Carson City, Nevada--(Newsfile Corp. - September 12, 2019) - 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 excited to provide its shareholders with a corporate update.
In Fiscal year 2019 the Company received a Certificate of Conformity, from LabTest Certification Inc., for the ebalance Pro device (the "Device"). The certification tests performed qualified the Device as a Class A and Class B device. Class A allows the Device to be used in professional settings, which include doctors, clinics, and hospitals; Class B allows the Device to be used in home by an end-user. In addition, the Device was certified to CSA, CE and UL standards for electrical safety and emission standards, and is eligible to bear the LabTest Certification Mark with adjacent indicators "C" and "US".
The Company has been working with ICON plc to prepare a 510k submission to the US FDA. The documentation process has taken longer than the Company anticipated as further tests and documentation were required during this process. However, the Company believes it is close to finalizing the documentation and anticipates filing the application in the fourth quarter of calendar 2019.
Currently Cell MedX can market the Device in Canada as a wellness device without making any medical claims. The Company will be able to start marketing the Device in the United States only after the device receives premarket clearance.
The Company has also been working with ICON plc to obtain their ISO 13485:2016 Quality Management System which is needed to apply for the Class II license from Health Canada ("HC").
As of January 1, 2019, all medical device manufacturers had to update their previous ISO certifications to meet the new Medical Device Single Audit Program (MDSAP) standards to sell in Canada.
The MDSAP certification allows for a single Quality Management Systems audit which may include Australia, Brazil, Canada, Japan and the USA where regulatory requirements have been met.
Due to the backlog of existing manufacturers applying for their required audits and a shortage of inspectors, Cell MedX has been informed to expect the MDSAP audit not earlier than the last quarter of calendar 2019.
If approved as a Class II device, the Company intends to market the Device to professional institutions and home users through established licensed dealers and distributors of medical equipment, as well as the Company's in-house sales team.
Upon receiving the Certificate of Conformity, the Company collaborated with its Canadian production facility operated by NDS Electronic Solutions Inc. ("NDS") in order to manufacture the ebalance devices. The first 100 Canadian manufactured ebalance devices, based on new findings that enhanced the ebalance devices, were successfully completed in the third quarter of the Company's Fiscal 2019. The majority of the Devices manufactured in the third quarter were used for further in-house observations as well as for promotional and introductory material.
During the fourth quarter of the Company's Fiscal 2019, the Company started manufacturing an additional 60 Devices, which the Company has started marketing and selling to its end-users represented mostly by local wellness and naturopathic clinics.
In the first quarter of its Fiscal 2020 the Company entered into agreements with two individuals ("Sales Representatives") to market and sell the Devices in Canada.
On May 30, 2019 the Company announced a non-brokered private placement offering (the ``Offering``) at a set price of $0.12 per Unit for up to 6,250,000 Units for a maximum of $750,000. Each Unit sold under the Offering was to consist of one common share of the Company and one share purchase warrant (the "Warrant") expiring on the second-year anniversary of the date of issuance of the Warrant and exercisable into one share of the Company's common stock at $0.20 per share.
The Units were to be issued pursuant to the provisions of Regulation S of the United States Act of 1933 as amended (the "Act") to the persons who are not residents of the United States and are otherwise not "U.S. Persons" as that term is defined in Rule 902(k) of Regulation S of the Act. The Units to U.S. Persons were to be issued pursuant to the provisions of Rule 506(b) of Regulation D of the Act who qualify as "accredited investors" as that term is defined under Regulation D of the Act.
As at July 22, 2019, the Company had closed on proceeds of $486,000 of the Offering and issued 4,050,000 Units. No further Units were issued under this Offering and the Offering was closed as of the date of the filing of the Company's Annual Report on Form 10-K.
Exercise of Warrants
On August 28, 2019, a major shareholder exercised his warrants to acquire 7,482,960 shares of the Company. To exercise the warrants the major shareholder exercised the warrants by applying $374,148, the Company owed the major shareholder for a line of credit and notes payable due on demand. The shares were issued on September 9, 2019.
On September 10, 2018, the Company entered into a non-binding letter of intent (the "LOI") with Live Current Media, Inc. ("LIVC") an arms-length party, for worldwide distribution rights to the Device to the end-user (" Home Devices") market, which was superseded by a definitive exclusive worldwide distribution agreement (the "Agreement") on March 21, 2019. To secure the right to earn the exclusive worldwide distribution rights LIVC paid the company a one-time fee of $250,000 pursuant to the LOI. In order to maintain the exclusivity, LIVC must order a minimum of 2,000 devices by the end of a 24-month period from the date the Device receives its 510K clearance from the FDA (the "Initial Term"). LIVC will be able to order the ebalance device at a 20% discount to the regular retail price at the time of the order (the "License Fee"), with 50% of the License Fee payable at the time of placing an order, and remaining 50% payable on the specific delivery date of the Devices. During the Initial Term the License Fee for the Device will be fixed at CAD$2,400 per device.
In addition to the License Fee, LIVC will be required to pay monthly recurring fee per each Device equal to 50% of the regular monthly home-use fee set by the Company. Following the Initial Term, the minimum monthly fee will be $100,000.
In June of 2019 the Company entered into a Non-Binding Letter of Intent ("LOI") with Neptex Healthcare Technology Corporation ("NHTC"), for the Device distribution rights to clinics, doctors, and practitioners in all of Mainland China, excluding Hong Kong. NHTC paid the Company a $25,000 non-refundable fee. The LOI expires on February 1, 2020.
On September 6, 2018, the Company entered into an IP Royalty Agreement with an IP Vendor. Pursuant to the IP Royalty Agreement the Company agreed to acquire certain additional development and improvements for its Devices that were developed by the IP Vendor in exchange for a perpetual royalty of USD$350 or CND$350 depending on the currency the revenue is generated in, for each Device sold, distributed or licensed whether through a distributor, sales representative or by the Company itself.
Also, on September 6, 2018, the Company entered into a royalty agreement with Mr. Richard Jeffs, the Company's major shareholder. Pursuant to the royalty agreement, the Company agreed to pay Mr. Jeffs, in perpetuity, a 10% royalty on the revenue the Company receives from its distributors or end-users introduced to the Company by Mr. Jeffs.
For additional information about the Company and its current operations please refer to the Company's Annual Report on Form 10-K the Company filed with the SEC on September 6, 2019, and visit the Company's website at: www.cellmedx.com.
About Cell MedX Corp.
Cell MedX Corp. 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. For more information about the Company and its technology please visit our website at: www.cellmedx.com.
On behalf of the Board of Directors of Cell MedX Corp.
Chief Executive Officer and President
Forward Looking Statements
The information included in this press release has not been reviewed by the FDA, 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. 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 visit: www.cellmedx.com.
Or phone: 1-844-238-2692
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