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United Health Products Provides Regulatory and Business Update

United Health Products Provides Regulatory and Business Update

美联航保健品公司提供监管和业务更新
GlobeNewswire ·  2022/04/27 09:40

Henderson, NV, April 27, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on its FDA regulatory process and other matters.  

亨德森,内华达州,2022年4月27日(环球通讯社)NewMediaWire-联合保健品公司(OTCPK:UEEC),(UHP)今天提供了其FDA监管程序和其他事项的最新情况。

Regulatory Review

监管审查

As previously disclosed in the company's Form 10-K, the U.S. Food & Drug Administration (FDA) requested in late January 2022 that i) the responses submitted by UHP to previous FDA questions be incorporated into its full Premarket Approval (PMA) application and ii) that the application be reformatted to conform to the FDA's "eSubmitter" online format. On April 20, 2022, UHP completed these tasks and there are currently no requests outstanding from the FDA. As is customary, the company and its regulatory consultant have requested a meeting within the next 30 days with the committee responsible for reviewing its PMA application. There can be no assurance that the PMA application will be approved.

正如该公司之前在Form 10-K中披露的那样,美国食品和药物管理局(FDA)于2022年1月底要求i)将UHP对先前FDA问题的答复纳入其完整的上市前批准(PMA)申请中,以及ii)重新格式化申请以符合FDA的“eSubmitter”在线格式。2022年4月20日,UHP完成了这些任务,目前FDA没有尚未处理的请求。按照惯例,该公司及其监管顾问已要求在未来30天内与负责审查其PMA申请的委员会举行会议。不能保证PMA的申请会得到批准。

Support for Ukraine

对乌克兰的支持

In an effort to support the people of Ukraine and those working to defend the country against the Russian invasion, UHP is donating 10,000 units of its HemoStyp hemostatic gauze to aid with much needed civilian and military medical care. UHP, with donations from certain of its existing shareholders, has partnered with a U.S. based charitable relief organization and will deliver an initial 4,000 units in the coming days and the remainder as the packaging and sterilization process is complete. UHP is proud to be able to bring some measure of comfort and relief to the victims of Russia's brutal aggression, and continues to pursue commercial avenues to deliver its HemoStyp hemostatic products to this region.    

为了支持乌克兰人民和那些努力保卫国家免受俄罗斯入侵的人,UHP捐赠了10,000个单位的HemoStyp止血纱布,以帮助提供急需的平民和军事医疗护理。在某些现有股东的捐赠下,UHP已与一家总部位于美国的慈善救援组织合作,将在未来几天交付最初的4000台,其余的将在包装和消毒过程完成后交付。UHP为能够为俄罗斯野蛮侵略的受害者带来一定程度的安慰和解脱而感到自豪,并继续寻求商业途径,向该地区提供其HemoStyp止血产品。

Investor relations:

投资者关系:

Philippe Niemetz

菲利普·尼梅茨

212 344-6464

212 344-6464

p.niemetz@panconsultants.com

邮箱: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. 

关于美联航保健品--联合保健品公司开发、制造和营销HemoStyp™,这是一种获得专利的中和氧化再生纤维素止血剂。HemoStyp是一种全天然产品,旨在控制出血。UHP目前向牙科、兽医和消费市场提供一系列止血产品,并专注于获得进入人类外科市场的批准。

For more information on UHP visit:  or contact the Company at info@unitedhealthproductsinc.com.

欲了解有关UHP的更多信息,请访问:或通过INFO@unitedHealthProductsinc.com联系该公司。

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.

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。


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