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Market ClerkRecap
Tue Oct 27 · markets closed1 signal on Oct 26140 insider buys this week · $73.9MCIRO short report next: Oct 30The week ahead

DROR

Dror Ortho-Design, Inc.
OTC · HEALTH CARE · DENTAL EQUIPMENT & SUPPLIES
0.01
+0.00 +0.00%
USD · close Oct 23

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How DROR rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
86%
of sentences unchanged
Added
47
new sentences
Dropped
58
sentences removed
Length
−430
words, now 22,596

New in FY2025

  • In its report dated February 27, 2026, Barzily & Co., our independent registered public accounting firm, expressed substantial doubt about our ability to continue as a going concern as we have suffered recurring losses from operations and have insufficient liquidity to fund our future operations.
  • As of December 31, 2025, we had approximately $228 thousand of cash.
  • Hamas also launched extensive rocket attacks on Israeli population, industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel.
  • While a ceasefire was reached between Israel and Hamas in October 2025, the situation remains volatile.
  • In addition, since the commencement of these events, there have been continued hostilities along Israel’s northern border with Lebanon (with the Hezbollah terror organization) and on other fronts from various extremist groups in region, such as the Houthis in Yemen and various rebel militia groups in Syria and Iraq.
  • In October 2024, Israel began limited ground operations against Hezbollah in Lebanon, and in November 2024, a ceasefire was brokered between Israel and Hezbollah.
  • In addition, in April 2024 and October 2024, Iran launched direct attacks on Israel involving hundreds of drones and missiles and has threatened to continue to attack Israel and is widely believed to be developing nuclear weapons.
  • In June 2025, in light of continued nuclear threats and intelligence assessments indicating imminent attacks, Israel launched a preemptive strike directly targeting military and nuclear infrastructure inside Iran, aimed at disrupting Iran’s capacity to coordinate or launch further hostilities against Israel, as well as to degrade its nuclear program.
  • In response, Iran launched multiple waves of drones and ballistic missiles at Israeli cities.
  • While most of these attacks were intercepted, several caused civilian casualties and damage to infrastructure.
  • The Israeli military has since conducted additional operations against Iranian assets.
  • While a ceasefire was reached between Israel and Iran in June 2025 after 12 days of hostilities, the situation remains volatile.
  • A broader regional conflict involving additional state and non-state actors remains a significant risk.
  • Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza, Hezbollah in Lebanon, the Houthi movement in Yemen and various rebel militia groups in Syria and Iraq.
  • These situations may potentially escalate in the future to more violent events which may affect Israel and us.
  • Additionally, Yemeni rebel group, the Houthis, launched series of attacks on global shipping routes in the Red Sea, causing disruptions of supply chain.
  • Such clashes may escalate in the future into a greater regional conflict.
  • There have been travel advisories imposed as related to travel to Israel, and restrictions on travel, or delays and disruptions as related to imports and exports may be imposed in the future.
  • Several employees of our vendors are subject to military service in the IDF and have been or may be called to serve.
  • It is possible that there will be further military reserve duty call-ups in the future, which may affect our business due to a shortage of skilled labor and loss of institutional knowledge, and necessary mitigation measures we may take to respond to a decrease in labor availability, such as overtime and third-party outsourcing, which may have unintended negative effects and adversely impact our results of operations, liquidity or cash flows.
  • The ongoing conflict is rapidly evolving and developing, and could disrupt our business and operations, interrupt our sources and availability of supplies and hamper our ability to raise additional funds or sell our securities, among others.
  • Our business could be impacted by major public health issues, including future pandemics.
  • For the years ended December 31, 2025 and 2024, we incurred net losses of $2.5 million and $5.8 million, respectively.
  • In connection with the Private Placement (as defined herein) that closed in August 2023, we granted the Private Placement Investors a right to participate in future financings, until the second anniversary of the closing of the Private Placement, that involve the issuance of our Common Stock or Common Stock equivalents for cash consideration.
  • Our products (both the first generation Aerodentis system and the recently cleared ZSmile Platform) (including the currently cleared version, as well as the next generation Platform for which we have not yet submitted the requisite 510(k) application to FDA) are considered medical devices and, accordingly, are subject to rigorous regulation by government agencies in the U.S. and other countries in which we intend to sell our products.
  • We may not receive the necessary authorizations to market any future new products, and any failure to timely do so may adversely affect our ability to grow our business.
  • Both our first generation Aerodentis system and the recently cleared ZSmile Platform are classified as Class II medical devices, which were cleared by FDA for commercialization in the U.S. pursuant to the 510(k) notification process for movement and alignment of teeth during orthodontic treatment of malocclusion in April 2020 and February 2026, respectively.
  • While our first generation Aerodentis System and ZSmile Platform received 510(k) clearance in 2020 and 2026, respectively, we may in the future make other modifications to our products, including our Platform, and determine, based on our review of the applicable FDA regulations and guidance, that in certain instances new 510(k) clearances or other premarket submissions are not required.
  • If executive actions impose constraints on FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.
  • MDR was adopted in March 2023, extending existing transitional provisions.
  • In February 2026, we received 510(k) clearance for the Platform for marketing in the U.S. by the FDA only for movement and alignment of teeth during orthodontic treatment of malocclusion.
  • Although our Common Stock is quoted on the OTC Pink Limited Market operated by the OTC Markets Group Inc., there is a limited public market for shares of our Common Stock, and limited trades of our Common Stock have taken place on the OTC Pink Limited Market.
  • Even if the shares of our Common Stock may in the future trade greater volume on the OTC Pink Limited Market, the liquidity and price of our Common Stock is expected to be more limited than if such securities were quoted or listed on a national exchange.
  • Even if our Common Stock will in the future trade more actively on the OTC Pink Limited Market, the price of such Common Stock could be subject to wide fluctuations, in response to quarterly variations in our operating results, announcements by us or others, developments affecting us, and other events or factors.
  • The Sarbanes-Oxley Act and rules subsequently implemented by the SEC have required changes in corporate governance practices of public companies.
  • As a public company, we expect these rules and regulations to increase our compliance costs and to make certain activities more time consuming and costly.
  • As a public company, we also expect that these rules and regulations may make it more difficult and expensive for us to obtain director and officer liability insurance in the future and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage.
  • In connection with the Share Exchange, Private Dror shareholders are subject to the lock-up provisions contained in the Share Exchange Agreement.
  • Financial, Tax and Accounting Risks Changes in, or interpretations of, accounting rules and regulations, could result in unfavorable accounting charges.
  • We have identified a material weakness in our internal control over financial reporting, and if we are unable to remediate the material weakness, or if we experience additional material weaknesses in the future, our business may be harmed.

and 7 more.

Gone since FY2024

  • In its report dated February 19, 2025, Barzily & Co., our independent registered public accounting firm, expressed substantial doubt about our ability to continue as a going concern as we have suffered recurring losses from operations and have insufficient liquidity to fund our future operations.
  • As of December 31, 2024, we had approximately $549 thousand of cash.
  • Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel.
  • Moreover, the clash between Israel and Hezbollah in Lebanon may escalate in the future into a greater regional conflict.
  • There have been travel advisories imposed as related to travel to Israel, and restriction on travel, or delays and disruptions as related to imports and exports may be imposed in the future.
  • Several employees of our vendors are subject to military service in the IDF and have been and may be called to serve.
  • It is possible that there will be further military reserve duty call-ups in the future, which may affect our business due to a shortage of skilled labor and loss of institutional knowledge, and necessary mitigation measures we may take to respond to a decrease in labor availability, such as overtime and third-party outsourcing, for example, which may have unintended negative effects and adversely impact our results of operations, liquidity or cash flows.
  • The ongoing conflict is rapidly evolving and developing, and could disrupt our business and operations, interrupt our sources and availability of supply and hamper our ability to raise additional funds or sell our securities, among others.
  • Our business could be impacted by major public health issues, including pandemics such as the spread of COVID-19.
  • For the years ended December 31, 2024 and 2023, we incurred net losses of $5.8 million and $3.6 million, respectively.
  • In connection with the Private Placement, we granted the Private Placement Investors a right to participate in future financings, until the second anniversary of the closing of the Private Placement, that involve the issuance of our common stock or common stock equivalents for cash consideration.
  • Our products (including the currently cleared version, as well as the next generation Platform for which we have not yet submitted the requisite 510(k) application to FDA) are considered medical devices and, accordingly, are subject to rigorous regulation by government agencies in the U.S. and other countries in which we intend to sell our products.
  • We may not receive the necessary authorizations to market our Platform or any future new products, and any failure to timely do so may adversely affect our ability to grow our business.
  • Our first generation Aerodentis System is a Class II medical device, which was cleared by FDA for commercialization in the U.S. pursuant to the 510(k) notification process for movement and alignment of teeth during orthodontic treatment of malocclusion in April 2020.
  • We are preparing to apply for 510(k) clearance for the updated version of the currently cleared device.
  • Such updated Platform contains new and/or different components than the original device, which is why a new 510(k) clearance is required prior to marketing the Platform in the U.S.
  • We have not yet filed a 510(k) submission for the Platform, and it has, thus, not been found by the FDA to be substantially equivalent to the first generation Aerodentis System.
  • While our first generation Aerodentis System has received 510(k) clearance in 2020, we are preparing to apply for 510(k) clearance for the updated components of our Platform, which must, then, be found by the FDA to be substantially equivalent to the Aerodentis System and, thus, may not be lawfully marketed in the U.S. until FDA make a substantial equivalence determination and issues the requisite 510(k) clearance for the updated Platform.
  • Although the development of our Platform has been carefully monitored and documented by professionals who are experienced in the FDA clearance process, there is no assurance that the FDA will agree that our Platform is substantially equivalent to the Aerodentis System and allow our Platform to be marketed in the United States.
  • The FDA may determine that the device is not substantially equivalent and require a PMA or, more likely, a de novo reclassification, and/or require further information, such as additional test data, including data from clinical studies, before it is able to make a determination regarding substantial equivalence.
  • By requesting additional information, the FDA can delay market introduction of our Platform.
  • Delays in receipt of or failure to receive any necessary 510(k) clearance, de novo classification, or PMA, or the imposition of stringent restrictions for our Platform could have a material adverse effect on our business, results of operations and financial condition.
  • In the future, we may make other modifications to our products, including our Platform, and determine, based on our review of the applicable FDA regulations and guidance, that in certain instances new 510(k) clearances or other premarket submissions are not required.
  • For example, the Trump Administration previously enacted several executive actions that could impose significant burdens on, or otherwise materially delay, FDA’s ability to engage in routine regulatory and oversight activities.
  • It is difficult to predict how these executive actions and executive actions that may be taken under the Biden Administration may affect FDA’s ability to exercise its regulatory authority.
  • If these executive actions impose constraints on FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.
  • MDR was recently adopted in March 2023, extending existing transitional provisions.
  • We are preparing to apply for 510(k) clearance for the Platform.
  • If and when our Platform receives 510(k) clearance, it will be cleared for marketing by the FDA only for movement and alignment of teeth during orthodontic treatment of malocclusion.
  • Although our common stock is quoted on the OTC Pink Market operated by the OTC Markets Group Inc., there is a limited public market for shares of our common stock, and limited trades of our common stock have taken place on the OTC Pink Market.
  • Even if the shares of our common stock may in the future trade greater volume on the OTC Pink Market, the liquidity and price of our common stock is expected to be more limited than if such securities were quoted or listed on a national exchange.
  • Even if our common stock will in the future trade more actively on the OTC Pink Market, the price of such common stock could be subject to wide fluctuations, in response to quarterly variations in our operating results, announcements by us or others, developments affecting us, and other events or factors.
  • We cannot assure you that our common stock will become eligible for listing or quotation on any exchange and the failure to do so may adversely affect your ability to dispose of our common stock in a timely fashion.
  • In order for our common stock to become eligible for listing or quotation on any exchange, reverse merger companies must have had their securities traded on an over-the-counter market for at least one year, maintained a certain minimum closing price for not less than 30 of the most recent 60 days prior to the filing of an initial listing application and prior to listing, and timely filed with the SEC all required reports since consummation of the reverse merger, including one annual report containing audited consolidated financial statements for a full fiscal year commencing after the date of filing of the Current Report on Form 8-K which discloses the reverse merger.
  • We may not be able to meet all of the filing requirements above and may not be able to satisfy the initial standards for listing or quotation on any exchange in the foreseeable future or at all.
  • Even if we are able to become listed or quoted on an exchange, we may not be able to maintain a listing of the common stock on such stock exchange.
  • The Sarbanes-Oxley Act and new rules subsequently implemented by the SEC have required changes in corporate governance practices of public companies.
  • As a public company, we expect these new rules and regulations to increase our compliance costs and to make certain activities more time consuming and costly.
  • As a public company, we also expect that these new rules and regulations may make it more difficult and expensive for us to obtain director and officer liability insurance in the future and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage.
  • We may apply the proceeds of the Private Placement to uses that ultimately do not improve our operating results or increase the price of our common stock.

and 18 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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