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United Health Products, Inc. (OTCPK: UEEC), based in Cocoa, Florida, specializes in the development, manufacturing, and marketing of innovative medical solutions. At the core of UHP’s product lineup is HemoStyp™, a patented Neutralized Regenerated Cellulose hemostatic agent designed to control bleeding effectively. HemoStyp is an all-natural product, making it a safe choice for various medical applications, including dental, veterinary, and emergency medicine.
UHP has made significant strides in seeking approval to expand into the human surgical market. The company has recently been focused on its FDA Premarket Approval (PMA) application process. This involved comprehensive testing to ensure the product's safety and efficacy. These tests have included assessments of packaging integrity, durability under transport conditions, and various sterilization and bio burden checks. As of March 21, 2024, UHP has officially submitted its PMA application via the FDA's eSTAR portal for review by both the FDA and Health Canada.
Recent updates from UHP indicate that their products have undergone rigorous testing without any non-conforming results. This is a significant milestone, ensuring that all products shipped to customers are sterile and free from any damage or contamination. Despite facing delays due to external service providers, UHP remains committed to seeing through the PMA application process to facilitate broader market access.
For stakeholders and investors, UHP represents a company at the forefront of medical innovation with a robust portfolio and ongoing projects aiming to enhance healthcare outcomes. For further information, UHP can be reached via their new website at www.uhpcorp.com or by contacting them directly at info@uhpcorp.com or via phone/text at 475.755.1005.
United Health Products (OTCPK: UEEC) has provided an update on its FDA Premarket Approval application for HemoStyp, a hemostatic agent. The company has completed its review of Standard Operating Procedures and is waiting for the results of external laboratory tests on samples produced under a new manufacturing agreement. The submission of the full PMA application is anticipated shortly, although approval is not guaranteed. UHP aims to secure access to the human surgical market, building on its existing offerings in dental, veterinary, and emergency medicine.
United Health Products, Inc. (OTCPK: UEEC) has updated its FDA Premarket Approval application for its hemostatic gauze product, confirming collaboration with its contract manufacturing partner on testing. They are on track to submit a revised application by November 22nd, following the completion of required documentation and evaluations. Additionally, the company is expected to disclose its third-quarter financial results on or before November 14th, showing modest commercial revenue generation for the first time since 2019.
United Health Products, Inc. (OTCPK: UEEC) has entered a $10 million common stock purchase agreement with White Lion Capital for a 36-month term. Sales will be based on the prevailing market price at the time. The company will use proceeds for general corporate purposes, including establishing a manufacturing operation for its HemoStyp hemostatic gauze and completing FDA PMA application requirements. Additionally, a settlement agreement has been reached regarding a legal dispute, providing UHP with over $1 million in capital without diluting shareholders.
United Health Products, Inc. (OTCPK: UEEC) has reached a final settlement with the SEC regarding a previous investigation. UHP will pay a civil penalty of $450,000 in four installments over 270 days and is permanently enjoined from violating various sections of the Securities Exchange Act. The company has also settled with former CEO Douglas Beplate, requiring him to make $1,020,000 in disgorgement payments. CEO Brian Thom expressed relief over concluding this four-year process, allowing the company to refocus on business priorities and pursue damages against its former auditor.
United Health Products (OTCPK: UEEC) announced an update regarding its FDA regulatory review process on May 18, 2022. The company submitted a supplemented Premarket Approval (PMA) response for its hemostatic gauze, HemoStyp™, to the FDA on April 20, 2022. UHP has scheduled a meeting with the review committee for July 6, 2022, where it anticipates receiving feedback on its application. However, the outcome of the PMA application remains uncertain, as approval cannot be guaranteed.
United Health Products (OTCPK: UEEC) announced progress in its FDA regulatory review, having submitted a revised Premarket Approval (PMA) application. Completed on April 20, 2022, this application now meets FDA formatting requirements, with no outstanding requests. Additionally, UEEC is supporting Ukraine by donating 10,000 units of its HemoStyp hemostatic gauze, aimed at aiding medical care amidst the ongoing conflict. The company emphasizes its commitment to both regulatory compliance and humanitarian efforts.
United Health Products, Inc. (OTCPK:UEEC) provided a corporate update on June 28, 2021, detailing product development and commercialization activities. In anticipation of FDA approval for its HemoStyp hemostatic agent, UHP is conducting an 80-patient study for laparoscopic procedures. Additionally, the company is refining its HemoStyp gel format and seeking partnerships for a post-dialysis adhesive bandage. To fund these initiatives, UHP entered a $4 million Common Stock Purchase Agreement with Triton Funds, which may enhance market competitiveness. The PMA application is under FDA review, with no assurance of approval.
United Health Products, Inc. (OTCPK: UEEC) has received notification from the FDA that its Pre-market Approval application for HemoStyp gauze has been accepted for Substantive Review. CEO Brian Thom expressed confidence that HemoStyp will enhance patient outcomes in surgical procedures. While the FDA's acceptance signals progress, there is no assurance that the PMA will ultimately be granted. The Company is also exploring potential commercial partnerships and strategic transactions, including a possible sale, although no concrete outcomes are guaranteed.
United Health Products, Inc. (OTC: UEEC) has announced the international publication of its patent application for a hydrocolloid format of its hemostatic agent, HemoStyp, under the Patent Cooperation Treaty. This publication allows UHP up to one year to file specific patents in desired countries as it progresses with gel-related R&D. CEO Brian Thom highlighted the potential to expand HemoStyp's market beyond gauze formats, targeting surgical fields like spinal and vascular procedures. The company emphasizes the significance of establishing a global IP portfolio for maximizing technology value.
United Health Products, Inc. (OTC: UEEC) has appointed John Phillips as Vice President of Marketing & Commercial Strategy, effective December 15, 2020. With over 30 years of experience in product commercialization, he will lead UHP’s global commercial strategies for its patented hemostatic agent, HemoStyp. UHP anticipates receiving its FDA PMA, transitioning to commercialization, and enhancing revenue across priority markets. The company aims to leverage Phillips' industry relationships and expertise to improve patient outcomes and reduce care costs.
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