공시 • Feb 20
Dror Ortho-Design, Inc. Receives 510(K) FDA Clearance for Next-Generation Smile Correction Solution Dror Ortho-Design, Inc. announced that the U.S. Food and Drug Administration ("FDA") has granted 510(k) clearance for the Company's next-generation ZSmile Platform, or ZSmile. this milestone clearance validates ZSmile's approach to orthodontic treatment -- using proprietary pulsating air technology delivered through a single custom-made smart aligner designed to work painlessly while patients sleep -- and unlocks the pathway for the next step to full U.S. commercialization. ZSmile is the first and only reported FDA-cleared orthodontic system intended to correct people's smile usingumatic tooth movement technology. Unlike traditional clear aligners that may require dozens of trays and up to 22 hours of daily wear, ZSmile delivers treatment through a single custom aligner designed to be worn only while at home or during sleep. Patients are free to go about their day unencumbered, free to eat, drink, speak, and engage in professional and social life with no aligner in their mouth. ZSmile aims to be provide a painless, hassle-free, and entirely discreet smile correction experience. that has already been tested across more than 300 patients in clinical trials and other testing programs. Next-Generation ZSmile Platform: Key Innovations: Building on the Company's first-generation system, which received FDA clearance in April 2020, the next-generation Z Smile Platform incorporates significant technological advancements: Proprietary Pulsating Air Technology: A redesigned micropump and motor system quietly delivers calibratedumatic forces through a single smart aligner, designed for painless and effective tooth movement during sleep. AI-Powered Cloud Analytics: Proprietary artificial intelligence algorithms assist in analyzing tooth movement to assist in remote monitoring capabilities for practitioners. IoT-Connected Smart Aligner: Built-in Internet of Things (IoT) connectivity provides data transmission between the aligner, the patient’s smartphone application, and the practitioner’s dashboard, creating an integrated digital orthodontic ecosystem. Integrated Mobile Application: Smartphone app designed to be patients’ treatment concierge, providing real-time treatment tracking, compliance monitoring, and direct lines of communication with their dental provider. Single-Aligner Treatment Model: Unlike most conventional systems requiring dozens of sequential trays, ZSmile uses one custom-fabricated smart aligner for the entire treatment course, reducing material waste, practitioner chair time, and perceived patient burden compared to conventional systems. 공시 • Jan 13
Dror Ortho-Design, Inc. Secures Israeli Regulatory Approval to Market and Sell Its Next Generation Smile Correction Solution Dror Ortho-Design, Inc. 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. 공시 • Nov 18
Dror Ortho-Design, Inc. announced delayed 10-Q filing On 11/17/2025, Dror Ortho-Design, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. 공시 • Aug 20
Dror Ortho-Design, Inc. Launches Global ZSmile Innovation Network Initiative to Transform the Stagnating Aligner Market Dror Ortho-Design, Inc. announced the launch of the ZSmile Innovation Network, a global community of dental professionals committed to advancing patient care beyond the limitations of traditional aligner systems. The initiative introduces dentists and orthodontists to Dror's breakthrough ZSmile technology, which offers a revolutionary alternative to the decade-old clear aligner model. The launch comes as market data reveals mounting headwinds for conventional aligners, including slowing growth, declining patient compliance, and rising treatment discontinuations. In a comprehensive survey of 1,000 aligner users conducted by Dror, 86% reported that aligners interfered with daily activities, while 77% experienced discomfort during treatment--findings that mirror broader industry reports of market failure. The ZSmile Innovation Network will connect forward-thinking dental professionals globally who recognize the limitations of current orthodontic solutions. Network members will gain access to ZSmile's proprietary technology, which provides effective smile correction while patients sleep, eliminating the social and professional disruptions associated with traditional aligners. Since the ZSmile solution is a completely different paradigm for smile correction, network members will be educated on this new treatment method, which does not require multiple aligner trays but rather uses one smart aligner to gently move teeth using pulsating air. Network doctors will learn how to keep track of their patients' treatment compliance in real-time and how the ZSmile platform encourages patients to stick to the prescribed regimen, which usually achieves the desired results in about half the time of traditional aligners. The ZSmile Platform integrates Internet of Things (IoT) connectivity, AI-driven cloud analytics, and a patient-friendly smartphone app, enabling both clinicians and patients to track treatment progress seamlessly. 공시 • Jun 06
Dror Ortho-Design, Inc. announced that it expects to receive $0.3 million in funding Dror Ortho-Design, Inc. announced that it will issue debentures aggregating to a principal amount of $300,000. In addition, pursuant to the purchase agreement, the company agreed to issue warrants to purchase up to a number of shares of common stock, par value $0.0001 equal to: (i) in the event the debentures are outstanding as of the date of the consummation of the public offering, 150% of the debenture shares issued, if any; or (ii) in the event that the debentures are not outstanding as of the public offering closing date, 100% of the debenture shares that would have been issued, if any, as if such debentures were outstanding as of the public offering closing date. The Private Placement is exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D of the Securities Act and in reliance on similar exemptions under applicable state laws. 공시 • May 29
Dror Ortho-Design, Inc. has filed a Follow-on Equity Offering. Dror Ortho-Design, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Prefunded Warrants
Security Type: Equity Warrant 