United Health Products Advances FDA Approval Process for Hemostatic Agent
TL;DR
UHP expects to submit additional responses to FDA in early February, advancing its study protocol and potentially gaining a competitive edge.
UHP submitted an IDE to FDA in November, resolving concerns on testing protocols and aiming to complete the clinical study report by mid-summer.
UHP's CelluSTAT aims to control bleeding, seeking FDA approval to access the surgical market, potentially improving patient outcomes.
UHP raised over $400,000 for clinical study, applied for OTCQB uplisting, and developed training materials for investigator, showing proactive progress.
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United Health Products (OTCPK: UEEC) is making significant strides in its regulatory journey for CelluSTAT, an all-natural hemostatic agent designed to control mild to moderate bleeding. The company has successfully addressed preliminary FDA concerns regarding its Investigational Device Exemption (IDE) application and is preparing to submit comprehensive responses to preclinical and clinical comments in early February.
The medical device company has strategically positioned itself for the next phase of development by identifying surgical sites through a large, multi-state healthcare services provider. Concurrent negotiations with a Central IRB and development of investigator training materials are underway, with anticipated completion before March 15. These efforts support the company's goal of completing its clinical study report by mid-summer.
To support its regulatory and research objectives, United Health Products has raised over $400,000 through private placement transactions with existing shareholders. The company is also exploring additional funding strategies and has applied to OTC Markets to uplist its shares from the OTCPK to the OTCQB exchange, potentially increasing investor visibility and market accessibility.
While the company remains focused on advancing its FDA approval process, it acknowledges the inherent uncertainties in regulatory submissions. The potential approval of CelluSTAT could represent a significant milestone for United Health Products in accessing the human surgical market with its innovative hemostatic technology.
Curated from NewMediaWire
