United Health Products Faces FDA Hurdle in Medical Device Approval Process
TL;DR
UHP's uplisting to OTCQB market enhances visibility and liquidity, attracting more investors for potential gains.
UHP's common shares move from OTC 'Pink' to OTCQB to improve transparency, liquidity, and investor reach.
UHP's Hemostatic Gauze approval aims to control bleeding, advancing medical technology for better surgical outcomes.
FDA's regulatory update affects UHP's clinical study progress, highlighting ongoing efforts for innovative medical solutions.
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United Health Products (UEEC) has been approved for uplisting to the OTCQB Venture Market, a significant milestone for the medical technology company, while simultaneously confronting challenges in its FDA premarket approval process for its CelluSTAT Hemostatic Gauze.
The company's transition to the OTCQB platform represents an opportunity to enhance investor visibility and improve stock liquidity. CEO Brian Thom characterized the uplisting as reflecting the company's commitment to corporate transparency and expanding its investor base.
However, the FDA has declined to approve the company's Investigational Device Exemption (IDE) application for a follow-on clinical study. The regulatory agency cited findings from Bioresearch Monitoring audits of UHP's 2019 clinical study, despite not identifying specific design deficiencies in the proposed research protocol.
UHP is proactively scheduling a teleconference with FDA representatives within the next ten days, hoping to resolve the outstanding issues and secure IDE approval. In the interim, the company continues to advance preparatory clinical study tasks that do not require immediate FDA clearance.
The development underscores the complex regulatory landscape medical technology companies navigate when seeking market approval for innovative healthcare products. While the OTCQB uplisting provides financial market advantages, the FDA's current stance represents a potential temporary setback in UHP's strategic development of its hemostatic gauze product.
Curated from NewMediaWire
