share_log

United Health Products Provides Regulatory Update

United Health Products Provides Regulatory Update

联合健康产品公司提供最新监管信息
GlobeNewswire ·  2022/05/18 10:36

Henderson, NV, May 18, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on its FDA regulatory process.  

内华达州亨德森,2022 年 5 月 18 日(GLOBE NEWSWIRE)— 通过NewMediaWire— United Health Products, Inc.(OTCPK:UEEC)(UHP)今天提供了其FDA监管程序的最新情况。

Regulatory Review
As previously disclosed, on April 20, 2022, UHP delivered to the U.S. Food & Drug Administration (FDA) a supplemented and e-formatted Premarket Approval (PMA) response for its HemoStyp™ hemostatic gauze and, as is customary, requested a meeting with the committee responsible for reviewing its PMA application. UHP has accepted the FDA's offer to meet on July 6, 2022, and anticipates receiving feedback on its latest response in advance of this meeting. The company will continue to engage with members of the review committee to address any remaining requests and to ensure a productive interaction in July.  There can be no assurance that the PMA application will be approved.

监管审查
正如先前披露的那样,UHP 于 2022 年 4 月 20 日向美国食品药品监督管理局 (FDA) 提交了针对其HemoStyp™ 止血纱布的补充和电子格式的上市前批准 (PMA) 回复,并按照惯例,要求与负责审查其PMA申请的委员会举行会议。UHP 已接受美国食品和药物管理局关于在2022年7月6日举行会议的提议,并预计将在本次会议之前收到有关其最新回应的反馈。该公司将继续与审查委员会成员接触,以处理任何剩余的请求,并确保在7月份进行富有成效的互动。无法保证PMA申请会获得批准。

Investor relations:
Philippe Niemetz
212 344-6464
p.niemetz@panconsultants.com

投资者关系:
菲利普·尼米兹
212 344-6464
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. 

关于联合健康产品— United Health Products 开发、制造和销售 HemoStyp™,这是一种获得专利的中和氧化再生纤维素 (NORC) 止血剂。HemoStyp 是一种全天然产品,旨在控制出血。UHP目前为牙科、兽医和消费市场提供一套止血产品,并专注于获得进入人体外科市场的批准。

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

有关 UHP 的更多信息,请访问:或通过 info@unitedhealthproductsinc.com 联系公司

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》发表的安全港声明:本新闻稿可能包含经修订的1933年《证券法》第27A条和经修订的1934年《证券交易法》第21E条所指的前瞻性信息,包括包含 “相信”、“期望”、“预期” 或类似表述的陈述。此类前瞻性陈述涉及已知和未知的风险、不确定性和其他因素,这些因素可能导致公司的实际业绩、业绩或成就与此类前瞻性陈述所表达或暗示的业绩、业绩或成就存在重大差异。


声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
    抢沙发