United Health Products Provides Update on FDA PMA Application Process
United Health Products Provides Update on FDA PMA Application Process
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.
內華達州梅斯基特，2023 年 3 月 29 日（GLOBE NEWSWIRE）— 通過 NewMediaWire — United Health Products, Inc.（OTCPK：UEEC）今天提供了該公司FDA上市前批准申請流程的最新情況。
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.
正如在2023年1月31日的新聞稿中披露的那樣，UHP生產了三批HemoStyp紗布產品，以顯示出穩定的生產結果，該公司認爲這是上市前批准的重要標準。對這些批次樣品的實驗室測試已經完成，以確認公司製造過程的一致性，這些結果將包含在其最終的PMA申請中。測試結果顯示，產品pH值和水分含量存在一些異常，該公司在與實驗室領導層協商後認爲，這些異常是由外部組件供應商進行的樣品切割和包裝過程中意外部分氧化造成的。該公司指出，該過程是爲了創建測試樣本而進行的，不是標準制造、包裝和滅菌過程的組成部分，美國食品藥品管理局將在PMA申請中對此進行審查。UHP進一步指出，所有樣品中其他特性（例如氯化物含量）的測試結果都遠低於耐受閾值。
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.
鑑於這些異常情況，正在進行第二輪製造一致性測試。該公司已經生產了新的批次，這些批次已直接運送到實驗室，樣本將在更可控的環境中採集。然後，將對這些樣品進行必要的測試，以確認公司製造過程的統一性和一致性。與此同時，公司的包裝合作伙伴將繼續爲包裝產品測試做準備，爲包裝完整性、有效滅菌和其他標準提供必要的確認。
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.
由於所需的測試是由外部服務提供商執行的，因此很難肯定地預測公司PMA應用程序中這些最後步驟的完成時間。根據最近的實驗室表現以及與包裝合作伙伴就建立符合嚴格的 III 類標準的包裝程序的必要協議進行的詳細討論，該公司現在預計可能需要到 2023 年 6 月底才能完成、分析這些程序和結果，並將其納入合併的 PMA 申請中。
There can be no assurance that the company's PMA application will be approved.
無法保證該公司的PMA申請會獲得批准。
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.
關於聯合健康產品 — 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目前爲牙科、獸醫和急診醫學市場提供一套止血產品，並正在尋求進入人體外科市場的批准。
For more information on UHP visit the company's new website: or contact the company at info@uhpcorp.com.
有關 UHP 的更多信息，請訪問該公司的新網站： 或者通過 info@uhpcorp.com 聯繫該公司。
The company can also be reached by phone or text message at 475.755.1005.
也可以通過電話或短信撥打475.755.1005與該公司聯繫。
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.
1995年《私人證券訴訟改革法》下的安全港聲明：本新聞稿可能包含經修訂的1933年《證券法》第27A條和經修訂的1934年《證券交易法》第21E條所指的前瞻性信息，包括包含 “相信”、“期望”、“預期” 或類似表達方式的聲明。此類前瞻性陳述涉及已知和未知的風險、不確定性和其他因素，這些因素可能導致公司的實際業績、業績或成就與此類前瞻性陳述所表達或暗示的業績、業績或成就存在重大差異。
譯文內容由第三人軟體翻譯。