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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 submitted an Investigational Device Exemption (IDE) application to the FDA for its CelluSTAT Hemostatic Gauze product. The planned clinical trial will involve approximately 30 subjects across 3-5 surgical facilities to test non-inferiority and superiority versus standard care in abdominal surgeries. The company has selected a CRO partner and is evaluating surgical sites. UHP needs external funding to complete the clinical study and FDA requirements. The company plans several corporate initiatives including board expansion, investor relations enhancement, and potential uplisting from OTCPK, targeted for Q1 2025.
United Health Products (OTCPK: UEEC) provided an update on its FDA Premarket Approval (PMA) application for CelluSTAT hemostatic gauze. Following an October 29 meeting with the FDA, the company discussed its clinical trial results involving 232 patients, which showed non-inferiority and superiority for time to hemostasis. Despite positive results, the FDA requested additional data for surgical procedures in intestinal and thoracic organ spaces. The company will conduct a supplemental study, requiring approximately 6-7 months to complete. The FDA's 180-day review period remains paused until all deficiencies are addressed.
United Health Products (OTCPK: UEEC) has provided an update on its FDA Premarket Approval (PMA) application process. The company submitted a Submission Issue Request to the FDA on August 15, responding to questions and outlining its approach to address deficiencies identified in the FDA's June 18 'Deficiencies Letter'. UHP has requested a video conference with the FDA PMA application review team, expected to take place in early September. The FDA's 180-day review period, currently at about 90 days, remains paused during this engagement. CEO Brian Thom expressed anticipation for an interactive discussion with the FDA to clarify necessary actions for a final determination on the PMA application. However, there is no guarantee of approval for the company's PMA application.
United Health Products, Inc. (OTCPK: UEEC) updated investors on its FDA Premarket Approval (PMA) application for the HemoStyp gauze product. The company reported anomalies in pH levels and moisture content during laboratory testing of batches, attributed to unintended oxidation by an external supplier. UHP is conducting a second round of tests in a more controlled environment and has produced new batch lots for further testing, anticipating completion by June 2023. The company cautioned that approval of the PMA application is not guaranteed.
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