CST: 25/06/2016 18:18:10   

LED Medical Diagnostics Inc. Announces Successful Resolution to FDA Warning Letter

164 Days ago

VANCOUVER, BC --(Marketwired - January 12, 2016) - LED Medical Diagnostics ("LED Medical" or "the Company") (TSX VENTURE: LMD)(OTCQX: LEDIF)(FRANKFURT: LME) subsidiary LED Dental is pleased to announce that it has received confirmation from the United States Food and Drug Administration (FDA) that it has adequately addressed the agency's concerns outlined in a Warning Letter sent to the company dated May 12, 2014. This confirmation brings to a conclusion the negotiations between LED Dental and the FDA regarding certain marketing verbiage on the LED Dental website pertaining to the VELscope Vx system. LED Dental completed the requested changes to the website in December 2015 and received notification shortly thereafter that the changes were acceptable.

Dr. David Morgan, chief technology officer of LED Dental, remarked, "Although we felt justified in the language that we originally utilized, we also understand the agency's position and, in the end analysis, do not feel that the FDA's requested changes diminish in any way the compelling value proposition of the VELscope Vx communicated on our website."

About LED Medical Diagnostics Inc.

Founded in 2003 and headquartered in Vancouver, British Columbia, Canada, LED Medical Diagnostics Inc., through its wholly-owned subsidiaries LED Dental Inc. and LED Dental Ltd, provide dentists and oral health specialists with advanced diagnostic imaging products and software, in addition to the award- winning VELscope® Vx tissue fluorescence visualization technology. Backed by an experienced leadership team and dedicated to a higher level of service and support, LED Dental is committed to providing dental practitioners with the best technology available by identifying and adding leading products to its growing portfolio.

The Company is currently listed on the TSX-V under the symbol "LMD", the OTCQX under the symbol "LEDIF", as well as the Frankfurt Stock Exchange under the symbol "LME". For more information, call 884.952.7327 or visit www.leddental.com/investor-relations.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward Looking Statements

This press release contains statements which, to the extent that they are not recitations of historical fact, may constitute forward-looking information under applicable Canadian securities legislation that involve risks and uncertainties. Such forward-looking statements or information include statements regarding, but not limited to the Company's future growth strategy, its distribution strategy and product offerings, potential expansion of the Company's technology to other medical applications or markets, or the potential introduction of new technologies by the Company. Persons reading this press release are cautioned that such statements or information are only predictions, and that the Corporation's actual future results or performance may be materially different. Factors that could cause actual events or results to differ materially from those suggested by these forward-looking statements include, but are not limited to competition risks, distributor risks, product development risks such as regulatory, design, intellectual property and other factors described in the Corporation's reports filed on SEDAR including its Annual Information Form and financial report for the year ended December 31, 2015. These and other factors should be considered carefully and readers should not place undue reliance on such forward-looking information. All forward-looking statements made in this press release are qualified by this cautionary statement and there can be no assurance that actual results or developments anticipated by the Company will be realized. The Company disclaims any intention or obligation to update or revise forward-looking information, whether as a result of new information, future events or otherwise, except as required by law.

Investor Relations:
MZ Group
Mike Cole
Phone: 949.444.1341
Email: mike.cole@mzgroup.us

Media Contact:

LED Dental
Chris Koch
Phone: 678.293.9413
Email: chris.koch@leddental.com

Corporate Contact:

LED Medical
David Gane, CEO
Phone: 604-434-4614 x227
Email: david.gane@leddental.com