Health Canada Issues Updated Medical Device License to Align Technology For the Invisalign® Palatal Expander System to Address Skeletal and Dental Expansion

• Invisalign® Palatal Expanders offer doctors a removeable, safe, and clinically effective alternative to traditional palatal expanders.

• Combined with Invisalign First™ aligners, Invisalign Palatal Expanders provide doctors with a full early intervention treatment solution, including both skeletal (orthopedic) and dental (orthodontic) arch expansion.

Align Technology, Inc. (“Align”) (Nasdaq: ALGN) a leading global medical device company that designs, manufactures, and sells the Invisalign® System of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, today announced that Health Canada issued an updated medical device license to Align for its Invisalign® Palatal Expander System*. The updated license is for broad patient applicability, including growing children, teens, and adults (with surgery or other techniques). The Invisalign Palatal Expander System is available on a limited basis in Canada.

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Dr. Sandra Tai’s patient independently inserting Invisalign® Palatal Expander. (Photo: Business Wire)

Previously introduced at the Align Technology Investor Day in September 2023, the Invisalign Palatal Expander System is a modern and innovative direct 3D printed device based on proprietary and patented technology. Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw) with primary, mixed, or permanent dentition during treatment of patients. The Invisalign Palatal Expander is Align’s first direct 3D printed orthodontic device and provides a safe, comfortable, and clinically effective* alternative to traditional palatal expanders that require manually turning a screw in the device in the mouth daily to achieve expansion.

The Invisalign Palatal Expander System consists of a series of removable devices staged in small increments of movement to expand a patient’s narrow maxilla to a position determined by their treating doctor.** Each direct 3D printed device is customized to the patient’s unique anatomy based on an iTero™ intraoral digital scan. A palatal expansion treatment plan and device design are then developed using Align’s proprietary AI-driven orthodontic software.

Combined with Invisalign First™ aligners, Invisalign Palatal Expanders provide doctors with a full early intervention treatment solution for Phase 1 treatment, an early interceptive orthodontic treatment for young patients. Phase 1 treatment is 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***.

“Many parents in my practice have found it challenging to physically turn the screws on traditional palatal expanders,” said Dr. David Walt, an orthodontist in Vaughan, Ontario and participant in Align's Invisalign Palatal Expander System limited release program in Canada. “The Invisalign Palatal Expander removes this concern and creates a better overall experience for patients and their parents. Beyond that, there have not been related emergency visits, something that is more common with traditional palatal expanders.”

“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 parents’ fear of causing pain to their child in treatment,” said Dr. Sandra Tai, an orthodontist in Vancouver and participant in Align's Invisalign Palatal Expander System limited release program in Canada. “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 pending pre-market notification 510(k) clearance by the U.S. Food and Drug Administration and is not yet available in the United States. It is expected to be available in other markets pending regulatory approvals starting in 2024.

*Based on a survey in August 2023 in Canada of 10 Invisalign trained orthodontists who participated in the Invisalign Palatal Expander System Technical Design Assessment and have treated at least 1 patient age 6-11 years with IPE. Data on file at Align Technology, Inc. as of October 30, 2023.

**Based on data from a multi-site US IDE (Investigational Device Exemption) clinical study (n=29 subjects, ages 7-10 years) of expansion treatment with Invisalign® Palatal Expanders. Data on file at Align Technology, Inc. as of October 30, 2023

***Data on File at Align Technology, as of June 2021.

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 252 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 16.4 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.

For additional information about the Invisalign System or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

Invisalign, iTero, exocad, Align, and Align Digital Platform are trademarks of Align Technology, Inc.

About The Invisalign Palatal Expander System*

The Invisalign Palatal Expander System* is a modern, innovative direct 3D printed orthodontic appliance designed based on proprietary and patented technology. Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch, palate) with primary, mixed (primary and permanent), or permanent dentition during interceptive treatment such as Phase 1 treatment and orthodontic or orthopedic treatment in children, adolescents or adults in conjunction with surgery or other interventions when necessary. Devices are 3D printed and are manufactured based on digital scan data from commercially available iTero® intraoral scanners offered by Align Technology, Ltd. The devices are removable and more hygienic than traditional appliances; manufactured to custom fit each patient’s anatomy for optimal comfort and aesthetics, expanders fit comfortably in the patient’s mouth and changed daily (no screw required).

The System is comprised of Invisalign Palatal Expanders (active expansion, each stage comes with a programmed expansion of 0.25mm/day, changed daily or as per doctor’s discretion) and Invisalign Palatal Holders, (copy of the last stage ​of the expansion designed to hold the maxilla post-active expansion phase, changed every 2-4 weeks as directed by the treating doctor).

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