United Health Products, Inc.

Previous wording

For the years ended December 31, 2024 and 2023, the Company had a net loss of $2,001,733 and $2,623,267, respectively. We may continue to lose money in the future, and we will rely on financing to fund our business strategy for the foreseeable future as discussed in the Risk Factor “We will need additional financing to execute our business plan and fund operations, which may not be available”.

Current wording

For the years ended December 31, 2025 and 2024, the Company had a net loss of $2,669,348 and $2,001,733, respectively. We may continue to lose money in the future, and we will rely on financing to fund our business strategy for the foreseeable future as discussed in the Risk Factor “We will need additional financing to execute our business plan and fund operations, which may not be available”.

Previous wording

We can provide no assurances that the FDA will approve our Class III application for internal surgical procedures in the U.S. market for ourCelluSTAT product.

Current wording

We can provide no assurances that the FDA will approve our Class III application for internal surgical procedures in the U.S. market for our CelluSTAT product.

Previous wording

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 deficiencies in our application, which we responded to and discussed with the FDA during 2024, and which we continue to address.See Item 1 “Business – Developments”.

Current wording

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 continue to address.See Item 1 “Business – Developments”.

Previous wording

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. 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.

Current wording

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. In the event we receive Class III 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.

Previous wording

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.

Current wording

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.

Previous wording

Our neutralized, oxidized, regenerated cellulose (“NORC”) products are manufactured in Asia and the United States to our specifications. Unforeseen events at any manufacturing or packaging location may result in a disruption of production 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 our manufacturer’s facility could have a material adverse impact on our operations and business.

Current wording

Our regenerated cellulose 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 deliveries that could negatively impact our ability to supply our customers and generate revenues. While we intend to maintain significant supplies of finished product inventory, any prolonged disruption at one of our manufacturers’ facilities could have a material adverse impact on our operations and business..

Previous wording

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. We presently have a small management team, which we intend to expand in conjunction with our planned operations and growth. 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.

Current wording

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. Currently, our 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 material adverse effect on our business, financial condition and results of operations. In addition, the concentration of management responsibilities in one individual may result in limited internal controls, reduced segregation of duties, and 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.

Previous wording

Our Chief Executive Officer and Principal Financial Officer have concluded that, as of December 31, 2024, 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.

Current wording

Our Chief Executive Officer has concluded that, as of December 31, 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.

Previous wording

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.

Current wording

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

Previous wording

The Company’s common stock is quoted on the OTC Pink. 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.

Current wording

The Company’s common stock is quoted on the 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.