United Health Products Advances FDA Approval Process for Novel Hemostatic Device
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.
United Health Products (OTCPK: UEEC) has made significant progress in its pursuit of FDA approval for CelluSTAT, a neutralized regenerated cellulose hemostatic agent designed to control surgical bleeding. The company has successfully addressed key FDA concerns regarding preclinical testing protocols and plans to submit additional responses to all preclinical and clinical comments in early February.
The development represents a crucial step forward in bringing a new medical device to the surgical market, where effective bleeding control remains a critical need. UHP has already identified surgical sites through a large, multi-state healthcare services provider for conducting the required clinical studies, with contract negotiations currently underway.
To support these regulatory efforts, UHP has secured over $400,000 through private placement transactions with existing shareholders and is pursuing additional funding. The company has also applied for an uplisting to the OTCQB exchange from its current OTCPK platform, a move that could increase visibility and accessibility for investors.
The company anticipates completing its clinical study report by mid-summer, pending successful execution of its planned timeline. If approved, CelluSTAT could provide surgeons with an all-natural alternative for managing mild to moderate bleeding during surgical procedures. This development could potentially impact surgical outcomes and patient care across multiple medical specialties, though the company notes there is no guarantee of FDA approval.
Curated from NewMediaWire