Dror Secures Israeli Regulatory Approval to Market and Sell Its Next Generation Smile Correction Solution
Rhea-AI Summary
Dror (OTC PINK: DROR) announced that its second‑generation ZSmile platform received regulatory approval from the Israeli Ministry of Health AMAR division, clearing the way for a 2026 launch in Israel as a precursor to planned rollouts in the U.S. and Europe. ZSmile is a smart nighttime appliance using proprietary pulsating air technology to correct smiles overnight and includes a companion mobile app for real‑time monitoring and patient‑doctor communication. Management said the device aligns with treatment criteria validated in prior FDA‑ and CE‑cleared clinical trials and that the company will continue pursuing U.S. FDA and EU MDR clearances.
Positive
- AMAR approval obtained for ZSmile in Israel
- 2026 Israel launch planned as initial commercial rollout
- Nighttime appliance with proprietary pulsating air technology
- Companion app enables real‑time treatment monitoring
Negative
- U.S. FDA and EU MDR clearances remain pending
News Market Reaction
On the day this news was published, DROR gained 12.50%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
AMAR regulatory approval will allow the Company to launch ZSmile in Israel in 2026 as a precursor to a larger product launch in the US and Europe
JERUSALEM, Jan. 13, 2026 (GLOBE NEWSWIRE) -- Dror Ortho-Design, Inc. ("Dror" or the "Company") (OTC PINK: DROR), a pioneer in AI-powered orthodontic solutions, today announced that its second-generation ZSmile platform has received regulatory approval from the Israeli Ministry of Health's AMAR Division, the authority responsible for medical device regulation in Israel.
The approval clears the path for Dror to bring to market a breakthrough orthodontic solution in that corrects patients' smiles overnight, eliminating the need to wear clear plastic aligners during waking hours. Powered by proprietary pulsating air technology delivered through a smart nighttime appliance, ZSmile represents a fundamental reimagining of how orthodontic treatment is delivered. The platform's companion mobile app enables real-time treatment monitoring and seamless patient-doctor communication.
"Receiving AMAR approval is a critical milestone in bringing ZSmile to the millions of people who want to correct their smile while they sleep," said Lee Haddad, Chief Executive Officer of Dror. "ZSmile doesn't just improve on existing solutions; it redefines what patients should expect from orthodontic care. We believe that there is pent-up demand for a solution that avoids the pain, inconvenience, and social discomfort associated with traditional aligner-based treatments, a gap that has gone largely unaddressed for more than a decade.”
Asaf Gur, Dror's Regulatory and Quality Assurance Director, who brings 25 years of medical device development and regulatory expertise, added: "Our engineering teams have achieved a meaningful advancement of our core technology while maintaining full alignment with the treatment criteria validated in our FDA- and CE-cleared clinical trials. AMAR’s approval reinforces our confidence as we continue pursuing regulatory clearances from the U.S. FDA and under the EU MDR framework.”
Image 1 & 2 - Second generation ZSMILE solution
Image 3 - ZSMILE works while you sleep
About Dror Ortho-Design, Inc.
Dror Ortho-Design, Inc. is pioneering an AI-powered orthodontic platform with a proprietary solution that straightens teeth using pulsating air technology delivered through a single custom-made smart aligner. Positioned to transform the traditional aligner market, Dror offers a revolutionary alternative for the millions seeking smile correction without the limitations of conventional treatments.
Unlike existing solutions that require patients to wear plastic aligners throughout the day and night, our ZSmile technology provides a discreet, comfortable correction process that works while patients sleep. This breakthrough approach eliminates the social and professional disruptions associated with traditional aligners while delivering effective results.
Beyond enhancing patient experience, ZSmile creates significant opportunities for both general dentists and orthodontists to expand their practices by offering an innovative, scalable service that meets growing consumer demand for convenient, non-intrusive orthodontic treatments.
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
SOURCE: Dror Ortho-Design, Inc.
Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/54bfe771-adb5-486f-b91e-edee65c7005c
https://www.globenewswire.com/NewsRoom/AttachmentNg/01d94bf1-87e3-44da-bbe4-48dd86fb0565
https://www.globenewswire.com/NewsRoom/AttachmentNg/ce318971-7dda-45b8-977f-e19e71a83f8a
FAQ
What did Dror (DROR) announce on January 13, 2026 about ZSmile?
How does ZSmile from Dror (DROR) work and what makes it different?
Will ZSmile be available in the U.S. and Europe now that AMAR approved it?
Does Dror (DROR) cite clinical validation for ZSmile?
When is the ZSmile commercial rollout expected in Israel for DROR shareholders?
