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United Health Products Achieves OTCQB Listing Amid FDA Regulatory Challenges

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 Achieves OTCQB Listing Amid FDA Regulatory Challenges

United Health Products, Inc. (OTCQB: UEEC) has marked a significant corporate milestone by uplifting its stock to the OTCQB Venture Market, a move that underscores the company's growth trajectory and its efforts to enhance trading liquidity and investor visibility. This transition from the OTC 'Pink' market, effective May 1, 2025, allows the company's shares to continue trading under the ticker symbol 'UEEC'. The OTCQB platform, operated by OTC Markets Group Inc., is renowned for hosting developing companies and is recognized by the SEC as an 'established public market', providing a solid foundation for United Health Products to attract a broader investor base.

Brian Thom, Chief Executive Officer of United Health Products, highlighted the strategic importance of this listing upgrade, emphasizing its role in reinforcing the company's commitment to transparency and corporate governance. The OTCQB listing requires companies to adhere to stringent SEC financial reporting standards and undergo annual verification processes, criteria that United Health Products meets, further validating its operational integrity and financial health.

However, the company faces regulatory challenges with the Food and Drug Administration (FDA) concerning its Investigational Device Exemption (IDE) application for a clinical study of its flagship product, CelluSTAT Hemostatic Gauze. The FDA's decision to decline the IDE application, based on findings from Bioresearch Monitoring (BIMO) audits of the company's 2019 clinical study, presents a hurdle in the product's development pathway. Despite this, United Health Products is actively engaging with the FDA, scheduling a teleconference to address and resolve the cited issues, demonstrating its proactive approach to regulatory compliance and product development.

CelluSTAT Hemostatic Gauze, an all-natural product aimed at controlling mild to moderate bleeding, represents a significant innovation in the medical technology sector. The product's potential access to the human surgical market hinges on the successful navigation of the FDA review process. Meanwhile, the company continues to advance preparatory tasks for its clinical study that do not require immediate IDE approval, maintaining momentum in its product development efforts.

This dual focus on achieving corporate milestones and addressing regulatory challenges illustrates United Health Products' resilience and dedication to advancing medical technology solutions. The OTCQB listing not only enhances the company's market presence but also positions it favorably among investors looking for growth opportunities in the healthcare sector. For more information on the OTCQB Venture Market, visit https://www.otcmarkets.com.

Curated from NewMediaWire

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