GlobeNewswire

FDA clearance paves the way for U.S. commercial launch of innovative alternative to traditional aligners

JERUSALEM, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Dror Ortho-Design, Inc. ("Dror" or the "Company") (OTC PINK: DROR), a pioneer in AI-powered orthodontic solutions, today 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 using pneumatic 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.

"We believe receiving FDA clearance for our next-generation ZSmile Platform is a transformative milestone for Dror and a defining moment for the aligner industry," said Lee Haddad, Chief Executive Officer of Dror. "For over a decade, many clear aligners have asked patients to make the same compromises: wear plastic in your mouth for up to 22 hours a day, remove it every time you eat or drink, and hope nobody notices during meetings, presentations, or conversations. ZSmile may limit many of these compromises. Our patients have reported ‘sleeping their way to a better smile’ and functioning normally throughout the day with minimal pain, embarrassment and disruption. In our view, for executives, attorneys, salespeople, broadcasters, teachers, and anyone whose speech and appearance are central to their career, ZSmile is not just a better aligner — it is a paradigm shift in smile correction. With FDA clearance now secured, we believe we are positioned to capture significant share in what we believe is an enormous and growing market."

Dr. Joel Becker DMD, MSc, accredited by Hadassah School of Dentistry and Orthodontic Consultant at Dror, commented, "In my experience with three decades of orthodontic practice and across treatment modalities from traditional braces to clear aligners, ZSmile is a significant advancement. From my assessment, the system effectively addresses Class I and Class II malocclusions with minimal discomfort and maximum discretion. I have seen many patients who need a smile correction solution but are unwilling to accept the lifestyle sacrifices demanded by traditional aligners. I believe ZSmile is the solution for them."

Next-Generation ZSmile Platform: Key Innovations

Building on the Company’s first-generation system, which received FDA clearance in April 2020, the next-generation ZSmile Platform incorporates significant technological advancements:

• Proprietary Pulsating Air Technology: A redesigned micropump and motor system quietly delivers calibrated pneumatic 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.
  

Addressing a Massive and Growing Market Opportunity
The global clear aligner market is projected to exceed $56 billion by 2033 and continue growing at a double-digit compound annual rate, driven by rising consumer demand for discreet, effective smile correction solutions.¹ Despite this growth, the fundamental technology behind clear aligners has remained largely unchanged since its introduction — relying on sequential thermoplastic trays that must be worn for the vast majority of each day, imposing meaningful lifestyle compromises on patients.

ZSmile represents a different approach: a single smart aligner, worn only during sleep, powered by AI and pneumatic precision technology. The platform is designed to be optimized for correction of malocclusions affecting the "social six” - the front upper and lower six teeth most visible when smiling — addressing what the Company believes is the largest and most commercially attractive segment of unmet demand in cosmetic orthodontics. By making treatment designed to be painless, invisible, and non-disruptive to daily life, ZSmile is to unlock demand from the large portion of the adult population who could benefit from a smile correction solution but have never pursued it because existing solutions are too visible, too uncomfortable, or too inconvenient.

Commercial Launch and Growth Strategy
With FDA clearance now in hand, Dror intends to initiate a phased U.S. commercial launch, beginning with select markets and key opinion leader practices. ZSmile is focused on creating compelling practice economics for both general dentists and orthodontists by offering a differentiated treatment option that can expand patient volume and drive incremental revenue.

In addition to the U.S. market, ZSmile has previously received CE marking and Israeli regulatory approval, positioning the Company for international expansion across multiple high-value markets, including Europe and the Middle East.

About Dror Ortho-Design, Inc.
Dror Ortho-Design, Inc. (OTC PINK: DROR) is pioneering an AI-powered orthodontic platform with a proprietary solution intended to straighten teeth using pulsating air technology delivered through a single custom-made smart aligner. Positioned to transform the clear aligner market, Dror offers a painless alternative for the millions seeking smile correction without the limitations and daily disruptions of conventional treatments. The ZSmile Platform is designed to provide a discreet, comfortable correction process that works while patients sleep, allowing patients to eat, drink, speak, and live freely throughout the day with nothing in their mouth. Beyond enhancing patient experience, ZSmile is designed to create significant opportunities for both general dentists and orthodontists to expand their practices. The Company is publicly traded on OTC PINK under the symbol DROR and is backed by U.S.-based technology investment funds. For more information, please visit: www.ZSmile.com

Forward-Looking Statements
Statements made in this press release may be forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Words such as "expect," "anticipate," "should", "believe", "target", "project", "goals", "estimate", "potential", "predict", "may", "will", "could", "intend", and variations of these terms or the negative of these terms and similar expressions are intended to identify these forward-looking statements. Moreover, forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control and include, but are not limited to, statements regarding the anticipated commercial launch and timing of the ZSmile Platform, the Company’s expected market opportunities and growth, the Company’s competitive position and business strategy, the anticipated benefits and patient experience of the ZSmile Platform, and the results of clinical trials and patient testing programs. These forward-looking statements are made as of the date of this release and are based on management’s current assumptions and expectations of future events and trends, and are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, which could cause actual results to differ materially from those expressed or implied. The Company's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: the Company’s ability to successfully commercialize the ZSmile Platform, market acceptance of the platform, the ability to manufacture at scale, competition from established orthodontic and clear aligner companies, the availability of sufficient capital to fund operations, product defects, risks of government regulations, the impact resulting from geopolitical conflicts and any resulting sanctions, the ability to obtain patents and defend intellectual property against competitors, the impact of competitive products and solutions, and the Company's ability to maintain and enhance its brand. Additional risk factors are contained in the Company’s periodic reports filed with the U.S. Securities and Exchange Commission. Except as required by law, the Company assumes no obligation to update any forward-looking statements contained in this press release to reflect new information or future events or otherwise.

Investor Relations Contact
Ben Shamsian
Lytham Partners, LLC
646-829-9701
shamsian@lythampartners.com

SOURCE: Dror Ortho-Design, Inc.

¹ Grand View Research Study, 2025: https://www.grandviewresearch.com/industry-analysis/clear-aligners-market