United Health Products, Inc. (OTCQB: UEEC) announced a collaboration with NAMSA, a global MedTech contract research organization, to sponsor a new clinical study of the company's CelluSTAT Hemostatic Gauze. The agreement follows the FDA's approval in March of UHP's proposal to have a non-affiliated party oversee the study.
Under the arrangement, 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 study data for use in a revised Premarket Approval (PMA) application. This strategy allows the study to proceed (subject to IDE approval) 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 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, stated, “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.”
The clinical study is a critical step for UHP as it seeks approval to access the human surgical market. CelluSTAT Hemostatic Gauze is an all-natural product designed to control mild to moderate bleeding. For more information on UHP, visit the company’s website at www.uhpcorp.com. The original press release can be viewed on www.newmediawire.com.
This collaboration underscores UHP's commitment to advancing its hemostatic technology through rigorous clinical evaluation, potentially paving the way for market entry and addressing the FDA's concerns.
