TORONTO & 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 announced that Health Canada issued an updated medical device license to Align for its Invisalign® Palatal Expander System*.

多伦多和亚利桑那州坦佩（BUSINESS WIRE）--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Invisalign®透明对准器系统iTero™口内扫描仪和exocad™用于数字正畸和修复牙科的CAD/CAM软件今天宣布，加拿大卫生部发布了更新的医疗设备许可证，以校准其Invisalign®腭扩张器系统*。

The updated license is for broad patient applicability, including growing children, teens, and adults (with surgery or other techniques). The Invisalign Palatal Expander System is available on a limited basis in Canada..

更新后的许可证适用于广泛的患者，包括成长中的儿童，青少年和成人（使用手术或其他技术）。Invisalign腭扩张器系统在加拿大有限。。

Previously introduced at the Align Technology Investor Day in September 2023, 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腭扩张器系统之前于2023年9月的Align技术投资者日推出，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腭扩张器用于在患者治疗期间快速扩张和随后保持具有原发性，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 Align’s first direct 3D printed orthodontic device and 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..

Invisalign腭扩张器是Align的第一个直接3D打印正畸设备，它提供了一种安全，舒适且临床有效的*替代传统的腭扩张器，该扩张器需要每天在口腔中手动转动设备中的螺钉以实现扩张。。

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打印设备都是根据患者独特的解剖结构根据iTero定制的™口内数字扫描。

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了腭扩张治疗计划和设备设计。。

Combined with Invisalign First™ aligners, Invisalign Palatal Expanders 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.

先与Invisalign结合™aligners，Invisalign腭扩张器为医生提供了一个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***。。

“Many parents in my practice have found it challenging to physically turn the screws on traditional palatal expanders,” said Dr. David Walt, an orthodontist in Vaughan, Ontario and participant in Align's Invisalign Palatal Expander System limited release program in Canada. “The Invisalign Palatal Expander removes this concern and creates a better overall experience for patients and their parents.

安大略省沃恩市的正畸医生、加拿大Align公司Invisalign腭扩张器系统有限释放项目的参与者David Walt博士说：“在我的实践中，许多父母都发现用身体转动传统腭扩张器上的螺钉是一项挑战。”。“Invisalign腭扩张器消除了这种担忧，为患者及其父母创造了更好的整体体验。

Beyond that, there have not been related emergency visits, something that is more common with traditional palatal expanders.”.

除此之外，还没有相关的紧急就诊，这在传统的腭扩张器中更为常见。”。

“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.

Align全球临床高级副总裁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%，并且正在增加。”。“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 a game changer, as it alleviates the most common challenges with palatal expansion, including maintaining proper hygiene, emergency appointments, turning the screw, and the parents’ fear of causing pain to their child in treatment,” said Dr. Sandra Tai, an orthodontist in Vancouver and participant in Align's Invisalign Palatal Expander System limited release program in Canada.

Sandra Tai博士说：“Invisalign腭扩张器系统改变了游戏规则，因为它减轻了腭扩张器最常见的挑战，包括保持适当的卫生，紧急预约，拧螺丝以及父母担心在治疗中给孩子带来痛苦。”，温哥华的一名正畸医生，加拿大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.”.

“它是可拆卸的，支持口腔卫生，同时为成长中的患者提供临床上有效且舒适的治疗体验，达到父母报告的高满意度。”。

The Invisalign Palatal Expander System is pending pre-market notification 510(k) clearance by the U.S. Food and Drug Administration and is not yet available in the United States. It is expected to be available in other markets pending regulatory approvals starting in 2024.

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）的批准，目前尚不在美国提供。预计将于2024年开始在其他市场上市，等待监管部门的批准。

*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.

*根据2023年8月在加拿大进行的一项调查，有10名接受过Invisalign培训的正畸医生参加了Invisalign腭扩张器系统技术设计评估，并接受了至少1名6-11岁的IPE患者的治疗。截至2023年10月30日，Align Technology，Inc.存档的数据。

**Based on data from a multi-site US IDE (Investigational Device Exemption) clinical study (n=29 subjects, ages 7-10 years) of expansion treatment with Invisalign® Palatal Expanders. Data on file at Align Technology, Inc. as of October 30, 2023

**基于使用Invisalign®腭扩张器进行扩张治疗的多地点美国IDE（研究设备豁免）临床研究（n=29名受试者，年龄7-10岁）的数据。截至2023年10月30日在Align Technology，Inc.存档的数据

***Data on File at Align Technology, as of June 2021.

***截至2021年6月，Align Technology存档的数据。

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

Align Technology设计和制造Invisalign®系统，这是世界上最先进的清晰对准系统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，为大约252000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 26 years, Align has helped doctors treat over 16.4 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系统治疗了1640多万名患者，并通过Align数字平台推动了数字牙科的发展™,我们集成了一套独特的专有技术和服务，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.

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*

The 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, adolescents or adults in conjunction with surgery or other interventions when necessary.

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打印正畸器械。Invisalign腭扩张器用于快速扩张和随后在截留治疗（例如1期治疗和儿童正畸或骨科治疗）期间用初级，混合（初级和永久）或永久性牙列固定骨骼和/或牙齿狭窄的上颌骨（上颌，牙弓，上颚），青少年或成年人在必要时结合手术或其他干预措施。

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。这些设备是可移动的，比传统设备更卫生；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，并且每天更换（无需螺钉）。。

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

该系统由Invisalign腭扩张器（主动扩张，每个阶段都有0.25mm/天的程序扩张，每天更换或根据医生的判断）和Invisalign腭支架（最后一阶段的副本）组成​按照主治医生的指示，每2-4周更换一次旨在保持上颌骨活动后扩张阶段的扩张）。。