United Health Products, Inc. (OTCQB: UEEC) announced an agreement with NAMSA, a global leader in MedTech contract research, to sponsor a clinical study of the company's CelluSTAT Hemostatic Gauze. The move follows the FDA's approval in March of a proposal for a non-affiliated party to oversee the study, addressing an outstanding Warning Letter.
Under the agreement, 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, which will be used in a revised Premarket Approval (PMA) application. This approach allows the study to proceed subject to IDE approval while UHP works with the FDA to resolve regulatory issues.
NAMSA, 100% focused on medical device and in vitro diagnostic technologies, brings decades of experience in clinical trial management for Class III hemostatic agents, including expertise working with the FDA Center for Devices and Radiological Health. Brian Thom, UHP's CEO, 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 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."
The clinical study is a critical step for UHP as it seeks to access the human surgical market with its all-natural hemostatic agent designed to control mild to moderate bleeding. The company has developed and patented a Neutralized Regenerated Cellulose hemostatic technology. Positive study results could pave the way for market approval, offering surgeons a new option for bleeding control.
For the medical device industry, this collaboration highlights the importance of third-party sponsorship in clinical studies, particularly when regulatory challenges exist. The outcome may influence how other companies approach FDA interactions and study design. If successful, CelluSTAT could compete with existing hemostatic agents, potentially impacting surgical protocols and patient outcomes.
More information about United Health Products is available on its website at www.uhpcorp.com. The original press release can be viewed at www.newmediawire.com.
This news matters because it represents a strategic effort to advance a medical device through regulatory hurdles, with potential implications for surgical care and the broader medtech landscape.
