Dror Ortho-Design filings document the regulatory record of a Delaware medical-device company developing the ZSmile orthodontic platform. The company’s SEC disclosures include Form S-1 amendments related to registered securities offerings, Form 8-K reports for material definitive agreements, and Form 12b-25 notices tied to periodic-report timing.
Key filing subjects include common stock, private placements of debentures, warrant provisions, capital-structure disclosures, smaller reporting company status, and the company’s lack of securities registered under Section 12(b). The filings also provide formal context for governance, financing arrangements, reporting obligations, and risk disclosures associated with its orthodontic technology business.
Dror Ortho-Design, Inc. reported a first-quarter 2026 net loss of $638,666 as it continues developing its orthodontic alignment platform with no material revenues. Operating expenses were $497,194, mainly research and development and general and administrative costs.
Cash fell to $23,802 at March 31, 2026, while total liabilities reached $3,566,158 against total assets of $253,781, resulting in a stockholders’ deficit of $3,312,377. Management disclosed substantial doubt about the company’s ability to continue as a going concern and is relying on bridge debentures from existing investors and future capital raises to fund operations.
The company is advancing an AI-based orthodontic platform and expects to spend about $1.5 million over 18 months on development and regulatory work. It also noted regional war risks in Israel, though impacts to date were described as immaterial. In April 2026, it added new bridge financing and appointed Ran Israeli as Chief Financial Officer.
Dror Ortho-Design, Inc. entered into a Securities Purchase Agreement for a private placement of 0% interest debentures with an aggregate principal amount of $275,000, due on June 28, 2026. The debentures may automatically convert into common stock at the per-share price of any future public offering.
If a public offering occurs, investors are also entitled to receive warrants to buy common stock, with the number of warrants tied to the potential conversion shares and the size of the public offering allocation. Any warrants issued will be exercisable immediately at the public offering price and will expire five years after issuance. Both the debentures and any warrants carry ownership caps that generally limit a holder to beneficial ownership below 4.99%, with an option to increase this cap to 9.99% on 61 days’ notice. The transaction was completed as an unregistered offering under Section 4(a)(2) and Regulation D.
Dror Ortho-Design, Inc. is registering up to 3,636,364 shares of common stock, 3,636,364 prefunded warrants, 254,545 underwriter warrants, and 3,890,909 underlying shares in a firm-commitment public offering tied to a planned Nasdaq Capital Market listing.
The assumed public offering price is $4.13 per share, with a 30‑day over-allotment option for 545,455 additional shares. A 1‑for‑550 reverse stock split will occur prior to effectiveness. Net proceeds are estimated at about $13 million, or $15 million with full over-allotment, mainly for working capital and general corporate purposes.
On a post‑split basis, common stock outstanding is expected to rise from 1,776,358 to 5,412,722 shares, assuming no prefunded warrants are sold and no underwriter warrants are exercised. The company has a going concern warning, cash of about $228 thousand as of December 31, 2025, and plans to commercialize its FDA 510(k)‑cleared ZSmile clear-aligner platform while operating amid elevated geopolitical and macroeconomic risks.
Dror Ortho-Design, Inc. entered into a Securities Purchase Agreement for a private placement of 0% senior debentures with an aggregate principal amount of $200,000, due April 27, 2026. The transaction closed the same day for a $200,000 purchase price.
If the company completes a public offering before maturity, the outstanding debentures automatically convert into common stock at the public offering share price, with resulting shares carrying the same terms as offering shares. Investors may also receive multi-year warrants with exercise prices tied to the public offering price, subject to formulas based on whether the debentures remain outstanding.
Both debenture conversions and warrant exercises are limited by a 9.99% beneficial ownership cap per holder. The securities were sold in a private placement to accredited investors under Section 4(a)(2) and Regulation D exemptions.
Dror Ortho-Design, Inc. files its annual report as a pre-revenue medical device company developing ZSmile, an AI-driven, nighttime smart aligner platform for treating Class 1 and 2 malocclusions. The platform combines a smartphone app, cloud-based AI analysis, and an IoT-enabled smart aligner using patented pulsating-air technology.
The company received FDA 510(k) clearance for its updated ZSmile platform as a Class II device in February 2026, building on prior clearance for its first-generation Aerodentis system. It reports only $228 thousand of cash as of December 31, 2025, net losses of $2.5 million in 2025 and $5.8 million in 2024, and a going concern warning from its auditor.
Dror operates entirely from Israel, exposing it to significant geopolitical and military risk, including recent regional conflicts. Management plans to spend about $1 million over the next 12 months on further ZSmile software, hardware, regulatory and IP development, but states it must raise additional equity or debt to fund operations and avoid severe strategic cutbacks.
Dror Ortho-Design, Inc. is registering 2,020,203 shares of common stock, related prefunded warrants and underwriter warrants in a firm-commitment public offering conditional on NYSE American listing approval. The company expects net proceeds of about $8.9 million, or $10.3 million with full over-allotment, mainly for working capital and general corporate purposes.
Dror plans a 1-for-450 reverse stock split before or upon effectiveness, which would raise post-split shares outstanding from 2,171,104 to about 4,191,307 if all common shares are sold and no prefunded or underwriter warrants are exercised. The business is pre-revenue, developing an AI-based orthodontic platform and has incurred recurring losses, with only $549 thousand of cash at December 31, 2024 and $240,362 at September 30, 2025, leading auditors and management to express substantial doubt about its ability to continue as a going concern without additional capital.
Operations are concentrated in Israel, exposing Dror to significant geopolitical and macroeconomic risks, including recent regional conflicts, potential supply chain disruptions and staffing impacts. The company also faces extensive regulatory, market-acceptance and competitive risks as it seeks FDA 510(k) clearance for its updated platform and attempts to enter a clear-aligner market dominated by large, established players.
Dror Ortho-Design, Inc. received an amended Schedule 13G/A showing significant institutional ownership in its common stock. Orin Hirschman reports beneficial ownership of 95,662,500 shares, representing 9.9% of the common stock, with sole voting and dispositive power over these shares.
AIGH Capital Management LLC, a Delaware investment adviser, reports beneficial ownership of 87,000,000 shares, or 9.1% of the class, also with sole voting and dispositive power. The filing notes additional common shares are issuable from preferred stock and warrants but are not currently convertible or exercisable due to beneficial ownership limits, and certifies the holdings are in the ordinary course of business and not for changing control.
Dror Ortho-Design, Inc. entered into a Securities Purchase Agreement for a private placement of Debentures with an aggregate principal amount of $250,000, which closed on December 30, 2025. The Debentures bear 0% interest and mature on February 28, 2026, with holders able to extend maturity in 60-day increments. If the company completes a public offering before maturity, the outstanding principal will automatically convert into common stock at the same per-share price used in that offering, and the resulting shares will carry the same terms as those sold in the offering.
Subject to completion of a public offering, investors are also entitled to receive Warrants to buy common stock at the public offering price, expiring five years from issuance, with customary anti-dilution and price-based adjustments. Both the Debentures and any Warrants include a 9.99% beneficial ownership cap, limiting how much equity any holder can acquire through conversion or exercise. The transaction was conducted as an unregistered offering under Section 4(a)(2) and Regulation D, with all purchasers represented as accredited investors.
Dror Ortho-Design, Inc. entered into a Securities Purchase Agreement for a private placement of 0% debentures with an aggregate principal amount of $200,000, maturing on February 2, 2026. If the company completes a public offering before maturity, the outstanding debentures will automatically convert into common shares at the public offering share price, with those shares carrying the same terms and any accompanying warrants and registration rights as in the offering.
Subject to the completion of that public offering, investors are also entitled to warrants for additional common shares, with quantities tied to the number of debenture conversion shares and a defined “warrant subscription amount.” Any warrants issued will be immediately exercisable at the public offering price and will expire five years after issuance. Both debenture conversions and warrant exercises are capped so that a holder cannot beneficially own more than 9.99% of outstanding common stock. The transaction was conducted as an unregistered private placement under Section 4(a)(2) and Regulation D.
Dror Ortho-Design, Inc., a pre-revenue Israeli orthodontic device developer, reported a net loss of $653,528 for the quarter and $1,988,989 for the nine months ended September 30, 2025, narrower than a year ago as research and development and share-based compensation declined.
Cash fell to $240,362 with total assets of $271,218, while current liabilities reached $2,420,477, resulting in a stockholders’ deficit of $2,317,813. Management states there is substantial doubt about the company’s ability to continue as a going concern and it remains dependent on external financing.
During the first nine months of 2025 Dror raised $1,100,000 via zero-interest convertible debentures that may convert into common shares in a future public offering and created a derivative warrant liability of $478,285. The company continues developing its AI-based, sleep-time orthodontic alignment platform and plans to seek new FDA 510(k) clearance for this updated device.