United Health Products, Inc. (OTCQB: UEEC) has announced a collaboration with NAMSA, a global leader in MedTech contract research, to conduct a new clinical study of its CelluSTAT Hemostatic Gauze. Under the agreement, NAMSA will serve as the Sponsor of the study, initially seeking an Investigational Device Exemption (IDE) from the FDA. This approach aligns with the company's earlier proposal to have an independent party oversee the study, which received FDA approval in March.
NAMSA will 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, which it intends to 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's expertise is specifically focused on medical device and in vitro diagnostic technologies, with decades of 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, 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. The company is seeking approval to access the human surgical market. More information is available on the company's website at www.uhpcorp.com.
This collaboration marks a significant step for UHP in its efforts to bring its hemostatic technology to market. By leveraging NAMSA's regulatory and clinical expertise, the company aims to generate robust clinical data that could support FDA approval. The successful completion of the study and subsequent PMA application could position CelluSTAT as a viable option in the surgical hemostatic market, addressing an unmet need for natural, effective bleeding control products.
This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.
