Cell MedX Corp. Provides an Update on Progress Toward US Premarket Clearance and Clarifies its eBalance Certification
Carson City, Nevada--(Newsfile Corp. - February 12, 2019) - Cell MedX Corp. (OTCQB: CMXC) ("Cell MedX" or the "Company"), an early development stage biotech company focusing on the discovery, development and commercialization of therapeutic and non-therapeutic products that promote general wellness is pleased to announce significant progress toward obtaining premarket clearance in the US for its eBalance device. The eBalance device is not yet available for sale in the US.
The Company has been working with ICON plc to assemble the necessary documentation to support the 510(k) premarket notification for the eBalance device with a goal to obtain premarket clearance and make the medical device available to the US market. The Company anticipates filing the application in the first quarter of 2019.
The Company also wishes to clarify its statement issued in the news release dated December 12, 2018, regarding the certification the Company received on its eBalance device. In the news release the Company incorrectly stated that its eBalance device received a UL Certification: "Upon receiving its Certificate of Conformity, qualifying the eBalance devices as Class A (professional use) and Class B (in-home use) as well as its CSA, CE and UL Certifications for meeting electrical safety and emission standards from LabTest Certification Inc."
The Company would like to clarify that the eBalance device received the Certificate of Conformity as Class A (professional use) and Class B (in-home use) device from LabTest Certification Inc. ("LabTest"). To qualify the device, LabTest used CSA, CE and UL standards for electrical safety and emission. The Company did not receive a certificate directly from the Underwriters Laboratories ("UL"). Following receipt of the certification, eBalance is eligible to bear the LabTest Certification Mark with adjacent indicators "C" and "US."
About Cell MedX Corp.
Cell MedX Corp. is an early development stage 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, and high blood pressure. 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.
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, 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. 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.
Cell MedX Corp.
For further information please visit: www.cellmedx.com
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