United Health Products Inc
For the period ended Sep 30, 2024. Filed Nov 12, 2024.
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.
Sep 30, 2024 · Filed Nov 12, 2024
UEECStored price and day change unavailable
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-13.
0001477932-24-004723
Item 1A. Risk FactorsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0001477932-24-007039
Item 1A. Risk FactorsThe 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 9 previous paragraphs and 10 current paragraphs.
5 unchanged; 4 reworded; 1 added; 0 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 1 previous and 3 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 (1)
Current report
The following summarizes all sales of our unregistered securities from January 1, 2024 through September 30, 2024. The securities in the below-referenced transactions were (i) issued without registration and (ii) were subject to restrictions under the Securities Act and the securities laws of certain states, in reliance on the private offering exemptions contained in Sections 4(a)(2), 4(a)(6) and/or 3(b) of the Securities Act and on Regulation D promulgated under the Securities Act, and in reliance on similar exemptions under applicable state laws as transactions not involving a public offering. No placement or underwriting fees were paid in connection with these transactions. All cash proceeds from the sale of securities were used for working capital purposes.
Reworded paragraphs (4)
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 our HemoStyp 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 ourCelluSTAT product.
Previous wording
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 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 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.
Previous wording
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 wording
We cannot be assured that our CelluSTAT product will meet the PMA requirements for FDA approval or that we will ever receive the requisite PMA for our CelluSTAT product.
Previous wording
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 wording
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.