United Health Products, Inc. (OTCPK: UEEC, “UHP”) today announced that it has uploaded the full results of its Human Trial study, Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting, to the ClinicalTrials.gov website; these results are expected to be made available to the public within 7-14 days. UHP’s randomized study of 238 patients undergoing thoracic, cardiac, abdominal, and vascular surgical procedures compared hemostatic performance of its patented HemoStyp gauze to the industry standard of care. The results of this study demonstrate a statistically superior performance of HemoStyp over J&J’s Ethicon’s SURGICEL Original product. UHP will be submitting final documents requested by the FDA in conjunction with its PMA (Class III) application to use HemoStyp in internal surgeries. The company expects the FDA to seek additional information or approve the file within 30 days following the submission of the final documents.
All details and updates regarding the Human Trial will be available to the public at:
UHP is progressing in its R&D efforts to develop and seek FDA approval for a hydrocolloid (flowable) formulation of its HemoStyp product and has filed patent applications for this hemostatic technology.
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study.
About United Health Products
United Health Products develops technology; and manufactures and markets patented hemostatic products for the healthcare and wound care sectors. The Company’s product, HemoStyp, is derived from regenerated oxidized cellulose. HemoStyp is an all-natural product designed to 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, Inc. visit: www.unitedhealthproductsinc.com
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United Health Products, Inc.