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Align Technology Among Top 300 Worldwide Organizations Granted U.S. Patents in 2023

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Align Technology, Inc. (NASDAQ: ALGN) has been included in the Intellectual Property Owners Association annual report of the top 300 organizations granted U.S. patents. In 2023, Align is at position #270, with 158 U.S. patents granted, a 36% increase compared to 2022. The patents cover technologies that revolutionize the field of orthodontics and digital dentistry. The recognition reflects Align's investment in developing next-generation devices and technology that provide what their doctor customers want and need for their patients.
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Align Technology's significant increase in granted U.S. patents reflects a strategic emphasis on innovation and intellectual property (IP) as a competitive advantage. This development is likely to bolster investor confidence in Align's commitment to maintaining and expanding its market leadership in digital orthodontics and restorative dentistry. The surge in patents, particularly in technologies like AI for treatment planning and direct 3D printed devices, indicates potential new revenue streams and the strengthening of Align's product portfolio.

The company's focus on enhancing customer experience with products like the iTero Lumina intraoral scanner, which promises improved scanning speed and comfort, could translate into increased adoption rates by dental professionals. This adoption underpins future sales growth and could positively influence Align's market share and financial performance. However, the costs associated with R&D and IP protection should be monitored as they might impact profit margins.

With Align Technology's substantial investment in R&D culminating in a 36% increase in patents, there is a clear signal of the company's intent to lead in regulatory innovation. The granted patents, particularly for products like Invisalign Palatal Expanders and iTero Lumina intraoral scanners, suggest that Align is not only expanding its technological capabilities but also ensuring that these innovations meet stringent U.S. regulatory standards.

For stakeholders, this can mean a more robust defense against competitive pressures and potential market expansion due to regulatory compliance. However, the global regulatory landscape is diverse and Align must navigate each region's unique requirements to fully capitalize on its IP portfolio. The long-term success of these patented technologies will depend on their global regulatory approval and subsequent market acceptance.

The announcement of Align Technology's increased patent portfolio is a clear indicator of the company's aggressive growth strategy through innovation. The financial implications of this growth can be multi-faceted. On one hand, the development of cutting-edge products can lead to increased sales and market differentiation. On the other hand, the amortization of the associated R&D costs might affect short-term earnings.

Investors should consider the potential for these patents to act as barriers to entry for competitors, which could secure Align's market position and lead to sustained long-term profitability. Nevertheless, the cost of maintaining and defending this IP on a global scale is substantial and must be weighed against the expected future cash flows generated by these innovations.

Intellectual Property Owners Association Annual Report Lists 158 U.S. Patents Granted to Align in 2023 – a 36% Increase from 2022

TEMPE, Ariz.--(BUSINESS WIRE)-- Align Technology, Inc. (NASDAQ: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign® system of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, today announced that for the first time, Align Technology is included in the Intellectual Property Owners Association annual report of the top 300 organizations granted U.S. patents. For 2023, Align is at position #270, with 158 U.S. patents granted, a 36% increase compared to 2022.

“We’re pleased to be among the top worldwide organizations creating new possibilities through proven research in their industries,” said Julie Coletti, Align executive vice president, chief legal and regulatory officer. “Developing new solutions that delight our customers fuels Align’s purpose to transform smiles and change lives. Our patient-focused research and development programs have led to innovations designed to deliver world-class products that doctors and their patients trust to create better smiles.”

The patents granted by the United States Patent and Trademark Office cover technologies that revolutionize the field of orthodontics and digital dentistry, through advancements in clear aligners, intraoral scanners, direct 3D printed orthodontic devices, restorative CAD/CAM software, and artificial intelligence (AI) in treatment planning. These patents include notable coverage for recently introduced groundbreaking products, such as:

  • iTero™ Lumina intraoral scanner: The next generation of digital scanning technology that pushes the boundaries of what intraoral scanners can do and sets a new standard for practice performance. ​New proprietary iTero Multi-Direct Capture™ technology offers 3x wider field of capture1, high accuracy5 and maximum capture distance of 25 mm** for a smooth scanning experience for users and patients. Photorealistic scans enable high quality clinical decisions the same way intraoral photos do3.​ Advanced software enabling effortless, uninterrupted, and flexible scanning experience at 2x the speed4 ​in a 50% smaller2 wand for a more comfortable6 experience, for adults, kids, and teens alike.​ The iTero Lumina™ intraoral scanner is available in both cart and mobile configurations on the iTero Plus Series platform.
  • Invisalign® Palatal Expanders: Align’s first direct 3D printed orthodontic device provides a safe, comfortable, and clinically effective* alternative to traditional palatal expanders that require manually turning a screw in the device in the mouth daily to achieve expansion.

“Align has invested approximately $2B in R&D for nearly 27 years, and our dedicated team of research scientists and engineers has continuously expanded the possibilities of digital dentistry through transformative innovations in 3D computer modeling, material science, and biomechanics that moves this industry forward and helps doctors transform smiles and change the lives of their patients,” said Srini Kaza, Align senior vice president, product research & development. “The recognition on this list of top patent producers reflects our investment in developing next generation devices and technology that provide what our doctor customers want and need for their patients.”

1. Compared to the field of view of the iTero Element™ 5D imaging system, when the iTero Lumina™ intraoral scanner’s scanning distance is 12 mm.*
2. Compared to iTero Element™ 5D imaging system wand, excluding the wand cable.*
3. For Invisalign record-taking cases only. Based on a survey in September 2023 of n=22 users who participated in a global limited market release, working with iTero Lumina™ intraoral scanner for an average period of 6 months, representing both Invisalign trained general practitioners and orthodontists in NA, EU and APAC, who were presented with a 4 point level of agreement scale from strongly agree to strongly disagree with the following statement: “iTero Lumina™ intraoral scanner 3D model is comparable to that of an intraoral photo.” and “iTero Lumina™ intraoral scanner photorealistic scans enable orthodontic clinical assessment the same way intraoral photos do.” and “iTero Lumina™ intraoral scanner 3D model’s superior 3D model eliminates the need to take intraoral photos.” and “iTero Lumina™ intraoral scanner 3D model’s superior 3D model boosts patient engagement.”*
4. Compared to iTero Element™ 5D wand with tolerance AVE=±0.1 operating at a working distance from 0-20 mm.*
5. The iTero Lumina™ intraoral scanner has scientifically proven greater accuracy* for your clinical orthodontic needs.
6. For doctors and their staff: Over other iTero™ scanners in their respective clinics. Based on a survey in September 2023 of n=22 users who participated in a global limited market release, working with iTero Lumina™ intraoral scanner for an average period of 6 months, representing both Invisalign® trained general practitioners, orthodontists, and their staff in NA, EMEA and APAC, who were presented with a 4 point level of agreement scale from strongly agree to strongly disagree with the following statement: “I prefer the iTero Lumina™ intraoral scanner over other iTero scanners in my clinic due to the comfortable scanning experience it provides. For patients: Compared to iTero Element™ 5D imaging system wand.
*Compared to the accuracy of the iTero Element™ 5D imaging system.
**Data on file at Align Technology, as of November 15, 2023.

*Based on a survey in August 2023 in Canada of 10 Invisalign trained orthodontists who participated in the Invisalign Palatal Expander System Technical Design Assessment and have treated at least 1 patient age 6-11 years with IPE. Data on file at Align Technology, Inc. as of October 30, 2023.

About Align Technology, Inc.

Align Technology designs and manufactures the Invisalign® system, the most advanced clear aligner system in the world, iTero™ intraoral scanners and services, and exocad™ CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 256 thousand doctor customers and is key to accessing Align’s 600 million consumer market opportunity worldwide. Over the past 26 years, Align has helped doctors treat approximately 17 million patients with the Invisalign system and is driving the evolution in digital dentistry through the Align Digital Platform™, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

Align Technology

Madelyn Valente

(909) 833-5839

mvalente@aligntech.com

Zeno Group

Sarah Johnson

(828) 551-4201

sarah.johnson@zenogroup.com

Source: Align Technology, Inc.

Align was granted 158 U.S. patents in 2023, representing a 36% increase from 2022.

The patents cover technologies that revolutionize the field of orthodontics and digital dentistry, including advancements in clear aligners, intraoral scanners, direct 3D printed orthodontic devices, restorative CAD/CAM software, and artificial intelligence (AI) in treatment planning.

Align is at position #270 in the Intellectual Property Owners Association annual report of the top 300 organizations granted U.S. patents.

The ticker symbol for Align Technology, Inc. is ALGN.

The iTero Lumina intraoral scanner is the next generation of digital scanning technology that offers a 3x wider field of capture, high accuracy, and maximum capture distance of 25 mm for a smooth scanning experience for users and patients.

Invisalign Palatal Expanders are Align's first direct 3D printed orthodontic device that provides a safe, comfortable, and clinically effective alternative to traditional palatal expanders.

Align has invested approximately $2B in R&D for nearly 27 years, leading to transformative innovations in 3D computer modeling, material science, and biomechanics.

Julie Coletti is the executive vice president, chief legal and regulatory officer of Align Technology, Inc.
Align Technology, Inc.

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About ALGN

align technology is a global medical device company with industry-leading innovative products -- invisalign clear aligners and itero intraoral scanners -- that help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients. invisalign system invisalign clear aligners have been used to straighten teeth and treat minor to complex malocclusion for more than 3 million patients worldwide. the invisalign system is a combination of proprietary virtual modeling software and rapid mass-manufacturing processes used to develop a treatment plan and with custom-made aligners for each patient. invisalign is prescribed to patients through invisalign-trained orthodontists and general practitioner dentists (gp) and is offered in over 90 countries. learn more at www.invisalign.com itero intraoral scanner the itero scanner’s parallel confocal imaging technology uses optical and laser scanning to achieve a high level of precisi