United Health Products Inc (UEEC)

[rodman]

United Health Products Files IDE Pre-Submission with the FDA for Approval to Begin Human Trials of HemoStyp(R)....

HENDERSON, Nev., June 19, 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 after successfully completing a series of animal tests, it has filed an IDE pre-submission application with the Food and Drug Administration (FDA) to begin human trials of HemoStyp. The filing was made in conjunction with a previously filed Class III PMA submission application for HemoStyp for general surgical use in abdominal, cardiovascular and thoracic procedures to control bleeding sites.

An Investigational Device Exemption (IDE) allows an investigational device (i.e., a device that is the subject of a clinical study) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA). All statistical power calculations have been completed, and procedural protocols have been vetted for this submission. UHP expects to confer imminently with the FDA to confirm receipt of the Protocol, and to begin testing upon approval.

About IDE pre-submission:

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046164.htm

About Premarket Approval (PMA):

https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/
Lets Go UEEC!