Align's (ALGN) Invisalign Palatal Expander System Gets FDA Nod
Align Technology, Inc. ALGN announced the FDA clearance for Align’s Invisalign Palatal Expander System for commercial availability in the United States. The FDA 510(k) clearance is for broad patient applicability, including growing children, teens and adults (with surgery or other techniques).
The Invisalign Palatal Expander System is only accessible in Canada and the United States on a limited basis. It is likely to be offered in other areas beginning in 2024, subject to regulatory approvals.
More on Invisalign Palatal Expander System
The Invisalign Palatal Expander System, previously announced at the Align Technology Investor Day in September 2023, is a modern and unique direct 3D printed device based on proprietary and patented technology.
The Invisalign Palatal Expander is Align's first direct 3D printed orthodontic device, and it offers a safe, pleasant, and clinically effective alternative to traditional palatal expanders, which need the patient to physically spin a screw in the device in the mouth every day to accomplish expansion.
Invisalign Palatal Expanders, when combined with Invisalign FirstTM aligners, provide clinicians with a complete early intervention treatment solution for Phase 1 therapy, an early interceptive orthodontic treatment for young patients.
Benefits of Invisalign Palatal Expander System
The most recent advancement in digital orthodontics is the Invisalign Palatal Expander System, which is built on patented and proprietary technology. It is intended for treating children and teenagers, such as Invisalign First aligners and Mandibular Advancement treatment.
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With the Invisalign Palatal Expanders, a patient's narrow maxilla can be expanded to a position specified by their treating physician through a succession of detachable devices that are staged in tiny movement increments. Utilizing an iTeroTM intraoral digital scan, each direct 3D printed device is tailored to the specific anatomy of the patient.
Physicians can address the most common skeletal and dental malocclusions in growing children with the use of Invisalign Palatal Expanders in conjunction with Invisalign First aligners. When it comes to addressing skeletal and dental imbalances, jaw correction and bite correction for their growing teenage patients, doctors now have additional alternatives thanks to the mandibular advancement capabilities included in Invisalign aligners.
Industry Prospects
Per a report by Precedence Research, the global orthodontics market size was valued at USD 16.90 billion in 2022 and is expected to reach more than $53.78 billion by 2032 and poised to witness a CAGR of 12.3% from 2023 to 2032. The market is primarily driven by the growing prevalence of malocclusion, rising awareness regarding dental problems, technological advancements in orthodontic treatments and a surging number of dentists across the globe.
Progress Within Invisalign Portfolio
In the third quarter of 2023, the company successfully continued to roll out the Invisalign Comprehensive Three and Three product in APAC, where it is now available in China, Hong Kong, Korea, Taiwan and India. Instead of unlimited additional aligners within five years of the treatment end date, the latest configuration offers Invisalign comprehensive treatment with three additional aligners included within three years of the treatment end date.
Align Technology also launched the Invisalign Palatal Expander System, an advanced direct 3D printed device based on a proprietary and patented technology.
Price Performance
In the past year, ALGN’s shares have gained 30.4% compared with the industry’s rise of 10.9%.
Zacks Rank and Key Picks
Align Technology currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Haemonetics HAE, Insulet PODD and DexCom DXCM. While Haemonetics and DexCom each carry a Zacks Rank #2 (Buy), Insulet sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Haemonetics’ shares have increased 11.6% in the past year. Earnings estimates for Haemonetics have increased from $3.82 to $3.86 in 2023 and $4.07 to $4.11 in 2024 in the past 30 days.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.1%. In the last reported quarter, it posted an earnings surprise of 5.3%.
Estimates for Insulet’s 2023 earnings per share have increased from $1.61 to $1.90 in the past 30 days.
PODD’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 105.1%. In the last reported quarter, it delivered an average earnings surprise of 77.4%.
Estimates for DexCom’s 2023 earnings per share have increased from $1.23 to $1.41 in the past 30 days. The stock has fallen 7.8% in the past year compared with the industry’s decline of 7.1%.
DXCM’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 36.4%. In the last reported quarter, it delivered an average earnings surprise of 47.1%.
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Align Technology, Inc. (ALGN) : Free Stock Analysis Report
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