ROTKREUZ, Switzerland - Align Technology , Inc. (NASDAQ:ALGN), a prominent medical device company, has announced the receipt of the CE Mark in Europe for its Invisalign® Palatal Expander System. The product has also completed registration with the United Kingdom (TADAWUL:4280)'s Medicines and Healthcare products Regulatory Agency (MHRA). These regulatory milestones allow for the broad use of the device, catering to children, teens, and adults, including those requiring surgical interventions.
The Invisalign Palatal Expander System is a direct 3D printed device designed for the orthodontic treatment of patients with a narrow upper jaw. It represents Align Technology's commitment to advancing digital orthodontics by offering greater efficiency for healthcare providers and improved treatment experiences for patients. The system includes a series of removable devices, each customized to the patient's specific anatomy using an iTero™ intraoral digital scan and Align's orthodontic software.
Align Technology's portfolio for early orthodontic intervention, which includes the Invisalign First™ aligners, now provides a comprehensive treatment solution for Phase 1 treatment in young patients. This phase typically involves managing malocclusions in children aged 6 through 10, before all permanent teeth have emerged.
The Invisalign Palatal Expander System, along with Invisalign First aligners, equips doctors to address common skeletal and dental malocclusions in growing children. Additionally, the Invisalign aligners with mandibular advancement features offer more options for treating jaw imbalances and bite correction in teenagers.
Align Technology's products are instrumental in digital orthodontic and restorative workflows, aiming to improve patient outcomes and practice efficiencies. The company supports over 271 thousand doctor customers and has treated approximately 18.9 million patients with the Invisalign System over the past 27 years.
The Invisalign Palatal Expander System is anticipated to be commercially available across the EMEA region in Q1 2025. Currently, the system is available in the U.S., Canada, Australia, New Zealand, Hong Kong, and Singapore, with plans to expand to additional markets subject to regulatory approval.
This news is based on a press release statement from Align Technology, Inc.
In other recent news, Align Technology reported a slight increase in Q3 2024 revenues, rising 1.8% year-over-year to $978 million. Clear Aligner volumes grew by 2.5% to 617,000, primarily due to expansion in international markets. The company has announced a plan to repurchase $275 million of its common stock, which is part of a larger $1.0 billion stock repurchase program. Analyst firms Piper Sandler, Needham, and Stifel maintained their ratings on Align Technology, despite reducing the price target to $275.
Piper Sandler's recent analysis shows mixed signals in the orthodontic industry, with teen clear aligner volumes experiencing a year-over-year rebound but still falling behind braces and wires. Despite the mixed results, the firm emphasized the long-term potential of Align Technology. Align Technology's adoption of direct 3D printing technology and upcoming product launches are expected to contribute to future growth. The company also plans to implement a restructuring program aimed at operational margin expansion in 2025. These are among the recent developments in the company.
InvestingPro Insights
Align Technology's recent regulatory achievements in Europe for its Invisalign® Palatal Expander System reflect the company's ongoing innovation and market expansion efforts. This development aligns with several key financial metrics and insights from InvestingPro.
According to InvestingPro data, Align Technology boasts a market capitalization of $16.7 billion, underscoring its significant presence in the medical device industry. The company's revenue for the last twelve months as of Q3 2024 stood at $3.96 billion, with a modest revenue growth of 4.03% over the same period. This growth, albeit slow, indicates the company's ability to maintain its market position and potentially benefit from new product launches like the Invisalign Palatal Expander System.
Align Technology's gross profit margin of 70.32% for the last twelve months as of Q3 2024 demonstrates its strong pricing power and efficient cost management. This robust margin could provide the financial flexibility needed to support the commercialization of new products across different markets.
InvestingPro Tips highlight that management has been aggressively buying back shares, which could signal confidence in the company's future prospects. Additionally, analysts predict that the company will be profitable this year, which is encouraging given the recent product developments and market expansions.
It's worth noting that Align Technology operates with a moderate level of debt, potentially allowing for investment in research and development to fuel future innovations like the Invisalign Palatal Expander System.
For investors considering Align Technology, it's important to be aware that the stock is trading at a high P/E ratio of 37.87, which may reflect market expectations for growth from new product lines. The company's stock price movements are also quite volatile, which could present both opportunities and risks for investors.
InvestingPro offers 10 additional tips for Align Technology, providing a more comprehensive analysis for those interested in delving deeper into the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.