United Health Products, Inc. (OTCQB: UEEC) announced an agreement with NAMSA, a global leader in MedTech contract research, to serve as Sponsor of a new clinical study of UHP’s CelluSTAT Hemostatic Gauze. This collaboration follows the company’s recent proposal to the FDA, which was approved in March, 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.
Upon completion of the study, UHP will hold an exclusive right of reference to all data for use in a revised Premarket Approval (PMA) application. This structure allows the study to proceed while UHP works with the FDA to resolve an outstanding Warning Letter. NAMSA’s expertise in clinical trial management for Class III hemostatic agents and experience with the FDA Center for Devices and Radiological Health positions it to efficiently sponsor a human study that validates the safety and effectiveness of the product.
Brian Thom, UHP’s CEO, expressed confidence in the partnership, noting NAMSA’s deep experience in clinical studies of new medical devices and the FDA approval process. The company views this as a critical step toward accessing the human surgical market with its all-natural, neutralized regenerated cellulose hemostatic agent 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 is available at www.newmediawire.com.
