FDA Submission and Corporate Update
Carson City, Nevada, September 20, 2022, 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 providing the following corporate update including the U.S. Food and Drug Administration (FDA) premarket notification (510(k)) submission.
FDA Premarket Notification (510(k)) Update;
In September 2021, Cell MedX filed its US premarket notification (510(k)) submission with the FDA. The FDA acknowledged receipt of the 510(k) and began its review. The first round of comments included updating the electrical testing report to an additional standard. Cell MedX received the updated electrical certification report on March 11, 2022, and submitted the report to the FDA on March 15, 2022. The FDA continued their review and forwarded a second round of comments to the Company on May 13, 2022. Cell MedX is currently in the process of responding to the latest FDA comments with the assistance of outside consultants.
Requests for clarification comments from the FDA are standard practice and usually companies have 180 days to respond, however, due to COVID-19 delays the FDA has extended the response time to 360 days. The FDA has asked the Company to submit the information for their most recent request by May 2023, however, it is Cell MedX’s intention to submit a response to the FDA long before the due date.
Corporate Update on Financial Condition;
As a result of COVID and subsequent down-turn in the economy, the Company has had to make some cutbacks in order to keep operations moving forward during these difficult times and is currently exploring all avenues of financing in order to meet its financial obligations. Some of these financial obligations include, but are not limited to, completion and filing of year-end audited financial statements, engaging third party testing and consultants in response to current FDA comments, further research and marketing of its eBalance® Home and eBalance® Pro Systems and general working capital.
The Company believes that it will receive the necessary financing to meet its financial obligations over time and be successful in its 510(k) submission but the Company can make no assurances at this time.
Cell MedX thanks its shareholders for continued support of the Company on its journey to bring eBalance® Technology to health professionals and the general public.
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 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 for 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. For more information about the Company and its technology please visit www.cellmedx.com/investors/overview/.
On behalf of the Board of Directors of Cell MedX Corp.
Dwayne Yaretz
Director, 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