United Health Products, Inc.
For the period ended Jun 30, 2025. Filed Aug 14, 2025.
View on SEC.govAbout this filing
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.
Jun 30, 2025 · Filed Aug 14, 2025
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-05.
0001477932-25-003321
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001477932-25-005894
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 56 previous paragraphs and 67 current paragraphs.
39 unchanged; 16 reworded; 7 added; 1 removed; 0 previous and 5 current paragraphs rearranged.
Tables are not compared: 4 previous and 5 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 (7)
Current 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.
Current report
The timing to resolve the FDA Warning Letter is uncertain. Since the April notice of disapproval of the 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, identifying an alternative sponsor acceptable to the FDA to oversee the clinical study on the Company’s behalf. In such an arrangement, UHP would retain full and exclusive rights to the data and analysis contained in a Clinical Trial Report and incorporate into a revised PMA application.
Current report
The decrease in operating expenses for the three months ended June 30, 2025 was primarily due to the Company having a decrease in legal and professional expenses of $135,669, a decrease in obsolete inventory write off of $33,598 offset by an increase in research and development expenses of $15,263, and an increase in marketing activities of $15,404.
Current report
Six Months ended June 30, 2025 versus Six Months ended June 30, 2024
Current report
Operating Expenses
Current report
Total operating expenses for the six months ended June 30, 2025 and 2024 were $1,757,572 and $830,271, respectively.
Current report
Other income (expense)
Removed paragraphs (1)
Previous report
The FDA's 180-day PMA application review period is on pause while we work to address the FDA’s requests and will resume once we submit all our responses.
Reworded paragraphs (16)
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 & 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 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.
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 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.
Current 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.
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 can 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 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 will 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 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.
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.
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 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 address the violations. As of the date of this filing, the FDA has not responded to our submission responding to the Warning Letter.
Previous wording
Total operating expenses for the three months ended March 31, 2025 and 2024 were $1,489,216 and $425,094, respectively.
Current wording
Total operating expenses for the three months ended June 30, 2025 and 2024 were $268,356 and $405,177, respectively.
Previous wording
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 $57,350 in legal and 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 legal and professional expenses is due to the Company terminating services with consultants.
Current wording
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 $185,592 in legal and 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 legal and professional expenses is due to the Company terminating services with certain regulatory consultants.
Previous wording
Other income (expense) for the three months ended March 31, 2025 and 2024 was $(42,443) and $(26,844), respectively. The increase in other expense was due to an increase in interest expenses due to having larger outstanding loan balances.
Current wording
Other income (expense) for the six months ended June 30, 2025 and 2024 was $(89,274) and $(53,688), respectively. The increase in other expense was due to an increase in interest expenses due to having larger outstanding loan balances.
Previous wording
Our net loss for the three months ended March 31, 2025 was $1,531,659 as compared to net loss of $451,938 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 $1,064,122 and an increase in other expense of $15,599, as explained above.
Current wording
Our net loss for the six months ended June 30, 2025 was $1,846,846 as compared to net loss of $883,959 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 $927,301 and an increase in other expense of $35,586, as explained above.
Previous wording
As of March 31, 2025, the Company had a negative working capital of $1,771,186. 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 June 30, 2025, the Company had a negative working capital of $1,883,479. 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.
Previous wording
The Company’s cash on hand at March 31, 2025 and December 31, 2024 was $4,914 and $168,883, respectively.
Current wording
The Company’s cash on hand at June 30, 2025 and December 31, 2024 was $225 and $168,883, respectively.
Previous wording
The following table summarizes selected items from our statements of cash flows for the three months ended March 31, 2025 and 2024:
Current wording
The following table summarizes selected items from our statements of cash flows for the six months ended June 30, 2025 and 2024:
Previous 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.
Current wording
Net cash used in operating activities for the six months ended June 30, 2025 was $458,658. The Company had a net loss of $1,846,846 offset by stock for services and compensation of $1,120,125, amortization expense of $2,025, amortization of right-of-use asset of $110, an increase in accounts payable and accrued expenses of $125,534, an increase in accrued liabilities - related party of $43,462 and an increase in accrued compensation of $95,238. The Company also had a decrease prepaid and other current assets of $1,914.
Previous wording
Net cash used in operating activities for the three months ended March 31, 2024 was $405,763. The Company had a net loss of $451,938 offset by amortization expense of $1,012, amortization of right-of-use asset of $346, a decrease in prepaid and other current assets of $7,632 and an increase in accrued liabilities - related party of $49,481. The Company also had a decrease in accounts payable and accrued expenses of $12,296.
Current wording
Net cash used in operating activities for the six months ended June 30, 2024 was $693,481. The Company had a net loss of $883,959 offset by amortization expense of $2,025, write-off of inventory of $33,598, amortization of right-of-use asset of $578, a decrease in prepaid and other current assets of $15,264, an increase in accrued liabilities - related party of $98,962 and an increase in accounts payable and accrued expenses of $40,051.
Previous wording
The Company did not have any investing activities during the three months ended March 31, 2025 and March 31, 2024.
Current wording
The Company did not have any investing activities during the six months ended June 30, 2025 and June 30, 2024.
Previous 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.
Current wording
Net cash provided by financing activities for the six months ended June 30, 2025 was $290,000. This was due to the result of the Company receiving proceeds of $290,000 from convertible notes, receiving advances from related party of $20,000 offset by repayment of advances from related party of $20,000.
Previous wording
Net cash provided by financing activities for the three months ended March 31, 2024 was $391,225. This was due to the result of the Company receiving proceeds of $395,425 from the sale of stock offset by making payments of offering costs of $4,200.
Current wording
Net cash provided by financing activities for the six months ended June 30, 2024 was $616,815. This was due to the result of the Company receiving net proceeds of $616,815 from the sale of common stock
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
Other income (expense) for the three months ended June 30, 2025 and 2024 was $(46,831) and $(26,844), respectively. The increase in other expense was due to an increase in interest expense from the larger outstanding loan balances.
Current report — wording carried from elsewhere
Our net loss for the three months ended June 30, 2025 was $315,187 as compared to net loss of $432,021 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 $136,821 offset by an increase in other expense of $19,987, as explained above.
Current report — wording carried from elsewhere
Results of Operations for the six months ending June 30, 2025 and 2024
Current report — wording carried from elsewhere
The following table sets forth a summary of certain key financial information for the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
During the six months ended June 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.