ATLANTA, GA—(Marketwired – August 07, 2015) – LED Medical Diagnostics Inc. (“LED Medical” or “the Company”) (TSX VENTURE: LMD) (OTCQX: LEDIF) (FRANKFURT: LME) and its subsidiary, LED Dental, has provided a business update that outlines ongoing developments in the organization that will be shaping its activities over the next several months. Included in the update is a summary of the latest additions to the LED Dental imaging product portfolio, international market expansion for the Rayscan Alpha – Expert 3D Imaging System, and an update on the VELscope product line.
New CAD/CAM Imaging Products
LED Medical has recently added 3D intraoral scanning and 3D printing technologies to its robust imaging product portfolio through distribution agreements with 3Shape and EnvisionTec Inc.
Under the terms of the 3Shape agreement, LED Dental will become a distributor for the TRIOS line of products, including the new TRIOS 3 digital impression system for the orthodontic market. Boasting a new, more compact hand–piece design, RealColor â„¢ intraoral photography, and flexible hardware configurations, the TRIOS 3 can perform a variety of digital tasks for both general dentists offering orthodontic services and orthodontic specialty practices.
Dr. Jeffrey Brooks, vice president of imaging for LED Dental, sees the myriad of benefits that come with introducing intraoral scanning technologies during the planning of orthodontic treatments. “Utilizing 3Shape's advanced scanning technologies and related software opens up digital workflow for the orthodontist.” Dr. Brooks continued, “The capability to quickly acquire full color 3D scans of the patient's dentition and related structures negates the need for putty impressions and gypsum models, while opening up new opportunities for diagnosis, treatment simulation and patient understanding.”
LED Dental's partnership with EnvisionTec Inc incorporates state–of–the–art 3D printing technologies into the LED Dental imaging product line, allowing clinicians to rapidly produce crowns, bridges, models, surgical guides and a range of orthodontic appliances right in their office. This 3D printing technology complements the 3Shape 3D intraoral scanning technologies that LED Dental also recently announced.
“We are very committed to 3D imaging technologies and offering a complete dental CAD/CAM workflow,” stated LED Medical CEO, Dr. David Gane.” EnvisionTec provides world–class solutions that are complementary to our current product portfolio and the print media will be an additional source of recurring revenue.”
According to a report published by SmarTech in May ('3D Printing in Dentistry 2015: A Ten Year Opportunity Forecast and Analysis'), the forecasted value of hardware, materials, and printed components enabled by 3D printing in dentistry is expected to hit $3.1 billion by 2020, crossing $2 billion next year. They also note that total sales of 3D printing systems to dental labs or professionals, which is currently at $240 million, will double by 2020.
Market Expansion
LED Medical has received clearance by Health Canada to market and sell the Rayscan Alpha Cone Beam Computed Tomography (CBCT) system pursuant to the exclusive distribution agreement it has with Ray Company. This will allow LED Dental to start selling the Rayscan Alpha 3D in the Canadian market, alongside the previously cleared Rayscan Alpha Panoramic and Cephalometric imaging system.
Upcoming Events
LED Dental will be exhibiting at several trade shows and association meetings this fall, demonstrating both the VELscope Vx and their complete line of digital imaging and CAD/CAM solutions.
Schedule at a Glance:
Northeastern Society of Orthodontists, Sept. 11–15 – Providence, RI – booth 307
AAOMS Annual Meeting, Oct. 1–3 – Washington, DC – booth 863
Pacific Coast Society of Orthodontists, Oct. 24–25 – Palm Springs, CA – booth 329
ADA Annual Meeting, Nov. 5–7 – Washington, DC – booth 3429
Southwestern Society of Orthodontists, Nov. 6–7 – San Antonio, TX – booth 122
American Academy of Periodontology, Nov. 15–17 – Orlando, FL – booth 1525
Greater New York Dental Meeting, Nov. 29–Dec. 2 – New York, NY – booth 2822
AAOMS Dental Implant Conference, Dec. 4–5 – Chicago, IL – booth 116
VELscope Product Line
The VELscope was recently awarded the Pride Institute's 2015 “Best of Class” Technology Award, taking home the honor for a fifth consecutive year. This accomplishment is shared by only one other product over the history of the “Best of Class” awards. The VELscope and LED Dental will be represented at the 2015 Technology Expo, which features all “Best of Class” award winners and is hosted during the American Dental Association Annual Meeting, November 5–10 in Washington, DC.
In June, LED Dental launched the VELscope Vx Imaging Adapter and VELscope Photo System application, which allow the VELscope Vx to integrate with the Apple iPod touch® for clinical photographic documentation & secure sharing of images of oral lesions for improved case collaboration. Providing high–resolution photography for both white–light and fluorescence examinations, improved wireless network performance, and a user–friendly interface, the VELscope Vx Imaging Adapter and VELScope Photo System Application (available from the Apple® App Store) bring clinical documentation of oral health screenings into a more streamlined workflow. This new system is compatible with both 5thand 6th generation Apple iPod touch devices, which are available from Apple retailers.
“The market has responded very positively to this new VELscope Vx imaging solution,” stated Wayne Rees, vice president of VELscope imaging for LED Dental. “The simple workflow and image sharing capabilities inherent in this new system have made clinical documentation & case collaboration of both white–light and fluorescence screenings a seamless process.”
On May 12, 2014, the FDA issued a warning letter to LED Medical Diagnostics Inc. and LED Dental Inc. relating to VELscope marketing claims on the Company's website. LED has responded to the FDA and is awaiting their response. In connection with the warning letter, the FDA has issued an import alert for the VELscope which could result in the VELscope being refused customs clearance into the United States. To date, however, the import alert has not negatively impacted LED's VELscope business in the United States.
The warning letter can be reviewed on the FDA website at the following link:
http://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm397798.htm
Dr. David Gane, CEO of LED Medical Diagnostics, concludes: “We anticipate that FDA concerns with regard to the marketing of the VELscope will be resolved in the coming weeks. We are excited about the outlook of both our digital imaging and VELscope product lines for the remainder of 2015 and into the future, especially relating to our expanding product portfolio and market reach. The addition of 3Shape & EnvisionTec products to our imaging portfolio, our first measured steps into dental CAD/CAM, are a prime example of how we are executing to grow revenues by creating additional and diverse revenue streams, while leveraging our sales and marketing infrastructure.”
For more information on LED Dental please visit www.leddental.com or call 844.952.7327.
For more information on 3Shape and the TRIOS scanner, please visit www.3shape.com.
For more information on EnvisionTec 3D printers, please visit www.envisiontec.com.
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, that the FDA warning letter will not impact LED's business, 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, 2014. 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.