United Health Products Provides Update on FDA PMA Application Process

Rhea-AI Summary

United Health Products, Inc. (OTCPK: UEEC) updated investors on its FDA Premarket Approval (PMA) application for the HemoStyp gauze product. The company reported anomalies in pH levels and moisture content during laboratory testing of batches, attributed to unintended oxidation by an external supplier. UHP is conducting a second round of tests in a more controlled environment and has produced new batch lots for further testing, anticipating completion by June 2023. The company cautioned that approval of the PMA application is not guaranteed.

Positive

• UHP is producing new batch lots for controlled testing, enhancing validation of the product consistency.
• Testing results for chloride content were well below tolerance thresholds, indicating potential product reliability.

Negative

• Anomalies in product testing raised concerns regarding manufacturing consistency.
• The timeline for completion of PMA application processes has been extended to June 2023, indicating potential delays.

Mesquite, NV, March 29, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval application process.  

As disclosed in a press release on January 31, 2023, UHP produced three batch lots of its HemoStyp gauze product to demonstrate consistent manufacturing results, which the company believes to be an important criterion for Premarket Approval. Laboratory testing on samples of these lots was completed to confirm the consistency of the company’s manufacturing process, which results are to be included in its final PMA application. The testing results showed several anomalies in product pH level and moisture content that the company, in consultation with the laboratory leadership, believes resulted from unintended partial oxidation during the sample cutting and packaging process that was conducted by an external component supplier. The company notes that this process was carried out to create testing samples and is not an element of the standard manufacturing, packaging and sterilization process that will be reviewed by the FDA in the PMA application. UHP notes further that testing results for other characteristics, such as chloride content, were well below tolerance thresholds in all samples. 

In light of these anomalies a second round of testing for manufacturing consistency is underway. The company has produced new batch lots which have been delivered directly to the lab where samples will be taken in a more controlled environment. These samples will then undergo the required tests to confirm the uniformity and consistency of the company’s manufacturing process. In parallel with this effort, preparation for packaged product testing by the company’s packaging partner will continue, providing necessary confirmation of packaging integrity, effective sterilization and other criteria.

Because the required tests are being performed by external service providers it is difficult to predict with certainty the time to completion of these final steps in the company’s PMA application. Based on recent lab performance and detailed discussions with its packaging partner regarding the necessary protocols to establish packaging procedures that meet the rigorous Class III standards, the company now anticipates it may take until the end of June 2023 to complete, analyze and incorporate these procedures and results into a consolidated PMA application.

There can be no assurance that the company’s PMA application will be approved.

About United Health Products -- UHP develops, manufactures and markets HemoStyp™, a patented Neutralized Regenerated Cellulose 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 emergency medicine markets, and is seeking approval to access the human surgical market. 

For more information on UHP visit the company’s new website: www.uhpcorp.com or contact the company at info@uhpcorp.com.

The company can also be reached by phone or text message at 475.755.1005.

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.

FAQ

What is the current status of United Health Products' PMA application for HemoStyp?

United Health Products is conducting additional testing after anomalies were found in lab results, with completion anticipated by June 2023.

What issues were identified in the FDA testing for UEEC's HemoStyp product?

The testing revealed anomalies in pH and moisture levels, attributed to unintended oxidation during sample preparation.

How does the delay in UHP's PMA application affect investors?

The delay may impact investor confidence as the approval timeline has been extended, which can influence stock performance.

What is the significance of the chloride content results for UEEC's HemoStyp?

The well-below tolerance levels for chloride content suggest that the product may maintain reliability despite other testing anomalies.

Is there a guarantee that UHP's PMA application will be approved?

No, UHP has cautioned that there can be no assurance of PMA approval despite ongoing testing efforts.