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
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
End-to-end development and pilot manufacturing of absorbable hemostatic formats derived from oxidized regenerated cellulose, including gauze and gel/foam prototypes.
Design and execution of randomized clinical studies for surgical hemostasis and registration/reporting of results on public registries.
Preparation of regulatory documentation, formatting to eSubmitter requirements, coordination with external regulatory consultants and engagement with regulatory review committees.
End-to-end development and pilot manufacturing of absorbable hemostatic formats derived from oxidized regenerated cellulose, including gauze and gel/foam prototypes.
Design and execution of randomized clinical studies for surgical hemostasis and registration/reporting of results on public registries.
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
News & Updates
The FDA has commenced its Substantive Review of UHP's PMA application for HemoStyp, a key step towards market approval for surgical use.
The Journal of Wound Care published a peer-reviewed article demonstrating HemoStyp's superior performance over Surgicel in surgical hemostasis.
Filed international patent applications under the Patent Cooperation Treaty for a hydrocolloid (gel) format of HemoStyp.
The FDA has commenced its Substantive Review of UHP's PMA application for HemoStyp, a key step towards market approval for surgical use.
The Journal of Wound Care published a peer-reviewed article demonstrating HemoStyp's superior performance over Surgicel in surgical hemostasis.
Filed international patent applications under the Patent Cooperation Treaty for a hydrocolloid (gel) format of HemoStyp.