Dror Ortho-Design, Inc.

What they do

Dror Ortho-Design is developing and planning to commercialize ZSmile, a single smart aligner that uses pulsating air to move teeth while patients sleep. The company has a Class II medical device 510(k) clearance from the FDA (obtained February 2026) for the U.S. market. It also holds patents on the technology. Currently, the company does not generate any revenue and is focused on product development and preparing for commercialization.

Revenue drivers

• ZSmile platform (formerly Aerodentis) — The sole product line, intended to be sold as a nighttime orthodontic treatment. No revenue generated to date.

Recent performance

As of June 30, 2026, the company had cash of $93,563, total assets of $365,689, total liabilities of $4.3 million, and a shareholder deficit of $3.9 million. The most recent annual net loss was $2.5 million for 2025, following losses of $5.8 million in 2024 and $3.6 million in 2023. Operating cash flow was negative $2.1 million in 2025. The company's independent auditor has expressed substantial doubt about its ability to continue as a going concern.

Strategy

Management plans to spend approximately $1 million over the next 12 months on software and hardware development, regulatory approvals, and IP protection. The company rebranded its next-generation solution from Aerodentis to ZSmile to emphasize nighttime use. It positions ZSmile as a less painful and less intrusive alternative to traditional 12-to-15 month all-day aligner therapies. The company is also seeking to raise additional capital through unregistered sales of equity, as evidenced by multiple 8-K filings in 2025 and 2026.

Risks

• Going concern risk — The company has insufficient liquidity and recurring losses; its auditor has expressed substantial doubt about its ability to continue as a going concern.
• No revenue or operating history — The company has never generated revenue from product sales and has no history in manufacturing or distributing orthodontic devices.
• Dependence on FDA clearance and market acceptance — Although the ZSmile platform received 510(k) clearance, commercial success depends on acceptance by consumers and orthodontists, and any product modifications may require new clearances.
• Competition from established aligner companies — The company faces competition from large, internationally established aligner companies whose products are widely accepted.

Outlook

Management expects to continue incurring significant losses as it develops the platform and has no assurance of future profitability. The company must raise additional capital to fund operations, and if it cannot, it may need to delay, reduce, or eliminate R&D programs, sell assets, or merge. There is currently no liquid market for its common stock.