Align Technologies (ALGN) Secures Updated Medical Device License
Align Technologies ALGN received an updated medical device license from Health Canada for its Invisalign Palatal Expander system for broad patient applicability, including growing children, teens and adults (with surgery or other techniques). The system was unveiled at the company’s 2023 Investor Day in September and is presently available on a limited basis in Canada.
The Invisalign Palatal Expander system is pending the FDA’s 510(k) submission and is not yet available in the United States. ALGN is revolutionizing digital dentistry through the Align Digital Platform, an integrated suite of proprietary technologies and services designed to deliver a seamless, end-to-end solution for patients and consumers, orthodontists, general practitioners (GP) dentists and lab partners.
About the Invisalign Palatal Expander System
The Invisalign Palatal Expander is designed based on the company’s proprietary and patented technology. The modern, innovative direct 3D printed orthodontic appliance 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. These 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 the treatment of patients.
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The 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. Following this, a palatal expansion treatment plan and device design are developed using Align Technology’s proprietary AI-driven orthodontic software.
The Invisalign Palatal Expander system is expected to be available in other markets pending regulatory approvals beginning 2024.
Strategic Advantages
With the launch of Invisalign Palatal Expanders, ALGN intends to increase market opportunity in the teen market by addressing a portion of cases that were otherwise not possible to treat without these devices. The system eases the usual challenges associated with palatal expansion, including maintaining proper hygiene, emergency appointments, turning the screw and the parents’ fear of causing pain to their child in treatment.
Combined with Invisalign First aligners, Invisalign Palatal Expanders provides doctors with a full early intervention treatment solution for Phase 1 treatment, which makes up 20 percent of orthodontic cases starting each year. The early interceptive treatment is typically done at ages six through ten, through arch expanders or partial metal braces, before all permanent teeth have erupted. 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.
Industry Prospects
Per a Research report, the 3D printing market is valued at $15 billion in 2023 and is expected to witness a CAGR of 18.1% till 2028.
Other Notable Developments
The company is transforming orthodontic treatment through the adoption of next-generation tools and customized treatment plans based on years of research and intelligence from millions of patients treated with the Invisalign System. At the foundation of this goal lies the Align Digital Platform, which utilizes the Align Digital Workflow, comprising dedicated tools and capabilities for each stage of the Invisalign treatment journey.
In September 2023, ALGN introduced the Plan Editor tool in the Plan stage of the Align digital workflow. This enables enhanced flexibility and customization in Invisalign treatment planning for Invisalign-trained orthodontists and GP dentists. The company also launched new software innovations — the Align Oral Health Suite and iTero-exocad Connector — to accelerate digital practice transformation.
Price Performance
In the past six months, ALGN shares have lost 22.1% compared with the industry’s fall of 2.2%
Zacks Rank and Key Picks
Align Technologies currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Haemonetics HAE, Insulet PODD and DexCom DXCM. Haemonetics and DexCom carry a Zacks Rank #2 (Buy) each, while Insulet sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
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