Cell MedX Corp. Files Two Applications for Class II Medical Device Licenses with Health Canada
Carson City, Nevada, July 7, 2020, Cell MedX Corp. (OTCQB: CMXC, 9CX:MUN) (“Cell MedX” or the “Company”), a bio-tech company focusing on the discovery, development and commercialization of therapeutic and non-therapeutic products that promote general wellness, announced today that the Company has filed an application for a Class II Medical Device License for the eBalance Pro System and the eBalance Home System with Health Canada.
The applications consisted of the Device License Application and Fee Forms, Labelling and Quality System Requirements: Quality System Certificate for ISO 13485:2016 issued by a MDSAP certified registrar, BSI. The submission was prepared according to Health Canada’s Guidance document – Preparation of Regulatory Activities in the “Non-eCTD Electronic-Only” format and submitted to Health Canada via email.
The eBalance Home System and the eBalance Pro System are non-invasive, fully automated microcurrent electrotherapy systems that administer pre-programmed algorithms through the epidermis with the touch of a button for general relaxation and temporary relief of pain.
The Company anticipates a response from Health Canada within thirty days. The Company has also been compiling the necessary paperwork for the 510(K) submission to the US FDA.
eBalance Pro System
The eBalance Pro System includes the eBalance Console which acts as the central controller for three (3) pre-programmed microcurrent algorithms (Wellness, Pain Managementt, & Dual) referred to as Treatment Options. Treatments are administered to patients using Hand Bars, Foot Plates, and/or Pen Probes. The treatment duration and treatment intensity are controlled by the eBalance Console. The Hand Bars and Foot Plates are used for general wellness and pain management while the Pen Probes are used in localized pain management. The eBalance Pro System is a safe, effective, easy-to-use therapeutic option for practitioners who want to deliver frequency-specific microcurrent to clients in their practice.
eBalance Home System
The eBalance Home System includes the eBalance Console which acts as the central controller for three (3) pre-programmed microcurrent algorithms (Wellness, Pain Management, & Dual) referred to as Treatment Options. Treatments are administered using Hand Bars and Foot Plates. The general wellness and pain management treatment duration and treatment intensity are controlled by the eBalance Console. The eBalance Home System is a safe, effective, easy-to-use therapeutic option for those wanting to use frequency-specific microcurrent for pain relief and general relaxation at home.
Frank McEnulty, the Company’s CEO and Director, stated, “We were very pleased to receive the MDSAP certification, in June 2020, along with the ISO 13485:2016 certification we received in March of 2020, and certificate of conformity as Class A (Professional Use) Device and a Class B (Home Use) Device we received in 2018. With these certificates under our belt, we have applied to have the eBalance device classified as a Class II medical device, allowing us to fulfill our mission of allowing individuals to pursue optimal health and wellness through innovative 21st-century therapies and technologies.”
About Cell MedX Corp.
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 final report on the Observational Clinical Trials has been received by Health Canada. For more information about the Company and its technology please visit the Company’s website at 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, Director
Forward Looking Statements
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, and Annual 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. In particular, the Company’s eBalance technology is still in development. 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.
The information presented in this press release, including the statements made regarding the eBalance® device, have not been evaluated by the Food and Drug Administration or Health Canada, nor has it been peer reviewed. eBalance® should not be viewed as a substitute for professional medical advice, diagnosis, or treatment. 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.
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