FDA Commences Review of Cell MedX’s Premarket Notification (510K) and Health Canada Renews Class II Medical Device Licenses for eBalance(R) Systems
Carson City, Nevada–(Newsfile Corp. – November 15, 2021) – Cell MedX Corp. (OTCQB: CMXC) (“Cell MedX” or the “Company”), a biotech company focusing on the discovery, development and commercialization of therapeutic and non-therapeutic products that promote general wellness, is pleased to announce that the U.S. Food and Drug Administration (FDA) has acknowledged the receipt of the premarket notification (510K) for the eBalance® Home System and eBalance® Pro System. The submission is in the initial review stage and the Company has received an anticipated request for additional information.
The eBalance® Pro System and eBalance® Home System, are microcurrent electrotherapy systems intended to administer a specific variety of therapeutic microcurrent algorithms for temporary relief of pain associated with sore/aching muscles in the shoulders, waist, back, neck, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household-or work-related activities, as well as for general relaxation.
The eBalance® Pro System is intended for use by professionals in the clinical setting and the eBalance® Home System is intended for home use by laypersons.
In addition, on October 26th the Company received confirmation from Health Canada that the Company’s EBALANCE HOME SYSTEM licensed under Licence No. 104925 and EBALANCE PRO SYSTEM licensed under Licence No. 105044 as Class II Medical Device Systems have been successfully renewed, which allows the Company to continue to sell both systems in Canada under the Company’s Manufacturing ID: 142793.
The Company’s EBALANCE trademark number 1867918 and issued certificate of registration number 1,104,935 registering the trademark EBALANCE in the name of the Company will be added to the documentation for Health Canada as an amendment in 2022.
The Company’s applications to register EBALANCE as a trademark in the United States, which the Company filed with the United States Patent and Trademark Office on December 11, 2017, continues to be under review.
About Cell MedX Corp. (OTCQB: CMXC)
Cell MedX Corp. is a biotech company focused on the discovery, development and commercialization of therapeutic and non-therapeutic products that promote general wellness and alleviate complications associated with medical conditions including, but not limited to: diabetes, Parkinson’s disease, high blood pressure, neuropathy and kidney function. The Company’s main focus is on continued research and development of its eBalance® Technology and its eBalance® Home and eBalance® Pro Systems, which have received Health Canada Approval as Class II Medical Device Systems in the summer of 2020. For more information about the Company and its technology please visit www.cellmedx.com/investors/overview/. For the Company’s newsletter please visit: www.cellmedx.com/media/newsletters/.
On behalf of the Board of Directors of Cell MedX Corp.
Frank McEnulty
CEO
Forward-Looking Statements
The information included in this press release has not been reviewed by the FDA or Health Canada, nor has it been peer reviewed. This press release contains forward-looking statements. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “expects”, “intends”, “estimates”, “projects”, “anticipates”, “believes”, “could”, and other similar words. All statements addressing product performance, events, or developments that the Company expects or anticipates will occur in the future are forward-looking statements. Because the statements are forward-looking, they should be evaluated in light of important risk factors and uncertainties, some of which are described in the Company’s Quarterly, Annual and Current Reports filed with the United States Securities and Exchange Commission (the “SEC”). Should one or more of these risks or uncertainties materialize, or should any of the Company’s underlying assumptions prove incorrect, actual results may vary materially from those currently anticipated. In addition, undue reliance should not be placed on Company’s forward-looking statements. Except as required by law, Cell MedX Corp. disclaims any obligation to update or publicly announce any revisions to any of the forward-looking statements contained in this press release. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. No stock exchange, securities commission or other regulatory body has reviewed nor accepts responsibility for the adequacy or accuracy of this release. Investors are advised to carefully review the reports and documents that Cell MedX Corp. files from time to time with the SEC, including its Annual, Quarterly and Current Reports.
SOURCE:
Cell MedX Corp.
For further information visit: www.cellmedx.com.
Investor Relations: 1-844-238-2692
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