NanoVibronix Announces Completion of Pilot Phase of Clinical Study of UroShield® at the University of Michigan
NanoVibronix (NASDAQ: NAOV) has successfully completed the pilot phase of a Randomized Control Trial study for UroShield® at the University of Michigan. The study, primarily conducted with nursing home residents, focused on evaluating UroShield's impact on reducing urinary tract infections, catheter blockages, and pain associated with long-term urinary catheter use.
The completed pilot phase served as a validation step before advancing to the full study, which is expected to commence in 2025. The research team has achieved their initial goals, including refining recruitment strategies and developing data collection tools. This research complements previous studies and product launches in the UK, Australia, and New Zealand, as well as the recent introduction to the European market. The company is simultaneously preparing for a U.S. launch, pending FDA 510K clearance.
NanoVibronix (NASDAQ: NAOV) ha completato con successo la fase pilota di uno studio clinico randomizzato per UroShield® presso l'Università del Michigan. Lo studio, condotto principalmente con residenti in case di riposo, si è concentrato sulla valutazione dell'impatto di UroShield sulla riduzione delle infezioni del tratto urinario, delle ostruzioni dei cateteri e del dolore associato all'uso di cateteri urinari a lungo termine.
La fase pilota completata ha servito come passo di validazione prima di passare allo studio completo, che dovrebbe iniziare nel 2025. Il team di ricerca ha raggiunto i suoi obiettivi iniziali, inclusa la perfezione delle strategie di reclutamento e lo sviluppo di strumenti per la raccolta dei dati. Questa ricerca si aggiunge a studi precedenti e lanci di prodotto nel Regno Unito, in Australia e in Nuova Zelanda, oltre all'introduzione recente nel mercato europeo. Nel contempo, l'azienda si sta preparando per un lancio negli Stati Uniti, in attesa dell'approvazione FDA 510K.
NanoVibronix (NASDAQ: NAOV) ha completado con éxito la fase piloto de un estudio controlado aleatorio para UroShield® en la Universidad de Michigan. El estudio, realizado principalmente con residentes de hogares de ancianos, se centró en evaluar el impacto de UroShield en la reducción de infecciones del tracto urinario, bloqueos de catéter y el dolor asociado con el uso de catéteres urinarios a largo plazo.
La fase piloto completada sirvió como un paso de validación antes de avanzar al estudio completo, que se espera que comience en 2025. El equipo de investigación ha alcanzado sus objetivos iniciales, incluyendo la refinación de estrategias de reclutamiento y el desarrollo de herramientas de recolección de datos. Esta investigación complementa estudios previos y lanzamientos de productos en el Reino Unido, Australia y Nueva Zelanda, así como la reciente introducción en el mercado europeo. La empresa también se está preparando para un lanzamiento en EE. UU., a la espera de la autorización 510K de la FDA.
NanoVibronix (NASDAQ: NAOV)는 미시간 대학교에서 UroShield®를 위한 무작위 대조 시험 연구의 파일럿 단계를 성공적으로 완료했습니다. 이 연구는 주로 요양원 거주자를 대상으로 하여 UroShield가 요로 감염, 카테터 막힘, 그리고 장기 카테터 사용과 관련된 통증을 줄이는 데 미치는 영향을 평가하는 데 중점을 두었습니다.
완료된 파일럿 단계는 전체 연구로 진행하기 전의 검증 단계로 작용했으며, 전체 연구는 2025년에 시작될 것으로 예상됩니다. 연구팀은 모집 전략을 다듬고 데이터 수집 도구를 개발하는 등 초기 목표를 달성했습니다. 이 연구는 영국, 호주, 뉴질랜드에서의 이전 연구 및 제품 출시를 보완하며, 최근 유럽 시장에의 도입과도 연관됩니다. 회사는 동시에 FDA 510K 승인 대기 중인 미국 출시 준비도 하고 있습니다.
NanoVibronix (NASDAQ: NAOV) a réussi à compléter la phase pilote d'une étude de contrôle randomisé pour UroShield® à l'Université du Michigan. L'étude, principalement réalisée auprès de résidents de maisons de retraite, a permis d'évaluer l'impact d'UroShield sur la réduction des infections des voies urinaires, des obstructions de cathéter et de la douleur liée à l'utilisation prolongée de cathéters urinaires.
La phase pilote achevée a servi de étape de validation avant de passer à l'étude complète, qui devrait commencer en 2025. L'équipe de recherche a atteint ses objectifs initiaux, notamment l'affinement des stratégies de recrutement et le développement d'outils de collecte de données. Cette recherche complète des études précédentes et des lancements de produits au Royaume-Uni, en Australie et en Nouvelle-Zélande, de même que l'introduction récente sur le marché européen. L'entreprise se prépare également à un lancement aux États-Unis, en attente de l'approbation 510K de la FDA.
NanoVibronix (NASDAQ: NAOV) hat erfolgreich die Pilotphase einer randomisierten kontrollierten Studie für UroShield® an der Universität von Michigan abgeschlossen. Die Studie, die hauptsächlich mit Bewohnern von Altenheimen durchgeführt wurde, konzentrierte sich darauf, die Auswirkungen von UroShield auf die Reduzierung von Harnwegsinfektionen, Katheterverstopfungen und Schmerzen im Zusammenhang mit der langfristigen Verwendung von Harnkathetern zu bewerten.
Die abgeschlossene Pilotphase diente als Validierungsschritt, bevor zur vollständigen Studie übergegangen wird, die voraussichtlich im 2025 beginnen soll. Das Forschungsteam hat seine anfänglichen Ziele erreicht, einschließlich der Verfeinerung von Rekrutierungsstrategien und der Entwicklung von Datensammlungstools. Diese Forschung ergänzt frühere Studien und Produkteinführungen im Vereinigten Königreich, Australien und Neuseeland sowie die kürzliche Einführung auf dem europäischen Markt. Gleichzeitig bereitet sich das Unternehmen auf einen Markteintritt in den USA vor, der von der FDA mit der 510K-Zulassung abhängig ist.
- Successful completion of UroShield® pilot study at University of Michigan
- Expansion of market presence with recent European market entry
- Established presence in UK, Australia, and New Zealand markets
- Progress toward potential US market entry pending FDA 510K clearance
- Full study not commencing until 2025
- Still awaiting FDA 510K clearance for US market entry
Insights
Research expected to advance to ‘Full Study’ phase in 2025
This first phase of the trial is a precursor to the full study by researchers at UM. It was conducted primarily with nursing home residents and was aimed at studying the impact of UroShield® on improving patient’s quality of life by its potential to reduce urinary tract infections, catheter blockages and pain caused by the long-term use of urinary catheters.
Brian Murphy, Chief Executive Officer of the Company, commented, “The first phase of the study served as a validation pilot in advance of a full study. With this phase now complete, researchers at UM can advance to the next phase, a full Randomized Control Trial of additional patients. We expect the full trial to commence in 2025.”
Mr. Murphy continued, “The validation our products continue to receive from independent research and the progress we are making towards further commercializing UroShield is highly encouraging. This research builds on previously concluded studies and product launches in the
Dr. Lona Mody, Professor of Internal Medicine at the University of
About NanoVibronix, Inc.
NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device company headquartered in
Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with: (i) market acceptance of our existing and new products or lengthy product delays in key markets; (ii) negative or unreliable clinical trial results; (iii) inability to secure regulatory approvals for the sale of our products; (iv) intense competition in the medical device industry from much larger, multinational companies; (v) product liability claims; (vi) product malfunctions; (vii) our limited manufacturing capabilities and reliance on subcontractor assistance; (viii) insufficient or inadequate reimbursements by governmental and/or other third party payers for our products; (ix) our ability to successfully obtain and maintain intellectual property protection covering our products; (x) legislative or regulatory reform impacting the healthcare system in the
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Investor Contact:
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brett@haydenir.com
(646) 536-7331
Source: NanoVibronix, Inc.
FAQ
When will the full UroShield® clinical trial begin at University of Michigan for NAOV?
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What was the primary focus of NAOV's UroShield® pilot study?
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