ROTKREUZ, Switzerland--(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 announced that it has received CE Mark in Europe under the Medical Device Regulation (MDR 2017/745) for Align’s Invisalign® Palatal Expander System.

瑞士罗特克鲁兹——（商业新闻短讯）——Align Technology，Inc.（“Align”）（纳斯达克：ALGN）是一家领先的全球医疗器械公司，设计、制造和销售用于数字正畸和修复牙科的Invisalign®透明对准器系统、iTero™口内扫描仪和exocad™CAD/CAM软件，今天宣布已根据《医疗器械条例》（MDR 2017/745）在欧洲获得Align的Invisalign®腭扩张器系统CE标志。

The Invisalign Palatal Expander System has also completed registration with MHRA for the United Kingdom and overseas territories..

Invisalign腭扩张器系统也已在英国和海外地区的MHRA完成注册。。

Both approvals are for broad patient applicability, including growing children, teens, and adults (with surgery or other techniques).

这两项批准都适用于广泛的患者，包括成长中的儿童，青少年和成年人（通过手术或其他技术）。

These approvals mark a significant milestone in Align’s efforts to enhance clinical outcomes and efficiency in orthodontics.

这些批准标志着Align努力提高正畸临床结果和效率的重要里程碑。

The Invisalign Palatal Expander System is a modern and innovative direct 3D printed device 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) with primary, mixed, or permanent dentition during treatment of patients..

Invisalign腭扩张器系统是一种基于专有和专利技术的现代创新直接3D打印设备。Invisalign腭扩张器用于快速扩张和随后在患者治疗期间固定具有原发性，混合性或永久性牙列的骨骼和/或牙齿狭窄的上颌骨（上颌）。。

“The Invisalign Palatal Expander is an example of Align’s continuous commitment to innovative digital orthodontics by delivering products with greater efficiency for doctors and better treatment experiences for young patients,” said Simon Beard, Align Technology executive vice president and managing director, Europe, Middle East and Africa (EMEA).

Align技术执行副总裁兼欧洲、中东和非洲（EMEA）董事总经理西蒙·比尔德表示：“Invisalign腭扩张器是Align不断致力于创新数字正畸的一个例子，它为医生提供了更高效的产品，为年轻患者提供了更好的治疗体验。”。

“We are thrilled to extend the availability of this transformative alternative to traditional palatal expanders to doctors and their patients across the EMEA region.”.

“我们很高兴将这种替代传统腭扩张器的变革性替代品扩展到整个EMEA地区的医生和患者。”。

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™ intraoral digital scan.

Invisalign腭扩张器系统由一系列可移动设备组成，这些设备以较小的运动增量进行分期，以将患者狭窄的上颌骨扩展到由主治医生确定的位置。每个直接3D打印设备都是根据iTero™口内数字扫描根据患者独特的解剖结构定制的。

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

然后使用Align专有的正畸软件开发了腭扩张治疗计划和设备设计。。

With Invisalign First™ aligners and Invisalign Palatal Expanders, Align Technology can provide doctors with a full early intervention treatment solution for Phase 1 treatment, an early interceptive orthodontic treatment for young patients. Phase 1 treatment is traditionally done through arch expanders or partial metal braces, before all permanent teeth have erupted – typically at ages 6 through 10.

使用Invisalign First™对准器和Invisalign腭扩张器，Align技术可以为医生提供完整的早期干预治疗解决方案，用于第一阶段治疗，这是一种针对年轻患者的早期拦截正畸治疗。传统上，第一阶段的治疗是在所有恒牙萌出之前通过牙弓扩张器或部分金属支架进行的，通常在6至10岁之间。

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..

Invisalign First clear Aligner专门设计用于解决广泛的年轻患者的错牙合，包括较短的临床牙冠，牙列爆发的管理以及可预测的牙弓扩张。。

“Phase 1 or early interceptive treatment accounts for 20 percent of orthodontic case starts each year and is growing,” said Dr. Mitra Derakhshan, Align Technology executive vice president, chief clinical officer. “Together with Invisalign First aligners, Invisalign Palatal Expanders enables Align Technology to provide doctors with a solution set to treat the most common skeletal and dental malocclusions in growing children.

Align技术执行副总裁兼首席临床官Mitra Derakhshan博士说：“每年开始的第一阶段或早期拦截治疗占正畸病例的20%，并且正在增长。”。。

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，用于治疗骨骼和牙齿下颌失衡，并为青少年时期成长中的患者提供咬合矫正。”。

The Invisalign Palatal Expander System is expected to be commercially available across EMEA in Q1 2025.

Invisalign腭扩张器系统预计将于2025年第一季度在欧洲、中东和非洲地区上市。

About Align Technology, Inc.

关于Align Technology，Inc。

Align Technology designs and manufactures the Invisalign® System, 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 271 thousand doctor customers and is key to accessing Align’s 600 million consumer market opportunity worldwide.

Align Technology设计和制造Invisalign®系统、iTero™口内扫描仪和服务以及exocad™CAD/CAM软件。这些技术构建模块能够增强数字正畸和修复工作流程，为超过27.1万名医生客户改善患者预后和实践效率，是获得Align全球6亿消费者市场机会的关键。

Over the past 27 years, Align has helped doctors treat approximately 18.9 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27年中，Align帮助医生使用Invisalign系统治疗了大约1890万名患者，并通过Align™数字平台推动了数字牙科的发展，Align™数字平台是我们独特的专有技术和服务的集成套件，为患者和消费者、正畸医生和全科医生以及实验室/合作伙伴提供无缝的端到端解决方案。

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牙科CAD/CAM产品和exocad转销商合作伙伴列表的更多信息，请访问www.exocad.com。。

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

。

About the Invisalign® Palatal Expander System

关于Invisalign®腭扩张器系统

The Invisalign® Palatal Expander System is a modern, innovative direct 3D printed orthodontic appliance designed based on proprietary and patented technology. The Invisalign Palatal Expander System is intended for the orthodontic treatment of malocclusion. The system is used for the rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and teeth, palate) with primary, mixed, or permanent dentition during orthopedic treatment in children or adolescents.

Invisalign®腭扩张器系统是一种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腭扩张器系统用于正畸治疗错牙合。该系统用于在儿童或青少年矫形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，牙弓和牙齿，上颚），具有初级，混合或永久性牙列。

In adults, it is to be used in conjunction with surgery or other interventions when necessary. 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 for better oral hygiene1; manufactured to custom fit each patient’s anatomy for optimal comfort and aesthetics, expanders fit comfortably in the patient’s mouth and are changed daily (no screw required)..

在成人中，必要时可与手术或其他干预措施结合使用。设备是3D打印的，并且是根据Align Technology，Ltd.提供的市售iTero™口内扫描仪的数字扫描数据制造的。这些设备是可拆卸的，以改善口腔卫生1；扩张器定制适合每位患者的解剖结构，以获得最佳的舒适度和美学效果，扩张器舒适地适合患者的口腔，并且每天都会更换（不需要螺钉）。。

The System is comprised of Invisalign Palatal Expanders (active expansion, each stage comes with a programmed expansion of up to 0.25mm/stage, changed daily or as per doctor’s discretion) and Invisalign Palatal Holders (copies of the last stage ​of the expansion phase designed to hold the maxilla post-active expansion and changed every 2-4 weeks as directed by the treating doctor), Invisalign Attachment Templates and proprietary 3D shape generation software.

该系统由Invisalign腭扩张器（主动扩张，每个阶段都有一个高达0.25mm/阶段的程序扩张，每天或根据医生的判断进行更换）和Invisalign腭支架（扩张阶段最后阶段的副本，用于固定上颌骨主动扩张后，并按照治疗医生的指示每2-4周更换一次），Invisalign附件模板和专有的3D形状生成软件。

These products are not available for purchase by the general public. However, the products are available for purchase from Invisalign® trained dentists and orthodontists..

这些产品不可供公众购买。但是，这些产品可从经过Invisalign®培训的牙医和正畸医生处购买。。

The Invisalign Palatal Expander System is currently available in the U.S., Canada, Australia, New Zealand, Hong Kong, and Singapore, and is expected to be available in additional markets, pending regulatory approvals. The Invisalign Palatal Expander System is expected to be commercially available across EMEA in Q1 2025..

Invisalign腭扩张器系统目前已在美国、加拿大、澳大利亚、新西兰、香港和新加坡上市，预计将在其他市场上市，等待监管部门的批准。Invisalign腭扩张器系统预计将于2025年第1季度在欧洲、中东和非洲地区上市。。

1Based on the survey in August 2023 in CAN 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, who responded to the question: “Please indicate your agreement with the following statement: Patients treated with the Invisalign® Palatal Expander System experience better oral hygiene than those patients treated with traditional palatal expanders (such as Schwartz, Hyrax, etc.)”.

1根据2023年8月在CAN对10名接受过Invisalign培训的正畸医生进行的调查，他们参加了Invisalign®腭扩张器系统技术设计评估，并用IPE治疗了至少1名6-11岁的患者，他们回答了这个问题：“请表明你同意以下陈述：使用Invisalign®腭扩张器系统治疗的患者比使用传统腭扩张器（如Schwartz，Hyrax等）治疗的患者口腔卫生更好。”。

Agreement scale is 1-4 with 1 being “strongly disagree” and 4 being “strongly agree”. Data on file at Align Technology, as of October 30, 2023..

协议量表为1-4，其中1表示“非常不同意”，4表示“非常同意”。。。