Mr. Chris Koch reports

LED MEDICAL PROVIDES AUGUST, 2015, BUSINESS UPDATE

LED Medical Diagnostics Inc. and its subsidiary, LED Dental, have provided a business update that outlines continuing 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 3-D imaging system -- and an update on the VELscope product line.

New CAD/CAM imaging products

LED Medical has recently added 3-D intraoral scanning and 3-D 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 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-colour 3-D 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 incorporates state-of-the-art 3-D 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 3-D printing technology complements the 3Shape 3-D intraoral scanning technologies that LED Dental also recently announced.

"We are very committed to 3-D imaging technologies and offering a complete dental CAD/CAM workflow," stated LED Medical chief executive officer, 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 (3-D printing in dentistry 2015: a 10-year opportunity forecast and analysis), the forecasted value of hardware, materials and printed components enabled by 3-D printing in dentistry is expected to hit $3.1-billion by 2020, crossing $2-billion next year. It also notes that total sales of 3-D 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 system pursuant to the exclusive distribution agreement it has with Ray Company. This will allow LED Dental to start selling the Rayscan Alpha 3-D in the Canadian market, alongside the previously cleared Rayscan alpha panoramic and cephalometric imaging system.

Coming events

LED Dental will be exhibiting at several trade shows and association meetings this fall, demonstrating both the VELscope Vx and its complete line of digital imaging and CAD/CAM solutions.

Schedule at a glance:

• Northeastern Society of Orthodontists, Sept. 11 to 15, Providence, R.I., Booth 307;
• AAOMS annual meeting, Oct. 1 to 3, Washington, Booth 863;
• Pacific Coast Society of Orthodontists, Oct. 24 to 25, Palm Springs, Calif., Booth 329;
• ADA annual meeting, Nov. 5 to 7, Washington, Booth 3429;
• Southwestern Society of Orthodontists, Nov. 6 to 7, San Antonio, Tex., Booth 122;
• American Academy of Periodontology, Nov. 15 to 17, Orlando, Fla., Booth 1525;
• Greater New York Dental meeting, Nov. 29 to Dec. 2, New York, N.Y., Booth 2822;
• AAOMS dental implant conference, Dec. 4 to 5, Chicago, Ill., Booth 116.

VELscope product line

The VELscope was recently awarded Pride Institute's 2015 best-of-class technology award, taking home the honour 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, Nov. 5 to 10 in Washington. 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 and 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 fifth- and sixth-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 and case collaboration of both white light and fluorescence screenings a seamless process."

On May 12, 2014, the Food and Drug Administration issued a warning letter to LED Medical Diagnostics and LED Dental relating to VELscope marketing claims on the company's website. LED has responded to the FDA and is awaiting its 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.

Dr. Gane, chief executive officer of LED Medical Diagnostics, concluded: "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 and 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 the LED Dental website, or call 844-952-7327.

For more information on 3Shape and the Trios scanner, please visit the 3shape website.

For more information on EnvisionTec 3-D printers, please visit the EnvisionTec website.

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