HENDERSON, Nev., Aug. 08, 2018 (GLOBE NEWSWIRE) — United Health Products, Inc. (UHP) (OTC: UEEC), manufacturer and marketer of HemoStyp, a patented hemostatic gauze for the healthcare and wound care sectors, today announced that its protocol submission for human testing has been reviewed by the Food and Drug Administration (FDA). This FDA review has been provided to the Institutional Review Board (IRB) for protocol and hospital site approval. United Health Products expects the human trial study to commence mid-August.
The IRB is a committee that is independent of the FDA, and that is formally designated to approve, monitor, and review biomedical and behavioral research involving humans. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study.
UHP’s human trial protocol calls for the application of HemoStyp in abdominal, cardiovascular thoracic and vascular surgical procedures to control bleeding sites. Prior to finalizing its human trial protocol, UHP submitted a Q-Sub — a request for FDA review — to the FDA, in conjunction with its previously filed Class III PMA submission application.
The HemoStyp human trial is a prospective, non-inferiority, multi-center, randomized, open-label trial to observe HemoStyp in the management of bleeding during surgery; and, to assess the efficacy and safety of HemoStyp as an adjunct for management of secondary hemostasis in an operative setting. UHP’s independently developed protocol has established endpoints for bleeding control and stopping. The trial will operate under the Non-Significant Risk (NSR) category of Investigational Device Exemption (IDE). NSR devices do not pose a significant risk to the human subjects. Submissions for NSR device investigations are made directly to the IRB of each participating institution.
“We expect that this human trial will be the last step to clear in obtaining FDA PMA Class III approval for HemoStyp,” said, Louis Schiliro, COO, UHP. “We have recruited a team of leading surgeons to conduct the study, and our lead investigator has successfully conducted over 20 FDA trials as Primary Investigator. These are indeed exciting times for UHP, as we aim to complete the final regulatory stage and prepare for entry into the $ 2.9 billion domestic hemostasis surgical market.”
About United Health Products
United Health Products develops, manufactures, and markets patented hemostatic gauze for the healthcare and wound care sectors. The product, HemoStyp®, is derived from regenerated oxidized cellulose, which is all natural, and designed to absorb exudate/drainage from superficial wounds and helps control bleeding. UHP is focused on identifying new markets and applications for its products, and expanding its current markets. For more on United Health Products visit: www.unitedhealthproductsinc.com
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Company Contact: 877-358-3444/ IR Contact: Philippe Niemetz, PAN Consultants Ltd. 212-344 -6464
