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United Health Products (OTCQB: UEEC) selects NAMSA to sponsor CelluSTAT FDA clinical study

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(Very High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

United Health Products, Inc. entered into a collaboration with MedTech contract research organization NAMSA, which will act as Sponsor of a new clinical study of UHP’s CelluSTAT Hemostatic Gauze. NAMSA will first 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 study data for use in a revised Premarket Approval (PMA) application. This approach permits the study to proceed, subject to IDE approval, while UHP continues working with the FDA to resolve an outstanding Warning Letter. NAMSA focuses entirely on medical device and in vitro diagnostic technologies and has experience with clinical trial management for Class III hemostatic agents and with the FDA Center for Devices and Radiological Health.

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Insights

Collaboration advances UEEC’s clinical and FDA pathway but key approvals remain pending.

The agreement with NAMSA gives United Health Products access to a specialist MedTech CRO to sponsor and run a clinical study of CelluSTAT Hemostatic Gauze. NAMSA plans to obtain an Investigational Device Exemption to conduct the study and generate data for a revised Premarket Approval submission.

The plan allows clinical work to move forward while a prior FDA Warning Letter is addressed, but both IDE and PMA approvals are still uncertain outcomes. NAMSA’s experience with Class III hemostatic agents and FDA device review may help design a study that supports safety and effectiveness, yet investors remain dependent on future regulatory decisions following the IDE request and the later PMA filing.

Announcement date July 7, 2026 Date of collaboration announcement between United Health Products and NAMSA
Device classification Class III hemostatic agents Area of NAMSA’s clinical trial management experience relevant to CelluSTAT
Forward-looking statement acts Section 27A of 1933 Act; Section 21E of 1934 Act Legal references in the Safe Harbor Statement for forward-looking information
Investigational Device Exemption (IDE) regulatory
"NAMSA will initially seek an Investigational Device Exemption (IDE) to organize and conduct a study"
An investigational device exemption (IDE) is a regulatory permission that allows a medical device to be used in clinical studies so companies can gather safety and effectiveness data before full market approval. For investors, an IDE is a key milestone because it lets a company test real-world performance and move toward commercial clearance or approval—much like a trial run that, if successful, can unlock larger revenue opportunities and reduce regulatory risk.
Premarket Approval (PMA) regulatory
"use in a revised Premarket Approval (PMA) application"
Premarket Approval (PMA) is the strict regulatory review process used by the U.S. authority for high-risk medical devices to prove they are safe and effective before they can be sold. For investors, a granted PMA is like receiving a key to a locked market: it can open exclusive sales opportunities, reduce near-term competition, and justify higher valuations, while also signaling that the company has cleared a costly, time-consuming hurdle.
Warning Letter regulatory
"while UHP works with the FDA to resolve the outstanding Warning Letter"
A warning letter is a formal notice from a government regulator saying a company has violated laws or rules, often about product safety, manufacturing, labeling, or marketing claims. Like a landlord’s official notice to fix a dangerous problem, it signals the company must correct issues or face fines, product holds, or reputational harm—risks that can delay sales, approvals, or damage share value, so investors watch them closely.
Class III hemostatic agents medical
"experience in clinical trial management for Class III hemostatic agents"
Neutralized Regenerated Cellulose hemostatic agent medical
"UHP has developed and patented a Neutralized Regenerated Cellulose hemostatic agent"

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What collaboration did United Health Products (UEEC) announce with NAMSA?
United Health Products announced that NAMSA, a MedTech contract research organization, will serve as Sponsor of a new clinical study of UHP’s CelluSTAT Hemostatic Gauze, overseeing organization and conduct of the trial.

What is the purpose of the new CelluSTAT clinical study for UEEC?
The clinical study is intended to generate data on UHP’s neutralized cellulose hemostat technology that UHP can use in a revised Premarket Approval (PMA) application to support FDA review of CelluSTAT Hemostatic Gauze.

What regulatory steps will NAMSA take in the UEEC collaboration?
NAMSA will initially seek an Investigational Device Exemption (IDE), which is required to organize and conduct the new clinical study of UHP’s CelluSTAT Hemostatic Gauze under FDA oversight in human subjects.

How will United Health Products (UEEC) use the study data from NAMSA’s trial?
Upon completion of the study, United Health Products will have an exclusive right of reference to all study data, allowing it to use the results in a revised PMA application for CelluSTAT Hemostatic Gauze.

How does the NAMSA-sponsored study relate to UEEC’s FDA Warning Letter?
The plan allows the clinical study to proceed, subject to IDE approval, while United Health Products continues working with the FDA to resolve its outstanding Warning Letter, separating trial sponsorship from the company.

What expertise does NAMSA bring to UEEC’s CelluSTAT clinical program?
NAMSA is focused on medical device and in vitro diagnostic technologies and has decades of experience in clinical trial management for Class III hemostatic agents, plus experience working with the FDA Center for Devices and Radiological Health.

EXHIBIT 99.1

 

United Health Products Establishes Collaboration to Conduct Clinical Study

 

DARIEN, CT - July 7, 2026 - United Health Products, Inc. (OTCQB: UEEC) today announced an agreement with NAMSA, a global leader in MedTech contract research, whereby NAMSA will serve as Sponsor of a new clinical study of UHP's CelluSTAT Hemostatic Gauze.

 

Consistent with the company's recent proposal to the FDA to have a non-affiliated party oversee a new clinical study, which the FDA approved in March of this year, NAMSA will initially seek an Investigational Device Exemption (IDE) to organize and conduct a study of UHP's neutralized cellulose hemostat technology. Upon completion of the study, UHP will hold an exclusive right of reference to all data from the study to use in a revised Premarket Approval (PMA) application. This plan will allow a study to proceed (subject to granting of the IDE) while UHP works with the FDA to resolve the outstanding Warning Letter. 

 

NAMSA is 100% focused on medical device and in vitro diagnostic technologies and its experts have decades of experience in clinical trial management for Class III hemostatic agents, as well as experience working for the FDA Center for Devices and Radiological Health. 

 

Brian Thom, UHP's CEO, commented, "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."

 

About United Health Products -- UHP 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. UHP is seeking approval to access the human surgical market.

 

For more information on UHP visit the company's new website: www.uhpcorp.com or contact the company at info@uhpcorp.com.

 

The company can also be reached by phone or text message at 475.755.1005.

 

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.

 

Source: View Original Filing on SEC EDGAR

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