|Exchange:||NASDAQ national market|
|Stock:||Align Technology, Inc.|
|Align Technology, Inc. was incorporated in Delaware in April 1997. The Company designs, manufactures and markets a system of clear aligner therapy, intra-oral scanners and CAD/CAM (computer-aided design and computer-aided manufacturing) digital services used in dentistry, orthodontics, and dental records storage. The Company has two operating segments namely Clear Aligner, known as the Invisalign system; and Scanners and CAD/CAM Services, known as iTero and iOC intra-oral scanners and OrthoCAD services. The Company distributes the vast majority of its products directly to its customers: orthodontists and general practitioner dentists, or GPs, as well as to restorative dentists, including prosthodontists, periodontists, and oral surgeons. The Company received the United States Food and Drug Administration (“FDA”) clearance to market the Invisalign system in 1998. The Invisalign system is regulated by the FDA as a Class II medical device. In order to provide Invisalign treatment to their patients, orthodontists and GPs must initially complete an Invisalign training course. The Invisalign system is sold in North America, Europe, Asia Pacific, Latin America and Japan. The Company uses a distributor model for the sale of its products in non-core country markets in the Asia Pacific, Europe, the Middle East and Africa (EMEA), and Latin America regions. Malocclusion and Traditional Orthodontic Treatment is one of the most prevalent clinical dental conditions, affecting nearly a billion people, or approximately 50 to 75% of the population of major developed countries. Approximately 6.8 million people annually elect treatment by orthodontists worldwide, of which approximately 2.6 million have mild to moderate malocclusion and are applicable to Invisalign treatment-it served market. The Invisalign system is a proprietary method for treating malocclusion based on a series of doctor-prescribed, custom manufactured, clear plastic removable orthodontic aligners. The Invisalign system offers a range of treatment options, specialized services, and proprietary software for treatment visualization. The Company markets Invisalign by communicating the benefits of the Invisalign system to dental professionals through its training programs, mail campaigns, trade shows, trade journals and print media, and to consumers through advertising, digital media, event marketing and social networking activities. Based on its experience with advertising and commercial sales, the Company believes that making consumers aware of Invisalign as a new treatment alternative generates significant demand for Invisalign. It competes for the attention of dental professionals with manufacturers of traditional orthodontic appliances (or wires and brackets), which include 3M’s Unitek, Danaher Corporation’s Sybron Dental Specialties, and Dentsply International, Inc.|
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