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.
内华达州梅斯奎特,2023年3月29日(环球通讯社)NewMedia Wire-联合保健品公司(OTCPK:UEEC)今天提供了该公司FDA上市前批准申请程序的最新情况。
如2023年1月31日的新闻稿披露,UHP生产了三批HemoStyp纱布产品,以证明一致的制造结果,该公司认为这是上市前批准的重要标准。完成了对这些批次样品的实验室测试,以确认该公司制造过程的一致性,结果将包括在其最终的PMA申请中。测试结果显示,在与实验室领导层协商后,该公司认为,产品的pH值水平和水分含量出现了几个异常,这是由于外部零部件供应商在样品切割和包装过程中意外的部分氧化造成的。该公司指出,执行这一过程是为了创建测试样品,而不是FDA将在PMA申请中审查的标准制造、包装和灭菌过程的一个要素。UHP还指出,对其他特性的检测结果,如氯化物含量,在所有样品中都远低于容许阈值。
鉴于这些异常情况,第二轮生产一致性测试正在进行中。该公司已经生产了新的批次,这些批次已经直接交付给实验室,在那里将在更受控制的环境中采集样本。然后,这些样品将接受所需的测试,以确认该公司制造过程的一致性和一致性。与此同时,该公司的包装合作伙伴将继续为包装产品测试做准备,为包装完整性、有效灭菌和其他标准提供必要的确认。
由于所需的测试是由外部服务提供商执行的,因此很难确定地预测完成该公司PMA应用程序中的这些最后步骤的时间。根据最近的实验室表现和与包装合作伙伴就建立符合严格III类标准的包装程序所需协议的详细讨论,该公司现在预计可能需要到2023年6月底才能完成、分析这些程序和结果,并将其纳入合并的PMA应用程序。
不能保证该公司的PMA申请会获得批准。
关于美联航保健品--UHP开发、制造和销售HemoStyp,这是一种获得专利的中和再生纤维素止血剂。HemoStyp是一种全天然产品,旨在控制出血。UHP目前向牙科、兽医和急救药物市场提供一系列止血产品,并正在寻求进入人类外科市场的批准。
有关超高压的更多信息,请访问该公司的新网站:或通过info@uhpcorp.com联系该公司。
也可以通过电话或短信475.755.1005联系到该公司。
根据1995年《私人证券诉讼改革法》所作的安全港声明:本新闻稿可能包含符合1933年《证券法》第27A条(经修订)和《1934年证券交易法》(经修订)第21E条的含义的前瞻性信息,包括含有“相信”、“预期”、“预期”或类似表述的陈述。这些前瞻性陈述涉及已知和未知的风险、不确定因素和其他因素,这些风险、不确定因素和其他因素可能导致公司的实际结果、业绩或成就与这些前瞻性陈述中明示或暗示的大不相同。