GUIDED THERAPEUTICS INC
For the period ended Dec 31, 2025. Filed Mar 31, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 31, 2026
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-31.
0001477932-25-002200
Item 7. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-31.
0001477932-26-001723
Item 7. 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 59 previous paragraphs and 81 current paragraphs.
21 unchanged; 20 reworded; 40 added; 18 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 1 previous and 1 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 (40)
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 February 2026, the status of the FDA application is as follows:
Current report
Most sections of the application have been prepared. We are waiting for pathology results from outside pathology experts to complete the results section and submit the application. A short delay (approximately four to six weeks) has resulted from the loss of one of the study’s outside pathologist, who has since been replaced. We currently expect to submit the application to the FDA in the second quarter of 2026. However, there can be no assurance that the analysis and submission will be completed within the expected timeframe or that the results will support regulatory clearance or approval.
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 willing ness 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 May 2026, with potential approval in the third 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.
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, Cost of Goods Sold and Gross Profit from Devices and Disposables: Revenues from the sale of LuViva devices and disposables for the year ended December 31, 2025 were $766,948, compared to $6,940 for the year ended December 31, 2024. Cost of goods sold was $195,797 during the year ended December 31, 2025, compared to $4,574 during the year ended December 31, 2024. Revenue in the current period was attributed to the shipment of ten instrumentation packages and 49,031 RFID chips to our customers in China. In 2024, revenue was minimal and consisted primarily of sales of LuViva disposables.
Current report
The increase in revenue was primarily driven by the recognition of $488,766 of revenue in the fourth quarter of 2025 related to amounts previously recorded as deferred revenue under the Company’s arrangement with SMI. During the fourth quarter, SMI breached the agreement and no further performance obligations remained. Accordingly, consistent with ASC 606, the Company recognized the remaining deferred revenue in the current period.
Current report
Cost of goods sold consists primarily of direct materials, third-party manufacturing and assembly costs, and shipping and handling. Cost of goods sold for 2025 also included approximately $75,000 of inventory-related charges, consisting of physical inventory count adjustments and write-offs of obsolete inventory, which negatively impacted gross margin and may not be indicative of future results. Gross margin in 2025 reflects limited production volumes, reliance on third-party manufacturers, and the inventory-related charges noted above. While the Company expects its cost structure may improve as production scales, the timing and extent of any such improvement remain uncertain.
Current report
As of December 31, 2025, 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, or whether revenue will be greater than that reported for 2025.
Current report
Sales and Marketing Expenses: Sales and marketing expenses were $168,511 and $287,016 during the years ended December 31, 2025 and 2024, respectively. The decrease of $118,505, or 41.3%, was primarily due to reductions of $87,412 in salaries and benefits, $26,418 in rent and utilities (due to a decline in allocated rent expense and a decline in ancillary charges from the landlord) and $6,008 of travel costs. Sales and marketing expenses in 2026 are expected to remain limited as the Company continues to focus its efforts on obtaining regulatory approvals in the United States and China. As a result, the Company does not currently expect to incur significant sales and marketing expenses in those markets during 2026. Sales and marketing activities are expected to be primarily concentrated in Turkey, including personnel-related costs, which are currently expected to include approximately $90,000 related to a regional sales resource. The overall level of sales and marketing expense in 2026 will depend on the timing of regulatory approvals and the extent to which commercialization activities expand.
Current report
General and Administrative Expense:** **General and administrative expenses were $2,304,827 and $1,296,537 during the years ended December 31, 2025 and 2024, respectively. The increase of $1,008,290, or 77.8%, was primarily driven by an increase of $866,503 in salaries and benefits, including one-time non-cash charges of $270,389 for warrants and $548,102 for a conversion option, and a $40,000 increase in the Chief Executive Officer’s annual salary effective June 1, 2025, resulting in approximately $23,333 of additional expense in 2025. The increase also reflects higher consulting fees of $96,131, stock-based compensation of $26,419, allocated rent expense of $12,900, and an allowance for credit losses of $6,825.
Current report
Loss from Extinguishment of Debt:** **The $532,864 loss on extinguishment of debt during the year ended December 31, 2025 was primarily attributable to debt-for-equity exchange transactions completed in connection with the Company’s March, August and November 2025 private placement offerings. In these transactions, the Company exchanged an aggregate of $246,246 of outstanding principal and accrued interest for units consisting of common stock and warrants. As a result, the Company recognized a total loss on extinguishment of debt of $532,864, reflecting the excess of the fair value of the equity instruments issued over the carrying value of the debt extinguished.
Current report
Other Income: Other income was $163,686 for the year ended December 31, 2025, compared to $17,102 in 2024. The increase was primarily driven by $183,525 recognized pursuant to an agreement with SMI, under which prior payments were applied toward reimbursement of certain expenses incurred by the Company in 2023 and 2024. These amounts were recognized in other income as they represent recoveries of previously incurred costs and do not relate to the transfer of goods or services under ASC 606.
Current report
Other income also included $52,400 related to refundable payroll tax credits received under the Employee Retention Credit program. These increases were partially offset by an $84,000 loss on the write-off of a long-term asset.
Current report
Preferred Stock Dividends:* *Expense related to preferred stock dividends was $149,790 and $173,724 for the years ended December 31, 2025 and 2024, respectively. The decrease was primarily attributable to the conversion of preferred shares into common stock during 2025, which reduced the number of outstanding preferred shares subject to dividend accrual.
Current report
Liquidity
Current report
In February 2026, the Company entered into warrant exchange agreements with certain holders of its outstanding warrants, pursuant to which approximately 9,250,000 warrants were exchanged for new warrants with lower exercise prices. In connection with these transactions, approximately 4,825,000 of the newly issued warrants were exercised, resulting in aggregate cash proceeds of approximately $980,000. The remaining approximately 4,425,000 warrants remain outstanding and expire in 2027.
Current report
Promissory Notes
Current report
As of December 31, 2025, the Company had outstanding promissory notes totaling approximately $105,000, compared to approximately $139,000 as of December 31, 2024. These balances primarily relate to insurance premium financing arrangements and a deferred compensation note. The decrease was primarily due to repayments during the year, including the full repayment of certain short-term promissory notes. The majority of these obligations are classified as current, with approximately $82,000 due within the next twelve months.
Current report
Convertible Debt
Current report
As of December 31, 2025, the Company had multiple outstanding convertible debt instruments, several of which are in default or contain embedded conversion features that may result in dilution.
Current report
The Company’s $1.13 million 10% Senior Unsecured Convertible Debenture, which matured on May 17, 2024, remains in default and continues to accrue interest at the default rate of 18%. Total accrued interest on the debenture was approximately $104,000 as of December 31, 2025, and the balance is classified as short-term debt in default.
Current report
The Company also has several convertible notes with institutional and third-party lenders, including notes with Diagonal Lending LLC, GS Capital Partners, LLC, and Labrys Fund II, L.P. These notes generally include original issue discounts, near-term repayment obligations through 2026, and embedded conversion features that have been bifurcated and accounted for as derivative liabilities.
Current report
As of December 31, 2025, total convertible promissory notes outstanding were approximately $447,000, or $347,000 net of discounts and issuance costs. During 2025, the Company entered into multiple exchange and conversion agreements with noteholders, including the full settlement of certain convertible notes, which reduced outstanding balances but resulted in losses on extinguishment of debt.
Current report
Related Party Debt
Current report
As of December 31, 2025, the Company had outstanding debt obligations to related parties totaling approximately $641,000, compared to approximately $534,000 as of December 31, 2024. These balances primarily consist of deferred compensation-related obligations and a contingently convertible promissory note issued in September 2025.
Current report
The Company issued a $160,000 contingently convertible promissory note to Dr. John Imhoff during 2025, of which $150,000 remained outstanding as of December 31, 2025. The note requires monthly payments and may be converted into common stock upon certain events, including payment default.
Current report
The Company also maintains outstanding deferred compensation-related obligations to executive officers, certain of which are past due, amended, or partially settled through equity issuances. During 2025, the Company entered into exchange agreements with related parties to settle portions of outstanding balances in common stock and warrants, resulting in losses on extinguishment of debt.
Current report
Summary of our Cash Flows
Current report
Net cash used in operating activities was $1,068,000 for the year ended December 31, 2025, compared to $1,119,000 in the prior year, and remained relatively consistent year over year. The change reflects a higher net loss of $779,000 and a decrease in deferred revenue of $660,000, partially offset by favorable changes in accounts payable and accrued liabilities of $1,363,000 and inventory of $185,000. Non-cash adjustments increased year over year, including higher stock-based compensation of $377,000, loss on extinguishment of debt of $533,000, and amortization of debt discounts and issuance costs of $244,000. These increases were partially offset by a $65,000 gain from the change in fair value of derivative liabilities compared to an $18,000 loss in the prior year.
Current report
Net cash used in investing activities was $2,000 for the year ended December 31, 2025, compared to nil in the prior year, and consisted of purchases of property and equipment.
Current report
Net cash provided by financing activities was $745,000 for the year ended December 31, 2025, compared to $916,000 in the prior year. The decrease of $171,000 was primarily due to lower proceeds from the issuance of common stock and warrants in private placement offerings of $268,000, partially offset by higher net borrowings from notes payable and related party financing.
Current report
As a result, total cash decreased by $325,000 during the year ended December 31, 2025, compared to a decrease of $203,000 during the same period in 2024.
Current report
Recent conflicts and heightened geopolitical tensions in the Middle East have contributed to increased uncertainty in global financial markets and may result in volatility in commodity prices, including oil and natural gas, as well as disruptions to international trade routes. Any escalation or expansion of these conflicts could adversely affect global supply chains, increase transportation and energy costs, and create additional regulatory or economic uncertainty. While the Company does not currently have significant direct exposure to the region, the indirect effects of continued instability could adversely impact the Company’s operations, financial condition, and results of operations.
Removed paragraphs (18)
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 have been trained in their use. All four sites have undergone one or more 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. Findings from the ongoing clinical study monitoring visits include:
Previous report
Based on current and expected enrollment rates, we expect the study to be completed in 2025, depending in part by how many women are diagnosed with cervical disease. 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 believes NMPA approval could happen within six months, although there can be no assurance that NMPA approval will occur within the projected time frame, or ever.
Previous report
In Europe, our distribution partners, Newmars Medical Technologies (“Newmars”), is actively pursuing potential customers in Poland, Hungary and Romania, where we have obtained the required approvals to sell our products though Newmars. In addition, an application for approval has been filed in Russia, although current geopolitics presents uncertainty as to the ability to sell and market new medical technology in that country.
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 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 December 31, 2024 and 2023.
Previous report
Sales Revenue, Cost of Goods Sold and Gross Profit from Devices and Disposables: Revenues from the sale of LuViva devices and disposables for the year ended December 31, 2024 were $6,940, compared to $97,706 for the year ended December 31, 2023. Cost of goods sold was $4,574 during the year ended December 31, 2024, compared to $62,382 during the year ended December 31, 2023. In the prior year, the majority of our revenue was derived from the sale of four instrumentation packages (“IPs”) to SMI. We currently hold purchase orders with our partner SMI and one other Chinese distributor for approximately $2.45 million in LuViva devices and disposables. Timing of approval by NMPA is likely a factor in when we will receive these payments, ship our inventory and recognize revenue. As of December 31, 2024, we have a deferred revenue balance of $848,917, which will be recognized as revenue when our products are shipped. We anticipate shipping and therefore recognizing revenue for the majority of these products in 2025, based in part on timing of NMPA approval. .
Previous report
Sales and Marketing Expenses: Sales and marketing expenses were $287,016 and $268,375 during the years ended December 31, 2024 and 2023, respectively. The increase of $18,641, or 6.9%, was primarily due to $10,981 of additional rent expense allocated to our sales and marketing department. The remaining increase was due to higher travel and payroll-related expenses. Sales and marketing expenses have remained relatively consistent year-over-year due to the fact that our international distribution partners are responsible for sales and marketing expenses in their respective countries and also because our sales team’s pay is not commission-based.
Previous report
***General and Administrative Expense:***General and administrative expenses were $1,296,537 and $2,997,424 and during the years ended December 31, 2024 and 2023, respectively. The decrease of $1,700,887, or 56.7%, was primarily driven by a decline of $1,006,320 of expense for consulting fees, which was caused by (1) $827,472 less expense recognized for shares of common stock and warrants issued to Mr. Blumberg, (2) $99,837 less expense for warrants issued to Mr. Grujic and (3) a decline of $13,011 in fees for other outside consultants, attorneys and our auditors. The decrease in our current year general and administrative expenses was also due to a $600,402 decline in payroll and benefits expenses (including payroll taxes), which was primarily caused by a one-time charge of $679,959 recorded for warrants issued in relation to the appointment of Dr. Mark Faupel as the Company’s President and Chief Executive Officer during the prior year period. Additionally, expense for stock options decreased $155,824 in the current period due to (1) a one-time charge of $59,216 in the prior year for the modification of a stock option award and (2) fewer stock option awards vesting in the current period versus the prior. The remaining decrease of $4,341 was driven by a decrease in rent and other miscellaneous expenses in the current period versus the prior.
Previous report
Other Income: Other income for the years ended December 31, 2024 and 2023 was $18,102 and $39,271, respectively. The decrease of $21,169, or 53.9%, was primarily due to a decrease in write-offs of accounts payable balances that management no longer considered to be valid liabilities in the current year.
Previous report
***Deemed Dividend for Warrant Exchanges:***Expense related to deemed dividends was nil and $98,972 for the years ended December 31, 2024 and 2023, respectively. The expense in the prior period was recognized as the excess fair value of warrant instruments exchanged over the fair value of the original warrants.
Previous report
Preferred Stock Dividends:* *Expense related to preferred stock dividends of $173,724 and $170,803 for the years ended December 31, 2024 and 2023, respectively, was materially consistent over the two periods.
Previous report
There is no assurance that we will ever be profitable or that debt or equity financing will be available to us in the amounts, on terms, and at times deemed acceptable to us, if at all. The issuance of additional equity or equity- linked securities by us could result in significant dilution in the equity interests of our current stockholders. Obtaining commercial loans, assuming those loans would be available, would increase our liabilities and future cash commitments and may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, expending capital, or declaring dividends, or which impose financial covenants on us that limit our ability to achieve our business objectives. If we are unable to obtain financing in the amounts and on terms deemed acceptable to us, we may be unable to continue our business as planned and as a result may be required to scale back or cease operations, which could cause our stockholders to lose some or all of their investment in us. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should we be unable to continue as a going concern.
Previous report
Liquidity and Capital Resources
Previous report
Our major cash flows for the year ended December 31, 2024 consisted of cash used for operating activities of $1.12 million and net cash provided by financing activities of $916 thousand, which was primarily attributed to $835 thousand of proceeds from the issuance of common stock and warrants in private placement offerings.
Previous report
Our major cash flows for the year ended December 31, 2023 consisted of cash used for operating activities of $1.75 million and net cash provided by financing activities of $24 thousand, which was attributed to proceeds from warrant exercises, less payments made on notes payable.
Reworded paragraphs (20)
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 and, as of December 31, 2024 we have an accumulated deficit of approximately $153.7 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 and, as of December 31, 2025 we have an accumulated deficit of approximately $157.1 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.
Previous wording
Based on written agreements and ongoing discussions with SMI, we currently hold and expect to generate additional purchase orders which we expect to result in actual sales of approximately $1.5 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. 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 which we are preparing to fulfill. These orders are expected to result in approximately $500,000 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. 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 and also with a medical device distributor located in Ankara.
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 $63,000 are expected to be released in 2026 and the study concluded in the first half of 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 expect additional orders for 22 – 26 devices in 2025.
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 the second quarter of 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
Valuation of Equity Instruments Granted to Employee, Service Providers and Investors: On the date of issuance, the instruments are recorded at their fair value as determined using the Black-Scholes or binomial lattice valuation models.
Current wording
Valuation of Equity Instruments Granted or Issued to Employees, Service Providers and Investors: On the date of issuance, the instruments are recorded at their fair value as determined using the Black-Scholes or binomial lattice valuation models.
Previous wording
**Inventory Valuation:**All inventories are stated at lower of cost or net realizable value, with cost determined substantially on a “first-in, first-out” basis. Selling, general, and administrative expenses are not inventoried, but are charged to expense when incurred.
Current wording
**Inventory Valuation:**All inventories are stated at lower of cost or net realizable value, with cost determined substantially on a “first-in, first-out” basis. Selling, general, and administrative expenses are not inventoried, but are charged to expense when incurred. The Company periodically evaluates its inventory for excess, obsolete, or slow-moving items and records an inventory reserve, when necessary, to reduce inventory to its estimated net realizable value. Estimates of net realizable value are based on management’s assessment of forecasted demand, expected selling prices, remaining product life cycles, regulatory approvals, technological changes, and other factors that may affect the recoverability of inventory. As the Company is in the early stages of commercialization of its medical devices and certain products remain subject to regulatory approvals in various jurisdictions, actual demand and market conditions may differ from management’s estimates. Adjustments to inventory reserves are recorded in the period in which such estimates change.
Previous wording
Research and Development Expenses: Research and development expenses were $525,650 and $228,132 during the years ended December 31, 2024 and 2023, respectively. The increase of $297,518, or 130.4%, was primarily due to a $321,018 increase in research and development clinical costs and payroll-related expenses related to clinical trials. This increase was offset by a decrease of $23,500 in fees for patent maintenance and other miscellaneous research and development costs.
Current wording
Research and Development Expenses: Research and development expenses were $468,588 and $525,650 during the years ended December 31, 2025 and 2024, respectively. The decrease of $57,062, or 10.9%, was primarily due to a $62,083 decrease in research and development clinical costs and payroll-related expenses related to clinical trials.
Previous wording
Interest Expense: Interest expense during the years ended December 31, 2024 and 2023 was $380,717 and $278,350, respectively. The increase of $102,367 (or 36.8%), was due to an increase in debt in the current period versus the prior.
Current wording
Interest Expense: Interest expense during the years ended December 31, 2025 and 2024 was $617,205 and $380,717, respectively. The increase of $236,488 (or 62.1%), was primarily due to higher outstanding debt balances and increased amortization of debt discounts associated with convertible instruments.
Previous wording
Change in Fair Value of Derivative Liability: The change in the fair value of our derivative liability resulted in a loss of $18,643 in the year ended December 31, 2024, versus a gain of $5,104 during the year ended December 31, 2023. The change in the fair value in the current period was attributed to changes in our forecasted stock price. The gain due to the change in fair value of the derivative liability in the year ended December 31, 2023 was due to changes in our stock price.
Current wording
Change in Fair Value of Derivative Liability: The change in the fair value of our derivative liability resulted in a gain of $64,747 in the year ended December 31, 2025, versus a loss of $18,643 during the year ended December 31, 2024. The change in the fair value in the current period 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.
Previous wording
***Gain (Loss) from Extinguishment of Debt:***The gain from extinguishment of debt during the years ended December 31, 2024 and 2023 was $68,622 and $196,206, respectively. The decrease of $127,584 or 65.0%, was due to a lower amount of debt forgiven in the current period, as the balances owed to our creditors have declined.
Current wording
***Gain from Extinguishment of Debt:***The gain from forgiveness of debt of $96,294 and $68,622 during the years ended December 31, 2025 and 2024, respectively, was due to forgiveness of debt from our creditors.
Previous wording
Net Loss: Net loss attributable to common stockholders was $2,590,848 and $3,759,032 during the years ended December 31, 2024 and 2023, respectively. The reasons for the decrease are explained above.
Current wording
Net Loss: Net loss attributable to common stockholders was $3,345,908 and $2,590,848 during the years ended December 31, 2025 and 2024, respectively. The reasons for the decrease are explained above.
Previous wording
We have incurred significant losses since our inception. At December 31, 2024, the Company had a negative working capital of approximately $5.0 million, accumulated deficit of $153.7 million, and incurred a net loss including preferred and deemed dividends of $2.6 million for the year then ended. Stockholders’ deficit totaled approximately $4.9 million at December 31, 2024, primarily due to recurring net losses from operations. We expect our capital expenses and operational expenses to increase in the future due to increased sales and marketing expenses, operational costs, and general and administrative costs. Therefore, we believe our operating losses will continue or even increase at least through the near term.
Current wording
We have incurred significant losses since our inception. At December 31, 2025, the Company had negative working capital of approximately $6.0 million, accumulated deficit of $157.1 million, and incurred a net loss including preferred dividends of $3.35 million for the year then ended. Stockholders’ deficit totaled approximately $6.0 million at December 31, 2025, primarily due to recurring net losses from operations.
Previous wording
The Company may need to continue to raise capital in order to provide funding for its operations and FDA/NMPA approval process. If sufficient capital cannot be raised, the Company will continue its plans of curtailing operations by reducing discretionary spending and staffing levels and attempting to operate by only pursuing activities for which it has external financial support. However, there can be no assurance that such external financial support will be sufficient to maintain even limited operations or that the Company will be able to raise additional funds on acceptable terms, or at all. In such a case, the Company might be required to enter into unfavorable agreements or, if that is not possible, be unable to continue operations, and to the extent practicable, liquidate and/or file for bankruptcy protection.
Current wording
The Company will need to continue to raise capital in order to provide funding for its operations and FDA approval process. If sufficient capital cannot be raised, the Company will continue its plans of curtailing operations by reducing discretionary spending and staffing levels and attempting to operate by only pursuing activities for which it has external financial support. However, there can be no assurance that such external financial support will be sufficient to maintain even limited operations or that the Company will be able to raise additional funds on acceptable terms, or at all. In such a case, the Company might be required to enter into unfavorable agreements or, if that is not possible, be unable to continue operations, and to the extent practicable, liquidate and/or file for bankruptcy protection.
Previous wording
The Company’s primary liquidity requirements are for working capital, funding clinical studies, and other costs associated with achieving regulatory approval to sell our products. Although income taxes are not currently a significant use of funds, after the benefits of our net operating loss carryforwards are fully recognized, they could become a material use of funds, depending on our future profitability and future tax rates. Over the next 12 months we expect our burn rate to increase somewhat 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 $300 thousand to complete and file our US FDA study. Thus, we estimate that approximately $2.5 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 $250 thousand to complete and file our FDA. 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.
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 December 31, 2024, we had cash of approximately $0.4 million and negative working capital of $4.9 million.
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 December 31, 2025, we had cash of approximately $63 thousand and negative working capital of $6.0 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
Tariffs imposed and/or publicly contemplated by the U.S. government in the first quarter of 2025, particularly as to China, create significant uncertainty with respect to future tax and trade regulations and the potential competitive effects of such actions. The countries in which our products will be manufactured or imported may from time to time impose additional quotas, duties, tariffs or other restrictions on our imports or adversely modify existing restrictions. It is unclear what the U.S. administration or foreign governments specifically will or will not do with respect to tariffs, tax policies, or other international trade agreements, regulations and policies. A trade war, other governmental action related to tariffs or international trade agreements, changes in U.S. social, political, regulatory and economic conditions or in laws and policies governing foreign trade, manufacturing, development and investment in the territories and countries where we manufacture and sell products or any resulting negative sentiments towards the United States could materially adversely affect the Company’s business, financial condition, operating results and cash flows.
Current wording
Tariffs imposed and/or publicly contemplated by the U.S. government, particularly as to China, create significant uncertainty with respect to future tax and trade regulations and the potential competitive effects of such actions. The countries in which our products will be manufactured or imported may from time to time impose additional quotas, duties, tariffs or other restrictions on our imports or adversely modify existing restrictions. It is unclear what the U.S. administration or foreign governments specifically will or will not do with respect to tariffs, tax policies, or other international trade agreements, regulations and policies. A trade war, other governmental action related to tariffs or international trade agreements, changes in U.S. social, political, regulatory and economic conditions or in laws and policies governing foreign trade, manufacturing, development and investment in the territories and countries where we manufacture and sell products or any resulting negative sentiments towards the United States could materially adversely affect the Company’s business, financial condition, operating results and cash flows.