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
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.
內華達州梅斯奎特，2023 年 1 月 31 日 (環球通訊社)--通過新媒體--聯合健康產品公司（OTCPK 代碼：UEEC）今天提供了有關該公司 FDA 售前批准申請流程以及與白獅資本修訂協議的最新信息。
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 繼續向美國食品和藥物管理局推進其上市前批准申請。去年 12 月，根據其新製造安排生產的許多 HmoStyp 紗布被證明具有與該公司人體試驗中使用的 HemoStyp 產品的物理和化學特性有效相同。隨後，該公司與其監管顧問協商並反映了 FDA 的反饋，生產了額外批次的 HemoStyp 產品以證明生產一致的生產，該公司認為這是上市前批准的重要標準。這些額外批次的樣品現正進行類似的實驗室測試程序，以確認該公司製造過程的一致性，該結果將納入其最終 PMA 申請中。
There can be no assurance that the company's PMA application will be approved.
不能保證公司的 PMA 申請一定會獲得批准。
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，該公司與白獅資本有限責任公司簽訂了一份普通股購買協議，根據該協議，該公司有權以相當於五天成交量加權平均交易價 93% 的價格將其普通股的股份出售給白獅。該公司已成功籌集了超過 35 萬美元，用於根據《協議》的業務運營。該協議包含一項條件，即公司股價必須高於每股 0.25 美元（最低價格）才能發出股份購買通知，白獅可以自行決定放棄該通知。2023 年 1 月 25 日，公司與白獅公司修訂了協議，如果該公司在股份低於底價時發出購買通知，白獅放棄最低價格條件，則白獅在該交易中的每股購買價格將為五天成交量加權平均交易價格的 90%，而不是 93%。協議的所有其他條款保持不變。
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.
關於聯合健康產品--UHP 研發、製造和銷售 HmoStyp™，這是一種專利的中和氧化再生纖維素 (NORC) 止血劑。HmoStyp 是一種全天然產品，旨在控制出血。UHP 目前為牙科、獸醫和急診醫學市場提供一系列止血產品，並正在尋求進入人類外科市場的批准。
For more information on UHP visit the company's new website: or contact the company at info@uhpcorp.com.
有關 UHP 的更多信息，請訪問該公司的新網站：或通過 info@uhpcorp.com 與公司聯繫。
The company can also be reached by phone or text message at 475.755.1005
本公司亦可透過電話或簡訊聯絡本公司，電話 475.755.1005
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