ROTKREUZ, Switzerland – Alignment technology Inc. (NASDAQ: ), a leading medical device company, announced the receipt of the CE Mark in Europe for the Invisalign® Palatal Expander System. The product has also completed United registration Kingdom (TADAWUL:) of the Medicines and Healthcare products Regulatory Agency (MHRA). These regulatory milestones allow for widespread use of the device, which targets children, adolescents and adults, including those requiring surgical procedures.
The Invisalign Palatal Expander System is a direct 3D printed appliance designed for the orthodontic treatment of patients with a narrow maxilla. It represents Align Technology’s commitment to advancing digital orthodontics, bringing greater efficiency to healthcare providers and improved treatment experiences for patients. The system includes a series of removable appliances, each tailored to the patient’s specific anatomy using an iTero™ intraoral digital scan and Align’s orthodontic software.
Align Technology’s early intervention orthodontic portfolio, which includes Invisalign First™ aligners, now provides a comprehensive treatment solution for Phase 1 treatment in young patients. This phase usually involves management of anomalies in children aged 6 to 10 years, before all permanent teeth have erupted.
The Invisalign Palatal Expander System, along with Invisalign First aligners, equips doctors to address common skeletal and dental abnormalities in growing children. In addition, Invisalign aligners with mandibular advancement features offer more options for treating jaw imbalances and bite correction in teenagers.
Align Technology’s products play a critical role in orthodontic and restorative digital workflows to improve patient outcomes and practice efficiency. The company supports over 271 thousand physician clients and has treated approximately 18.9 million patients with the Invisalign system over the past 27 years.
The Invisalign Palatal Expander System is expected to be commercially available across EMEA in Q1 2025. The system is currently available in the US, Canada, Australia, New Zealand, Hong Kong and Singapore, with plans to expand into additional markets subject to regulatory approval.
This news is based on a press release from Align Technology, Inc.
In other recent news, Align Technology reported a slight increase in third quarter 2024 revenue, up 1.8% year-over-year to $978 million. Clear Aligner volumes increased 2.5% to 617,000, primarily due to expansion in international markets. The company announced a plan to repurchase $275 million of its common stock, which is part of a larger $1.0 billion share repurchase program. Analysts Piper Sandler, Needham and Stifel maintained their ratings on Align Technology, despite lowering their price target to $275.
Piper Sandler’s recent analysis shows mixed signals in the orthodontic industry, with teen net aligner volumes rebounding year-over-year but still lagging behind braces and wires. Despite the mixed results, the company 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 expanding the operating margin in 2025. These are among the recent developments at the company.
InvestingPro Insights
Align Technology’s recent regulatory achievements in Europe for the Invisalign® Palatal Expander System reflect the company’s continued efforts to innovate and expand the market. This development is in line with many 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 trailing twelve months from Q3 2024 was $3.96 billion, with modest revenue growth of 4.03% over the same period. This growth, although slow, shows the company’s ability to maintain its position in the market and potentially benefit from the launch of new products such as the Invisalign Palatal Expander System.
Align Technology’s gross profit margin of 70.32% for the trailing twelve months from Q3 2024 demonstrates its strong pricing power and effective cost management. This strong margin could provide the financial flexibility needed to support the commercialization of new products in different markets.
InvestingPro Tips highlights that management is aggressively buying shares, which could signal confidence in the company’s future prospects. Additionally, analysts predict the company will be profitable this year, which is encouraging given recent product developments and market expansions.
It’s worth noting that Align Technology operates with a modest level of debt, potentially allowing for research and development investments to fuel future innovations like the Invisalign Palatal Expander System.
For investors considering Align Technology, it’s important to know that the stock trades at a high P/E ratio of 37.87, which may reflect market expectations for growth from new product lines. The company’s share price movements are also quite volatile, which could present opportunities and risks for investors.
InvestingPro offers 10 additional tips for Align Technology, providing a more comprehensive analysis for those interested in delving into a company’s financial health and market position.
This article was created with the support of artificial intelligence and reviewed by an editor. For more information, see our Terms and Conditions.
