delayed if any third party fails to provide sufficient quantities of products or components, or fails to do so at acceptable quality levels or prices, or fails to maintain or achieve satisfactory regulatory compliance; the Company expects to incur significant ongoing costs and obligations relating to its investment in infrastructure, growth, research and development, regulatory compliance and operations; and other risks and uncertainties described in the Listing Statement. The Company has attempted to identify important factors that could cause actual results, performance or achievements to vary from those expectations expressed or implied by the forward-looking statements, however, there may be other factors that cause results, performance or achievements not to be as expected and that could cause actual results, performance or achievements to differ materially from current expectations. These forward-looking statements are only current as of the date of this news release. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties and the Company provides no assurance that they will prove to be correct. Readers should not place undue reliance on such forward-looking statements. The Company does not undertake any obligation to update forward-looking statements contained herein, other than as required by applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.
前瞻性陳述必須基於大量估計和假設，這些估計和假設包括但不限於：預期的未來發展；總體經濟狀況；公司實現其業務目標的能力；以及公司於2022年2月18日的上市聲明(“上市聲明”)中描述的其他估計和假設。列表語句“)，其副本可在SEDAR上的公司簡介下獲得，網址為：。前瞻性陳述本身就會受到許多重大風險和不確定因素的影響，這些風險和不確定因素可能導致實際結果或事件與前瞻性陳述中描述的大不相同。可能導致實際結果或事件與預期大不相同的重要風險和不確定因素包括但不限於：如果任何第三方未能提供足夠數量的產品或部件，或未能以可接受的質量水平或價格這樣做，或未能維持或實現令人滿意的法規遵從性，公司作為一家持續經營企業繼續經營的能力，公司的產品研發和商業化可能會停止或推遲；公司預計將產生與其基礎設施投資、增長、研究和開發、監管合規和運營相關的重大持續成本和義務；以及上市聲明中描述的其他風險和不確定性。公司試圖找出可能導致實際結果、業績或成就與前瞻性陳述中明示或暗示的預期大不相同的重要因素，然而，可能還有其他因素導致結果、業績或成就與預期的不同，並可能導致實際結果、業績或成就與當前的預期大不相同。這些前瞻性陳述僅是截至本新聞稿發佈之日的最新情況。儘管本公司認為該等前瞻性陳述所反映的預期是合理的, 這類陳述涉及風險和不確定性，該公司不能保證它們將被證明是正確的。讀者不應過分依賴這種前瞻性陳述。除適用法律要求外，公司不承擔更新本文中包含的前瞻性陳述的任何義務。所有前瞻性陳述均受本警告性聲明的限制。
The CSE has in no way passed upon the merits of the business of the Company and has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof.
聯交所對本公司業務的優劣並無過錯，對本新聞稿的內容既不批准也不反對，對本新聞稿的充分性或準確性不承擔任何責任。
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