United Health Products, Inc. (OTCQB: UEEC) announced an agreement with NAMSA, a global MedTech contract research organization, 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. NAMSA will initially seek an Investigational Device Exemption (IDE) to organize and conduct the study of UHP's neutralized cellulose hemostat technology.
Under the agreement, UHP will hold an exclusive right of reference to all data from the study for use in a revised Premarket Approval (PMA) application. This arrangement allows the study to proceed while UHP works with the FDA to resolve an outstanding Warning Letter. NAMSA, with decades of experience in clinical trial management for Class III hemostatic agents and familiarity with the FDA Center for Devices and Radiological Health, is well-positioned to manage the process.
Brian Thom, UHP's CEO, expressed confidence in the partnership, noting NAMSA's deep experience in clinical study and FDA approval processes. "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," Thom said. He added that NAMSA's expertise gives him confidence that they can efficiently sponsor a human study validating the safety and effectiveness of CelluSTAT.
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.
The successful completion of this clinical study could be pivotal for UHP, potentially leading to FDA clearance and market entry for its hemostatic gauze in surgical settings. The study's outcomes will be critical in demonstrating the product's safety and efficacy, addressing regulatory concerns, and paving the way for commercialization.
