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United Health Products Provides Update on FDA PMA Application and Amendment to White Lion Agreement

United Health Products Provides Update on FDA PMA Application and Amendment to White Lion Agreement

United Health Products提供FDA PMA申请和白狮协议修正案的最新情况
GlobeNewswire ·  2023/01/31 22:05

Mesquite, NV, Jan. 31, 2023 (GLOBE NEWSWIRE) --  via NewMediaWire -- United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on the company's FDA Premarket Approval application process and the amendment of its Agreement with White Lion Capital.  

内华达州梅斯基特,2023年1月31日(GLOBE NEWSWIRE)——通过NewMediaWire——联合健康产品公司(OTCPK:UEEC)(UHP)今天提供了该公司FDA上市前批准申请程序及其与White Lion Capital协议修正案的最新情况。

UHP continues to advance its Premarket Approval application with the Food and Drug Administration. Last December, a batch lot of HemoStyp gauze produced under its new manufacturing arrangements was shown to have physical and chemical characteristics that were effectively identical to those of the HemoStyp product utilized in the company's human trial. Subsequently, the company, in consultation with its regulatory consultant and reflecting feedback from the FDA, has produced additional batch lots of HemoStyp product to demonstrate consistent production, which the company believes is an important criterion for Premarket Approval. Samples of these additional lots are now undergoing similar laboratory testing procedures to confirm the consistency of the company's manufacturing process, which results will be included in its final PMA application.

UHP 继续向美国食品药品监督管理局推进其上市前批准申请。去年12月,根据其新的生产安排生产的一批HemoStyp纱布被证明具有与该公司人体试验中使用的HemoStyp产品的物理和化学特性实际上相同。随后,该公司经与监管顾问协商并反映了美国食品药品管理局的反馈,额外生产了批次的HemoStyp产品,以证明产量稳定,该公司认为这是上市前批准的重要标准。这些额外批次的样品目前正在接受类似的实验室测试程序,以确认该公司制造过程的一致性,这些结果将包含在其最终的PMA申请中。

There can be no assurance that the company's PMA application will be approved.

无法保证该公司的PMA申请会获得批准。

Separately, in September 2022 the company entered into a Common Stock Purchase Agreement with White Lion Capital, LLC under which the company has the right to sell shares of its common stock to White Lion at a price equal to 93% of the five-day volume weighted average trading price. The company has successfully raised over $350,000 to fund its operations under the Agreement. The Agreement contains a condition that the company share price must be above $0.25 per share (the Floor Price) in order to issue a share purchase notice, which White Lion can waive at its discretion. On January 25, 2023, the company and White Lion amended the Agreement such that if the company issues a purchase notice when its shares are trading below the Floor Price and White Lion waives the Floor Price condition, White Lion's purchase price per share in that transaction will be 90% of the five-day volume weighted average trading price rather than 93%. All other terms of the Agreement remain unchanged.

另外,2022年9月,该公司与White Lion Capital, LLC签订了普通股购买协议,根据该协议,该公司有权以等于五天交易量加权平均交易价格的93%的价格向White Lion出售其普通股。该公司已成功筹集了超过35万美元,为其在该协议下的运营提供资金。该协议包含一项条件,即公司股价必须高于每股0.25美元(最低价格)才能发布股票购买通知,White Lion可以自行决定放弃该通知。2023年1月25日,公司和White Lion修改了协议,规定如果公司在其股票交易价格低于底价时发布收购通知,而White Lion放弃底价条件,则该交易中White Lion的每股收购价格将为五天成交量加权平均交易价格的90%,而不是93%。协议的所有其他条款保持不变。

About United Health Products -- UHP 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 emergency medicine markets, and is seeking approval to access the human surgical market. 

关于联合健康产品— UHP 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 是一种旨在控制出血的全天然产品。UHP 目前向牙科、兽医和急诊医学市场提供一套止血产品,并正在寻求进入人体外科市场的批准。

For more information on UHP visit the company's new website:  or contact the company at info@uhpcorp.com.

有关 UHP 的更多信息,请访问该公司的新网站:或通过 info@uhpcorp.com 与该公司联系。

The company can also be reached by phone or text message at 475.755.1005

也可以通过电话或短信联系该公司 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.

1995年《私人证券诉讼改革法》下的安全港声明: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” 或类似表达方式的陈述。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。


译文内容由第三方软件翻译。


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