SOURCE: LED Medical Diagnostics Inc.

LED Medical Diagnostics Inc.

September 09, 2015 07:30 ET

LED Medical Diagnostics' VELscope® Vx Receives Regulatory Approval for Distribution in China

Approval Expands Global Market Reach of Award-Winning VELscope Vx System

VANCOUVER, BC--(Marketwired - September 09, 2015) - LED Medical Diagnostics Inc. ("LED Medical" or "the Company") (TSX VENTURE: LMD) (OTCQX: LEDIF) (FRANKFURT: LME) and its subsidiary LED Dental have received regulatory approval for the distribution of the VELscope® Vx Enhanced Oral Assessment System in China, opening up a large new market for the award-winning adjunctive screening device. Geneformation Technology, a distributor of laboratory equipment and consumables with offices in China, Hong Kong and the United States, has worked closely with the Company to obtain regulatory approval for the VELscope Vx from the China Food and Drug Administration. As of August 6, 2015, the VELscope Vx Enhanced Oral Assessment System is approved for sale in China as a medical apparatus, Category I, under approval number "国械备20151176."

"China has the largest population globally, so this is a significant milestone for our company," said Dr. David Morgan, chief technology officer of LED Dental. "Ongoing reform of the Chinese dental care system, coupled with a rise in per capita disposable income and an increased awareness of health, is bolstering accelerated growth of China's oral healthcare industry. The result is the emergence of a large number of small private new clinics that are taking advantage of relaxed government regulations for private health care centers. Over 50,000 of these are estimated to be in operation to date."

"The Chinese dental market is a significant opportunity for global expansion of the VELscope Vx system," remarked Wayne Rees, vice president of VELscope imaging for LED Dental. "Our partnership with Geneformation Technology, Inc. will provide an experienced distribution channel to the influential university and hospital markets in both China and Hong Kong, which provide the majority of dental services in China through thousands of state-run dental hospitals."

The VELscope Vx Enhanced Oral Assessment System is the dental industry´s leading adjunctive screening device for the early visualization of a range of oral mucosal abnormalities, including oral cancer, pre-cancer, infections and trauma. To date, more than 25 million VELscope® Vx exams have been performed by over 15,000 dentists in 23 countries.

About Geneformation Technology
Geneformation Technology Inc. is a leading distributor of life science laboratory equipment and consumables in China, dedicated to providing the most reputable, innovative products and technologies to customers in China and the Hong Kong territory. Their major products are the cell cultures mediums and cancer diagnostic reagents like florescence probes using Florescence in situ hybridization cytogenetic techniques.

Established in 2002, Geneformation Technology Inc. has two offices in China, located in Hong Kong and Beijing as well as one office in Charlotte, NC in the United States (www.geneformation.com). Our Beijing office has its own registered Chinese name 北京华创恒达有限公司 (www.huatron.net) based on Chinese regulations.

About LED Medical Diagnostics Inc.

Founded in 2003 and headquartered in Burnaby, 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 Venture Exchange (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 844.952.7327 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, 2013. 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.

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