United Health Products Inc

Current report

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 HemoStyp product..

Current report

We are reliant on receiving Premarket Approval (PMA) from the FDA for our HemoStyp product in order to implement our business strategy of targeting the surgical market. If we do not obtain a PMA for our HemoStyp product, we will have to materially change our strategy, which we cannot assure we would be successful in doing. We submitted our initial PMA application to the FDA in 2018, during 2022 and 2023, the Company worked to address certain deficiencies in its PMA application that were identified by the FDA in 2021. These deficiencies were largely related to the need for standardized procedures for our manufacturing process, and quality assurance procedures for finished, customer ready products.

Current report

On March 21, 2024, we submitted results of the human clinical trial and other information, including our manufacturing, sterilization and shipping processes, to the FDA. On June 18, 2024, the FDA issued a customary “Deficiencies Letter” to the company listing certain questions and comments on various elements of the application. The letter contained 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. The FDA’s 180-day PMA application review period will be paused while the Company develops its responses to the deficiencies that were identified, and will resume once all the responses have been submitted.

Current report

We cannot be assured that our HemoStyp product will meet the PMA requirements for FDA approval or that we will ever receive the requisite PMA for our HemoStyp product.

Current report

We are subject to extensive regulation by the FDA and must comply with the regulations of the FDA, as well as state, local and applicable international regulations. Failure to do so could harm our business.

Current report

Our HemoStyp 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.

Current report

The FDA has substantial discretion in the PMA approval process. The FDA can limit or deny approval of a product for many reasons, including, but not limited, to:

Current report

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.