Le Lézard
Classified in: Health, Business
Subjects: NEW PRODUCTS/SERVICES, HEALTH, LICENSING AGREEMENTS

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


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 Kneetm 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 Kneetm Device with the U.S. Food and Drug Administration (the "FDA") in early 2024. The SpaceTek Kneetm 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 Kneetm 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 Kneetm 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 Kneetm 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:?

Mike Seckler
Chief Executive Officer
Tel: 1 (800) 760-6826
Email: [email protected]

Additional Information

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 Kneetm Device with the FDA in early 2024; SpaceTek Kneetm 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 Kneetm Device with the FDA in early 2024; and the Company receiving necessary regulatory approvals for the SpaceTek Kneetm 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?.?

______________________________
1
https://rheumatology.org/patients/joint-replacement-surgery



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