UEEC 10-K & 10-Q changes, risk factors and insider trading

We are reliant on receiving Premarket Approval (PMA) from the FDA for our CelluSTAT product in order to implement our business strategy of targeting the surgical market. If we do not obtain a PMA for our CelluSTAT product, we will have to materially change our strategy, which we cannot assure we would be successful in doing. We filed our initial PMA application with the FDA in 2021, and after addressing FDA comments in the ensuing years following the COVID pandemic, we submitted our revised PMA application to the FDA in March 2024. The FDA responded, notifying us of certain violations relating to the conduct of our 2019 clinical study and other deficiencies in our PMA application, which we responded to and discussed with the FDA during 2024, and which we continue to address. See Item 1 “Business – Developments”.

We continue to believe that the Class III surgical markets, both domestic and international, represent the most attractive market for our products due to the limited competition from other Class III approved Oxidized Regenerated Cellulose (ORC) products and the resulting premium pricing for hemostatic agents that can meet the demanding requirements of the human surgical environment. As of the filing date of this Form 10-K, the FDA review process is ongoing and we are preparing to submit an application for CE Mark approval in order to access the European and other markets.ongoing. In the event we receive Class III and CE Mark approvals, which cannot be assured, we are evaluating the best paths to grow our revenue and profits in all potential markets, which could include one or more commercial partnerships and licensing agreements with established market participants or an acquisition/merger agreement with any such participants, each as an alternative to raising the necessary capital to establish and grow our own marketing and distribution capabilities via organic growth. We will carefully evaluate the returns on investment to create shareholder value of each of these strategies. No assurances can be given that our plans to penetrate all market segments or be acquired/merged with an established market participant will be successful on terms satisfactory to us, if at all.

Our ability to obtain needed financing may be impaired by such factors as capital markets disruptions, both generally and specifically relating to the healthcare industry, and events that have a negative impact on existing and potential investors or funding sources. If the amount of capital we are able to raise from financing activities, together with our revenues from operations, is not sufficient to satisfy our capital needs we may be required to cease operations. See Item 1 “Business – Developments” for a discussion about our current financing by Alumni Capital.

No guarantee of market acceptance.acceptance of our CelluSTAT Hemostatic Gauze.

Our neutralized, oxidized, regenerated cellulose (“NORC”) products are manufactured in Asia and packaged and sterilized in the United States to our specifications. Unforeseen events at any manufacturing or packaging location may result in a disruption of productiondeliveries that could negatively impact our ability to supply our customers and generate revenues. We own certain specialized production equipment which is installed at our contract-manufacturer’s location which is not readily available should we need to replace it. While we intend to maintain significant supplies of finished product inventory, any prolonged disruption at one of our manufacturer’smanufacturers’ facilityfacilities could have a material adverse impact on our operations and business.business..

Our success will depend in large measure on the abilities, expertise, judgment, discretion, integrity and good faith of our management and other personnel in conducting our intended business. In addition, we depend on management and strategic consultants to correctly interpret and respond to market data, economic and other conditions to locate and adopt appropriate business opportunities. WeCurrently, presentlyour management consists solely of our Chief Executive Officer, who is also serving as our acting Chief Financial Officer. As a result, we are highly dependent on the continued service and performance of a single individual, and the loss, incapacity or unavailability of this individual could have a smallmaterial adverse effect on our business, financial condition and results of operations. In addition, the concentration of management team, which we intend to expandresponsibilities in conjunctionone withindividual ourmay plannedresult operationsin limited internal controls, reduced segregation of duties, and growth.increased operational risk. We intend to ensure that management and any key personnel are appropriately compensated; however, their continued service to the Company cannot be guaranteed. If we are unable to attract and retain additional key management personnel and enter into satisfactory employment and other agreements, our business may be adversely affected.

Our Chief Executive Officer and Principal Financial Officer havehas concluded that, as of December 31, 2024,2025, we had material weaknesses in our internal controls over financial reporting and that, as a result, our disclosure controls and procedures and our internal controls over financial reporting were not effective at such date. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting that creates a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

Our CelluSTAT products are subject to extensive regulation by the FDA. These regulations relate to manufacturing, labeling, sale, promotion, distribution and shipping. Before a new medical device, or a new intended use of a legally marketed device, can be marketed in the United States, it must be cleared or approved by the FDA through the applicable 510(k) premarket notification submission, granting of a de novo request, or Premarket Approval (PMA)), unless an exemption applies. The clearance and approval process is expensive, time-consuming, and uncertain. Failure to comply with applicable regulatory requirements of the FDA can result in an enforcement action, which could include a variety of sanctions, including fines, injunctions, civil penalties, recall or seizure of our products, operating restrictions, partial suspension, or total shutdown of production and criminal prosecution. The FDA may change its clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions, that may prevent or delay approval or clearance of our products or impact our ability to modify our products after clearance on a timely basis. Such policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain clearance for our products, increase the costs of compliance or restrict our ability to maintain products after clearance.

In addition, regulatory clearance or approval by the FDA does not ensure registration, clearance, approval, or certification by comparable foreign regulatory authorities. Complying with foreign regulatory requirements, including obtaining registrations, clearances, approvals, or certifications, can be expensive and time consuming, and we may not receive regulatory clearances, approvals, or certifications in each country or region in which we plan to market our products or we may be unable to do so on a timely basis. In turn, this could limit our ability to expand into international markets, which could have a material adverse effect on our business, financial condition, and results of operations. See Item 1 “Business – Developments” for a discussion about our FDA PMA process

The Company’s common stock is quoted on the OTC Pink.OTCQB. Management considers the market for our common stock to be limited. We can provide no assurances that an established trading market for our common stock will exist in the future.

The net loss for the year ended December 31, 20242025 was $2,001,733$2,669,348 as compared to a net loss of $2,623,267$2,001,733 for the prior year. The decreaseincrease in the net loss wasis due to the Company having aan decreaseincrease in operating expenses of $418,967$247,902 offset byand an increase in other income (expense) of $202,567$419,713 during the year ended December 31, 2024 to $5,839,2025, as explained above.

As of December 31, 2024,2025, the Company had a negative working capital of $1,449,469.$3,837,757. The Company has not yet attained a level of operations, and for the foreseeable future will not achieve commercial operations, which will allow it to meet its current overhead expense obligations. The report of our independent registered public accounting firm on our 20242025 and 20232024 financial statements includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. The Company generated no revenue during the years ended December 31, 20242025 and 20232024 due to focusing its capital and resources towards seeking a Class III PMA for its CelluSTAT hemostatic technology. 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.objectives.

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. As of the date of this filing, theThe Company has received approximately $3.2$3.3 million in proceeds from White Lion from the sale of shares under the CSPA which the Company has used to pay for its operations and finalization ofadvance 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. In addition, economic conditions and actions by policymaking bodies are contributing to rising interest rates and significant capital market volatility, which, along with increases in our borrowing levels, could increase our future borrowing costs.

Net cash provided by financing activities for the year ended December 31, 20242025 was $1,268,179.$1,083,308. This was due to the result of the Company receiving netproceeds of $770,000 from convertible notes, receiving proceeds of $863,579$250,000 from notes payable – related party, receiving proceeds of $65,708 from the sale of common stock offset by making payments of $11,400,$2,400, proceedsreceiving advances from related party of $66,000$145,000 offset by repayment of advances from therelated saleparty of units, $200,000 in proceeds from a convertible note payable, and $150,000 in proceeds from a promissory note payable.$145,000.

Net cash provided by financing activities for the year ended December 31, 20232024 was $2,285,538.$1,268,179. This was due to the result of the Company receiving net proceeds of $2,326,674$863,579 from the sale of common stock offset by making payments of offering$11,400, costsproceeds of $17,400,$66,000 repaymentsfrom the sale of $19,136units, on$200,000 in proceeds from a loanconvertible note payable, and repayments$150,000 ofin $4,000proceeds onfrom a loanpromissory payablenote – related party.payable.

From September 23 through October 4, 2024, the FDA conducted a Bioresearch Monitoring Program (BIMO) Inspection of our records and procedures relating to our 20192018-19 clinical study, following which the FDA delivered its Inspectional Observations on Form 483.

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.

The timing to resolve the FDA Warning Letter is uncertain and we may not proceed with thea clinicalPremarket studyApproval requestedapplication byto the FDA until its resolution. However, following consultation with the FDA, weNAMSA are in discussions with potential corporate partners regarding a collaboration that would allow a partner towill 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.

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,$289,267, 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 any portion of the outstanding principal and accrued interest into shares of the Company’s common stock at aan initial conversion price of $0.06039 per share.share, subject to certain adjustments. 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.

CelluSTAT hemostatic gauze is a flexible, silk-like material that is applied by placing the gauze onto the bleeding tissue. The supple material can be easily folded and manipulated as needed to fit the size of the wound or incision. In surface bleeding and surgical situations, the product quickly converts to a translucent gel that allows the physician or surgeon to monitor the coagulation process. The gel maintains a neutral pH level,level which avoids damaging the surrounding tissue. In superficial bleeding situations, CelluSTAT can be bonded to an adhesive plastic bandage or integrated into a traditional gauze component to address a broad range of needs, including traumatic bleeding injuries and prolonged bleeding following hemodialysis.

Our CelluSTAT technology received an FDA 510(k) approval in 2012 for use in external or superficial bleeding situations and we believe there is an opportunity for CelluSTAT products to address unmet needs in several medical applications that represent attractive commercial opportunities.situations. However, the Class III human surgical markets, both domestic and international, represent the most attractive market for our productstechnology due to the smaller number of competitors offering Class III approved hemostatic agents and the resulting premium pricing for products that can meet the demanding safety and effectiveness requirements of the human surgical environment. We believe that our extensive laboratory testing and our completed human trial indicate that the CelluSTAT technology could successfully compete against established Class III market participants, and could gain a significant market share. As described above, we are in the process of seeking FDA pre-market approval for our CelluSTAT product. There can be no assurance that an FDA PMA will be granted.

Results of Operations for the three months ending MarchJune 31,30, 2026 and 2025

The following table sets forth a summary of certain key financial information for the three months ended MarchJune 31,30, 2026 and 2025:

Three Months ended MarchJune 31,30, 2026 versus Three Months ended MarchJune 31,30, 2025

Company had $0 of revenues during the three months ended MarchJune 31,30, 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.

Total operating expenses for the three months ended MarchJune 31,30, 2026 and 2025 were $265,581$166,850 and $1,489,216,$268,356, respectively.

Other income (expense) for the three months ended MarchJune 31,30, 2026 and 2025 was $(50,261117,290) and $(42,44346,831), respectively. The increase in other expense was due to an increase in interest expense of $30,222$36,561 from the outstanding convertible notes and loan balances,balances offsetthat byare interest bearing and an increase in gainloss on derivative liabilities of $22,404.$33,898.

Our net loss for the three months ended MarchJune 31,30, 2026 was $315,842$284,140 as compared to net loss of $1,531,659$315,187 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$101,506 andoffset by an increase in other expense of $7,818,$70,459, as explained above.

As of MarchJune 31,30, 2026, the Company had a negative working capital of $4,143,918.$4,123,570. 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.

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 requiresgives the Company the right, but not the obligation to require 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.

The Company’s cash on hand at MarchJune 31,30, 2026 and December 31, 2025 was $1,029$24,495 and $65,249, respectively.

The following table summarizes selected items from our statements of cash flows for the threesix months ended MarchJune 31,30, 2026 and 2025:

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 was $84,339.$222,352. The Company had a net loss of $315,842,$599,982, amortization of right-of-use asset of $350, gain on derivative liabilities of $22,404,$583 and an increase in prepaid and other current assets of $6,028$26, offset by loss on derivative liabilities of $11,494, amortization expense of $1,013,$2,025, amortization of debt discount $9,276,$21,222, and,security deposit used for rent $2,850, an increase in accounts payable and accrued expenses of $179,240,$194,423, an increase in accrued liabilities - related party of $24,556$54,925 and an increase in accrued compensation of $46,200.$91,300.

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2025 was $273,969.$458,658. The Company had a net loss of $1,531,659$1,854,316 and amortization of right-of-use asset of $110, offset by stock for services and compensation of $1,120,125, amortization expense of $1,013, amortization of right-of-use asset of $4,$2,025, an increase in accounts payable and accrued expenses of $39,197,$133,004, an increase in accrued liabilities - related party of $21,731$43,462 and an increase in accrued compensation of $82,988.$95,238. The Company also had ana increasedecrease in prepaid and other current assets of $7,368.$1,914.

The Company did not have any investing activities during the threesix months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025.

Net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2026 was $20,119.$181,598. This was due to the result of the Company receiving proceeds of $26,250$96,250 from notes payable and $100,674 in proceeds from the sale of stock offset by repayments of notes payable of $6,131.$15,326.

Net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2025 was $110,000.$290,000. This was due to the result of the Company receiving proceeds of $90,000$290,000 from convertible notesnotes, andreceiving aadvances from related party of $20,000 advanceoffset by repayment of advances from a related party.party of $20,000.

As of MarchJune 31,30, 2026, we have no off-balance sheet arrangements.