GUIDED THERAPEUTICS INC
For the period ended Mar 31, 2026. Filed May 15, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 15, 2026
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001477932-25-008196
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-15.
0001477932-26-003195
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 86 previous paragraphs and 72 current paragraphs.
31 unchanged; 17 reworded; 24 added; 36 removed; 2 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (24)
Current report
We have not yet obtained clearance or approval from the U.S. FDA. However, we have completed patient enrollment in the clinical trial required to support an application for FDA approval to market and sell LuViva in the United States. As of April 2026, the status of the FDA application is as follows:
Current report
For us to market our products in Europe and some other international jurisdictions, we and our distributors and agents must obtain required regulatory registrations or approvals. We must also comply with extensive regulations regarding safety, efficacy and quality in those jurisdictions. We may not be able to obtain the required regulatory registrations or approvals, or we may be required to incur significant costs in obtaining or maintaining any regulatory registrations or approvals we receive. Delays in obtaining any registrations or approvals required for marketing our products, failure to receive these registrations or approvals, or future loss of previously obtained registrations or approvals would limit our ability to sell our products internationally. For example, international regulatory bodies have adopted various regulations governing product standards, packaging requirements, labeling requirements, import restrictions, tariff regulations, duties and tax requirements. These regulations vary from country to country. In order to sell our products in Europe, in 2018 we had to undergo an inspection and re-file for ISO 13485:2016 and the CE Mark, which is an international symbol of quality and compliance with applicable European medical device directives. Failure to maintain ISO 13485:2016 certification or CE mark certification or other international regulatory approvals would prevent us from selling in some countries in the European Union.
Current report
As of December 31, 2025, our products have achieved and maintained both ISO 13485:2016 certification and the CE Mark through our contract manufacturer, Newmars Technologies. However, because of our focus on countries that do not require the CE Mark, it is uncertain whether we will maintain the CE Mark for the short term, as standards are continually evolving.
Current report
For our products to be marketed and sold in the People’s Republic of China, they must gain approval from the NMPA. We have been working with SMI to obtain NMPA approval. In 2022, device safety compliance testing was completed, and in late 2023 enrollment in the pivotal clinical trial at four hospitals was completed. SMI filed the NMPA approval application on October 16, 2024. On January 6, 2025, SMI notified us that the NMPA had accepted the application as completed and commenced its review.
Current report
Although SMI no longer holds rights to LuViva in China, SMI and its partners HDMT and YMIC have indicated their willingness to continue assisting with the NMPA approval process. We are not obligated to grant long-term distribution or manufacturing rights in China to any of these parties. Both HDMT and YMIC continue to place product orders with us, as described above.
Current report
NMPA approval requires a successful manufacturing inspection. Current indications suggest that YMIC may be the entity to achieve this, as they are approved by the Chinese government to manufacture Class III medical devices. Based on current expectations, a manufacturing inspection could occur in the second quarter of 2026, with potential approval in the third or fourth quarter of 2026, although there is no assurance that this timeline will be met or that NMPA approval of LuViva will be obtained.
Current report
Following regulatory approval of LuViva in Russia on August 11, 2025, the Company’s distribution partner, Newmars Medical Technologies (“Newmars”), has shifted its focus from smaller Eastern European markets to the Russian market. The ongoing war between Russia and Ukraine has complicated efforts to market LuViva in Russia.
Current report
Step 4 – Allocate the transaction price to the performance obligations: If a contract contains multiple performance obligations, the transaction price is allocated to each performance obligation based on the relative standalone selling price of each promised good or service. Standalone selling prices are determined using observable market prices when available or estimated using appropriate pricing methods.
Current report
Step 5 – Recognize revenue when (or as) performance obligations are satisfied: Revenue is recognized when control of the promised goods or services transfers to the customer. For product sales, this generally occurs at a point in time when the device is shipped or delivered to the customer in accordance with the contractual shipping terms. Revenue related to services or other ongoing obligations, if any, is recognized over the period in which the services are performed.
Current report
Sales Revenue and Cost of Goods Sold: The Company did not recognize any revenue during the three months ended March 31, 2026 or 2025.
Current report
As of March 31, 2026, the Company had deferred revenue of $188,552, related to advance customer payments. Certain of these arrangements require additional payments or the satisfaction of contractual conditions, including the receipt of customer-provided components, prior to shipment. Accordingly, the timing of shipment and revenue recognition for these arrangements remains uncertain. The Company also has customer purchase orders for LuViva devices and disposables; however, the timing and fulfillment of these orders, and therefore revenue recognition, are dependent on various factors, including customer requirements, production timing, and regulatory considerations, including the status of approval by the NMPA.
Current report
While the Company believes that demand for its products may increase as regulatory approvals are obtained and commercial activities expand, there can be no assurance regarding the level or timing of revenue in 2026.
Current report
***General and Administrative Expense:***General and administrative expenses were $450,673 and $266,920 during the three months ended March 31, 2026 and 2025, respectively. The increase of $183,753, or 69%, was primarily due to increases of $76,380 in attorney's fees incurred in connection with the Company's uplisting to the Canadian stock exchange, $40,644 in stock option expense, $30,875 in rent and utilities (of which a portion reflects rent previously allocated to sales and marketing), $29,918 in payroll and benefits, and $19,355 in professional services and consulting, partially offset by decreases of $10,725 in property taxes and $2,694 in miscellaneous expenses.
Current report
***Gain on Remeasurement of Deferred Compensation Conversion Liability:***During the three months ended March 31, 2026, the Company recognized a gain of $217,062 on the remeasurement of the deferred compensation conversion liability related to Dr. Faupel's convertible deferred compensation arrangement. This liability is classified under ASC 718 because settlement into common stock is at the employee's election, and is carried at fair value with changes recognized each period. As of March 31, 2026, the conversion feature was out-of-the-money relative to the $0.25 conversion price, and accordingly its fair value was estimated using the Black-Scholes option pricing model, reflecting time value rather than intrinsic value. The resulting decrease in fair value from the prior period-end balance generated the gain recognized during the quarter.
Current report
Interest Expense: Interest expense was $150,831 and $146,899 during the three months ended March 31, 2026 and 2025, respectively, and remained materially consistent period over period.
Current report
***Inducement Charges:***During the three months ended March 31, 2026, the Company recognized inducement charges of $77,593 related to the issuance of warrants in connection with the conversion of outstanding debt.
Current report
Loss from Extinguishment of Debt*:*No loss on extinguishment of debt was recognized during the three months ended March 31, 2026, compared to $31,928 in the prior-year period, which related to the exchange of outstanding debt for equity securities in connection with a private placement completed in March 2025.
Current report
***Preferred Stock Dividends:***Preferred stock dividend expense was $3,242 and $35,559 during the three months ended March 31, 2026 and 2025, respectively. The decrease of $32,317 was primarily due to a reduction in outstanding dividend-bearing preferred stock and the cessation of dividend accruals on certain preferred stock series.
Current report
As of March 31, 2026, the Company had a working capital deficit of approximately $5.1 million and an accumulated deficit of approximately $158.0 million. The Company has historically incurred recurring losses from operations and expects such losses to continue as it advances its regulatory approval efforts and commercialization activities. During the three months ended March 31, 2026, the Company incurred a net loss attributable to common stockholders of approximately $1.0 million. The Company’s operating activities continue to require significant cash outflows, primarily related to research and development, general and administrative expenses, and debt servicing obligations.
Current report
Cash Flows
Current report
**Operating Activities:**Net cash used in operating activities was $616,947 during the three months ended March 31, 2026, compared to $330,302 in the prior-year period. The increase in cash used was primarily due to a net loss of $500,333 and unfavorable changes in working capital, primarily driven by a decrease in accounts payable and accrued liabilities of $97,111, partially offset by non-cash items including stock-based compensation of $68,316, inducement charges of $77,593, amortization of debt issuance costs and discounts of $47,514, and amortization of the lease right-of-use asset of $22,444, net of a non-cash gain on remeasurement of the deferred compensation conversion liability of $217,062.
Current report
**Investing Activities:**Net cash used in investing activities during the period was not material.
Current report
**Financing Activities:**Net cash provided by financing activities was $922,475 during the three months ended March 31, 2026, compared to $57,121 in the prior-year period. Cash provided by financing activities in the current period was primarily driven by $980,000 of proceeds from warrant exercises and $187,550 from the issuance of notes payable, partially offset by $215,119 of payments on notes payable, $2,406 of payments on notes payable issued to related parties, and $27,550 of debt issuance costs. In the prior-year period, financing activities consisted primarily of $204,500 of proceeds from a private placement offering, partially offset by $147,379 of payments on notes payable.
Current report
Capital Resources and Funding Requirements
Removed paragraphs (36)
Previous report
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Previous report
In the United States, the Company is actively pursuing FDA approval by conducting a clinical trial involving approximately 400 study participants, with the exact number depending in part on the numbers of women in the study both with and without cervical disease. The study protocol was drafted with input from FDA and physicians at the clinical centers that are participating in the study. In 2023, FDA completed its review of the protocol and had no further recommendations or questions. Also in 2023, four clinical sites agreed to participate in the study and all four of the study sites were fully IRB approved. The protocol was also approved by an independent, nationally recognized institutional review board. All four sites have received LuViva devices and were trained in their use. All four sites have undergone multiple clinical study monitoring visits by the Company’s clinical study monitors. Clinical study monitoring visits are required by FDA to ensure that the study is being conducted under FDA guidelines and in compliance with the study protocol.
Previous report
On August 13, 2025 the Company announced that it had surpassed the minimum number of enrolled subjects, both for each individual site and for the entire study. Based on this achievement, data analysis has begun. The initial analysis will focus on determining the number of study subjects with and without significant cervical disease to ensure that adequate numbers of both have been enrolled and tested. While this is occurring, study site close-out and monitoring visits are being scheduled. Below is a summary of the status of the study:
Previous report
We expect the study and data analysis to be completed in 2025. However, there can be no assurance that the study will progress and be completed within the expected timeframe, or ever.
Previous report
Regarding international sales efforts, our focus has been on achieving regulatory approval to sell LuViva in China. Our Chinese partner, SMI, filed the application with NMPA for approval of LuViva as a Class 3 medical device in China on October 16, 2024. The results for the 449 women tested by LuViva were better than required by NMPA with a sensitivity of 83% and a specificity of 54%. There were no adverse events reported during the use of LuViva in the study, adding further evidence as to the safety of the technology. The NMPA application was accepted as complete and is under review. SMI has informed us that a mandatory inspection of their manufacturing site has delayed until of 2026, which is consistent with NMPA approval in the first half of 2026, although there can be no assurance that NMPA approval will occur within the projected time frame, or ever.
Previous report
As of August 1, 2025, SMI was in contractual default due to late payments totaling $200,000 and failure to provide certain data to the Company as set forth in its agreements with the Company.
Previous report
As of October 31, 2025, SMI had not cured the defaults and had not achieved NMPA approval, resulting in SMI’s loss of rights to sell and market LuViva in China. Guided Therapeutics is currently in discussions with a new partner that works with SMI to assume the responsibilities formerly under the purview of SMI. In addition, during the nine months ended September 30, 2025, we entered into a supply agreement with Hangzhou Dongye Medical Technology Company, Ltd. (“HDMT”), the exclusive provider of gynecology products for 42 hospitals in China, for the purchase of 35 LuViva devices totaling $700,000. As of September 30, 2025, we have received $100,000 in payments and shipped three devices, resulting in the recognition of $60,000 in revenue for the quarter ended September 30, 2025.
Previous report
Based on regulatory approval of LuViva in Russia granted on August 11, 2025, our distribution partner, Newmars Medical Technologies (“Newmars”), is shifting its emphasis from smaller East European countries to the larger Russian market,
Previous report
Step 4 – Allocate the transaction price to the performance obligations in the contract: for a contract that has more than one performance obligation, the entity will allocate the transaction price to each performance obligation separately, in exchange for satisfying each performance obligation. The acceptable methods of allocating the transaction price include adjusted market assessment approach, expected cost plus a margin approach, and the residual approach (in limited circumstances). Discounts given should be allocated proportionately to all performance obligations unless certain criteria are met and the reallocation of changes in standalone selling prices after inception is not permitted.
Previous report
Step 5 – Recognize revenue as and when the entity satisfies a performance obligation: the entity should recognize revenue at a point in time, except if it meets any of the three criteria, which will require recognition of revenue over time: the entity’s performance creates or enhances an asset controlled by the customer, the customer simultaneously receives and consumes the benefit of the entity’s performance as the entity performs, and the entity does not create an asset that has an alternative use to the entity and the entity has the right to be paid for performance to date.
Previous report
**Valuation of Deferred Taxes:**We account for income taxes in accordance with the liability method. Under the liability method, we recognize deferred assets and liabilities based upon anticipated future tax consequences attributable to differences between financial statement carrying amounts of assets and liabilities and their respective tax bases. We establish a valuation allowance to the extent that it is more likely than not that deferred tax assets will not be utilized against future taxable income.
Previous report
**Allowance for Credit Losses:**Trade receivables are recorded net of allowances for chargebacks, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The allowance for credit losses was immaterial as of September 30, 2025 and December 31, 2024.
Previous report
Sales Revenue and Cost of Goods Sold: Revenue from the sale of LuViva devices and disposables was $60,000 for the three months ended September 30, 2025, compared to none in the prior-year period. The current period revenue was derived from the shipment of three instrumentation packages to Hangzhou Dongye Medical Technology Company, Ltd. (“HDMT”). Cost of goods sold totaled $25,288, of which $22,693 related to the devices shipped to HDMT, with the remainder attributable to inventory adjustments. As of September 30, 2025, we have a deferred revenue balance of $689,318 which will be recognized as revenue upon shipment of devices pending NMPA approval.
Previous report
***General and Administrative Expense:***General and administrative expenses were $361,898 and $374,190 during the three months ended September 30, 2025 and 2024, respectively. The decrease of $12,292, or 3.3%, was primarily driven by a decrease of $23,917 for consulting and professional fees, a decrease of $10,658 for taxes and a decrease of $7,481 for stock option expense. These increases were offset by an increase of $21,211 in salaries & benefits, $7,207 of additional rent expense allocated to general use purposes and a $1,346 increase in other miscellaneous expenses.
Previous report
Interest Expense: Interest expense was $129,304 and $107,500 during the three months ended September 30, 2025 and 2024, respectively. The increase of $21,804, or 20.3%, was primarily due to a higher level of outstanding debt.
Previous report
Change in fair value of derivative liability: The change in the fair value of our derivative liabilities resulted in a loss of $37,033 and $585 during the three months ended September 30, 2025 and 2024, respectively. The increase in the derivative liability was primarily attributable to accrued interest, which increased the amount subject to conversion features accounted for as derivative liabilities.
Previous report
Loss from Extinguishment of Debt*:*During the three months ended September 30, 2025, we recognized a loss on extinguishment of debt of $106,200 related to exchanges of debt for common stock and warrants.
Previous report
***Preferred Stock Dividends:***Preferred stock dividend expense was $42,837 for the three months ended September 30, 2025, compared to $38,194 in the prior-year period, and was materially consistent between periods.
Previous report
RESULTS OF OPERATIONS
Previous report
COMPARISON OF THE NINE MONTHS ENDED SEPTEMBER 30, 2025 AND 2024
Previous report
Sales Revenue and Cost of Goods Sold: Revenues from the sale of LuViva devices and disposables for the nine months ended September 30, 2025 were $177,462, compared to $5,720 for the nine months ended September 30, 2024. Revenue in the current period was attributed to the shipment of six instrumentation packages and 49,031 RFID chips to our customers in China. Cost of goods sold was $63,500 during the nine months ended September 30, 2025, of which $60,911 related to the devices and RFID chips shipped to China, with the remainder attributable to inventory adjustments. As of September 30, 2025, we have a deferred revenue balance of $689,318 which will be recognized as revenue upon shipment of devices pending NMPA approval.
Previous report
Research and Development Expenses: Research and development expenses were $342,359 and $386,417 during the nine months ended September 30, 2025 and 2024, respectively. The decrease of $44,058, or 11.4%, was primarily due to a $29,614 decrease in sponsored research costs, a $10,432 decrease in clinical travel expenses and a decrease of $5,394 in engineering staff salaries.
Previous report
Sales and Marketing Expenses: Sales and marketing expenses were $146,011 and $217,653 during the nine months ended September 30, 2025 and 2024, respectively. The decrease of $71,642, or 32.9% was primarily due to reductions of $49,503 in salaries & benefits, $15,312 in rent expense (due to a decline in allocated rent expense and a decline in ancillary charges from the landlord), and $7,577 in travel expenses.
Previous report
***General and Administrative Expense:***General and administrative expenses were $1,286,930 and $974,406 during the nine months ended September 30, 2025 and 2024, respectively. The increase of $312,524, or 32.1%, was primarily driven by an increase of $300,672 in payroll & benefits (including payroll taxes), which was primarily due to a one-time charge of $270,389 for warrants included in a board-approved compensation package for Dr. Faupel during the current period. Additionally, the Company recognized $20,009 of additional expense for stock options in the current period versus the prior and $4,464 of additional credit loss expense. These increases were offset by a decrease of $15,658 in taxes.
Previous report
Interest Expense: Interest expense was $432,752 and $246,990 during the nine months ended September 30, 2025 and 2024, respectively. The increase of $185,762, or 75.2%, was due to an increase in debt in the current period versus the prior.
Previous report
***Gain from Extinguishment of Debt:***The gain from forgiveness of debt of $46,136 and $49,205 during the nine months ended September 30, 2025 and 2024, respectively, was materially consistent period over period and was due to forgiveness of debt from our creditors.
Previous report
Loss from Extinguishment of Debt:* *During the nine months ended September 30, 2025, we recognized a loss on extinguishment of debt of $138,148 related to exchanges of debt for common stock and warrants.
Previous report
***Preferred Stock Dividends:***Expense related to preferred stock dividends of $125,875 and $126,030 for the nine months ended September 30, 2025 and 2024, respectively, was materially consistent over the two periods.
Previous report
We have incurred significant losses since our inception. At September 30, 2025, the Company had negative working capital of approximately $5.7 million, accumulated deficit of $155.8 million, and incurred a net loss including preferred dividends of $2.1 million for the nine months then ended. Stockholders’ deficit totaled approximately $5.7 million at September 30, 2025, primarily due to recurring net losses from operations.
Previous report
Liquidity
Previous report
Subsequent to September 30, 2025, the Company received approximately $200,000 in proceeds from an ongoing private placement offering of units consisting of one share of common stock, one three-year warrant exercisable at $0.26 per share, and one four-year warrant exercisable at $0.52 per share, sold at a price of $0.19 per unit. The Company expects to complete the issuance of the related securities during the fourth quarter of 2025, and intends to use the proceeds for general working capital and corporate purposes.
Previous report
Summary of our Cash Flows
Previous report
Net cash used in operating activities was $776,689 for the nine months ended September 30, 2025, compared to $786,783 in the prior-year period, and remained relatively consistent year over year. The change reflects a higher net loss of $213,848 and unfavorable working capital changes of $216,859, offset by higher non-cash adjustments, including increases in stock-based compensation ($219,267), loss on extinguishment of debt ($138,148), and amortization of debt discounts and issuance costs ($117,108). These increases were partially offset by a $46,227 gain from the change in fair value of derivative liabilities compared to a $7,935 loss in the prior period.
Previous report
For the nine months ended September 30, 2025, $1,797 of cash used for investing activities was for the purchase of computer equipment.
Previous report
Net cash provided by financing activities was $477,832 in the nine months ended September 30, 2025, compared to $390,100 in the prior-year period. The increase of $87,732 was due to $235,900 of additional proceeds from the issuance of notes payable, offset by an increase in debt payments of $74,519, a decrease in proceeds from issuances of equity instruments of $40,499 and an increase in debt issuance costs of $33,150.
Previous report
As a result, our total cash decreased by $300,654 during the nine months ended September 30, 2025, compared to a $396,683 decrease during the same period in 2024.
Reworded paragraphs (17)
Previous wording
Our prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. We have experienced operating losses since our inception in 1992 as SpectRx, Inc. and, as of September 30, 2025, we have an accumulated deficit of approximately $155.8 million. To date, we have engaged primarily in research and development efforts and the early stages of marketing our products. We do not have significant experience in manufacturing, marketing or selling our products. We may not be successful in growing sales for our products. Moreover, required regulatory clearances or approvals may not be obtained in a timely manner, or at all. Our products may not ever gain market acceptance and we may not ever generate significant revenues or achieve profitability. The development and commercialization of our products requires substantial development, regulatory, sales and marketing, manufacturing and other expenditures. We expect our operating losses to continue for the foreseeable future as we continue to expend substantial resources to complete commercialization of our products, obtain regulatory clearances or approvals, build our marketing, sales, manufacturing and finance capabilities, and conduct further research and development.
Current wording
Our prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. We have experienced operating losses since our inception in 1992 as SpectRx, Inc. and, as of March 31, 2026, we have an accumulated deficit of approximately $158.0 million. To date, we have engaged primarily in research and development efforts and the early stages of marketing our products. We do not have significant experience in manufacturing, marketing or selling our products. We may not be successful in growing sales for our products. Moreover, required regulatory clearances or approvals, described below, may not be obtained in a timely manner, or at all. Our products may not ever gain market acceptance and we may not ever generate significant revenues or achieve profitability. The development and commercialization of our products requires substantial development, regulatory, sales and marketing, manufacturing and other expenditures. We expect our operating losses to continue for the foreseeable future as we continue to expend substantial resources to complete commercialization of our products, obtain regulatory clearances or approvals, build our marketing, sales, manufacturing and finance capabilities, and conduct further research and development.
Previous wording
Based on written agreements and ongoing discussions with SMI and its Chinese partners, we currently hold and expect to generate additional purchase orders which we expect to result in actual sales of approximately $1.0 million within the next twelve months. We cannot be assured that we will generate all or any of these additional purchase orders, or that existing orders will not be canceled by the distributors or that parts to build product will be available to meet demand, such that existing orders will result in actual sales, in part because demand for LuViva is contingent upon Chinese regulatory approval which has not yet been achieved. Because we have a short history of sales of our products, we cannot confidently predict future sales of our products beyond this time frame and cannot be assured of any particular number of sales. Accordingly, we have not identified any particular trends with regard to sales of our products. In order to increase demand for LuViva, we are focused on three primary markets: the United States, China and Europe. In addition, we have recently received sales orders from Turkey and Indonesia, for which we have received the necessary regulatory approvals and are preparing to fulfill. These orders are expected to result in approximately $200,000 in revenue for 2025. When combined with sales to our Chinese partner, these constitute what we view as the current demand for our products.
Current wording
Based on existing purchase orders and ongoing discussions with potential customers and partners, we expect potential sales of approximately $1.0 million within the next twelve months. We cannot be assured that we will generate all or any of these additional purchase orders, or that existing orders will not be canceled by the distributors or that parts to build product will be available to meet demand, such that existing orders will result in actual sales, in part because demand for LuViva is contingent upon Chinese regulatory approval which has not yet been achieved. Because we have a short history of sales of our products, we cannot confidently predict future sales of our products beyond this time frame and cannot be assured of any particular number of sales. Accordingly, we have not identified any particular trends with regard to sales of our products. In order to increase demand for LuViva, we are focused on three primary markets: the United States, China and Europe. In addition, we have recently received sales orders from Turkey and Indonesia, for which we have received the necessary regulatory approvals and are preparing to fulfill. These orders are expected to result in approximately $200,000 in revenue for 2026. The amount may be lower depending on whether YMIC pays directly for some of the parts due to the origin of manufacture in China. We expect payment once this is resolved. When combined with sales to our Chinese partner, these constitute what we view as the current demand for our products.
Previous wording
In Turkey, we have been in contact with three different medical groups representing over 60 individual hospitals and clinics. We have entered contract discussions for supplying LuViva to the Turkish Ministry of Health (“MOH”). The current plan involves a collaboration with MOH to conduct a clinical study in Turkey to support the use of LuViva for primary screening of cervical cancer as a replacement for the Pap test under the public health system. The MOH has informed us that this would potentially involve up to 20 million tests annually in Turkey paid for by the Turkish national healthcare system. The clinical study is expected to involve about 800 patients, take less than six months to complete and will be funded by the MOH. As of October 31, 2025, MOH had approved the study and budget, including paying for LuViva devices and single use Cervical Guides. Funds are expected to be released in 2025 and the study concluded in the first half of 2026.
Current wording
In Turkey, we have been in contact with three different medical groups representing over 60 individual hospitals and clinics. We have entered contract discussions for supplying LuViva to the Turkish Ministry of Health (“MOH”). The current plan involves a collaboration with MOH to conduct a clinical study in Turkey to support the use of LuViva for primary screening of cervical cancer as a replacement for the Pap test under the public health system. The MOH has informed us that this could potentially involve significant annual testing volumes if implemented nationwide. The clinical study is expected to involve about 800 patients, take less than six months to complete and will be funded by the MOH. As of December 31, 2025, MOH had approved the study and budget, including paying for LuViva devices and single use cervical guides. Funds totaling approximately $63,000 are expected to be released in the second quarter of 2026 and the study concluded in 2026.
Previous wording
In Indonesia, our contracted distributors are in discussions with the local government hospital system of Sulawesi, one of the nation’s most populous islands. During the fourth quarter of 2024, we received an order and full payment for four devices from Indonesia. We have delayed shipment pending final payment for shipping and additional services requested by the customer. We expect to ship these devices in the fourth quarter of this year.
Current wording
In Indonesia, our contracted distributors are in discussions with the local government hospital system of Sulawesi, one of the nation’s most populous islands. During the fourth quarter of 2024, we received an order and full payment for four devices from Indonesia. We have delayed shipment pending final payment for shipping and additional services requested by the customer. We expect to ship these devices in 2026.
Previous wording
**Revenue Recognition:**ASC 606, Revenue from Contracts with Customers establishes a single and comprehensive framework which sets out how much revenue is to be recognized, and when. The core principle is that a vendor should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the vendor expects to be entitled in exchange for those goods or services. Revenue is now recognized when control over the goods or services is transferred to the customer. The application of the core principle in ASC 606 is carried out in five steps:
Current wording
**Revenue Recognition:ASC 606, Revenue from Contracts with Customers establishes a single and comprehensive framework which sets out how much revenue is to be recognized, and when. The core principle is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the vendor expects to be entitled in exchange for those goods or services. Revenue is recognized when control over the goods or services is transferred to the customer. For the Company, revenue is primarily generated from the sale of medical devices and related components, and in certain circumstances may also include service, licensing, or distribution arrangements. The application of the core principle in ASC 606 is carried out in five steps: **
Previous wording
Step 1 – Identify the contract with a customer: a contract is defined as an agreement (including oral and implied), between two or more parties that creates enforceable rights and obligations and sets out the criteria for each of those rights and obligations. The contract needs to have commercial substance and it is probable that the entity will collect the consideration to which it will be entitled.
Current wording
Step 1 – Identify the contract with a customer: a contract is defined as an agreement (including oral and implied), between two or more parties that creates enforceable rights and obligations and sets out the criteria for each of those rights and obligations. The contract needs to have commercial substance and it is probable that the entity will collect the consideration to which it will be entitled. In the medical device industry, contracts may include sales agreements with hospitals, clinics, distributors, or international partners.
Previous wording
Step 2 – Identify the performance obligations in the contract: a performance obligation in a contract is a promise (including implicit) to transfer a good or service to the customer. Each performance obligation should be capable of being distinct and is separately identifiable in the contract.
Current wording
Step 2 – Identify the performance obligations in the contract: a performance obligation in a contract is a promise (including implicit) to transfer a good or service to the customer. Each performance obligation should be capable of being distinct and is separately identifiable in the contract. For the Company, performance obligations typically consist of the delivery of medical devices, related disposables or accessories, and in certain arrangements may include installation services, training, technical support, or other post-delivery obligations.
Previous wording
Step 3 – Determine the transaction price: transaction price is the amount of consideration that the entity can be entitled to, in exchange for transferring the promised goods and services to a customer, excluding amounts collected on behalf of third parties.
Current wording
Step 3 – Determine the transaction price: transaction price is the amount of consideration that the entity can be entitled to, in exchange for transferring the promised goods and services to a customer, excluding amounts collected on behalf of third parties. Transaction prices for the Company’s products include fixed prices stated in purchase orders or distribution agreements.
Previous wording
Research and Development Expenses: Research and development expenses were $135,549 and $111,298 during the three months ended September 30, 2025 and 2024, respectively. The increase of $24,251, or 21.8%, was primarily due to $24,240 in additional sponsored research costs related to clinical trials.
Current wording
Research and Development Expenses: Research and development expenses were $44,511 and $74,122 during the three months ended March 31, 2026 and 2025, respectively. The decrease of $29,611, or 40%, was primarily due to a $60,450 reduction in clinical trial research expenses, partially offset by increases of $20,000 in payroll and $7,025 for professional services and consulting.
Previous wording
Sales and Marketing Expenses: Sales and marketing expenses were $22,500 and $75,850 during the three months ended September 30, 2025 and 2024, respectively. The decrease of $53,350, or 70.3%, was primarily due to reductions of $39,929 in salaries and benefits, $9,474 in allocated rent expense, and $4,439 in travel expenses.
Current wording
Sales and Marketing Expenses: Sales and marketing expenses were $22,500 and $72,993 during the three months ended March 31, 2026 and 2025, respectively. The decrease of $50,493, or 69%, was primarily due to a reduction of $41,285 in payroll and benefits and $8,907 in allocated rent expense.
Previous wording
Change in Fair Value of Derivative Liability: The change in the fair value of our derivative liabilities resulted in a gain of $46,227 during the nine months ended September 30, 2025 versus a loss of $7,935 during the nine months ended September 30, 2024. The change in the fair value was attributed to changes in our forecasted stock price. In addition, a greater number of derivative liabilities were recorded in the current year due to additional bifurcated conversion features associated with new debt issuances.
Current wording
Change in fair value of derivative liability: The change in the fair value of derivative liabilities resulted in a gain of $12,847 during the three months ended March 31, 2026, compared to a gain of $52,890 in the prior-year period. A greater number of derivative liabilities were recorded in the prior year due to additional bifurcated conversion features associated with new debt issuances.
Previous wording
Gain from Forgiveness of Debt:* *The gain from forgiveness of debt of $15,118 and $16,145 during the three months ended September 30, 2025 and 2024, respectively, was materially consistent period over period and was due to forgiveness of debt from our creditors.
Current wording
***Gain from Forgiveness of Debt:***Gain from forgiveness of debt was $3,278 and $16,291 during the three months ended March 31, 2026 and 2025, respectively, and was due to forgiveness of debt from our creditors.
Previous wording
***Other Income:***Other income was $161,087 and $12,372 during the nine months ended September 30, 2025 and 2024, respectively. During the nine months ended September 30, 2025, we reached an agreement with SMI to apply their payment of $180,000 towards reimbursement of certain expenses incurred during the years ended December 31, 2024 and 2023. As a result of this agreement, we recognized $180,000 of deferred revenue in other income during the current period. Additionally, we recorded other income of $52,400 in the current period to account for funds received from the Internal Revenue Service related to refundable payroll tax credits under the Employee Retention Credit program. This income was offset by a $84,000 loss recorded for the write-off of a long-term asset in the current period. Other income in the prior year period primarily reflected an adjustment to a previously recorded liability.
Current wording
***Other Income:***Other income was $14,588 and $98,090 during the three months ended March 31, 2026 and 2025, respectively. The higher amount in the prior-year period was primarily attributable to an agreement with SMI, under which a $180,000 payment was applied toward reimbursement of certain expenses incurred in prior periods and recognized in other income. This income was partially offset by an $84,000 loss recorded for the write-off of a long-term asset. Other income in the current period primarily relates to a vendor credit issued for amounts incurred in prior periods.
Previous wording
Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $785,445 and $692,417 during the three months ended September 30, 2025 and 2024, respectively. The change reflects the factors discussed above.
Current wording
***Net Loss Attributable to Common Stockholders:***Net loss attributable to common stockholders was $1,013,441 and $462,742 during the three months ended March 31, 2026 and 2025, respectively. The reasons for the increase are explained above.
Previous wording
Over the next 12 months we expect our burn rate to increase as we increase headcount, especially for meeting manufacturing demand. In addition, although we have significant inventory, we will need to order additional parts and services for production. Finally, we expect to spend another $425 thousand to complete and file our FDA study. Thus, we estimate that approximately $2.3 million will be needed to fund the business over the next 12 months. However, other than completing and filing the US FDA study results, additional expenditures for manufacturing production will be needed only if significant product is ordered and paid for in advance by customers, which is our current policy.
Current wording
Over the next 12 months we expect our burn rate to increase as we increase headcount, especially for meeting manufacturing demand. In addition, although we have significant inventory, we will need to order additional parts and services for production. Finally, we expect to spend another $350,000 to complete payments related to our FDA study, although these payments do not impact our schedule for filing the PMA during the second quarter of 2026. Thus, we estimate that approximately $2.4 million will be needed to fund the business over the next 12 months. However, other than completing and filing the US FDA study results, additional expenditures for manufacturing production will be needed only if significant product is ordered and paid for in advance by customers, which is our current policy.
Previous wording
Since our inception, we have raised capital through the public and private sale of debt and equity, funding from collaborative arrangements, and grants. As of September 30, 2025, we had cash of approximately $87 thousand and negative working capital of $5.7 million. Our outstanding debt obligations include a combination of short- and long-term promissory notes, insurance premium financing, and several convertible notes with varying maturities, interest rates, and terms.
Current wording
Since our inception, we have raised capital through the public and private sale of debt and equity, funding from collaborative arrangements, and grants. As of March 31, 2026, we had cash of approximately $368,886 and a working capital deficit of $5.1 million. Our outstanding debt obligations include a combination of short- and long-term promissory notes, insurance premium financing, and several convertible notes with varying maturities, interest rates, and terms.
Previous wording
As of September 30, 2025, we have a long-term note issued to a former employee with a remaining principal balance of $53,162, of which $24,000 is classified as short-term. This note accrues interest at 6% per annum and matures on May 5, 2028. Scheduled monthly payments of $2,000 are being made in accordance with the agreement.
Current wording
As of March 31, 2026, we have a promissory note issued to a former employee with an outstanding principal balance of approximately $41,000. The note accrues interest at 6% per annum and matures on May 5, 2028. Monthly payments of approximately $2,000 are required under the terms of the agreement.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $2,103,663 and $1,890,970 during the nine months ended September 30, 2025 and 2024, respectively. The change reflects the factors discussed above.
Previous report — wording carried elsewhere
There was no income tax benefit recorded for the nine months ended September 30, 2025 or 2024, due to recurring net operating losses.