Align Technology Introduces the Invisalign Palatal Expander System to Address Skeletal Expansion in Growing Patients, Including Teenage Patients Which Represent the Majority of Orthodontic Case Starts Globally - Seite 2

Phase 1 treatment is early interceptive orthodontic treatment for young patients, traditionally done through arch expanders or partial metal braces, before all permanent teeth have erupted – typically at ages 6 through 10. Invisalign First clear aligners are designed specifically to address a broad range of younger patients’ malocclusions, including shorter clinical crowns, management of erupting dentition, and predictable dental arch expansion.

“Phase 1 or early interceptive treatment makes up 20 percent of orthodontic case starts each year and is growing,” said Dr. Mitra Derakhshan, Align senior vice president, Global Clinical. “Together with Invisalign First aligners, Invisalign Palatal Expanders provide doctors with a solution set to treat the most common skeletal and dental malocclusions in growing children. The addition of mandibular advancement features to Invisalign aligners also provides doctors with more options for treating skeletal and dental jaw imbalances and bite correction for their growing patients during their teenage years.”

“The Invisalign Palatal Expander System is a game changer, as it alleviates the most common challenges with palatal expansion, including maintaining proper hygiene, emergency appointments, turning the screw, and the parent’s fear of causing pain to the child in treatment,” said Dr. Sandra Tai, an orthodontist in Vancouver, Canada and participant in Align's Invisalign Palatal Expander System limited release program. “It’s removable and supports oral hygiene while delivering a clinically effective and comfortable treatment experience for growing patients that achieves high satisfaction rates reported by parents.”

The Invisalign Palatal Expander System is currently available on a limited basis in Canada (excluding Quebec) and is expected to be available in other markets pending regulatory approvals starting in 2024.

The Invisalign Palatal Expander System is pending pre-market notification (510(k) submission) to the U.S. Food and Drug Administration and is not yet available in the United States.

*Data on file, Align Technology, as of August 2023.

** Data on file, Align Technology, as of August 2023.

Based on data from a multi-site US Early Feasibility Investigational Device Exemption (IDE) clinical study (n=29 subjects, ages 7-10 years) of expansion treatment with Invisalign Palatal Expanders.

About Align Technology, Inc.

Align Technology designs and manufactures the Invisalign System, the most advanced clear aligner system in the world, iTero intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for approximately 247 thousand doctor customers and are key to accessing Align’s 600 million consumer market opportunity worldwide. Over the past 26 years, Align has helped doctors treat over 15.7 million patients with the Invisalign System and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.