Avant Technologies and Ainnova Tech Announce Enhanced Patient Recruitment Strategy Ahead of FDA Clinical Trial
Avant Technologies (OTCQB: AVAI) and its joint venture partner Ainnova Tech have announced an enhanced patient recruitment strategy for their upcoming FDA clinical trial of the Vision AI platform, designed for early detection of diabetic retinopathy. The study will be conducted across 8-10 U.S. clinical sites, targeting approximately 1,000 multiethnic patients with diabetes.
The companies will collaborate with Fortrea, a renowned Contract Research Organization specializing in ophthalmology studies. The trial will focus on community clinics and primary care facilities rather than specialized centers to gather real-world data. This strategic approach aims to support the company's FDA 510(k) submission for Vision AI, with Ai-nova Acquisition Corp. (AAC) holding worldwide licensing rights for Ainnova's technology portfolio.
Avant Technologies (OTCQB: AVAI) e il suo partner di joint venture Ainnova Tech hanno annunciato una strategia potenziata di reclutamento dei pazienti per il prossimo trial clinico presso la FDA della piattaforma Vision AI, progettata per la diagnosi precoce della retinopatia diabetica. Lo studio sarà condotto in 8-10 centri clinici negli Stati Uniti, con l'obiettivo di arruolare circa 1.000 pazienti diabetici di diverse etnie.
Le società collaboreranno con Fortrea, una rinomata Contract Research Organization specializzata in studi oftalmologici. La sperimentazione si concentrerà su cliniche comunitarie e strutture di assistenza primaria anziché su centri specialistici, per raccogliere dati dal mondo reale. Questo approccio strategico è volto a supportare la presentazione 510(k) alla FDA per Vision AI, mentre Ai-nova Acquisition Corp. (AAC) detiene i diritti di licenza mondiali sul portafoglio tecnologico di Ainnova.
Avant Technologies (OTCQB: AVAI) y su socio en joint venture Ainnova Tech han anunciado una estrategia mejorada de reclutamiento de pacientes para su próximo ensayo clínico ante la FDA de la plataforma Vision AI, diseñada para la detección temprana de la retinopatía diabética. El estudio se llevará a cabo en 8-10 centros clínicos en EE. UU., con el objetivo de reclutar aproximadamente a 1.000 pacientes diabéticos multietnia.
Las compañías colaborarán con Fortrea, una reconocida Contract Research Organization especializada en estudios oftalmológicos. El ensayo se enfocará en clínicas comunitarias y centros de atención primaria en lugar de centros especializados para recopilar datos del mundo real. Este enfoque estratégico busca respaldar la presentación 510(k) ante la FDA para Vision AI, y Ai-nova Acquisition Corp. (AAC) posee los derechos de licencia mundiales sobre el portafolio tecnológico de Ainnova.
Avant Technologies (OTCQB: AVAI)와 그 합작 파트너 Ainnova Tech는 당뇨성 망막병증의 조기 발견을 위해 설계된 Vision AI 플랫폼의 향후 FDA 임상시험을 위한 환자 모집 전략을 강화했다고 발표했습니다. 이 연구는 미국 내 8~10개 임상 기관에서 진행되며 약 1,000명 규모의 다인종 당뇨 환자를 목표로 합니다.
양사는 안과 연구를 전문으로 하는 유명 계약연구기관인 Fortrea와 협력합니다. 본 임상시험은 전문 센터가 아닌 지역 클리닉 및 1차 진료 기관에 중점을 두어 실제 환경의 데이터를 수집할 예정입니다. 이러한 전략적 접근은 Vision AI의 FDA 510(k) 제출을 지원하기 위한 것이며, Ai-nova Acquisition Corp. (AAC)는 Ainnova의 기술 포트폴리오에 대한 전 세계 라이선스 권리를 보유하고 있습니다.
Avant Technologies (OTCQB: AVAI) et son partenaire en coentreprise Ainnova Tech ont annoncé une stratégie renforcée de recrutement de patients pour leur prochain essai clinique auprès de la FDA de la plateforme Vision AI, conçue pour la détection précoce de la rétinopathie diabétique. L'étude se déroulera dans 8 à 10 sites cliniques aux États-Unis, visant environ 1 000 patients diabétiques multiethniques.
Les sociétés collaboreront avec Fortrea, un CRO réputé spécialisé dans les études en ophtalmologie. L'essai se concentrera sur des cliniques communautaires et des structures de soins primaires plutôt que sur des centres spécialisés afin de collecter des données du monde réel. Cette approche stratégique vise à soutenir le dépôt 510(k) auprès de la FDA pour Vision AI, et Ai-nova Acquisition Corp. (AAC) détient les droits de licence mondiaux du portefeuille technologique d'Ainnova.
Avant Technologies (OTCQB: AVAI) und sein Joint-Venture-Partner Ainnova Tech haben eine verbesserte Patientenrekrutierungsstrategie für ihre bevorstehende FDA-Studie der Plattform Vision AI angekündigt, die zur Früherkennung der diabetischen Retinopathie entwickelt wurde. Die Studie wird an 8–10 klinischen Standorten in den USA durchgeführt und zielt darauf ab, etwa 1.000 multietnische Patienten mit Diabetes einzuschließen.
Die Unternehmen werden mit Fortrea zusammenarbeiten, einer renommierten Contract Research Organization, die auf ophthalmologische Studien spezialisiert ist. Die Studie konzentriert sich auf Gemeindekliniken und Einrichtungen der Primärversorgung statt auf spezialisierte Zentren, um Real-World-Daten zu erheben. Dieser strategische Ansatz soll die 510(k)-Einreichung bei der FDA für Vision AI unterstützen; Ai-nova Acquisition Corp. (AAC) hält die weltweiten Lizenzrechte am Technologieportfolio von Ainnova.
- None.
- FDA 510(k) approval still pending and subject to successful clinical trial results
- Significant resources required to conduct large-scale clinical trial across multiple sites
The planned clinical study, which will be performed in 8-10 clinical sites around the
"We are excited to move forward with an enhanced patient recruitment process," said Vinicio Vargas, Chief Executive Officer at Ainnova and a member of the Board of Directors of Ai-nova Acquisition Corp. (AAC), the company formed by the partnership between Avant and Ainnova to advance and commercialize Ainnova's technology portfolio. "By focusing on community clinics and targeting a multiethnic group of around 1,000 diabetic patients, we aim to ensure that our study accurately represents the diverse population affected by diabetic retinopathy.
"Working with Fortrea, an expert CRO in ophthalmology, allows us to confidently navigate this process with a partner that shares our commitment to quality and efficiency. We are getting closer to initiating a clinical study that will significantly contribute to obtaining FDA 510(k) approval and making our Vision AI platform a crucial tool in early disease detection."
Ainnova's collaboration with Fortrea underscores its commitment to conducting a rigorous and inclusive clinical study. By leveraging Fortrea's deep expertise in ophthalmology and medical device trials, Ainnova is well-positioned to deliver high-quality data to support the regulatory approval process to market Vision AI, a platform poised to transform early disease detection for diabetic patients worldwide, in
AAC has the worldwide licensing rights for Ainnova's technology portfolio. The licensing rights include the
About Ainnova Tech, Inc.
Ainnova is a
About Avant Technologies Inc.
Avant Technologies Inc. is an emerging technology company developing solutions in healthcare using artificial intelligence and biotechnologies. With a focus on pushing the boundaries of what is possible in AI and biotechnology, Avant serves a diverse range of industries, driving progress and efficiency through state-of-the-art technology.
More information about Avant can be found at https://avanttechnologies.com
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