Invisalign® Palatal Expander System by Align Technology Now Available in Australia and New Zealand for Skeletal and Dental Expansion in Growing Patients

Rhea-AI Summary

Align Technology, Inc. announced the commercial availability of Invisalign Palatal Expanders in Australia and New Zealand, offering an innovative and customizable orthodontic solution for patients. The system, featuring 3D printed devices, is designed for early intervention treatment, catering to a wide range of patient demographics. With a focus on digital orthodontics, Align aims to enhance treatment efficiency and patient experience in the Asia Pacific region.

Insights

Dental Industry Analyst

The introduction of the Invisalign Palatal Expander System in Australia and New Zealand represents Align Technology's strategic expansion within the digital orthodontics market. This innovation aligns with the broader industry trend towards minimally invasive and aesthetically pleasing dental solutions. The system's entry into the Australian Register of Therapeutic Goods (ARTG) and New Zealand's Web Assisted Notification of Devices Database (WAND) is a pivotal regulatory milestone, potentially increasing Align's market share in the Asia Pacific region.

From a business perspective, the product diversification may lead to increased revenue streams for Align. The company's ability to cater to a wide age demographic, including children, teens and adults, broadens the potential customer base. Moreover, the combination of the Invisalign Palatal Expander with Invisalign First aligners could enhance treatment efficacy, thereby strengthening brand loyalty among orthodontists and patients.

However, the success of this launch will hinge on the adoption rate by dental professionals and patient preference for this new technology over traditional palatal expanders. It will be important to monitor how Align Technology's investment in research and development translates into actual sales performance in these new markets.

Medical Device Regulatory Affairs Specialist

Align Technology's announcement regarding the Invisalign Palatal Expander System's inclusion in ARTG and WAND is indicative of the company's compliance with stringent regulatory standards. This compliance is essential for market penetration and consumer safety. The medical device industry is tightly regulated and gaining such approvals is a significant step that often precedes market acceptance and can impact the company's reputation and credibility.

For investors, regulatory approvals are a positive sign as they indicate potential for market expansion and growth. However, Align Technology will need to navigate varying regulatory landscapes as it seeks approvals in other APAC markets. The timeline for regulatory approvals can be unpredictable and may affect the speed at which the company can grow its presence in these markets.

Investors should also consider the long-term impact of Align's proprietary AI-driven orthodontic software on the company's competitive edge. The use of such advanced technology could set a new standard in the industry and lead to a more personalized and efficient patient care model.

Healthcare Market Research Analyst

The Invisalign Palatal Expander's launch is well-timed to capitalize on the growing demand for orthodontic treatments among younger demographics in Australia and New Zealand. The system's features, which promote comfort and oral hygiene, are likely to resonate with an increasingly health-conscious consumer base that values non-invasive treatment options.

Market research indicates a shift towards early intervention in orthodontics, with Phase 1 treatments gaining popularity. Align Technology's focus on this segment through the Invisalign Palatal Expander and Invisalign First aligners could drive market growth and increase the company's share of early orthodontic case starts.

However, the market response will depend on several factors, including the effectiveness of Align's marketing strategies, the product's reception by orthodontists and patient outcomes. It will be important to track patient satisfaction and clinical results to assess the long-term viability of the Invisalign Palatal Expander in the competitive landscape of digital orthodontics.

• Invisalign® Palatal Expanders offer doctors an effective and easily removable alternative to traditional palatal expanders, without the need for metal and screws.
• 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.

SYDNEY--(BUSINESS WIRE)-- 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 Align's Invisalign Palatal Expander System* has been included in the Australian Register of Therapeutic Goods (ARTG) and the New Zealand Web Assisted Notification of Devices Database (WAND), and is commercially available in both Australia and New Zealand. The ARTG and WAND entries for Invisalign Palatal Expender System cover broad patient applicability, including growing children, teens and adults (with surgery or other techniques).

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

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 an example of our continuous commitment to innovation by advancing digital orthodontics and delivering products with greater efficiency for doctors and provide better treatment experiences for patients and their parents,” said Raj Pudipeddi, Align Technology chief marketing officer, executive vice president and managing director, Asia Pacific. “We are delighted to introduce the Invisalign Palatal Expander system, Align’s first directly fabricated orthodontic appliance, to the Asia Pacific region.”

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 customised 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*.

“Phase 1 or early interceptive treatment makes up 20 percent of orthodontic case starts each year and is growing,” said Dr. Mitra Derakhshan, Align Technology 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.”

“We are excited to present the Invisalign Palatal Expander system, a significant advancement in the field of digital orthodontics, to our doctor customers in Australia and New Zealand,” said Jonathan Primmer, Align Technology vice president and managing director for Australia and New Zealand. “With the increasing demand for orthodontic treatment among children and teenagers in Australia and New Zealand, the launch of the Invisalign Palatal Expander system allows us to offer a more comprehensive early interceptive treatment solution in conjunction with Invisalign First™, alleviating the most complex challenges with palatal expansion while providing an exceptional patient experience that is both comfortable and supports proper oral hygiene.”

The Invisalign Palatal Expander System is now available in Australia and New Zealand. It is expected to be available in other APAC markets pending regulatory approvals starting in 2024.

*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 over 256 thousand doctor customers worldwide and are key to accessing Align’s 600 million consumer market opportunity worldwide. Over the past 26 years, Align has helped doctors treat over 17 million patients worldwide 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.au. For additional information about the iTero digital scanning system, please visit www.itero.com.au. 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 make it easier for patients to maintain oral hygiene compared to traditional palatal appliances; manufactured to custom fit each patient’s anatomy for optimal comfort and aesthetics, expanders fit comfortably in the patient’s mouth and are 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), Invisalign Attachment Templates and proprietary 3D shape generation software. These products are not available for purchase by the general public. However, the products are available for purchase from Invisalign® trained dentists and orthodontists.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240401790539/en/

Align Technology

Madelyn Valente

(909) 833-5839

mvalente@aligntech.com

Zeno Group

Sarah Johnson

(828) 551-4201

sarah.johnson@zenogroup.com

Source: Align Technology, Inc.

FAQ

What did Align Technology announce regarding Invisalign Palatal Expanders in Australia and New Zealand?

Align Technology announced the commercial availability of Invisalign Palatal Expanders in Australia and New Zealand, offering an innovative orthodontic solution.

What is the purpose of Invisalign Palatal Expanders?

Invisalign Palatal Expanders are intended for rapid expansion and holding of skeletal and dental narrow maxilla in patients during treatment.

How are Invisalign Palatal Expanders customized for patients?

Each Invisalign Palatal Expander device is customised to the patient's unique anatomy based on an iTero intraoral digital scan.

What is the significance of Invisalign First aligners in conjunction with Invisalign Palatal Expanders?

Invisalign First aligners, used in conjunction with Palatal Expanders, provide a full early intervention treatment solution for young patients with common malocclusions.

Where is the Invisalign Palatal Expander System currently available?

The Invisalign Palatal Expander System is currently available in Australia and New Zealand.