ALGN News & Events

Align Technology responded to the European Commission's June 30 press release announcing an investigation involving the company based on a complaint made by an Align competitor. "Align Technology is committed to conducting business with integrity and in full compliance with global competition laws," the company said. "We believe fair, lawful competition drives innovation, expands choice, and delivers better outcomes for doctors and patients. Our success in the teeth-straightening market is built on the strength of our products and services - quality, innovation, and customer experience - not on unfair practices, and we strongly dispute any suggestion to the contrary. Align's iTero intraoral scanning platform is designed to support an open and diverse digital dental ecosystem, and supports a wide range of clinical workflows, including implants, restorative dentistry, digital orthodontics, and clear aligner treatment. iTero generated scans can be freely exported to order aligners other than Invisalign aligners. Align maintains a scan acceptance policy designed to ensure clinical quality, patient safety, and system reliability, including validation requirements for digital file submissions and the operational resources needed to support consistent processing across workflows. The iTero intraoral scanning platform is used globally by dental professionals across diverse treatment modalities, with millions of scans performed annually, reflecting its role in enabling a broad and competitive marketplace for digital dentistry solutions. Since 2018, the iTero scanner has been used by healthcare professionals to perform over 24 million restorative, wellness, and orthodontic scans. The Commission's step is purely procedural and allows it to gather information. It does not reflect a conclusion on the merits of the case, nor does it constitute an accusation or a finding of wrongdoing. The opening of an investigation does not prejudge its outcome. Align is confident that any review of Align's scanner and scan acceptance policies will reflect the robust and dynamic nature of the teeth-straightening market and believes its practices comply with applicable competition laws. We will cooperate fully and engage constructively with the Commission through the appropriate channels. For nearly 30 years, Align Technology has helped transform a market long dominated by wires and brackets, offering meaningful choices to customers across Europe and around the world. By introducing innovative digital dentistry solutions that expand treatment possibilities for doctors and their patients, Align has helped doctors transform smiles and change lives for millions of patients, a testament to the value of innovation and better patient experience. What began as an innovation has grown into a widely accepted treatment category, one that now extends beyond Invisalign aligners and iTero scanners across a diverse and competitive ecosystem."

Shares of Align Technology are moving lower after the European Commission said it has opened a formal antitrust investigation to assess whether the company breached European Union competition rules by tying its intra-oral scanners to its dental clear aligners. "This investigation, which follows a complaint by a competitor, is the first formal antitrust investigation in the medical devices sector," the agency said in a statement. The commission is "concerned that Align Technology may have unfairly leveraged its market-leading Invisalign clear aligners, by effectively forcing dental professionals to purchase the iTero scanner if they wish to order Invisalign for their patients." The investigation focuses on Align's "restrictive interoperability strategy," the agency said, citing the company's refusal to approve competing scanners for the automated submission to Align of digital scans for Invisalign orders since 2017 and refusal to accept dental professionals' submissions of scans generated by other intra-oral scanners. Shares of Align Technology are down 4%, or $6.21, to $167.22 in midday trading.