United Health Products, Inc. (UEEC)

United Health Products, Inc. develops, manufactures, and markets a patented hemostatic gauze for the healthcare and wound care sectors. Its product, HemoStyp, is a neutralized, oxidized, regenerated cellulose (NORC) material derived from cotton, designed to absorb exudate and drainage from superficial wounds and help control bleeding. The company is seeking regulatory approval to sell HemoStyp into the U.S. Class III and European Union CE Mark surgical markets. During 2022 it worked to address deficiencies the FDA identified in 2021 in its Premarket Approval (PMA) application, mainly standardized manufacturing procedures and quality assurance for finished products. It has implemented Good Manufacturing Practices and is testing finished product before submitting a revised PMA application.

HemoStyp is a flexible, silk-like gauze that contains no chemical additives, thrombin, collagen, or animal-derived products, and is hypoallergenic. On contact with blood it converts to a translucent gel with a neutral pH that breaks down into glucose and salts. Laboratory testing showed it to be fully absorbable in the body within 24 hours. A human trial in 2019 and 2020 demonstrated its effectiveness in vascular, thoracic, and abdominal surgical procedures. The gauze is cut to several sizes and configurations, and can be bonded to an adhesive bandage or integrated into traditional gauze. It holds a 2012 FDA 510(k) clearance for external and superficial bleeding. The company holds patents on its NORC technology through 2029 and has filed additional U.S., international, and PCT applications covering a gel or hydrocolloid formulation. It also has a registered trademark for The Ultimate Bandage.

Potential customers include hospitals and surgery centers (for internal surgical use if Class III approval is obtained), hospitals, clinics, and physicians for external trauma, EMS, fire departments and other first responders, military medical providers, hemodialysis centers, nursing homes and assisted living facilities, dental and oral surgery offices, and veterinary hospitals. The company views Class III surgical markets, domestic and international, as the most attractive because of fewer competitors and premium pricing. It paused sales and marketing to non-Class III markets in 2018 to focus on the PMA process. In late 2021 it re-engaged consumers and distributors of 510(k) products, focusing on first-aid, dental surgery, and emergency medicine. It does not intend to commercialize independently or remain independent long term, and is considering a sale or merger with a wound care or surgical device leader, or commercial partnerships. It has held discussions with several medical technology companies that contacted it.

NORC products are made to the company's specifications on its equipment by an FDA-certified contract manufacturer. Cutting, packaging, and sterilization are done by U.S. service providers, with packaging outsourced to an ISO-certified partner. The U.S. wound care market is concentrated among large companies such as Baxter International, Becton Dickinson, Bristol-Myers Squibb, Johnson & Johnson, and 3M, which have greater resources. Competition turns on product performance, price, breadth of offerings, service, delivery, credit terms, and customer support. R&D spending was $624,564 in 2022 and $237,458 in 2021. As of March 27, 2023, the company had seven full-time personnel working under consulting agreements and four Medical Advisory Board members.