SYDNEY--(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 Align's Invisalign Palatal Expander System* has been included in the Australian Register of Therapeutic Goods (ARTG) and the New Zealand Web Assisted Notification of Devices Database (WAND), and is commercially available in both Australia and New Zealand.

悉尼--（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Align的Invisalign腭扩张器系统*已被纳入澳大利亚治疗产品注册（ARTG）和新西兰网络辅助设备通知数据库（WAND），并在澳大利亚和新西兰均可商购。

The ARTG and WAND entries for Invisalign Palatal Expender System cover broad patient applicability, including growing children, teens and adults (with surgery or other techniques)..

Invisalign Palatal Expender系统的ARTG和WAND条目涵盖了广泛的患者适用性，包括成长中的儿童、青少年和成人（使用手术或其他技术）。。

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 our continuous commitment to innovation by advancing digital orthodontics and delivering products with greater efficiency for doctors and provide better treatment experiences for patients and their parents,” said Raj Pudipeddi, Align Technology chief marketing officer, executive vice president and managing director, Asia Pacific.

Align技术首席营销官、亚太区执行副总裁兼总经理Raj Pudipeddi表示：“Invisalign腭扩张器是我们不断致力于创新的一个例子，它通过推进数字正畸技术，为医生提供更高效的产品，为患者及其父母提供更好的治疗体验。”。

“We are delighted to introduce the Invisalign Palatal Expander system, Align’s first directly fabricated orthodontic appliance, to the Asia Pacific region.”.

“我们很高兴向亚太地区推出Invisalign腭扩张器系统，这是Align的第一款直接制造的正畸器械。”。

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 customised 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 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.

结合Invisalign First™对准器，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*。。

“Phase 1 or early interceptive treatment makes up 20 percent of orthodontic case starts each year and is growing,” said Dr. Mitra Derakhshan, Align Technology 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 Technology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。”。

“We are excited to present the Invisalign Palatal Expander system, a significant advancement in the field of digital orthodontics, to our doctor customers in Australia and New Zealand,” said Jonathan Primmer, Align Technology vice president and managing director for Australia and New Zealand. “With the increasing demand for orthodontic treatment among children and teenagers in Australia and New Zealand, the launch of the Invisalign Palatal Expander system allows us to offer a more comprehensive early interceptive treatment solution in conjunction with Invisalign First™, alleviating the most complex challenges with palatal expansion while providing an exceptional patient experience that is both comfortable and supports proper oral hygiene.”.

Align技术副总裁兼澳大利亚和新西兰董事总经理乔纳森·普里默（JonathanPrimmer）表示：“我们很高兴向澳大利亚和新西兰的医生客户展示Invisalign腭扩张器系统，这是数字正畸领域的一项重大进步。”。“随着澳大利亚和新西兰儿童和青少年对正畸治疗的需求不断增加，Invisalign腭扩张器系统的推出使我们能够结合Invisalign First™提供更全面的早期拦截治疗解决方案，缓解腭扩张最复杂的挑战，同时提供舒适且支持适当口腔卫生的特殊患者体验。”。

The Invisalign Palatal Expander System is now available in Australia and New Zealand. It is expected to be available in other APAC markets pending regulatory approvals starting in 2024.

Invisalign腭扩张器系统现已在澳大利亚和新西兰上市。预计从2024年开始，该产品将在其他亚太市场上市，等待监管部门的批准。

*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 over 256 thousand doctor customers worldwide and are key to accessing Align’s 600 million consumer market opportunity worldwide.

Align Technology设计和制造Invisalign®系统、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，为全球超过25.6万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 26 years, Align has helped doctors treat over 17 million patients worldwide 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通过Invisalign系统帮助医生治疗了全球1700多万名患者，并通过Align digital Platform™推动了数字牙科的发展，Align digital Platform™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。

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com.au. For additional information about the iTero digital scanning system, please visit www.itero.com.au. 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.au。有关iTero数字扫描系统的更多信息，请访问www.iTero.com.au。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。。

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保持骨骼和/或牙齿狭窄的上颌骨（上颌，牙弓，上颚），在截留治疗期间具有初级，混合（初级和永久）或永久性牙列，例如儿童，青少年或成人的1期治疗和正畸或骨科治疗，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 make it easier for patients to maintain oral hygiene compared to traditional palatal appliances; 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)..

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。与传统的腭部器械相比，这些设备是可拆卸的，使患者更容易保持口腔卫生；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 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), 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​设计用于保持上颌骨活动后扩张阶段的扩张，按照主治医生的指示每2-4周更换一次），Invisalign附着模板和专有的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。