United Health Products, Inc. (OTCQB: UEEC) announced an agreement with NAMSA, a global leader in MedTech contract research, to sponsor a new clinical study of the company's CelluSTAT Hemostatic Gauze. The collaboration, detailed in a press release, follows FDA approval in March of a proposal allowing a non-affiliated party to 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 study completion, UHP will hold an exclusive right of reference to all data, which will be used in a revised Premarket Approval (PMA) application. This approach allows the study to proceed while UHP works to resolve an outstanding Warning Letter from the FDA.
NAMSA is 100% focused on medical device and in vitro diagnostic technologies, with experts possessing 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, stated, “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. For more information, visit the company’s website at www.uhpcorp.com.
The collaboration with NAMSA represents a critical step for UHP toward gaining FDA approval. By having an independent CRO sponsor the study, the company aims to address regulatory concerns and generate robust clinical data. For leaders in business and technology, this development highlights the importance of strategic partnerships in navigating complex regulatory pathways for medical devices. Success could open the surgical market for CelluSTAT, impacting patient care and competitive dynamics in hemostatic products.
The original press release is available at www.newmediawire.com.
