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Salona Global Announces the Debut of the Biodex SpaceTek Knee, a Revolutionary Portable Isokinetic Knee Dynamometer Medical Device Developed in NASA Collaboration

Salona Global Announces the Debut of the Biodex SpaceTek Knee, a Revolutionary Portable Isokinetic Knee Dynamometer Medical Device Developed in NASA Collaboration

Salona Global 宣佈首次推出 Biodex SpaceTek Knee,這是一款由美國宇航局合作開發的革命性便攜式等速膝蓋測力計醫療設備
GlobeNewswire ·  2023/11/16 23:27

NEW YORK, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Salona Global Medical Device Corporation (the ‎‎‎"Company") (TSXV:SGMD), soon to be renamed Evome Medical Technologies Inc., today announced the debut of the Biodex SpaceTek Knee Device: A revolutionary, portable medical device for treating patients with knee replacements and knee injuries.

紐約,2023年11月16日(GLOBE NEWSWIRE)——即將更名爲Evome Medical Technologies Inc. 的薩羅納環球醫療器械公司(‎‎‎ “公司”)(TSXV: SGMD)今天宣佈Biodex SpaceTek膝蓋設備首次亮相:一款用於治療膝關節置換術和膝蓋受傷患者的革命性便攜式醫療設備。

Approximately 790,000 total knee replacements are performed annually in the United States.1

在美國,每年總共進行約790,000例膝關節置換術。1

The Company's intention is to submit an application for approval of the SpaceTek Knee Device with the U.S. Food and Drug Administration (the "FDA") in early 2024. The SpaceTek Knee Device is to be offered exclusively by the Company's subsidiary, Biodex Medical Systems, Inc.‎ ("Biodex"), and its price point is meant to democratize the Biodex institutional grade technology and intellectual property to physical therapy chiropractic centers in the United States. Because of its compact size and price point, this product is designed to expand the current market for Biodex products. The SpaceTek Knee Device is portable, affordable and can be used in several locations depending on demand within a small clinic with the entire dynamometer and electronics packaged in a case weighing less than 70lbs.

該公司打算在2024年初向美國食品藥品監督管理局(“FDA”)提交批准SpaceTek膝蓋設備的申請。SpaceTek膝蓋設備將由該公司的子公司Biodex Medical Systems, Inc.‎(“Biodex”)獨家發售,其價格點旨在將Biodex機構級技術和知識產權民主化到美國的物理治療脊骨療法中心。由於其緊湊的尺寸和價格點,該產品旨在擴大Biodex產品的當前市場。SpaceTek Knee Device 便於攜帶、經濟實惠,可以根據需要在小型診所的多個地點使用,整個測功機和電子設備都裝在一個重量不到 70 磅的箱子裏。

The SpaceTek Knee Device was co-developed in collaboration with the National Aeronautics and Space Administration ("NASA") for use in outer space based on market leading technology available on the Biodex S4 ("S4") isokinetic machine with dynamometers. As the flagship product for Biodex, the S4 was created to treat knees, shoulders and other joints. However, because of its complexity and size, it has a large price tag and requires a trained expert to operate, historically limiting Biodex sales primarily to hospitals, universities, research centers, and sports teams.

SpaceTek 膝蓋設備是與美國國家航空航天局(“NASA”)合作開發的,用於外層空間,其基礎是帶有測力計的 Biodex S4(“S4”)等速動力學機器上可用的市場領先技術。作爲 Biodex 的旗艦產品,S4 專爲治療膝蓋、肩膀和其他關節而設計。但是,由於其複雜性和規模,它價格昂貴,需要訓練有素的專家才能操作,因此從歷史上看,Biodex的銷售主要侷限於醫院、大學、研究中心和運動隊。

The Company has built four prototypes which are expected to be available to the public in 2024 and are being used by Japanese, European and American distributors to finalize marketing and sales plans for 2024.

該公司已經建造了四款原型,預計將於2024年向公衆開放,日本、歐洲和美國的分銷商正在使用這些原型來敲定2024年的營銷和銷售計劃。

The Biodex Collaboration with NASA

Biodex 與美國宇航局的合作

Biodex and NASA entered into a Cooperative Research and Development Agreement (CRADA) to explore the development of rehabilitative, exercise, and measurement equipment for outer space. The collaboration has created an opportunity for creation of several potential devices. The first device Biodex has chosen to bring to market is the SpaceTek Knee Device.

Biodex和NASA簽訂了合作研究與開發協議(CRADA),探討開發外層空間康復、運動和測量設備。此次合作爲開發幾種潛在設備創造了機會。Biodex選擇向市場推出的第一款設備是SpaceTek Knee Device。

Details of the NASA and Biodex Agreement

美國宇航局和Biodex協議的細節

Biodex and NASA have solidified their collaboration with an Exclusive License Agreement (DE-681). Under the agreement, Biodex will have exclusive rights in the United States to the "Portable System and Apparatus for Dynamometry, Exercise, and Rehabilitation", NASA will be entitled to a royalty of 2.0% of the net sales, and the device is required to be substantially manufactured in the United States.

Biodex和美國宇航局通過獨家許可協議(DE-681)鞏固了合作。根據該協議,Biodex將在美國擁有 “用於測力、運動和康復的便攜式系統和設備” 的專有權,美國宇航局將有權獲得淨銷售額2.0%的特許權使用費,並且該設備必須主要在美國製造。

"After a record revenue quarter finally generating positive Adjusted EBITDA (as such term is defined in the Company's November 15, 2023 news release), we are moving boldly forward in debuting a product that we believe has great upside for Biodex. We expect this product to expand our market from a small, highly institutional footprint with a few thousand customers to thousands of customers worldwide. Simply put, we believe that this product can be a game changer for us."

“在創紀錄的收入季度終於產生了正的調整後息稅折舊攤銷前利潤(該術語在公司2023年11月15日的新聞稿中定義)之後,我們正在大膽地推出一款我們認爲對Biodex具有巨大上升空間的產品。我們預計,該產品將把我們的市場從擁有數千名客戶的規模小、高度機構化的規模擴大到全球成千上萬的客戶。簡而言之,我們相信這款產品可以改變我們的遊戲規則。”

For more information please contact:‎

欲了解更多信息,請聯繫:

Mike Seckler
Chief Executive Officer
Tel: 1 (800) 760-6826
Email: Info@Salonaglobal.com

邁克·塞克勒
首席執行官
電話:1 (800) 760-6826
電子郵件:Info@Salonaglobal.com

Additional Information

附加信息

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the ‎policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this ‎release.‎

多倫多證券交易所風險交易所及其監管服務提供商(該術語在多倫多證券交易所風險交易所的‎policies 中定義)均不對本‎release 的充分性或準確性承擔責任。‎

Certain statements contained in this press release constitute "forward-looking information" within the ‎meaning of the Private Securities Litigation Reform Act of 1995 and applicable Canadian securities ‎laws. These statements can be identified by the use of forward-looking terminology such as "expects" ‎‎"believes", "estimates", "may", "would", "could", ‎‎"should", "potential", ‎‎‎‎‎"will", "seek", "intend", ‎‎"plan", and "anticipate", and similar expressions as they relate ‎‎‎‎to the Company, including: the Company filing an application for approval of the SpaceTek Knee Device with the FDA in early 2024; SpaceTek Knee Device being available for shipment to customers globally in 2024; and the Company having four prototypes to be available to the public in 2024.

本新聞稿中包含的某些聲明構成了1995年《私人證券訴訟改革法》第‎meaning 條和適用的加拿大證券‎laws 中的 “前瞻性信息”。這些陳述可以通過使用前瞻性術語來識別,例如 “期望”‎‎ “相信”、“估計”、“可能”、“會”、“可以”、‎‎ “應該”、“潛力”、‎‎‎‎‎ “將”,“尋找”,”打算”、‎‎ “計劃” 和 “預期”,以及與之相關的類似表述‎‎‎‎to 公司,包括:公司提交批准申請 SpaceTek 膝蓋設備 2024 年初的 FDA;SpaceTek 膝部設備 將於2024年向全球客戶發貨;公司有四款原型將於2024年向公衆開放。

All ‎statements ‎other than statements of ‎historical fact may be forward-looking‎ information. Such ‎statements reflect the Company's current views and intentions with respect to future ‎events, and ‎current information available to the Company, and are subject to certain risks, ‎uncertainties and ‎assumptions, including: the Company completing all necessary steps to submit an application for approval of the SpaceTek Knee Device with the FDA in early 2024; and the Company receiving necessary regulatory approvals for the SpaceTek Knee Device products in 2024. The Company cautions that ‎the forward-looking statements contained herein are qualified by important factors that could cause ‎actual results to differ materially from those reflected by such statements. Such factors include but ‎are not limited to the ‎‎general business and ‎‎economic ‎conditions in the regions in ‎which the Company ‎operates; the ability of the Company to execute on key ‎‎priorities, ‎including the successful completion ‎of acquisitions, business‎ retention, and‎‎ strategic plans and to‎‎ attract, develop ‎and retain key ‎executives; difficulty integrating newly acquired businesses; ‎‎ongoing or new disruptions in the supply ‎chain, the extent and scope of such supply chain disruptions, and the timing or extent of the resolution ‎or improvement of such disruptions; the ability to‎‎‎ implement business strategies and pursue business ‎opportunities; ‎‎disruptions in or attacks (including ‎cyber-attacks) on the Company's information ‎technology, internet, network access or other ‎‎voice or data ‎communications systems or services; the ‎evolution of various types of fraud or other ‎‎‎criminal behavior to which ‎ the Company is exposed; the ‎failure of third parties to comply with their obligations to ‎‎ the Company or its ‎affiliates; the‎ impact of ‎new and changes to, or application of, current laws and regulations; ‎granting of permits and licenses ‎in a highly regulated business; the ‎overall difficult ‎‎‎‎‎litigation environment, including in the United ‎States; increased competition; changes in foreign currency rates; ‎increased ‎‎‎‎funding ‎costs and market ‎volatility due to market illiquidity and competition for funding; the ‎availability of funds ‎‎‎‎and ‎resources to pursue operations; critical ‎accounting estimates and changes to accounting standards, ‎policies,‎‎‎‎ and methods used by the Company; the occurrence of natural and unnatural‎‎ catastrophic ‎‎events ‎and claims ‎‎‎‎resulting from such events; as well as those risk factors discussed or ‎referred to ‎in ‎the ‎Company's disclosure ‎documents filed with United States Securities and Exchange Commission ‎‎and ‎available at ‎www.sec.gov, and with ‎the securities regulatory authorities in certain provinces of ‎Canada and ‎‎available at ‎. Should any ‎factor affect the Company in an unexpected ‎manner, or should ‎‎assumptions underlying ‎the forward-looking ‎information prove incorrect, the actual ‎results or events may differ ‎‎materially from the results ‎or events predicted. ‎Any such forward-looking ‎information is expressly qualified in its ‎‎entirety by this cautionary ‎statement. Moreover, ‎the Company ‎does not assume responsibility for the accuracy or ‎‎completeness of such ‎forward-looking ‎information. ‎The forward-looking information included in this press release ‎‎is made as of the ‎date of this press ‎‎release and the Company undertakes no obligation to publicly update or revise ‎‎any forward-‎looking ‎information, ‎other than as required by applicable law‎.‎

除‎historical 事實陳述外,所有‎statements‎other 都可能是前瞻性‎ 信息。此‎statements 反映了公司當前對公司未來可用的‎events 和‎current 信息的看法和意圖,並面臨某些風險,包括‎uncertainties 和‎assumptions,包括:公司完成所有必要步驟以提交 申請批准 SpaceTek 膝蓋設備 美國食品藥品管理局將於2024年初發布;以及 公司獲得了必要的監管批准 Spacetek 膝部設備 2024 年的產品。 該公司警告說,此處包含的‎the 前瞻性陳述受重要因素的限制,這些因素可能導致‎actual 業績與此類陳述所反映的結果存在重大差異。這些因素包括但‎are 不限於‎‎general 業務以及‎which the Company 中各地區的‎‎economic‎conditions;公司執行關鍵 #invisible_left_right_character_mask 的能力‎operates93827146‎priorities、‎including 成功完成‎of 收購、業務‎ 留存以及‎‎ 戰略計劃以及 to‎‎ 吸引、開發‎and 保留密鑰‎executives; 難以整合新收購的業務;‎‎ongoing 或新的供應中斷‎chain,此類供應鏈中斷的程度和範圍,以及解決方案‎or 改善此類中斷的時機或程度;‎‎‎ 實施業務戰略並開展業務‎opportunities;‎‎disruptions 對公司信息‎technology、互聯網、網絡訪問或其他‎‎voice 或數據的攻擊(包括‎cyber-攻擊)‎communications 系統或服務;‎ 公司面臨的各種欺詐或其他‎‎‎criminal 行爲中的‎evolution;第三方應遵守其禁令義務的‎failure‎‎ 公司或其‎affiliates;‎new 以及現行法律法規的變更或適用所產生的‎ 影響;‎granting 許可證和執照‎in 一家高度監管的企業;‎overall 困難‎‎‎‎‎litigation 環境,包括在美國‎States;競爭加劇;外幣匯率變化;‎increased‎‎‎‎由於市場流動性不足和資金競爭,爲‎costs 和 market‎volatility 提供資金;以開展運營爲目的的‎availability 基金‎‎‎‎and‎resources‎accounting會計準則、‎policies、‎‎‎‎ 和公司使用的方法的估計和變更;自然和非自然的發生‎‎ 災難性‎‎events‎and 聲稱‎‎‎‎resulting 來自此類事件;以及所討論的風險因素或‎referred to‎in‎the‎Company 的披露‎向美國證券交易委員會‎‎and‎available 提交的文件,網址爲‎www .sec.gov,向某些省‎Canada 和‎‎available 的‎the 證券監管機構提交的文件‎。如果任何‎factor 以意想不到的‎manner 影響公司,或者‎‎assumptions 標的‎the 前瞻性‎information 被證明不正確,則實際的‎results 或事件可能會有所不同‎‎materially 來自預測的結果‎or 事件。‎Any 這種前瞻性‎information 在其‎‎entirety 中有明確的限定‎statement。此外,‎the Company‎does 對這種看上去像‎forward-‎information 的準確性或‎‎completeness 不承擔任何責任。‎The 本新聞稿中包含的前瞻性信息‎‎is 截至本新聞稿‎date 發佈‎‎release 並且公司沒有義務向前公開更新或修改‎‎any‎looking‎information,‎other 低於適用法律的要求‎.‎

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譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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