United Health Products, 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 2025-11-14.
0001477932-25-008280
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.
0001477932-26-003228
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 66 previous paragraphs and 66 current paragraphs.
35 unchanged; 19 reworded; 11 added; 8 removed; 4 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 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 (11)
Current report
On October 25, 2024, we submitted our response to the FDA’s observations. On March 24, 2025, the FDA issued a Warning Letter that described five violations of applicable regulations that occurred during the planning and execution of the 2018-19 clinical study. These violations included: 1) failure to submit an IDE application to the FDA and failure to obtain FDA approval prior to beginning an investigation for which FDA’s approval is required, 2) failure to ensure proper monitoring of the investigation, 3) failure to monitor and ensure clinical investigators’ compliance with the study protocol and failure to terminate investigator’s participation in the study following non-compliance, 4) failure to immediately conduct an evaluation of any unanticipated adverse device effects and failure to report results of such an evaluation to the FDA and to the appropriate IRB, and 5) failure to maintain accurate, complete, and current device shipment and disposition records.
Current report
In response to the Warning Letter we conducted an analysis and investigation into root causes of these violations and developed Corrective and Preventative Actions (CAPAs) to address them, which we submitted to the FDA on April 14, 2025. In addition, we engaged an external monitor to review certain of the clinical data gathering during the clinical trial to report on the accuracy and reliability of the data, which we also submitted to the FDA in June and September 2025.
Current report
On December 10, 2025, the FDA issued a CAPA Assessment Letter that provided feedback on our response to the Warning Letter and our proposed CAPAs to address the violations that occurred during the 2019 study. In the letter, the FDA sought additional detail surrounding the Company’s 2018 correspondence with the WCG Institutional Review Board (IRB) regarding its approval of our clinical study, specifically relating to the FDA’s findings that the Company had modified certain FDA correspondence that it had presented to the IRB. In addition, FDA recommended that UHP conduct an audit of our processes, procedures and personnel (both internal and outside consultants) to ensure that the Company is able to ensure good clinical practices (GCP) when conducting a clinical study.
Current report
On January 5, 2026 we submitted to the FDA revised CAPAs and a proposal to conduct the recommended GCP Audit, and on February 16, 2026 submitted a report on our investigation of the 2018 IRB communications and a proposal for a third party monitor of our communications with the FDA and any IRB going forward to ensure the accuracy and regulatory compliance in these communications. On March 4, 2026 we held a Submission Issue Request (“SIR”) videoconference with the FDA to confirm their approval of our proposed collaboration with an established hemostatic device company wherein this company could serve as substitute Sponsor in a new pivotal IDE study of our CelluSTAT product, which the FDA did approve. On March 6, 2026, the FDA communicated their approval of the external audit firm that we had proposed on February 16 to conduct a GCP Audit of our procedures, process and personnel. This audit is expected to be completed by the end of July, 2026.
Current report
The timing to resolve the FDA Warning Letter is uncertain and we may not proceed with the clinical study requested by the FDA until its resolution. However, following consultation with the FDA, we are in discussions with potential corporate partners regarding a collaboration that would allow a partner to serve as substitute Sponsor of a CelluSTAT study, with UHP having an exclusive Rights to Reference to the study data for inclusion in a future PMA application. This plan would allow the study to be conducted concurrently with our ongoing efforts to resolve the Warning Letter, including the above mentioned GCP Audit.
Current report
Financing with Alumni Capital
Current report
On December 16, 2025, the Company entered into a Securities Purchase Agreement with Alumni Capital LP (“Alumni”), pursuant to which Alumni provided a loan to the Company in the amount of $289,267 on a 15% original discount basis, evidenced by a senior convertible promissory note (the “Note”). The Company received net proceeds of $250,000. The Note bears no interest and matures on December 31, 2026. Subject to the terms of the Note, Alumni may convert the outstanding principal and accrued interest into shares of the Company’s common stock at a conversion price of $0.06039 per share. Alumni has agreed to limit its beneficial ownership of the Company’s common stock to less than 9.99% of the Company’s outstanding shares. In connection with the transaction, the Company entered into a registration rights agreement requiring the Company to register the resale of shares underlying the Note.
Current report
On the same date, the Company also entered into an Any Market Purchase Agreement (“AMPA”) with Alumni. Under the AMPA, the Company has the right, but not the obligation, to sell to Alumni up to an aggregate of $4,000,000 in value of the Company’s common stock from time to time through December 31, 2027, subject to the terms and conditions of the agreement. The purchase price of shares sold under the AMPA is based on a discount to the volume-weighted average price of the Company’s common stock over a specified trading period prior to each purchase notice. In connection with the AMPA, the Company issued Alumni a five-year warrant to purchase up to 3,484,321 shares of the Company’s common stock at an exercise price of $0.07462 per share.
Current report
On January 30, 2026, the Company registered the resale of shares of the Company’s common stock issuable under the Note and the AMPA on a Form S-1 registration statement. On May 12, 2026, the Company filed a post-effective amendment to the registration statement which was declared effective on May 14, 2026.
Current report
Warrants
Current report
The Company accounts for common stock warrants in accordance with applicable accounting guidance provided in ASC 480Distinguishing Liabilities from Equity and ASC 815Derivatives and Hedging, as either derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement. The warrants classified within equity are indexed to the Company’s common stock, provide for settlement in a fixed number of registered or unregistered shares for a fixed exercise price, and are freestanding equity instruments. Accordingly, they meet the criteria for equity classification under ASC 815-40 and are not subject to remeasurement in future periods. For warrants classified as equity instruments the Company applies the Black Scholes model and expenses the fair value as financing costs. For warrants classified as derivative financial instruments, the Company applies the Black Scholes model to value the warrants.
Removed paragraphs (8)
Previous report
On March 27, 2025, we submitted an IDE application to the FDA seeking approval to conduct the above referenced 27-subject clinical trial. On April 25, 2025, the FDA issued a notice of disapproval of the IDE application, citing the unresolved Warning Letter regarding the audit of the 2019 clinical study. No other deficiencies were noted in the FDA communication.
Previous report
The timing to resolve the FDA Warning Letter is uncertain. Since the April notice of disapproval of our IDE application, UHP has engaged with the FDA to seek a path to timely approval of a new IDE and commencement of the clinical trial. We have retained a regulatory attorney to support our efforts in this regard and are discussing with the FDA various solutions including, among other options, conducting a new pivotal clinical trial that will yield sufficient data to confirm the safety and effectiveness of our product without reliance on data from the 2019 study.
Previous report
Nine Months ended September 30, 2025 versus Nine Months ended September 30, 2024
Previous report
Operating Expenses
Previous report
Total operating expenses for the nine months ended September 30, 2025 and 2024 were $1,990,751 and $1,222,174, respectively.
Previous report
The increase in operating expenses was primarily due to an increase of $1,120,125 in stock-based compensation offset by a decrease of approximately $330,058 in professional expenses. The increase in stock-based compensation is due to the vesting of 4,725,000 RSUs and recording $1,120,125 as stock-based compensation. The decrease in professional expenses is due to the Company terminating services with certain consultants.
Previous report
Other income (expense)
Previous report
Other income (expense) for the nine months ended September 30, 2025 and 2024 was $(141,689) and $34,553, respectively. The change in other income (expense) was due to an increase in interest expense of $61,157 from the larger outstanding loan balances and a decrease in gain on settlement of debt of $115,085 from a settlement of accounts payable in the same period of the prior year with no similar settlement in the current period.
Reworded paragraphs (19)
Previous wording
In March 2024, we submitted a full application for Premarket Approval to the FDA. The FDA responded in June 2024 with a “Deficiencies Letter” listing approximately 40 specific comments and requests for additional information covering the device description, sterility & shelf life, clinical safety & performance testing, and biocompatibility sections of the PMA application. In August 2024, we submitted a Submission Issue Request (SIR) to the FDA outlining our plan to address and respond to the FDA’s comments. Then, in August 2024, at the FDA’s request, the Company followed-up with a condensed list of questions relating to the prior SIR submission.
Current wording
In March 2024, we submitted a full application for Premarket Approval to the FDA. The FDA responded in June 2024 with a “Deficiencies Letter” listing approximately 40 specific comments and requests for additional information covering the device description, sterility & shelf life, clinical & performance testing, and biocompatibility sections of the PMA application.
Previous wording
From September 23 through October 4, 2024, the FDA conducted a Bioresearch Monitoring Program (BIMO) Inspection of our records and procedures relating to our clinical study, following which the FDA delivered its Inspectional Observations on Form 483. On October 25, 2024, we submitted our response to the FDA’s observations, which the FDA will consider in developing its final report on the BIMO Inspection. On March 25, 2015, FDA issued a Warning Letter identifying five violations of required clinical procedures occurred during the 2019 clinical trial. On April 14, 2025, we submitted a response to FDA that addressed the violations. As of the date of this filing, the FDA has not responded to our submission responding to the Warning Letter.
Current wording
From September 23 through October 4, 2024, the FDA conducted a Bioresearch Monitoring Program (BIMO) Inspection of our records and procedures relating to our 2019 clinical study, following which the FDA delivered its Inspectional Observations on Form 483.
Previous wording
In October 2024, the Company and FDA conducted a virtual meeting to discuss the SIR and the follow-up questions. During the discussion, the Company noted the results of its 2019 clinical trial involving 236 patients (of whom 118 were treated with its hemostatic gauze) that showed statistically superior performance in time to hemostasis using CelluSTAT over Ethicon’s Surgicel Original, the current standard of care. The study results also showed no evidence of heterogeneity of results across procedure categories, surgeons, or clinical sites, indicating both poolability and generalizability of study results. The Company also noted that none of the adverse events that occurred during the study were attributable to its hemostatic gauze product.
Current wording
In October 2024, the Company and FDA conducted a virtual meeting to discuss the Deficiencies Letter and our follow-up questions. During the discussion, the Company noted the results of its 2019 clinical trial involving 232 patients (of whom 118 were treated with its hemostatic gauze) that showed statistically superior performance in time to hemostasis using CelluSTAT over Ethicon’s Surgicel Original, the standard of care. The study results also showed no evidence of heterogeneity of results across procedure categories, surgeons, or clinical sites, indicating both poolability and generalizability of study results. The Company also noted that none of the adverse events that occurred during the study were attributable to its hemostatic gauze product.
Previous wording
Notwithstanding the safety record from the original clinical study, the FDA requested more data to confirm the safety and effectiveness of CelluSTAT in surgical procedures in the intestinal and thoracic organ space, where organ movement may impact the post operative stability of a hemostat and where observation of post operative rebleeding is more difficult. To address this concern, we proposed to enroll 27 human subjects in a multi-site study as an extension of the original pivotal study, with patients undergoing open surgical procedures within the organ space. The supplemental study process would consist of submitting an Investigational Device Exemption (IDE) for FDA approval, identifying and contracting suitable surgical sites, enrolling patents, and data collection and analysis.
Current wording
Notwithstanding the safety record from the original clinical study, the FDA requested more data to confirm the safety and effectiveness of CelluSTAT in surgical procedures in the intestinal and thoracic organ space, where the FDA was concerned that organ movement could impact the post-operative stability of a hemostat and where observation of post operative rebleeding is more difficult. To address this concern, we have proposed conducting a supplemental study, with patients undergoing open surgical procedures within the intestinal and thoracic organ space.
Previous wording
There can be no assurance that our PMA application will be approved.
Current wording
There can be no assurance that we will reach an agreement with any party to serve as Sponsor of such a study or that our planned PMA application will be approved.
Previous wording
During the three months ended September 30, 2025 and 2024, the Company had $0 of revenues, respectively. The Company did not generate any revenues in the current quarter due to the continued focus of the Company’s capital and resources towards obtaining a Class III PMA.
Current wording
Company had $0 of revenues during the three months ended March 31, 2026 and 2025. The Company did not generate any revenues in the current quarter due to the continued focus of the Company’s capital and resources towards obtaining a PMA.
Previous wording
Total operating expenses for the three months ended September 30, 2025 and 2024 were $233,179 and $391,903, respectively.
Current wording
Total operating expenses for the three months ended March 31, 2026 and 2025 were $265,581 and $1,489,216, respectively.
Previous wording
The decrease in operating expenses for the three months ended September 30, 2025 was primarily due to a decrease in consulting expenses of $158,521 as the Company terminated the services of certain consultants, and a decrease in research and development expenses of $40,551 as the Company purchased fewer external lab testing services, offset by an increase in legal services of $43,480 as the Company retained regulatory counsel to assist in correspondence with the FDA.
Current wording
The decrease in operating expenses was primarily due to a decrease of $1,120,125 in stock-based compensation due to the vesting of 4,725,000 RSUs, a decrease in consulting expenses of $90,065, as the Company terminated the services of certain consultants, and a decrease in research and development expenses of $103,689, as the company purchased fewer external lab testing services, offset by an increase in legal services of $75,215 as the Company retained regulatory counsel to assist in correspondence with the FDA.
Previous wording
Other income (expense) for the three months ended September 30, 2025 and 2024 was $(52,415) and $88,241, respectively. The change in other income (expense) was due to an increase in interest expense of $25,571 from the larger outstanding loan balances and a decrease in gain on settlement of debt of $115,085 from a settlement of accounts payable in the same period of the prior year with no similar settlement in the current period.
Current wording
Other income (expense) for the three months ended March 31, 2026 and 2025 was $(50,261) and $(42,443), respectively. The increase in other expense was due to an increase in interest expense of $30,222 from the outstanding convertible notes and loan balances, offset by an increase in gain on derivative liabilities of $22,404.
Previous wording
Our net loss for the three months ended September 30, 2025 was $285,594 as compared to net loss of $303,662 for the comparable period of the prior year. The decrease in the net loss is due to the Company having a decrease in operating expenses of $158,724 offset by an increase in other expense of $140,656, as explained above.
Current wording
Our net loss for the three months ended March 31, 2026 was $315,842 as compared to net loss of $1,531,659 for the comparable period of the prior year. The decrease in the net loss is due to the Company having a decrease in operating expenses of $1,223,635 and an increase in other expense of $7,818, as explained above.
Previous wording
As of September 30, 2025, the Company had a negative working capital of $1,963,227. The Company has not yet attained a level of operations which will allow it to meet its current overhead expense obligations. The report of our independent registered public accounting firm on our 2024 financial statements includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. The Company has been focusing its capital and resources towards seeking a Class III PMA for its CelluSTAT technology, and has funded its initial operations with private placements, and unsecured loans from related parties. There can be no assurance that adequate financing will continue to be available to the Company and, if available, on terms that are favorable to the Company. Our ability to continue as a going concern is also dependent on many events outside of our direct control, including, among other things, our ability to achieve our business goals and objectives, as well as improvement in the economic climate.
Current wording
As of March 31, 2026, the Company had a negative working capital of $4,143,918. The Company has not yet attained a level of operations which will allow it to meet its current overhead expenses. The report of our independent registered public accounting firm on our 2025 financial statements includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. The Company has been focusing its capital and resources towards seeking a Class III PMA for its CelluSTAT technology, and has funded its initial operations with private placements and unsecured loans from related parties. There can be no assurance that adequate financing will continue to be available to the Company and, if available, on terms that are favorable to the Company. Our ability to continue as a going concern is also dependent on many events outside of our direct control including, among other things, capital markets conditions, competing medical device product developments and the overall regulatory environment.
Previous wording
The Company entered into a common stock purchase agreement (“CSPA”) with White Lion, which gave the Company the right, but not the obligation, to require White Lion to purchase up to $10,000,000 of the Company’s common stock, subject to certain limitations and conditions set forth in the CSPA. The Commitment Period (as defined in the CSPA) ended on October 1, 2025 and has not been extended. We are evaluating alternatives to raise external capital to fund our operations on terms that minimize dilution to existing shareholders which may include agreements similar to the CSPA.
Current wording
As discussed in Note 6 of the financial statements, the Company entered into a common stock purchase agreement (“CSPA”) with White Lion, which gives the Company the right, but not the obligation, to require White Lion to purchase up to $10,000,000 of the Company’s common stock, subject to certain limitations and conditions set forth in the CSPA. The Company received approximately $3.3 million in proceeds from the sale of shares under the CSPA which the Company used to pay for its operations and advance its Class III PMA application. White Lion’s commitment under the CSPA expired in October 2025. On December 16, 2025 we entered into an Any Markets Purchase Agreement (“AMPA”) with Alumni Capital, LP, which requires Alumni Capital to purchase up to $4,000,000 of the Company’s common stock, subject to certain limitations and conditions set forth in the AMPA. The sale of additional equity or convertible debt securities would be dilutive to our shareholders.
Previous wording
The Company’s cash on hand at September 30, 2025 and December 31, 2024 was $18,376 and $168,883, respectively.
Current wording
The Company’s cash on hand at March 31, 2026 and December 31, 2025 was $1,029 and $65,249, respectively.
Previous wording
The following table summarizes selected items from our statements of cash flows for the nine months ended September 30, 2025 and 2024:
Current wording
The following table summarizes selected items from our statements of cash flows for the three months ended March 31, 2026 and 2025:
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2024 was $1,013,278. The Company had a net loss of $1,187,621 and a gain on settlement of debt of $115,085 offset by amortization expense of $3,038, write-off of inventory of $33,598, amortization of right-of-use asset of $582, a decrease in prepaid and other current assets of $2,896, an increase in accrued liabilities - related party of $195,193 and an increase in accounts payable and accrued expenses of $54,121.
Current wording
Net cash used in operating activities for the three months ended March 31, 2026 was $84,339. The Company had a net loss of $315,842, amortization of right-of-use asset of $350, gain on derivative liabilities of $22,404, and an increase in prepaid and other current assets of $6,028 offset by amortization expense of $1,013, amortization of debt discount $9,276, and, an increase in accounts payable and accrued expenses of $179,240, an increase in accrued liabilities - related party of $24,556 and an increase in accrued compensation of $46,200.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2025 was $633,815. The Company had a net loss of $2,132,440, amortization of right-of-use asset of $460, and an increase in prepaid and other current assets of $1,953 offset by stock for services and compensation of $1,120,125, amortization expense of $3,037, an increase in accounts payable and accrued expenses of $237,916, an increase in accrued liabilities - related party of $65,193 and an increase in accrued compensation of $74,767.
Current wording
Net cash used in operating activities for the three months ended March 31, 2025 was $273,969. The Company had a net loss of $1,531,659 offset by stock for services and compensation of $1,120,125, amortization expense of $1,013, amortization of right-of-use asset of $4, an increase in accounts payable and accrued expenses of $39,197, an increase in accrued liabilities - related party of $21,731 and an increase in accrued compensation of $82,988. The Company also had an increase prepaid and other current assets of $7,368.
Previous wording
The Company did not have any investing activities during the nine months ended September 30, 2025 and September 30, 2024.
Current wording
The Company did not have any investing activities during the three months ended March 31, 2026 and March 31, 2025.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2025 was $483,308. This was due to the result of the Company receiving proceeds of $420,000 from convertible notes, receiving net proceeds of $63,308 from the sale of common stock, receiving advances from related party of $20,000 offset by repayment of advances from related party of $20,000.
Current wording
Net cash provided by financing activities for the three months ended March 31, 2026 was $20,119. This was due to the result of the Company receiving proceeds of $26,250 from notes payable offset by repayments of notes payable of $6,131.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2024 was $961,641. This was due to the result of the Company receiving net proceeds of $811,841 from the sale of common stock and $150,000 in proceeds from a note payable.
Current wording
Net cash provided by financing activities for the three months ended March 31, 2025 was $110,000. This was due to the result of the Company receiving proceeds of $90,000 from convertible notes and a $20,000 advance from a related party.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
Results of Operations for the nine months ending September 30, 2025 and 2024
Previous report — wording carried elsewhere
The following table sets forth a summary of certain key financial information for the nine months ended September 30, 2025 and 2024:
Previous report — wording carried elsewhere
During the nine months ended September 30, 2025 and 2024, the Company had $0 of revenues, respectively. The Company did not generate any revenues due to the continued focus of the Company’s capital and resources towards obtaining a Class III PMA.
Previous report — wording carried elsewhere
Our net loss for the nine months ended September 30, 2025 was $2,132,440 as compared to net loss of $1,187,621 for the comparable period of the prior year. The increase in the net loss is due to the Company having an increase in operating expenses of $768,577 and an increase in other expense of $176,242, as explained above.