United Health Products, Inc. (OTCQB: UEEC) announced an agreement with NAMSA, a global leader in MedTech contract research, to sponsor a new clinical study of the company's CelluSTAT Hemostatic Gauze. NAMSA will initially seek an Investigational Device Exemption (IDE) to organize and conduct the study of UHP's neutralized cellulose hemostat technology. This move follows the company's recent proposal to the FDA, approved in March, to have a non-affiliated party oversee the study.
Upon completion, UHP will hold an exclusive right of reference to all data from the study, which will be used in a revised Premarket Approval (PMA) application. This approach allows the study to proceed while UHP works with the FDA to resolve an outstanding Warning Letter. NAMSA specializes in medical device and in vitro diagnostic technologies, with extensive experience in clinical trial management for Class III hemostatic agents and familiarity with the FDA Center for Devices and Radiological Health.
Brian Thom, UHP's CEO, expressed confidence in the partnership, noting NAMSA's deep experience in clinical studies and FDA approval processes. The collaboration aims to validate the safety and effectiveness of the CelluSTAT Hemostatic Gauze through a human study.
For more information, visit the company's website at www.uhpcorp.com or view the original release on www.newmediawire.com.
