Company Description
Dror Ortho-Design, Inc. (DROR) is an AI-based orthodontic platform company focused on developing a proprietary smile correction system that straightens teeth using pulsating air delivered through a single custom-made smart aligner. Traded on the OTC Pink market under the symbol DROR, the company positions its technology as an alternative to traditional clear aligner treatments.
According to multiple company disclosures, Dror’s platform is built around its ZSmile (also referenced as ZSMILE) solution. This system is designed to correct patients’ smiles while they sleep or at home, aiming to avoid the need to wear plastic aligners throughout the day. The core concept uses a smart aligner with a micro-balloon structure that is activated by controlled pulsating air, gently moving teeth toward their intended position. The company describes this as a discreet and hassle-free approach for people who want to improve their smiles without changing their daily lifestyle.
Business focus and technology
Dror describes itself as an AI-powered or AI-based orthodontic platform company. Its ZSmile platform integrates several technology elements:
- A single custom-made smart aligner that incorporates a balloon structure for air-driven tooth movement.
- A control unit with silent air pump technology that delivers precise, controlled air pulses to the aligner’s micro-balloon, following the practitioner’s treatment plan.
- An AI-driven software platform, including a mobile app and remote monitoring system, that supports treatment planning, compliance tracking, and patient–doctor communication.
- Smartphone-based video capture and AI algorithms that generate 3D models from 2D video for remote dental analysis, as described in the company’s patent filings.
The company has reported that its first-generation system received a European CE mark in 2013 and U.S. FDA 510(k) clearance in 2020, and that this earlier system has treated over 250 patients in Israel and Europe. Dror states that its second-generation ZSmile platform builds on these clinical foundations while adding enhanced usability, remote monitoring, and AI-based patient management features.
ZSmile platform and patient experience
Dror’s public communications emphasize patient experience and lifestyle compatibility. The company highlights several aspects of its ZSmile solution:
- Treatment is intended to be performed while the patient sleeps or discreetly at home, reducing the social and professional disruptions associated with wearing visible aligners during the day.
- The system is described as gentle and comfortable, using pulsating air rather than a sequence of rigid plastic trays that must be changed periodically.
- The company cites survey data of clear aligner users indicating interference with daily activities and discomfort, and contrasts this with its goal of a pain-free, sleep-based solution.
- Dror reports that many surveyed aligner users would prefer an overnight solution, and it presents ZSmile as a response to that stated preference.
The ZSmile mobile app is described as a companion tool for patients, allowing them to track progress, receive feedback, and scan their smiles using smartphone video for review by their doctor. The platform’s AI is intended to analyze these scans, monitor treatment compliance in real time, and support adjustments to the treatment plan.
Remote monitoring and AI platform
Dror’s filings and press releases describe an AI platform that supports remote dentistry and scalable treatment delivery. Key elements mentioned include:
- Use of smartphone video to create 3D models of a patient’s mouth, enabling remote assessment of teeth alignment status.
- Patent applications covering algorithms for depth mapping, detection of occlusions and gaps, and generation of final-state aligners with balloon structures for 3D printing.
- A patient management system that helps practitioners monitor progress, modify treatment plans, and schedule in-person or remote visits.
- Planned support from ZSmile orthodontic specialists to assist general dentists and other dental professionals through the treatment process.
The company presents these capabilities as a way to help dentists and orthodontists expand their practices by offering a unique, scalable service that fits growing demand for convenient, non-intrusive orthodontic treatments.
Regulatory and clinical milestones
Dror has disclosed several regulatory and clinical milestones related to its technology:
- The first-generation system received CE marking in Europe and FDA 510(k) clearance in the United States, with clinical trials demonstrating that its pulsating air system can straighten teeth similarly to traditional aligners.
- The company reports that this system has been used to treat over 250 patients in Israel and Europe.
- For its second-generation ZSmile platform, Dror has announced the completion of user experience trials involving patients, orthodontists, and dental professionals under real operating conditions, focusing on usability, comfort, and interaction with the mobile app and remote monitoring system.
- The company has also reported regulatory approval from the Israeli Ministry of Health’s AMAR Division to market and sell its second-generation ZSmile platform as a medical device in Israel.
Dror states that AMAR’s approval supports its ongoing efforts to pursue regulatory clearances from the U.S. FDA and under the EU MDR framework for its updated platform.
Environmental and resource considerations
In one of its announcements, Dror emphasizes the environmental implications of orthodontic treatments. Citing an external study on clear aligner therapy, the company notes that conventional treatments can generate substantial plastic waste due to multiple aligner trays and unused polymer sheets. Dror states that ZSmile’s single-aligner approach can significantly reduce plastic waste compared to traditional aligners and describes its solution as a more sustainable alternative in orthodontics. It also links remote monitoring and fewer in-office visits with potential reductions in the overall environmental footprint of treatment.
Professional community and ZSmile Innovation Network
Dror has introduced the ZSmile Innovation Network, which it describes as a global community of dental professionals interested in moving beyond traditional aligner systems. According to the company, members of this network gain access to ZSmile’s technology and education on its treatment paradigm, which uses one smart aligner and pulsating air instead of multiple trays. The initiative is presented as a way to connect practitioners who recognize the limitations of existing aligner solutions and want to adopt new methods that emphasize overnight, monitored treatment.
Through this network and its platform, Dror aims to provide tools for dentists and orthodontists to monitor patient compliance in real time, encourage adherence to treatment regimens, and potentially shorten treatment duration compared to traditional aligners, based on the company’s own survey and trial findings.
Partnerships and manufacturing
To support development and commercialization, Dror has announced a partnership with Aran Research & Development, an Israel-based medical device developer and manufacturer. The company states that this collaboration is intended to advance ZSmile’s hardware and production capabilities while aligning with regulatory standards such as FDA, CE, and ISO requirements. Dror notes that working with Aran allows it to access engineering and manufacturing expertise and to prepare for larger-scale production without building a large internal hardware development team.
Capital markets and SEC filings
Dror Ortho-Design, Inc. is incorporated in Delaware and files reports with the U.S. Securities and Exchange Commission. The company has disclosed private placements of debentures and related warrants through Current Reports on Form 8-K, describing the terms of these securities, their maturity dates, conversion features tied to potential public offerings, and reliance on exemptions from registration under the Securities Act of 1933. Dror has also filed a registration statement on Form S-1 and related prospectus, as referenced in its press releases, and has submitted a Form 12b-25 (NT 10-Q) explaining a delay in filing a quarterly report due to the need for additional time to complete financial statements.
These filings indicate that Dror has used debentures and warrants as financing instruments and that it has engaged in registration processes for its securities. The company’s disclosures also note that it does not have securities registered under Section 12(b) of the Exchange Act and that there is no established public trading market for its warrants.
Positioning within orthodontics
Across its public communications, Dror consistently presents itself as aiming to “disrupt” or transform the aligner market by offering an alternative to traditional multi-tray aligner systems. It emphasizes:
- Sleep-based, at-home treatment using a single smart aligner and pulsating air.
- AI-powered monitoring and smartphone-based scanning for remote care.
- Potential benefits for patients who seek less intrusive, more discreet treatment.
- Opportunities for dentists and orthodontists to expand services with a scalable platform.
While the company highlights these goals and differentiators, investors and patients should refer to Dror’s official filings and regulatory approvals for detailed information on indications, limitations, and risk factors associated with its technology.