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Dror Ortho-Design, Inc. Launches ZSMILE User Experience Trial

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Dror Ortho-Design (OTC PINK: DROR) has launched a user experience trial for its ZSMILE platform, an AI-based orthodontic solution that straightens teeth using pulsating air delivered by a single custom-made smart aligner. The trial, conducted in Israel, involves eligible patients, orthodontists, and dental professionals. ZSMILE is designed to be used while sleeping or discreetly at home.

The company's first-generation solution received CE mark in 2013 and FDA 510k clearance in 2020, having treated over 250 patients in Israel and Europe. The second-generation ZSMILE includes a mobile app for patients to track progress and a patient management system for doctors, utilizing AI technology for remote monitoring and treatment plan adjustments.

Dror Ortho-Design (OTC PINK: DROR) ha avviato un trial di esperienza utente per la sua piattaforma ZSMILE, una soluzione ortodontica basata su intelligenza artificiale che allinea i denti utilizzando aria pulsata fornita da un unico allineatore smart su misura. Il trial, condotto in Israele, coinvolge pazienti idonei, ortodontisti e professionisti del settore dentale. ZSMILE è progettato per essere utilizzato durante il sonno o discretamente a casa.

La soluzione di prima generazione dell'azienda ha ricevuto il marchio CE nel 2013 e l'approvazione FDA 510k nel 2020, avendo trattato oltre 250 pazienti in Israele e in Europa. La seconda generazione di ZSMILE include un'app mobile per consentire ai pazienti di monitorare i progressi e un sistema di gestione dei pazienti per i medici, utilizzando la tecnologia AI per monitoraggio remoto e aggiustamenti del piano di trattamento.

Dror Ortho-Design (OTC PINK: DROR) ha lanzado una prueba de experiencia de usuario para su plataforma ZSMILE, una solución ortodóntica basada en inteligencia artificial que alinea los dientes utilizando aire pulsante entregado por un solo alineador inteligente hecho a medida. La prueba, realizada en Israel, involucra a pacientes elegibles, ortodoncistas y profesionales dentales. ZSMILE está diseñado para ser usado mientras se duerme o de manera discreta en casa.

La solución de primera generación de la empresa recibió la marca CE en 2013 y la aprobación FDA 510k en 2020, habiendo tratado a más de 250 pacientes en Israel y Europa. La segunda generación de ZSMILE incluye una aplicación móvil para que los pacientes puedan realizar un seguimiento de su progreso y un sistema de gestión de pacientes para los médicos, utilizando tecnología de IA para el monitoreo remoto y ajustes del plan de tratamiento.

드로르 오르토 디자인 (OTC PINK: DROR)은 맞춤형 스마트 알라인서를 통해 펄스 공기를 이용하여 치아를 교정하는 AI 기반 교정 솔루션인 ZSMILE 플랫폼의 사용자 경험 시험을 시작했습니다. 이 시험은 이스라엘에서 진행되며, 적격 환자, 치과 의사 및 치과 전문직이 참여하고 있습니다. ZSMILE은 잠자는 동안이나 집에서 은밀하게 사용할 수 있도록 설계되었습니다.

회사의 1세대 솔루션은 2013년에 CE 마크를 받았고 2020년에 FDA 510k 승인을 받아 이스라엘과 유럽에서 250명 이상의 환자를 치료했습니다. 2세대 ZSMILE은 환자가 진행 상황을 추적할 수 있는 모바일 앱과 의사를 위한 환자 관리 시스템을 포함하고 있으며, 원격 모니터링 및 치료 계획 조정을 위해 AI 기술을 활용하고 있습니다.

Dror Ortho-Design (OTC PINK: DROR) a lancé un test d'expérience utilisateur pour sa plateforme ZSMILE, une solution orthodontique basée sur l'IA qui redresse les dents en utilisant un air pulsé délivré par un seul aligneur intelligent sur mesure. Le test, réalisé en Israël, implique des patients éligibles, des orthodontistes et des professionnels dentaires. ZSMILE est conçu pour être utilisé pendant le sommeil ou discrètement à la maison.

La solution de première génération de l'entreprise a reçu le marquage CE en 2013 et l'homologation FDA 510k en 2020, ayant traité plus de 250 patients en Israël et en Europe. La deuxième génération de ZSMILE comprend une application mobile permettant aux patients de suivre leurs progrès et un système de gestion des patients pour les médecins, utilisant la technologie IA pour le suivi à distance et les ajustements des plans de traitement.

Dror Ortho-Design (OTC PINK: DROR) hat eine Benutzererfahrungsstudie für seine ZSMILE-Plattform gestartet, eine KI-basierte kieferorthopädische Lösung, die Zähne mit pulsierender Luft aus einem einzigen maßgeschneiderten Smart-Aligner begradigt. Die Studie, die in Israel durchgeführt wird, umfasst geeignete Patienten, Kieferorthopäden und Zahnmedizinische Fachkräfte. ZSMILE ist so konzipiert, dass es während des Schlafs oder diskret zu Hause verwendet werden kann.

Die erstgenerationale Lösung des Unternehmens erhielt 2013 die CE-Kennzeichnung und 2020 die FDA 510k-Zulassung und behandelte über 250 Patienten in Israel und Europa. Die zweite Generation von ZSMILE umfasst eine mobile App, mit der Patienten ihren Fortschritt verfolgen können, sowie ein Patientenmanagementsystem für Ärzte, das KI-Technologie für die Fernüberwachung und Anpassungen des Behandlungsplans nutzt.

Positive
  • Launched user experience trial for ZSMILE platform, indicating progress towards commercial release
  • First-generation solution received CE mark (2013) and FDA 510k clearance (2020)
  • Successfully treated over 250 patients in Israel and Europe
  • Developed mobile app and patient management system with AI technology for remote monitoring
Negative
  • None.

JERUSALEM, Aug. 05, 2024 (GLOBE NEWSWIRE) -- Dror Ortho-Design, Inc. ("Dror" or the "Company") (OTC PINK: DROR), an AI-based orthodontic platform company that has developed a proprietary solution to correct people's smiles by straightening teeth using pulsating air delivered by a single custom-made smart aligner, today announced ahead of the commercial release of the ZSMILE platform, the launch of a user experience trial of its new revolutionary teeth straightening solution that is intended to be used while sleeping or discreetly at home.

ZSMILE Solution

Image 1 - Second generation ZSMILE solution

ZSMILE Platform

Image 2 - ZSMILE works while you sleep

The user experience trial for Dror's new AI-based orthodontic solution will involve a group of eligible patients, as well as orthodontists and dental professionals in Israel. The company's first-generation solution received the European CE mark in 2013 and FDA 510k clearance in 2020, demonstrating that the pulsating air system effectively straightens teeth similarly to traditional aligners. Beyond the clinical trials, this system has successfully treated over 250 patients in Israel and Europe.

Lee Haddad, CEO of Dror, stated, "Our goal with the usability trial of our second-generation solution is to understand how patients and doctors interact with the mobile application, remote monitoring, and patient management system that we developed. Over the past two years, we have designed this system to monitor patient treatment plan compliance in real time, providing essential feedback to both patients and doctors. We aim to make ZSMILE a pain-free, discreet solution that is easy to use and helps doctors scale their practice efficiently. Our mission is to provide millions of people a way to correct their smile without needing to have plastic in their mouth the entire day.”

The ZSMILE app is designed to be a companion for patients, allowing them to track their progress, schedule in-person and remote visits with their doctor, and receive encouraging feedback to remain compliant with their treatment plan. Patients can also use their smartphone's video capability to scan their smile weekly for doctor review. The ZSMILE patient management system is intended to assist doctors by using AI technology to review patient’s scans, monitor progress remotely, modify treatment plans, schedule appointments, and provide access to ZSMILE orthodontic specialists. These specialists would be able to support general dentists and other dental professionals through the ZSMILE process.

About Dror Ortho-Design, Inc.

Dror Ortho-Design, Inc. is an AI-based orthodontic platform company that has developed a proprietary solution to correct people's smiles by straightening teeth using pulsating air delivered by a single custom-made smart aligner. Dror plans to disrupt the aligner market by offering millions of people a revolutionary alternative to traditional aligners. The Company believes that people do not need to change their lifestyle to correct their smile as they are required to do with existing aligner solutions. Rather, we believe that our solution will be able to provide customers with a discreet and hassle-free way to improve their smiles, even while they sleep. The Company’s ZSMILE solution is also intended to provide general practice Dentists as well as Orthodontists a way to grow their practice efficiently by offering a unique and scalable service.

For more information, please visit: www.ZSmile.com

Forward-Looking Statements

Statements made in this news release may be forward-looking statements within the meaning of federal securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Dror to obtain funding; (ii) the ability of Dror to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the ability of Dror and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) the ability of Dror and/or a partner to obtain required governmental approvals; and (v) the ability of Dror and/or a partner to develop and commercialize products prior to, and that can compete favorably with those of, competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Dror's most recent periodic reports that are filed with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10‑K, our Quarterly Reports on Form 10‑Q, and certain Current Reports on Form 8‑K. Dror assumes no obligation to update and supplement forward-looking statements because of subsequent events.

For Investor Inquiries:
Ben Shamsian
Lytham Partners, LLC
646-829-9701
shamsian@lythampartners.com

SOURCE: Dror Ortho-Design, Inc.

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/01d94bf1-87e3-44da-bbe4-48dd86fb0565
https://www.globenewswire.com/NewsRoom/AttachmentNg/ce318971-7dda-45b8-977f-e19e71a83f8a


FAQ

What is the ZSMILE platform developed by Dror Ortho-Design (DROR)?

ZSMILE is an AI-based orthodontic solution that straightens teeth using pulsating air delivered by a single custom-made smart aligner, designed to be used while sleeping or discreetly at home.

When did Dror Ortho-Design (DROR) launch the user experience trial for ZSMILE?

Dror Ortho-Design launched the user experience trial for ZSMILE on August 5, 2024, ahead of its commercial release.

What regulatory approvals has Dror Ortho-Design (DROR) received for its orthodontic solution?

Dror Ortho-Design's first-generation solution received the European CE mark in 2013 and FDA 510k clearance in 2020.

How many patients has Dror Ortho-Design (DROR) treated with its orthodontic solution?

Dror Ortho-Design has successfully treated over 250 patients in Israel and Europe with its first-generation orthodontic solution.

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