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 FDA 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 a study of UHP's neutralized cellulose hemostat technology. Upon completion, UHP will hold an exclusive right of reference to all data for use in a revised Premarket Approval (PMA) application. This plan allows the study to proceed while UHP works with the FDA to resolve an outstanding Warning Letter.
NAMSA, which has decades of experience in clinical trial management for Class III hemostatic agents and FDA Center for Devices and Radiological Health experience, has previously partnered with UHP on preclinical testing. Brian Thom, UHP's CEO, expressed confidence in NAMSA's ability to efficiently sponsor a human study that will validate the safety and effectiveness of CelluSTAT.
CelluSTAT is an all-natural hemostatic agent designed to control mild to moderate bleeding, using Neutralized Regenerated Cellulose technology. UHP is seeking approval to access the human surgical market. The company's website provides more information at www.uhpcorp.com.
This development is significant for UHP as it moves toward resolving regulatory hurdles and potentially bringing a novel hemostatic product to surgical settings. The outcome of the study could impact the company's market access and provide surgeons with an additional option for bleeding control. Investors and industry observers will watch for IDE approval and subsequent study results, which are critical for UHP's PMA resubmission and eventual commercialization.
