07:54:36 EDT Fri 17 May 2024
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Salona Global Medical Device Corp
Symbol SGMD
Shares Issued 56,791,591
Close 2023-11-15 C$ 0.21
Market Cap C$ 11,926,234
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Salona launches Biodex SpaceTek Knee device

2023-11-16 14:25 ET - News Release

Mr. Mike Seckler reports

SALONA GLOBAL ANNOUNCES THE DEBUT OF THE BIODEX SPACETEK KNEE , A REVOLUTIONARY PORTABLE ISOKINETIC KNEE DYNAMOMETER MEDICAL DEVICE DEVELOPED IN NASA COLLABORATION

Salona Global Medical Device Corp., soon to be renamed Evome Medical Technologies Inc., today debuted 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.

The company's intention is to submit an application for approval of the SpaceTek Knee Device with the United States 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., and its price point is meant to democratize the Biodex institutional grade technology and intellectual property to physical therapy chiropractic centres 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 70 pounds.

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 centres 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 co-operative 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 licence 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 per cent 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 Nov. 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."

We seek Safe Harbor.

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