United Health Products Advances Hemostatic Agent Development with FDA and Market Expansion Strategy
TL;DR
UHP's submission to OTCQB market aims to attract more investors and enhance trading liquidity, potentially giving a competitive advantage.
UHP raised funds for clinical activities, submitted applications to OTC Markets and FDA, and negotiated a Clinical Trial Agreement with a hospital.
UHP's CelluSTAT could revolutionize surgical procedures by controlling bleeding naturally, potentially improving patient outcomes and reducing complications.
UHP's innovative hemostatic agent, CelluSTAT, could transform the medical field with its all-natural approach to controlling bleeding.
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United Health Products has initiated multiple strategic efforts to advance its medical device development and market positioning, focusing on its CelluSTAT hemostatic agent's path to FDA approval and potential market expansion.
The company has submitted an Investigational Device Exemption (IDE) application to the FDA, with recent discussions indicating the agency's request for additional sterilization and biotoxicity tests. These final tests are scheduled for completion by the end of March, which will enable the FDA to conduct its comprehensive review of the application.
In preparation for potential clinical trials, United Health Products has successfully negotiated a Clinical Trial Agreement with a national hospital and surgical center operator. The agreement identifies three facilities within the network prepared to conduct the 27 surgical procedures requested by the FDA, demonstrating significant progress in the device's development pathway.
Simultaneously, the company is pursuing enhanced market visibility by applying for quotation on the OTCQB market through OTC Markets. This strategic move aims to increase potential investor engagement and improve trading liquidity for its securities. OTC Markets has requested additional information, which the company plans to submit by the end of March.
To support its ongoing clinical activities and Premarket Approval process, United Health Products has successfully raised over $500,000 through private placement transactions. The company is confident in its ability to secure sufficient capital through similar private investment mechanisms to complete the remaining clinical study and PMA application.
Despite recent federal workforce reductions potentially impacting regulatory agencies, United Health Products notes that FDA response times remain consistent with historical patterns. The company has observed that FDA employees reviewing new drug and device applications are generally exempt from voluntary resignation programs.
The development of CelluSTAT, an all-natural hemostatic agent designed to control mild to moderate bleeding, represents a potentially significant advancement in surgical medical technology. If successfully approved, the product could provide healthcare professionals with an innovative solution for managing surgical bleeding.
While the company emphasizes that there are no guarantees of FDA approval or OTCQB listing, these strategic initiatives demonstrate a comprehensive approach to bringing its medical device to market and expanding its operational capabilities.
Curated from NewMediaWire
