United Health Products (OTCPK: UEEC) is moving forward with its regulatory strategy to obtain FDA approval for CelluSTAT, an all-natural hemostatic agent targeting the surgical medical market. The company has made substantial progress in addressing FDA requirements and preparing for its clinical study.
After submitting an Investigational Device Exemption (IDE) application in November, the company engaged in productive discussions with the FDA to resolve preclinical testing protocol concerns. These discussions culminated in a January 28th meeting that successfully addressed key regulatory questions, positioning the company to submit comprehensive responses in early February.
Simultaneously, United Health Products has strategically prepared for its upcoming clinical study. The company has identified multiple surgical sites operated by a large, multi-state healthcare services provider that meet the study's protocol requirements. Ongoing negotiations with the site operator and a Central Institutional Review Board (IRB) are progressing, with an anticipated completion before March 15.
To support its clinical research efforts, the company has successfully raised over $400,000 through private placement transactions with existing shareholders. Additionally, United Health Products is exploring further funding strategies and has applied to uplift its stock listing from the OTCPK to the OTCQB exchange, potentially increasing investor visibility and market accessibility.
The development of CelluSTAT represents a significant advancement in surgical hemostasis technology. As an all-natural product designed to control mild to moderate bleeding, the hemostatic agent could provide surgeons with an innovative solution for managing intraoperative hemorrhage, potentially improving patient outcomes and surgical efficiency.
While the company remains optimistic about its regulatory pathway, it acknowledges the inherent uncertainties in the FDA approval process. The anticipated completion of the clinical study report by mid-summer represents a critical milestone in CelluSTAT's journey toward market introduction.
