Salona Global Announces the Debut of the Biodex SpaceTek Knee™, a Revolutionary Portable Isokinetic Knee Dynamometer Medical Device Developed in NASA Collaboration
16 Novembre 2023 - 4:27PM
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:
Mike SecklerChief Executive OfficerTel: 1 (800)
760-6826Email: Info@Salonaglobal.com
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 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.
______________________________1
https://rheumatology.org/patients/joint-replacement-surgery
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