HENDERSON, Nevada – (BUSINESS WIRE) – United Health Products, Inc. (OTCPK: UEEC), (âUHPâ or the âCompanyâ), developer, manufacturer and distributor of HemoStypÂ®, a patented hemostatic agent of neutralized oxidized regenerated cellulose, this week received a notification from the Food & Drug Administration (FDA) that following the resubmission of its pre-market approval application for HemoStyp gauze on April 6e, the FDA has now accepted for review and has begun its substantive review of the application.
Brian Thom, CEO, said, âWe are extremely pleased to have taken this important step in the company’s efforts to enter the US market for Class III human surgery. In addition, we are convinced that our HemoStyp technology can make an important contribution to improving patient outcomes during surgical procedures in US and international healthcare facilities. We look forward to receiving FDA feedback on our application. ”
The initiation of the substantive review serves as confirmation that the FDA deems the content of a PMA application to be adequate and in an acceptable form to thoroughly review and assess the merits of the product and its proposed applications. The FDA has not yet proposed any assessment of the Company’s PMA application beyond this stage, and there can be no assurance that a PMA will be granted.
As previously reported, UHP continues to engage in discussions with several industry participants and financial investors regarding potential business partnerships and strategic transactions, including a possible sale of the Company. There can be no assurance that such a partnership or transaction will be identified and, if so, that it will be carried out.
About United Health Products – United Health Products develops, manufactures and markets patented hemostatic products for the health and wound care industries. The Company’s HemoStyp product is an all-natural neutralized oxidized regenerated cellulose product designed to control bleeding. UHP currently sells a range of hemostatic products to the dental, veterinary and consumer markets, and is focused on obtaining approval to enter the human surgery market.
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