United Health Products Provides Update on Clinical Study Process
UNITED HEALTH PRODUTS INC (UEEC)
NASDAQ:AMEX Investor Relations:
unitedhealthgroup.com/investors.aspx
Company Research
Source: GlobeNewswire
MT. LAUREL, N.J., Dec. 02, 2024 (GLOBE NEWSWIRE) -- United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s planned clinical study. As previously disclosed, United Health Products is conducting a clinical trial of its CelluSTAT Hemostatic Gauze product (formerly branded as HemoStyp) in response to the FDA’s request for additional clinical data. On November 29th, the company submitted to the FDA an Investigational Device Exemption application (IDE), the approval of which is a precondition to enroll patients in the planned study. The IDE contains, among other elements, a proposed study protocol for the testing of approximately 30 subjects across 3-5 surgical facilities, with the objectives of confirming non-inferiority and superiority, as well as safety, of CelluSTAT versus the standard of care in open surgical procedures in the abdominal space. The FDA generally seeks to respond to IDE applications within 30 days, subject to availability of resources.
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Sec Filings
- 12/19/24 - Form SCHEDULE
- 12/4/24 - Form SC
- 11/12/24 - Form 10-Q
- UEEC's page on the SEC website