United Health Products Provides Update on Clinical Study Process
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) ha presentato un Richiesta di Esenzione per Dispositivo Sperimentale (IDE) alla FDA per il suo prodotto CelluSTAT Emostatico Gauze. Il trial clinico previsto coinvolgerà circa 30 soggetti in 3-5 strutture chirurgiche per testare la non inferiorità e la superiorità rispetto alle cure standard nelle chirurgie addominali. L'azienda ha selezionato un partner CRO e sta valutando i siti chirurgici. UHP ha bisogno di finanziamenti esterni per completare lo studio clinico e i requisiti FDA. L'azienda prevede diverse iniziative aziendali tra cui l'espansione del consiglio, il potenziamento delle relazioni con gli investitori e un possibile passaggio da OTCPK, previsto per il primo trimestre del 2025.
United Health Products (OTCPK: UEEC) ha presentado una Solicitud de Exención de Dispositivo Investigacional (IDE) a la FDA para su producto CelluSTAT Gasa Hemostática. El ensayo clínico planificado involucrará aproximadamente 30 sujetos en 3-5 instalaciones quirúrgicas para probar la no inferioridad y superioridad en comparación con la atención estándar en cirugías abdominales. La empresa ha seleccionado un socio CRO y está evaluando los sitios quirúrgicos. UHP necesita financiamiento externo para completar el estudio clínico y los requisitos de la FDA. La empresa tiene previsto varias iniciativas corporativas, incluida la expansión de la junta, la mejora de las relaciones con los inversores y una posible cotización en OTCPK, programada para el primer trimestre de 2025.
United Health Products (OTCPK: UEEC)는 CelluSTAT 지혈 거즈 제품에 대해 FDA에 임상 시험 면제 신청서 (IDE)를 제출했습니다. 계획된 임상 시험은 약 30명의 피험자를 3-5개의 수술 시설에서 모집하여 복부 수술에서 표준 치료와의 비열등성 및 우수성을 시험할 것입니다. 회사는 CRO 파트너를 선택하고 수술 사이트를 평가하고 있습니다. UHP는 임상 연구와 FDA 요건을 완료하기 위해 외부 자금이 필요합니다. 회사는 이사회 확장, 투자자 관계 강화 및 OTCPK에서의 잠재적 상장 등 여러 기업 이니셔티브를 계획하고 있으며, 이는 2025년 1분기로 설정되어 있습니다.
United Health Products (OTCPK: UEEC) a soumis une Demande d'Exemption pour Dispositif d'Investigations (IDE) à la FDA pour son produit CelluSTAT Gaze Hémostatique. L'essai clinique prévu impliquera environ 30 sujets dans 3-5 établissements chirurgicaux pour tester la non-infériorité et la supériorité par rapport aux soins standards en chirurgie abdominale. L'entreprise a choisi un partenaire CRO et évalue les sites chirurgicaux. UHP a besoin de financements externes pour compléter l'étude clinique et les exigences de la FDA. L'entreprise prévoit plusieurs initiatives d'entreprise, notamment l'extension du conseil d'administration, l'amélioration des relations avec les investisseurs, et une possible cotation sur OTCPK, prévue pour le premier trimestre 2025.
United Health Products (OTCPK: UEEC) hat einen Antrag auf Erlaubnis für ein Prüfgerät (IDE) bei der FDA für sein CelluSTAT Hämostatik-Gaze-Produkt eingereicht. Die geplante klinische Studie wird etwa 30 Probanden in 3-5 chirurgischen Einrichtungen umfassen, um die Nichtunterlegenheit und Überlegenheit im Vergleich zur Standardbehandlung bei Bauchoperationen zu testen. Das Unternehmen hat einen CRO-Partner ausgewählt und bewertet chirurgische Standorte. UHP benötigt externe Finanzierung, um die klinische Studie und die Anforderungen der FDA abzuschließen. Das Unternehmen plant mehrere Unternehmensinitiativen, darunter die Erweiterung des Vorstands, die Verbesserung der Beziehungen zu Investoren und eine potenzielle Listung von OTCPK, die für das erste Quartal 2025 angestrebt wird.
- IDE application submitted to FDA for CelluSTAT clinical trial
- CRO partner selected for clinical study management
- Plans for potential uplisting from OTCPK to OTCQB
- External funding required to complete clinical study
- Potential shareholder dilution from upcoming private placement
- Currently experiencing low market price and liquidity issues
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.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.
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