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United Health Products Provides Regulatory Update

United Health Products Provides Regulatory Update

聯合健康產品公司提供最新監管信息
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.  

內華達州亨德森,2022 年 5 月 18 日(GLOBE NEWSWIRE)— 通過NewMediaWire— United Health Products, Inc.(OTCPK:UEEC)(UHP)今天提供了其FDA監管程序的最新情況。

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.

監管審查
正如先前披露的那樣,UHP 於 2022 年 4 月 20 日向美國食品藥品監督管理局 (FDA) 提交了針對其HemoStyp™ 止血紗布的補充和電子格式的上市前批准 (PMA) 回覆,並按照慣例,要求與負責審查其PMA申請的委員會舉行會議。UHP 已接受美國食品和藥物管理局關於在2022年7月6日舉行會議的提議,並預計將在本次會議之前收到有關其最新回應的反饋。該公司將繼續與審查委員會成員接觸,以處理任何剩餘的請求,並確保在7月份進行富有成效的互動。無法保證PMA申請會獲得批准。

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

投資者關係:
菲利普·尼米茲
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. 

關於聯合健康產品— United Health Products 開發、製造和銷售 HemoStyp™,這是一種獲得專利的中和氧化再生纖維素 (NORC) 止血劑。HemoStyp 是一種全天然產品,旨在控制出血。UHP目前爲牙科、獸醫和消費市場提供一套止血產品,並專注於獲得進入人體外科市場的批准。

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

有關 UHP 的更多信息,請訪問:或通過 info@unitedhealthproductsinc.com 聯繫公司

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.

根據1995年《私人證券訴訟改革法》發表的安全港聲明: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” 或類似表述的陳述。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。


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