ALIGN TECHNOLOGY INC (ALGN)

Align Technology, Inc. is a global medical device company that designs, manufactures and markets Invisalign clear aligners for treating malocclusion (misaligned teeth) through orthodontists and general dental practitioners. It also sells Vivera retainers, iTero intraoral scanners and services, and exocad CAD/CAM software for dental laboratories and practitioners. Its strategy is to revolutionize orthodontic and restorative dentistry through the Align Digital Platform, an integrated suite of proprietary software, systems and services that connects patients, consumers, doctors and labs in an end-to-end digital workflow. The workflow covers connecting with consumers, scanning, diagnosing, planning, treating, monitoring and retaining. Over 22 million people worldwide have been treated with the Invisalign System.

The company has two operating segments. Clear Aligner generated about 80% of 2025 net revenues, and Imaging Systems and CAD/CAM Services generated the remaining 20%. The Invisalign System is built on ClinCheck treatment planning software and custom, doctor-prescribed clear polymer aligners made from molds produced by stereolithography. It is offered in comprehensive and non-comprehensive packages, including Invisalign First for younger patients, Express, Lite, Moderate, and Go packages for general dentists, a doctor subscription program, and a system with mandibular advancement featuring occlusal blocks. Other products include the Invisalign Palatal Expander System, a direct 3D printed device that received FDA 510(k) clearance in December 2023, Vivera retainers, the Invisalign Professional Whitening System, and accessory products. iTero scanners support restorative and orthodontic procedures and Invisalign case submissions, and exocad software supports restorative dentistry, implantology, guided surgery and smile design. Recent 2025 announcements included restorative capabilities for iTero Lumina scanners, the iTero Lumina Pro imaging system, Align X-ray Insights AI software in the EU and UK, and enhancements to the Align Oral Health Suite.

Align sells mainly through a dedicated direct sales force to orthodontists, general dentists (including prosthodontists, periodontists and oral surgeons) and dental laboratories. It also uses sales agents and distributors in some countries and sells directly to dental support organizations. Invisalign accessory products are sold through e-commerce sites, its doctor portal, and retail and pharmacy stores. Doctors must complete an Invisalign training course before providing treatment. The company estimates that about 600 million people globally have malocclusion, that about 22 million start orthodontic treatment each year, and that its share of those orthodontist case starts is about 10%. Its strategy focuses on increasing share against traditional wires and brackets, especially among teens, and expanding digital orthodontics among adults, by training more doctors and educating consumers.

Over 95% of Invisalign prescriptions are submitted by digital scan, from iTero or compatible third-party scanners. Completed aligners are typically shipped directly to the dental professional. In January 2024 Align acquired Cubicure GmbH, whose direct 3D printing technology is intended to let it make devices without molds and scale to eventually print millions of custom devices per day. Limited direct-fabrication manufacturing has begun, with pilots of retainers and pre-fab attachments expected in 2026. The corporate headquarters is in Tempe, Arizona. Regional headquarters are in Raleigh, North Carolina (Americas), Rotkreuz, Switzerland (EMEA) and Singapore (Asia Pacific).