United Health Products, Inc 8-K, filed Jul 19, 2022
United Health Products, Inc. (UEEC)
About this 8-K
United Health Products, Inc filed this 8-K on July 19, 2022, reporting on events of July 15, 2022.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01. Regulation FD Disclosure and Other Events.
On July 15, 2022, United Health Products, Inc. (the “Company”) issued a press release providing an update on the Company’s Premarket Approval application with the Food and Drug Administration.
A copy of the press release is being furnished herewith as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit Number | Description | |
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104 |
| Cover Page Interactive Data File (formatted as Inline XBRL) |
2 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized, on July 19, 2022.
United Health Products, Inc. |
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| By: | /s/ Brian Thom | |
| Brian Thom Principal Executive Officer | ||
| By: | /s/ Kristofer Heaton | |
| Kristofer Heaton | ||
| Principal Financial Officer |
3 |
EXHIBIT 99.1
United Health Products Provides Update on FDA Review
Henderson, Nevada – July 15, 2022 – United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on the company’s FDA Premarket Approval application.
On July 13 the company and its regulatory consultant met with the full FDA team assigned to review its Class III PMA application. The focus of the meeting was to discuss the procedural approach taken by UHP to address certain observations made by the FDA in its initial review of its PMA application. UHP provided a detailed status assessment for each of the observations and an explanation of actions taken for their resolution.
Brian Thom, UHP’s Chief Executive Officer reported, “while the FDA does not respond in a piecemeal fashion in these discussions, their comments were very helpful and we conclude that the validation of certain elements of our manufacturing process are necessary to assemble a complete portfolio of information that the FDA can then use to complete its review our PMA application. We will work expeditiously with our manufacturing partner in the coming weeks to accomplish these remaining tasks.”
There can be no assurance that the company’s PMA application will be approved.
Investor relations:
Philippe Niemetz
212 344-6464
p.niemetz@panconsultants.com
About United Health Products -- United Health Products develops, manufactures and markets HemoStyp™, a patented Neutralized Oxidized Regenerated Cellulose (NORC) hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and consumer markets, and is focused on gaining approval to access the human surgical market.
For more information on UHP visit: www.unitedhealthproductsinc.com or contact the company at info@unitedhealthproductsinc.com
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.