United Health Products Provides Update on FDA PMA Application
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) ha fornito un aggiornamento sulla sua domanda di Approvazione Pre-Mercato (PMA) della FDA per la garza emostatica CelluSTAT. Dopo un incontro del 29 ottobre con la FDA, l'azienda ha discusso i risultati dei suoi studi clinici su 232 pazienti, i quali hanno mostrato non-inferiorità e superiorità per quanto riguarda il tempo necessario per l'emostasi. Nonostante i risultati positivi, la FDA ha richiesto dati aggiuntivi per procedure chirurgiche negli spazi organici intestinali e toracici. L'azienda condurrà uno studio supplementare, che richiederà circa 6-7 mesi per essere completato. Il periodo di revisione di 180 giorni della FDA rimane sospeso fino a quando tutte le carenze non saranno risolte.
United Health Products (OTCPK: UEEC) proporcionó una actualización sobre su solicitud de Aprobación Pre-Mercado (PMA) de la FDA para la gasa hemostática CelluSTAT. Después de una reunión del 29 de octubre con la FDA, la compañía discutió los resultados de sus ensayos clínicos que involucraron a 232 pacientes, los cuales mostraron no-inferioridad y superioridad en el tiempo hasta la hemostasia. A pesar de los resultados positivos, la FDA solicitó datos adicionales para procedimientos quirúrgicos en espacios orgánicos intestinales y torácicos. La compañía llevará a cabo un estudio suplementario, que requerirá aproximadamente de 6 a 7 meses para completarse. El período de revisión de 180 días de la FDA permanece en pausa hasta que se aborden todas las deficiencias.
United Health Products (OTCPK: UEEC)는 CelluSTAT 지혈 거즈에 대한 FDA 사전 시장 승인(PMA) 신청의 업데이트를 제공했습니다. 10월 29일 FDA와의 회의 이후, 회사는 232명의 환자를 대상으로 한 임상 시험 결과를 논의했으며, 이는 지혈까지의 시간을 기준으로 비열등성과 우수성을 나타냈습니다. 긍정적인 결과에도 불구하고, FDA는 장기 및 흉부 장기 공간에서의 수술 절차에 대한 추가 데이터를 요청했습니다. 회사는 보충 연구를 수행할 예정이며, 이 연구는 완료까지 약 6-7개월이 소요될 것입니다. FDA의 180일 검토 기간은 모든 결함이 해결될 때까지 중단된 상태입니다.
United Health Products (OTCPK: UEEC) a fourni une mise à jour sur sa demande d'Approbation Préalable au Marché (PMA) auprès de la FDA concernant le gaz hémostatique CelluSTAT. Suite à une réunion du 29 octobre avec la FDA, l'entreprise a discuté des résultats de ses essais cliniques impliquant 232 patients, qui ont montré une non-infériorité et une supériorité en ce qui concerne le temps jusqu'à l'hémostase. Malgré des résultats positifs, la FDA a demandé des données supplémentaires pour les procédures chirurgicales dans les espaces organiques intestinaux et thoraciques. L'entreprise mènera une étude complémentaire, qui nécessitera environ 6 à 7 mois pour être complétée. La période de révision de 180 jours de la FDA reste suspendue jusqu'à ce que toutes les carences soient résolues.
United Health Products (OTCPK: UEEC) hat ein Update zu seinem Antrag auf Vorabgenehmigung (PMA) der FDA für die hämostatische Gaze CelluSTAT bereitgestellt. Nach einem Treffen am 29. Oktober mit der FDA diskutierte das Unternehmen die Ergebnisse seiner klinischen Studien mit 232 Patienten, die Nichtunterlegenheit und Überlegenheit hinsichtlich der Zeit bis zur Hämostase zeigten. Trotz der positiven Ergebnisse verlangte die FDA zusätzliche Daten zu chirurgischen Eingriffen in den intestinalen und thorakalen Organen. Das Unternehmen wird eine ergänzende Studie durchführen, die ungefähr 6-7 Monate in Anspruch nehmen wird. Der 180-tägige Prüfungszeitraum der FDA bleibt bis zur Behebung aller Mängel ausgesetzt.
- Clinical trial demonstrated both non-inferiority and superiority for time to hemostasis
- No adverse events were attributed to the hemostatic gauze product
- FDA confirmed resolution of concerns regarding vascular graft procedures
- Clear path established for addressing remaining PMA deficiencies
- FDA requires additional clinical data, extending approval timeline by 6-7 months
- PMA review process remains paused until all deficiencies are addressed
- Additional costs required for supplemental study and testing
MOUNT LAUREL, N.J., Nov. 04, 2024 (GLOBE NEWSWIRE) -- United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval (PMA) application process.
Following the company’s August 15, 2024 submission of its Submission Issue Request (SIR) to the FDA which responded to certain questions in the FDA’s June 18 letter and described the company’s approach to addressing certain FDA-identified deficiencies in its PMA application, the company held a videoconference with the FDA on October 29. The purpose of the meeting was to present, discuss and seek feedback from the FDA on the company’s proposed resolutions to the deficiencies. Topics discussed include the company’s clinical testing (including the results of its human trial), biocompatibility, product sterilization and shelf life. This meeting has provided the company with certainty on how to address the deficiencies, with many of the issues already having been resolved.
During the discussion, the company noted the results of its clinical trial involving 232 patients (of whom 118 were treated with its hemostatic gauze) that showed both non-inferiority and superiority for time to hemostasis using CelluSTAT (fka HemoStyp) relative to the standard of care and showed no evidence of heterogeneity of results across procedure categories, surgeons, or clinical sites, indicating both poolability and generalizability of study results. UHP also noted that none of the adverse events that occurred during the study were attributed to its hemostatic gauze product.
Notwithstanding the statistical conclusions of the clinical trial results, the FDA would like to see more data to confirm the safety and effectiveness of CelluSTAT in surgical procedures in the intestinal and thoracic organ space, where organ movement can impact the postoperative stability of a hemostat and where observation of postoperative rebleeding is more difficult. To address this concern, UHP has proposed to enroll a limited number of human subjects in a multi-site study as an extension of the original pivotal study, with patients undergoing surgical procedures within the organ space. Separately, the FDA confirmed that its earlier stated concern regarding use of CelluSTAT in vascular graft procedures had been adequately addressed.
UHP’s Chief Executive, Brian Thom, commented: “While we are pleased to confirm the path to resolving the list of deficiencies in our PMA application, we are disappointed that the strong results of our pivotal study and low incidence of adverse events were not sufficient to address the FDA’s specific concern regarding organ space applications of our device. The company will devote its resources to completing these additional surgical procedures efficiently and is confident that the results will reinforce the results of the existing study.”
The supplemental study process will consist of submitting an Investigational Device Exemption (IDE) for FDA approval, recruiting a contract research organization to assist in data collection and monitoring, evaluating and selecting 3-5 suitable sites for the surgical procedures, patient enrollment and follow up, and data processing and analysis. The company anticipates that this process will take approximately 6-7 months to complete. During this period, UHP expects to complete certain additional biocompatibility and sterility testing that was agreed to with the FDA to address other remaining deficiencies. The FDA’s 180-day application review period, of which approximately 90 days have elapsed, remains paused until the company submits responses to all deficiencies.
Brian Thom commented further: “Much progress has been made since submitting our PMA application in March. The FDA, through its Bioresearch Monitoring program (BIMO) has conducted two site inspections to review our pivotal study procedures and data integrity. And last week’s SIR meeting provided clarity on the limited list of tasks that remain. While we would have preferred to conduct any additional surgical testing under a post-approval study protocol, we respect the FDA’s concerns over patient safety and acknowledge the risks associated with hemostatic products such as ours. While a PMA cannot be assured, we have never been more optimistic regarding the outcome of this application process.”
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.
FAQ
What were the results of UEEC's clinical trial for CelluSTAT?
Why did the FDA request additional data from UEEC in November 2024?
How long will UEEC's supplemental study take to complete?
