MT. LAUREL, N.J., Dec. 02, 2024 (GLOBE NEWSWIRE) -- United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s planned clinical study.
As previously disclosed, United Health Products is conducting a clinical trial of its CelluSTAT Hemostatic Gauze product (formerly branded as HemoStyp) in response to the FDA’s request for additional clinical data. On November 29th, the company submitted to the FDA an Investigational Device Exemption application (IDE), the approval of which is a precondition to enroll patients in the planned study. The IDE contains, among other elements, a proposed study protocol for the testing of approximately 30 subjects across 3-5 surgical facilities, with the objectives of confirming non-inferiority and superiority, as well as safety, of CelluSTAT versus the standard of care in open surgical procedures in the abdominal space. The FDA generally seeks to respond to IDE applications within 30 days, subject to availability of resources.
Concurrently with the preparation of its IDE, UHP has solicited and reviewed proposals from several contract research organizations to partner with the company and provide clinical study project management, site monitoring, safety oversight and data management services, in order to ensure strict compliance with Good Clinical Practice. Following the review and negotiation, a CRO partner has been selected. In addition, the company has engaged with surgical center operators to identify and evaluate suitable sites at which to conduct the clinical study. During the FDA’s review period, UHP will finalize surgical site evaluations, prepare training materials for site investigators, and engage a Central IRB to oversee the study process, with the objective of commencing enrollment of study subjects as soon as possible following FDA approval of its IDE.
The design, execution and analysis of the clinical study, along with the completion of remaining tasks to fully address the FDA deficiencies letter, will require UHP to secure external funding. The company is in discussions with several potential capital providers, including certain longtime investors in UHP, to raise the necessary funds. UHP will seek to negotiate investment terms of a private placement that minimize dilution to existing shareholders. The company does not currently anticipate drawing upon its existing stock purchase agreement with White Lion Capital.
Separate from PMA application activities, the company acknowledges the historically low market price of its common shares and the difficulties faced by certain investors to achieve liquidity in their shareholdings. UHP has identified several actions that it believes may address these market conditions including i) the expansion of its Board of Directors and establishment of a qualified Audit Committee, ii) the retention of an outside investors relations firm that can assist the company’s efforts to reach a broader investor universe, and iii) seeking an uplisting from the current OTCPK exchange to a more established trading platform such as OTCQB or similar exchange. Subject to raising the necessary capital, UHP anticipates completing these initiatives during the first quarter of 2025.
UHP will issue press releases on a regular basis going forward to provide progress reports on the clinical study process and results, as well as the above corporate actions. There can be no assurance that the PMA application will be approved.
About United Health Products
UHP has developed and patented a Neutralized Regenerated Cellulose hemostatic agent. CelluSTAT is an all-natural product designed to control mild to moderate bleeding. UHP is seeking approval to access the human surgical market.
For more information on UHP visit the company’s new website: www.uhpcorp.com or contact the company at info@uhpcorp.com.
The company can also be reached by phone or text message at 475.755.1005.
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