Align Technologies ALGN has received a CE Mark in Europe under the Medical Device Regulation (MDR 2017/745) for its Invisalign Palatal Expander System. The system has completed registration with MHRA for the United Kingdom and overseas territories.
The latest developments mark a milestone in the company’s efforts to enhance clinical outcomes and efficiency in orthodontics. Both approvals are for broad patient applicability, including growing children, teens and adults (with surgery or other techniques).
ALGN Stock's Potential Movement Following the News
ALGN shares finished at $223.87 yesterday and edged up 0.5% in the after-hours trading following the announcement. With the company actively commercializing its first direct 3D printed orthodontic appliance to more markets, we expect the latest development to boost market sentiment toward ALGN stock.
Align Technology has a market capitalization of $16.62 billion at present. Going by the Zacks Consensus Estimate, the company’s earnings are likely to increase 7.9% in 2024 on a 3.9% improvement in revenues. In the trailing four quarters, it delivered an earnings beat of 6.18%, on average.
Relevance of ALGN’s Invisalign Palatal Expander System
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 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.
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. A palatal expansion treatment plan and device design are then developed using the company’s proprietary AI-driven orthodontic software.
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The Invisalign Palatal Expanders, along with Invisalign First aligners, offer a full early intervention treatment solution for Phase 1 treatment, an early interceptive orthodontic treatment in patients aged six through 10. 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.
Align Technology expects to commercially avail the System across the EMEA in the first quarter of 2025. At present, it is available in the United States, Canada, Australia, New Zealand, Hong Kong and Singapore.
Industry Prospects Favoring ALGN
Per a Research report, the global 3D printing market is valued at $3.1 billion in 2023 and is expected to witness a compound annual rate of 26.4% through 2030. 3D printing dentistry has established a strong position in today’s dental products due to the combination of state-of-the-art technology and a potential footprint.
Other Developments in ALGN
Last month, the company unveiled the next innovation of Invisalign Smile Architect software, now with Multiple Treatment Plans, allowing doctors to visually compare and modify orthodontic-only and ortho-restorative treatment plans side-by-side. The Multiple Treatment Plans are integrated into ClinCheck treatment planning software for doctors to visually compare, review and choose the best treatment option for each patient.
ALGN Stock Price Performance
In the past month, ALGN shares have risen 6.2% compared with the industry’s 4.9% growth.
ALGN’s Zacks Rank and Key Picks
Align Technologies currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the broader medical space are Penumbra PEN, Haemonetics HAE and Globus Medical GMED, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Penumbra’s shares have risen 16.4% in the past year. Estimates for the company’s 2024 earnings per share have jumped 8.1% to $2.79 in the past 30 days. PEN’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, the average surprise being 10.54%. In the last reported quarter, it posted an earnings surprise of 23.19%.
Estimates for Haemonetics’ fiscal 2025 earnings per share have jumped 0.4% to $4.59 in the past 30 days. Shares of the company have rallied 14% in the past year against the industry’s 0.7% fall. HAE’s earnings surpassed estimates in three of the trailing four quarters and missed in one, the average surprise being 2.82%. In the last reported quarter, it delivered an earnings surprise of 2.75%.
Estimates for Globus Medical’s 2024 earnings per share have increased 0.4% to $2.95 in the past 30 days. Shares of the company have surged 14% in the past year against the industry’s 4.1% fall. GMED’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 17.65%. In the last reported quarter, it delivered an earnings surprise of 27.69%.
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