Dror Secures Israeli Regulatory Approval to Market and Sell Its Next Generation Smile Correction Solution

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

shamsian@lythampartners.com

SOURCE: Dror Ortho-Design, Inc.

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