United Health Products, Inc. (OTCQB: UEEC) has announced a collaboration with NAMSA, a global MedTech contract research organization, to conduct a 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 U.S. Food and Drug Administration. This move aligns with UHP's recent proposal, approved by the FDA in March, to have a non-affiliated party oversee a new clinical trial.
NAMSA, known for its expertise in medical device and in vitro diagnostic technologies, brings decades of experience in clinical trial management for Class III hemostatic agents and prior work with the FDA's Center for Devices and Radiological Health. Upon completion of the study, UHP will hold an exclusive right of reference to all data, which will be used to support a revised Premarket Approval (PMA) application. This strategy allows the study to proceed while UHP continues to resolve the outstanding Warning Letter from the FDA.
Brian Thom, CEO of United Health Products, 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. NAMSA's deep experience in 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 CelluSTAT Hemostatic Gauze is an all-natural product designed to control mild to moderate bleeding, utilizing UHP's patented Neutralized Regenerated Cellulose technology. The company is seeking approval to access the human surgical market, which represents a significant opportunity. The clinical study is a critical step toward demonstrating the safety and efficacy required for market clearance.
For more information on UHP, visit the company's website at www.uhpcorp.com. The original press release is available on www.newmediawire.com.
