Welcome to our dedicated page for United Health Pr news (Ticker: UEEC), a resource for investors and traders seeking the latest updates and insights on United Health Pr stock.
United Health Products, Inc. (UEEC) is a medical device company that develops, manufactures and markets hemostatic gauze products based on a patented Neutralized Regenerated Cellulose technology. Its news flow is heavily focused on regulatory milestones, clinical data and financing developments related to its CelluSTAT (formerly HemoStyp) hemostatic gauze.
On this page, readers can follow company press releases that detail United Health Products’ FDA Premarket Approval (PMA) application process, including submissions via the FDA’s eSTAR platform, responses to FDA deficiencies letters and interactions with regulators such as videoconferences and Submission Issue Requests. Updates also cover required testing on manufacturing consistency, packaging integrity, radiation sterilization, product stability and bioburden levels for its Class III medical device candidate.
News items highlight clinical trial results for CelluSTAT, including pivotal study outcomes on time to hemostasis versus standard of care, and describe the design and objectives of planned supplemental clinical studies in specific surgical settings. The company’s communications also address its efforts to secure external funding to support clinical work and regulatory tasks, as well as capital markets activities such as securities purchase agreements, convertible notes, purchase warrants and any market purchase arrangements.
Investors and observers can use this news feed to track how United Health Products advances its Neutralized Regenerated Cellulose hemostatic products in dental, veterinary, emergency medicine and potential human surgical markets, and to monitor statements about board composition, potential uplisting plans and investor relations initiatives. Bookmark this page for an organized view of UEEC press releases and related company announcements.
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.
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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.