United Health Products, Inc. (OTCQB: UEEC) has entered into an agreement with NAMSA, a global leader in MedTech contract research, to sponsor a new clinical study of the company's CelluSTAT Hemostatic Gauze. The collaboration follows the FDA's approval in March of UHP's proposal to have a non-affiliated party oversee the study, which is intended to support a revised Premarket Approval (PMA) application.
Under the agreement, NAMSA will initially seek an Investigational Device Exemption (IDE) to organize and conduct the 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 its PMA submission. This approach allows the study to proceed while UHP works with the FDA to resolve an outstanding Warning Letter.
NAMSA's expertise is particularly relevant, as the organization is 100% focused on medical device and in vitro diagnostic technologies, with decades of experience in clinical trial management for Class III hemostatic agents. Additionally, NAMSA's team includes former staff from the FDA Center for Devices and Radiological Health, providing valuable regulatory insight.
Brian Thom, UHP's CEO, expressed confidence in the partnership, stating, "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."
United Health Products has developed and patented a Neutralized Regenerated Cellulose hemostatic agent. CelluSTAT Hemostatic Gauze is an all-natural product designed to control mild to moderate bleeding, and the company is seeking approval to access the human surgical market. More information is available on the company's website at www.uhpcorp.com.
The successful completion of this clinical study could be pivotal for UHP, as it may provide the necessary data to satisfy FDA requirements and ultimately bring CelluSTAT to market, addressing a significant need in surgical bleeding management.
