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: 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.
內華達州梅斯奎特，2023年3月29日(環球通訊社)NewMedia Wire-聯合保健品公司(OTCPK：UEEC)今天提供了該公司FDA上市前批准申請程式的最新情況。
如2023年1月31日的新聞稿披露，UHP生產了三批HemoStyp紗布產品，以證明一致的製造結果，該公司認為這是上市前批准的重要標準。完成了對這些批次樣品的實驗室測試，以確認該公司製造過程的一致性，結果將包括在其最終的PMA申請中。測試結果顯示，在與實驗室領導層協商後，該公司認為，產品的pH值水準和水分含量出現了幾個異常，這是由於外部零部件供應商在樣品切割和包裝過程中意外的部分氧化造成的。該公司指出，執行這一過程是為了創建測試樣品，而不是FDA將在PMA申請中審查的標準制造、包裝和滅菌過程的一個要素。UHP還指出，對其他特性的檢測結果，如氯化物含量，在所有樣品中都遠低於容許閾值。
鑑於這些異常情況，第二輪生產一致性測試正在進行中。該公司已經生產了新的批次，這些批次已經直接交付給實驗室，在那裡將在更受控制的環境中採集樣本。然後，這些樣品將接受所需的測試，以確認該公司製造過程的一致性和一致性。與此同時，該公司的包裝合作夥伴將繼續為包裝產品測試做準備，為包裝完整性、有效滅菌和其他標準提供必要的確認。
由於所需的測試是由外部服務提供商執行的，因此很難確定地預測完成該公司PMA應用程式中的這些最後步驟的時間。根據最近的實驗室表現和與包裝合作夥伴就建立符合嚴格III類標準的包裝程式所需協定的詳細討論，該公司現在預計可能需要到2023年6月底才能完成、分析這些程式和結果，並將其納入合併的PMA應用程式。
不能保證該公司的PMA申請會獲得批准。
關於美聯航保健品--UHP開發、製造和銷售HemoStyp，這是一種獲得專利的中和再生纖維素止血劑。HemoStyp是一種全天然產品，旨在控制出血。UHP目前向牙科、獸醫和急救藥物市場提供一系列止血產品，並正在尋求進入人類外科市場的批准。
有關超高壓的更多資訊，請訪問該公司的新網站：或通過info@uhpcorp.com聯繫該公司。
也可以通過電話或簡訊475.755.1005聯繫到該公司。
根據1995年《私人證券訴訟改革法》所作的安全港聲明：本新聞稿可能包含符合1933年《證券法》第27A條(經修訂)和《1934年證券交易法》(經修訂)第21E條的含義的前瞻性資訊，包括含有“相信”、“預期”、“預期”或類似表述的陳述。這些前瞻性陳述涉及已知和未知的風險、不確定因素和其他因素，這些風險、不確定因素和其他因素可能導致公司的實際結果、業績或成就與這些前瞻性陳述中明示或暗示的大不相同。
