JERUSALEM, Jan. 13, 2026 (GLOBE NEWSWIRE) — Dror Ortho-Design, Inc. (OTC PINK: DROR) announced that its second-generation ZSmile platform has received regulatory approval from Israel’s Ministry of Health AMAR Division, clearing the way for commercial launch in Israel.
Dror, which specializes in AI-powered orthodontic solutions, said the approval allows it to introduce a nighttime-only orthodontic treatment designed to correct patients’ smiles while they sleep. The system eliminates the need for clear plastic aligners during daytime hours.
ZSmile uses proprietary pulsating air technology delivered through a smart appliance worn at night. A companion mobile application supports real-time treatment monitoring and enables direct communication between patients and clinicians.
Chief Executive Officer Lee Haddad described the approval as a key milestone for the company. He said ZSmile is intended to address longstanding patient concerns related to discomfort, inconvenience and social impact associated with traditional aligner-based orthodontic treatments.
Regulatory and Quality Assurance Director Asaf Gur said the platform builds on clinical criteria previously validated in FDA- and CE-cleared trials, while incorporating advances in the company’s core technology. He added that the AMAR decision supports Dror’s ongoing efforts to secure regulatory approvals in the United States and under the European Union’s Medical Device Regulation framework.
Dror said it believes the technology meets strong unmet demand for more discreet and patient-friendly orthodontic care.