Invisalign® Palatal Expander System by Align Technology Now Available in Turkey for Skeletal and Dental Expansion in Growing Patients
Align Technology (NASDAQ: ALGN) announced that its Invisalign Palatal Expander System has received approval from the Turkish Medicines and Medical Device Agency (TMMDA) and is now available in Turkey. The system offers a removable, safe alternative to traditional palatal expanders for skeletal and dental expansion in patients of all ages.
The system consists of customized 3D-printed devices designed using iTero intraoral scans and proprietary orthodontic software. Combined with Invisalign First™ aligners, it provides a complete early intervention treatment solution for Phase 1 treatment, which represents 20% of orthodontic case starts annually.
The expansion devices are created in small increments to gradually expand a patient's narrow maxilla (upper jaw). This innovation enhances Align's digital orthodontics portfolio, offering doctors improved efficiency and patients better treatment experiences in the EMEA region.
Align Technology (NASDAQ: ALGN) ha annunciato che il suo Sistema di Espansione Palatale Invisalign ha ricevuto l'approvazione dall'Agenzia Turca dei Medicinali e dei Dispositivi Medici (TMMDA) ed è ora disponibile in Turchia. Il sistema offre un'alternativa rimovibile e sicura agli espansori palatali tradizionali per l'espansione scheletrica e dentale in pazienti di tutte le età.
Il sistema consiste in dispositivi personalizzati stampati in 3D, progettati utilizzando scan intraorali iTero e software ortodontico proprietario. Combinato con Invisalign First™, fornisce una soluzione completa di trattamento per l'intervento precoce per il trattamento di Fase 1, che rappresenta il 20% delle prime istanze di casi ortodontici annualmente.
I dispositivi di espansione sono creati in piccoli incrementi per espandere gradualmente il mascellare (mascella superiore) di un paziente. Questa innovazione migliora il portfolio di ortodonzia digitale di Align, offrendo ai medici una maggiore efficienza e ai pazienti esperienze di trattamento migliori nella regione EMEA.
Align Technology (NASDAQ: ALGN) anunció que su Sistema de Expansor Palatino Invisalign ha recibido la aprobación de la Agencia Turca de Medicamentos y Dispositivos Médicos (TMMDA) y ahora está disponible en Turquía. El sistema ofrece una alternativa removible y segura a los expansores palatinos tradicionales para la expansión esquelética y dental en pacientes de todas las edades.
El sistema consiste en dispositivos personalizados impresos en 3D, diseñados utilizando escaneos intraorales iTero y software ortodóntico propietario. Combinado con Invisalign First™, proporciona una solución completa de tratamiento de intervención temprana para el tratamiento de Fase 1, que representa el 20% de los inicios de casos ortodónticos anualmente.
Los dispositivos de expansión se crean en pequeños incrementos para expandir gradualmente el maxilar (mandíbula superior) de un paciente. Esta innovación mejora el portafolio de ortodoncia digital de Align, ofreciendo a los médicos una mayor eficiencia y a los pacientes mejores experiencias de tratamiento en la región EMEA.
Align Technology (NASDAQ: ALGN)는 인비절라인 팔라탈 익스팬더 시스템이 터키 의약품 및 의료기기청(TMMDA)의 승인을 받았으며 이제 터키에서 사용 가능하다고 발표했습니다. 이 시스템은 모든 연령대의 환자를 위한 전통적인 구개 확장기에 대한 안전하고 탈부착 가능한 대안을 제공합니다.
이 시스템은 iTero 구강 내 스캔 및 독점적인 치열 교정 소프트웨어를 사용하여 설계된 맞춤형 3D 프린팅 장치로 구성됩니다. 인비절라인 퍼스트™ 교정기와 결합하면 1단계 치료에 대한 조기 개입 치료 솔루션을 제공하며, 이는 매년 치열 교정 사례 시작의 20%를 차지합니다.
확장 장치는 환자의 좁은 상악(윗턱)을 서서히 확장하기 위해 작은 단계로 만들어집니다. 이 혁신은 Align의 디지털 치열 교정 포트폴리오를 강화하여 의사에게는 효율성을 높이고 환자에게는 EMEA 지역에서 더 나은 치료 경험을 제공합니다.
Align Technology (NASDAQ: ALGN) a annoncé que son Système d’Expansion Palatine Invisalign a reçu l'approbation de l'Agence Turque des Médicaments et Dispositifs Médicaux (TMMDA) et est désormais disponible en Turquie. Ce système offre une alternative amovible et sécurisée aux expanseurs palatins traditionnels pour l'expansion squelettique et dentaire chez les patients de tous âges.
Le système se compose de dispositifs personnalisés imprimés en 3D, conçus à l'aide de scans intraoraux iTero et d'un logiciel orthodontique propriétaire. Associé aux aligneurs Invisalign First™, il fournit une solution complète de traitement d'intervention précoce pour la phase 1, qui représente 20% des débuts de cas orthodontiques chaque année.
Les dispositifs d'expansion sont créés par petites incréments pour élargir progressivement le maxillaire étroit d'un patient. Cette innovation améliore le portefeuille d'orthodontie numérique d'Align, offrant aux médecins une efficacité accrue et aux patients une meilleure expérience de traitement dans la région EMEA.
Align Technology (NASDAQ: ALGN) gab bekannt, dass ihr Invisalign Gaumenerweiterungssystem die Genehmigung der Türkischen Arzneimittel- und Medizinproduktebehörde (TMMDA) erhalten hat und nun in der Türkei verfügbar ist. Das System bietet eine abnehmbare, sichere Alternative zu herkömmlichen Gaumenerweiterungen für die skeletale und dentale Expansion bei Patienten jeden Alters.
Das System besteht aus maßgeschneiderten 3D-gedruckten Geräten, die mit iTero intraoralen Scans und proprietärer Kieferorthopädie-Software entworfen wurden. In Kombination mit Invisalign First™ bietet es eine umfassende Lösung für frühzeitige Interventionen im Rahmen der Phase-1-Behandlung, die 20 % der jährlichen Kieferorthopädie-Fallstarts ausmacht.
Die Expansionsgeräte werden in kleinen Schritten hergestellt, um den engen Oberkiefer eines Patienten schrittweise zu erweitern. Diese Innovation erweitert Aligns digitales Kieferorthopädie-Portfolio und bietet Ärzten verbesserte Effizienz sowie Patienten ein besseres Behandlungserlebnis in der EMEA-Region.
- Expansion into new market (Turkey) with TMMDA approval
- Addresses growing Phase 1 treatment market (20% of orthodontic case starts)
- Complements existing product line (Invisalign First™) for complete treatment solution
- None.
Insights
The Turkish regulatory approval for Align Technology's Invisalign Palatal Expander System represents a significant market opportunity in several dimensions:
- The approval's broad scope covering children, teens and adults maximizes the addressable market, particularly important as Turkey has a population of over 84 million with a relatively young demographic profile.
- The technology creates a compelling competitive moat through its proprietary 3D printing process and integration with iTero scanners and exocad software, strengthening Align's digital ecosystem and increasing switching costs for practitioners.
- The timing is strategic as the Phase 1 treatment market (ages 6-10) represents 20% of orthodontic case starts annually, with growth potential in emerging markets like Turkey.
The business implications are particularly noteworthy:
- The system's integration with Invisalign First aligners creates a complete early intervention solution, potentially increasing product adoption and customer loyalty while driving higher revenue per patient.
- The digital workflow enables better treatment planning and monitoring, which could lead to improved clinical outcomes and increased practitioner confidence.
- The removable nature of the device addresses patient comfort concerns, potentially expanding the market by attracting patients who might have otherwise avoided traditional metal expanders.
This expansion aligns with the company's strategy to digitize orthodontics and captures a critical growth segment in early intervention treatments. The technology's ability to provide customized solutions through digital scanning and 3D printing not only improves treatment efficiency but also strengthens Align's competitive position in the clear aligner market.
- Invisalign® Palatal Expanders offer doctors a removeable, safe, and clinically effective alternative to traditional palatal expanders.
- With Invisalign First™ aligners and Invisalign® Palatal Expanders, Align Technology now provides doctors with a full early intervention treatment solution, including both skeletal (orthopedic) and dental (orthodontic) arch expansion.
ROTKREUZ,
This approval marks another significant milestone in Align’s efforts to enhance clinical outcomes and efficiency in orthodontics.
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.
Simon Beard, Align Technology's executive vice president and managing director,
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. A palatal expansion treatment plan and device design are then developed using Align’s proprietary orthodontic software.
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. 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.
“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. 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.”
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 271.6 thousand doctor customers and are key to accessing Align’s 600 million consumer market opportunity worldwide. Over the past 27 years, Align has helped doctors treat approximately 19.5 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.
Invisalign, iTero, exocad, Align, Align Digital Platform, and iTero Lumina are trademarks of Align Technology, Inc.
About the Invisalign® Palatal Expander System
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. 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).
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. These products are not available for purchase by the general public. However, the products are available for purchase from Invisalign® trained dentists and orthodontists.
The Invisalign Palatal Expander System is currently available in the
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.)”. 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.
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Align Technology, Inc.
Madelyn Valente
(909) 833-5839
mvalente@aligntech.com
Zeno Group
Sarah Karlson
(828) 551-4201
sarah.karlson@zenogroup.com
Source: Align Technology, Inc.
FAQ
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