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.
Approximately 790,000 total knee replacements are performed annually in the United States.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.
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.
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.
The Biodex Collaboration with NASA
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.
Details of the NASA and Biodex Agreement
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.
“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.”
For more information please contact:
Chief Executive Officer
Tel: 1 (800) 760-6826
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.
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.
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 www.sedarplus.ca. 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.
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