United Health Products
United Health Products develops patented wound care technology, manufactures, and markets hemostatic products for the healthcare and wound care sectors. Their main product, HemoStyp, is an all-natural, Neutralized Oxidized Regenerated Cellulose product designed to control bleeding. The company is focused on expanding into new markets and applications, including the human surgical market, and currently sells products to dental, veterinary, and consumer markets.
Industries
Nr. of Employees
small (1-50)
United Health Products
Henderson, Nevada, United States, North America
Products
Absorbable hemostatic gauze (oxidized regenerated cellulose)
Sterile absorbable gauze hemostat derived from oxidized regenerated cellulose intended to assist with controlling bleeding in surgical and wound care settings; under regulatory review for higher-risk surgical indications.
Hydrocolloid (gel/flowable) hemostatic formulation (in development)
Flowable hydrocolloid/gel and foam formats of oxidized regenerated cellulose intended for internal surgical use, designed to accelerate coagulation and be absorbable when used internally.
Absorbable hemostatic gauze (oxidized regenerated cellulose)
Sterile absorbable gauze hemostat derived from oxidized regenerated cellulose intended to assist with controlling bleeding in surgical and wound care settings; under regulatory review for higher-risk surgical indications.
Hydrocolloid (gel/flowable) hemostatic formulation (in development)
Flowable hydrocolloid/gel and foam formats of oxidized regenerated cellulose intended for internal surgical use, designed to accelerate coagulation and be absorbable when used internally.
Services
Development and manufacture of absorbable hemostatic materials
End-to-end development and pilot manufacturing of absorbable hemostatic formats derived from oxidized regenerated cellulose, including gauze and gel/foam prototypes.
Clinical study conduct and public trial reporting
Design and execution of randomized clinical studies for surgical hemostasis and registration/reporting of results on public registries.
Regulatory submission and compliance support for PMA/IDE
Preparation of regulatory documentation, formatting to eSubmitter requirements, coordination with external regulatory consultants and engagement with regulatory review committees.
Development and manufacture of absorbable hemostatic materials
End-to-end development and pilot manufacturing of absorbable hemostatic formats derived from oxidized regenerated cellulose, including gauze and gel/foam prototypes.
Clinical study conduct and public trial reporting
Design and execution of randomized clinical studies for surgical hemostasis and registration/reporting of results on public registries.
Regulatory submission and compliance support for PMA/IDE
Preparation of regulatory documentation, formatting to eSubmitter requirements, coordination with external regulatory consultants and engagement with regulatory review committees.
Expertise Areas
- Hemostatic biomaterials development
- Clinical trial design and execution (surgical indications)
- Regulatory submissions for Class III devices (PMA) and IDEs
- Manufacturing scale-up and contract manufacturing management
Key Technologies
- Oxidized regenerated cellulose hemostatic materials
- Hydrocolloid/flowable hemostatic gel and foam formulations
- Randomized controlled surgical clinical trials
- eSubmitter electronic PMA submission format