
United Health Products (OTCPK: UEEC) has made significant strides in its regulatory process for CelluSTAT, an all-natural hemostatic agent targeting the surgical market. The company recently resolved critical preclinical testing protocol concerns with the FDA and expects to submit comprehensive responses in early February.
Following discussions with the FDA on January 28th, the company has aligned its investigational strategy. UHP has identified surgical sites through a large, multi-state healthcare services provider and is coordinating contract negotiations with the site operator and a Central Institutional Review Board (IRB).
To support its clinical study, the company has successfully raised over $400,000 through private placement transactions with existing shareholders. Additionally, UHP has applied to OTC Markets for an uplisting from the OTCPK to the OTCQB exchange to enhance investor interest.
The company is also developing investigator training materials with a digital media partner. These preparatory activities are anticipated to be completed by March 15, positioning UHP to complete its clinical study report by mid-summer as previously planned.
CelluSTAT represents a potential advancement in surgical bleeding control, offering an all-natural solution for managing mild to moderate bleeding. The product’s development and pending FDA approval could provide surgeons with an innovative hemostatic option.
While the company remains optimistic, it acknowledges uncertainties in the regulatory process. There is no guarantee of FDA approval for the Investigational Device Exemption or the OTC Markets uplisting application.

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