United Health Products, Inc. (OTCQB: UEEC) announced an agreement with NAMSA, a global leader in MedTech contract research, to serve as Sponsor of a new clinical study of the company's CelluSTAT Hemostatic Gauze. This collaboration follows the FDA's approval in March of the company's proposal to have a non-affiliated party oversee the study.
Under the agreement, NAMSA will initially seek an Investigational Device Exemption (IDE) to organize and conduct a study of UHP's neutralized cellulose hemostat technology. Upon completion, UHP will hold an exclusive right of reference to all data from the study for use in a revised Premarket Approval (PMA) application. This approach allows the study to proceed while UHP works with the FDA to resolve the outstanding Warning Letter.
NAMSA is 100% focused on medical device and in vitro diagnostic technologies, with experts who have decades of experience in clinical trial management for Class III hemostatic agents, as well as experience working for the FDA Center for Devices and Radiological Health. Brian Thom, UHP’s CEO, commented, “NAMSA has been a great partner to UHP for several years in our preclinical testing efforts and I am delighted that we are expanding our relationship with such a well-regarded and capable CRO. NAMSA’s deep experience in the clinical study of new medical devices and in working through the FDA approval process give me confidence that they can gain approval for, and efficiently sponsor a human study that will validate the safety and effectiveness of our CelluSTAT Hemostatic Gauze.”
This collaboration is significant because it marks a strategic step for UHP to advance its hemostatic technology toward the human surgical market. The involvement of NAMSA, a reputable contract research organization, increases the likelihood of a successful clinical study and subsequent FDA approval. For more information on UHP, visit the company’s website at www.uhpcorp.com.
