TORONTO & LAS VEGAS & SAN JOSE, Calif. & TEMPE, Ariz.--(BUSINESS WIRE)--Align Technology, Inc. (“Align”) (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 introduced the Invisalign® Palatal Expander System,* a modern and innovative direct 3D printed device based on a proprietary and patented technology.

多伦多和拉斯维加斯以及加利福尼亚州圣何塞和亚利桑那州坦佩（BUSINESS WIRE）-Align Technology，Inc.（“Align”）（纳斯达克：ALGN），这是一家领先的全球医疗器械公司，负责设计，制造并销售clear aligners的Invisalign®系统iTero™ 口内扫描仪和exocad™ 用于数字正畸和修复牙科的CAD/CAM软件今天推出了Invisalign®腭扩张器系统，*一种基于专有和专利技术的现代创新直接3D打印设备。

Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw) with primary, mixed, or permanent dentition during treatment of growing patients. The Invisalign Palatal Expander is Align’s first direct 3D printed orthodontic device and provides a safe, comfortable, and clinically effective** alternative to metal palatal expanders that require manually turning a screw in the device in the mouth daily to achieve expansion..

Invisalign腭扩张器用于快速扩张和随后在生长患者的治疗期间用原发性，混合性或永久性牙列保持骨骼和/或牙齿狭窄的上颌骨（上颌）。Invisalign腭扩张器是Align的第一个直接3D打印正畸装置，可提供安全，舒适和临床有效的**替代金属腭扩张器，需要每天手动转动口中装置的螺钉以实现扩张。。

Speaking from the company’s 2023 Investor Day in Las Vegas, Srini Kaza, Align senior vice president of product research & development said, “I am very proud to unveil the Invisalign Palatal Expander System, our latest innovation in digital orthodontics based on proprietary and patented technology that builds on many industry firsts designed for treatment of children and teens, including Invisalign treatment with Mandibular Advancement and Invisalign First aligners.

Align产品研发高级副总裁在拉斯维加斯Srini Kaza的2023投资者日发表演讲时说，“我非常自豪地推出了Invisalign腭扩张器系统，这是我们基于专有和专利技术的数字正畸技术的最新创新，该技术建立在许多专为儿童和青少年治疗而设计的行业领先的基础上，包括Invisalign治疗下颌前移和Invisalign First aligners。

It is extremely rewarding for our team of engineers and material scientists to produce Align’s first directly fabricated orthodontic appliance and pave the way for future innovation using direct 3D printing technology that enables more sustainable and efficient solutions.”.

对于我们的工程师和材料科学家团队来说，生产Align的第一个直接制造的正畸矫治器并为使用直接3D打印技术的未来创新铺平道路，从而实现更可持续和高效的解决方案非常有益。

The Invisalign Palatal Expander 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™ digital scan.

Invisalign腭扩张器系统由一系列可移动装置组成，这些装置以小的运动增量进行分级，以将患者的狭窄上颌骨扩展到由治疗医生确定的位置。每个直接3D打印设备都基于iTero根据患者的独特解剖结构进行定制™ 数字扫描。

A palatal expansion treatment plan and device design are then developed using Align’s proprietary AI-driven orthodontic software..

然后使用Align专有的AI驱动的正畸软件开发腭扩张治疗计划和设备设计。。

Phase 1 treatment is early interceptive orthodontic treatment for young patients, traditionally done through arch expanders or partial metal braces, before all permanent teeth have erupted – typically at ages 6 through 10. Invisalign First clear aligners are designed specifically to address a broad range of younger patients’ malocclusions, including shorter clinical crowns, management of erupting dentition, and predictable dental arch expansion..

第一阶段的治疗方法是对年轻患者进行早期拦截性正畸治疗，传统上是在所有恒牙萌出之前（通常在6至10岁）通过牙弓扩张器或部分金属牙套完成。Invisalign First clear Aligner专为解决广泛的年轻患者咬合不正而设计，包括较短的临床牙冠，喷发牙列的管理以及可预测的牙弓扩张。。

“Phase 1 or early interceptive treatment makes up 20 percent of orthodontic case starts each year and is growing,” said Dr. Mitra Derakhshan, Align senior vice president, Global Clinical. “Together with Invisalign First aligners, Invisalign Palatal Expanders provide doctors with a solution set to treat the most common skeletal and dental malocclusions in growing children.

全球临床Align高级副总裁Mitra Derakhshan博士说：“第一阶段或早期拦截治疗占每年正畸病例的20%并且正在增长。”。“与Invisalign First Aligner一起，Invisalign腭扩张器为医生提供了一套解决方案，用于治疗成长中儿童最常见的骨骼和牙齿错牙合。

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.”.

Invisalign对准器增加了下颌前移功能，也为医生提供了更多选择，用于治疗青少年时期不断增长的患者的骨骼和牙齿下颌不平衡和咬合矫正“。

“The Invisalign Palatal Expander System is a game changer, as it alleviates the most common challenges with palatal expansion, including maintaining proper hygiene, emergency appointments, turning the screw, and the parent’s fear of causing pain to the child in treatment,” said Dr. Sandra Tai, an orthodontist in Vancouver, Canada and participant in Align's Invisalign Palatal Expander System limited release program.

温哥华正畸医生Sandra Tai博士说：“Invisalign腭扩张器系统可以改变游戏规则，因为它可以缓解腭扩张最常见的挑战，包括保持适当的卫生习惯，紧急预约，转动螺钉以及父母担心给治疗中的孩子带来痛苦。”，加拿大和Align的Invisalign腭扩张器系统有限释放计划的参与者。

“It’s removable and supports oral hygiene while delivering a clinically effective and comfortable treatment experience for growing patients that achieves high satisfaction rates reported by parents.”.

“它是可移动的，支持口腔卫生，同时为成长中的患者提供临床有效和舒适的治疗体验，实现父母报告的高满意率。”。

The Invisalign Palatal Expander System is currently available on a limited basis in Canada (excluding Quebec) and is expected to be available in other markets pending regulatory approvals starting in 2024.

Invisalign腭扩张器系统目前在加拿大（不包括魁北克省）有限供应，预计将于2024年开始在其他市场上市，等待监管部门批准。

The Invisalign Palatal Expander System is pending pre-market notification (510(k) submission) to the U.S. Food and Drug Administration and is not yet available in the United States.

Invisalign腭扩张器系统正在等待美国食品和药物管理局的上市前通知（510（k）提交），目前尚未在美国提供。

*Data on file, Align Technology, as of August 2023.

*数据存档，Align Technology，截至2023年8月。

** Data on file, Align Technology, as of August 2023.

**数据存档，Align Technology，截至2023年8月。

Based on data from a multi-site US Early Feasibility Investigational Device Exemption (IDE) clinical study (n=29 subjects, ages 7-10 years) of expansion treatment with Invisalign® Palatal Expanders.

基于来自多站点美国早期可行性研究设备豁免（IDE）临床研究（n=29名受试者，年龄7-10岁）的数据，使用Invisalign®腭扩张剂进行扩张治疗。

About Align Technology, Inc.

关于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 approximately 247 thousand doctor customers and are key to accessing Align’s 600 million consumer market opportunity worldwide.

对齐技术设计和制造Invisalign®系统，这是世界上最先进的清晰对齐系统iTero™ 口内扫描仪和服务，以及exocad™ CAD/CAM软件。这些技术构建模块可增强数字正畸和修复工作流程，为大约24.7万医生客户改善患者结果和实践效率，并且是全球获得Align 6亿消费者市场机会的关键。

Over the past 26 years, Align has helped doctors treat over 15.7 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.

在过去的26年中，Align帮助医生使用Invisalign系统治疗超过1570万患者，并通过Align数字平台推动数字牙科的发展™, 我们的独特专有技术和服务集成套件，为患者和消费者，正畸医生和GP牙医以及实验室/合作伙伴提供无缝，端到端的解决方案。

Visit www.aligntech.com for more information..

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..

有关Invisalign系统的更多信息或在您所在地区寻找Invisalign医生，请访问www.Invisalign.com。有关iTero数字扫描系统的更多信息，请访问www.iTero.com。有关exocad dental CAD的更多信息/CAM产品和exocad经销商合作伙伴名单，请访问www.exocad.com。。

Invisalign, iTero, exocad, Align, and Align Digital Platform are trademarks of Align Technology, Inc.

Invisalign，iTero，exocad，Align和Align Digital Platform是Align Technology，Inc。的商标。

About The Invisalign Palatal Expander System*

关于Invisalign腭扩张器系统*

Invisalign Palatal Expander System* is a modern, innovative direct 3D printed orthodontic appliance designed based on proprietary and patented technology. Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch, palate) with primary, mixed (primary and permanent), or permanent dentition during interceptive treatment such as Phase 1 treatment and orthodontic or orthopedic treatment in children or adolescents.

Invisalign腭扩张器系统*是一款基于专有和专利技术设计的现代创新直接3D打印正畸矫治器。Invisalign腭扩张器用于在拦截治疗期间快速扩张和随后保持骨骼和/或牙齿狭窄的上颌骨（上颌，牙弓，腭），具有初级，混合（初级和永久）或永久性牙列，例如阶段1儿童或青少年的治疗和正畸或骨科治疗。

Devices are 3D printed and are manufactured based on digital scan data from commercially available iTero® intraoral scanners offered by Align Technology, Ltd. The devices are removable and more hygienic than traditional appliances; manufactured to custom fit each patient’s anatomy for optimal comfort and aesthetics, expanders fit comfortably in the patient’s mouth and changed daily (no screw required)..

设备是3D打印的，并且基于来自Align Technology，Ltd。提供的市售iTero®口内扫描仪的数字扫描数据制造。这些设备比传统器具可拆卸且更卫生；为了定制每个患者的解剖结构以获得最佳的舒适性和美观性，扩张器可以舒适地安装在患者的嘴中，并且每天更换（不需要螺钉）。。

*The System is comprised of Invisalign Palatal Expanders (active expansion, each stage comes with a programmed expansion of 0.25mm/day) and Invisalign Palatal Holders (holders, changed every 2-4 weeks).

*该系统由Invisalign腭扩张器（主动扩张，每个阶段都有0.25mm/天的程序扩展）和Invisalign腭支架（支架，每2-4周更换一次）组成。