Avant Technologies and JV Partner, Ainnova, Complete Pivotal Meeting with U.S. FDA
Avant Technologies (OTCQB: AVAI) and its joint venture partner Ainnova Tech have completed a crucial pre-submission meeting with the FDA regarding their Vision AI platform for early detection of diabetic retinopathy. The meeting provided essential guidance for their upcoming U.S. clinical trial, including protocol requirements and necessary resources.
Through their joint venture company Ai-nova Acquisition Corp. (AAC), which holds worldwide licensing rights to Ainnova's technology portfolio, the companies are preparing to conduct data collection across U.S. primary care clinics. The study will compare their AI-based retinal screening against readings from three retinologists. The trial's success is crucial for obtaining FDA 510(k) clearance to market the technology in the United States.
Avant Technologies (OTCQB: AVAI) e il suo partner in joint venture Ainnova Tech hanno completato un incontro preliminare fondamentale con la FDA riguardo alla loro piattaforma Vision AI per la diagnosi precoce della retinopatia diabetica. L'incontro ha fornito indicazioni essenziali per il prossimo studio clinico negli Stati Uniti, inclusi i requisiti del protocollo e le risorse necessarie.
Attraverso la loro società in joint venture Ai-nova Acquisition Corp. (AAC), che detiene i diritti di licenza mondiali sul portafoglio tecnologico di Ainnova, le aziende si stanno preparando a raccogliere dati in cliniche di medicina primaria negli USA. Lo studio confronterà lo screening retinico basato su AI con le valutazioni di tre retinologi. Il successo della sperimentazione è fondamentale per ottenere l'autorizzazione FDA 510(k) per commercializzare la tecnologia negli Stati Uniti.
Avant Technologies (OTCQB: AVAI) y su socio en empresa conjunta Ainnova Tech han completado una reunión previa crucial con la FDA sobre su plataforma Vision AI para la detección temprana de la retinopatía diabética. La reunión proporcionó orientaciones esenciales para su próximo ensayo clínico en EE. UU., incluyendo los requisitos del protocolo y los recursos necesarios.
A través de su empresa conjunta Ai-nova Acquisition Corp. (AAC), que posee los derechos de licencia mundial del portafolio tecnológico de Ainnova, las compañías se están preparando para recopilar datos en clínicas de atención primaria en EE. UU. El estudio comparará el cribado retiniano basado en IA con las lecturas de tres retinólogos. El éxito del ensayo es crucial para obtener la autorización FDA 510(k) para comercializar la tecnología en Estados Unidos.
Avant Technologies(OTCQB: AVAI)와 합작 파트너 Ainnova Tech는 당뇨병성 망막병증 조기 발견을 위한 Vision AI 플랫폼과 관련하여 FDA와 중요한 사전 제출 회의를 마쳤습니다. 이번 회의에서는 미국 임상 시험을 위한 프로토콜 요구사항과 필요한 자원 등 필수 지침이 제공되었습니다.
합작회사인 Ai-nova Acquisition Corp.(AAC)를 통해, Ainnova의 기술 포트폴리오에 대한 전 세계 라이선스 권리를 보유한 이들 회사는 미국 1차 진료 클리닉에서 데이터 수집을 준비 중입니다. 연구는 AI 기반 망막 스크리닝 결과를 세 명의 망막 전문의 판독과 비교할 예정입니다. 이 임상 시험의 성공은 미국 내 기술 마케팅을 위한 FDA 510(k) 승인 획득에 매우 중요합니다.
Avant Technologies (OTCQB : AVAI) et son partenaire en coentreprise Ainnova Tech ont achevé une réunion préliminaire cruciale avec la FDA concernant leur plateforme Vision AI pour la détection précoce de la rétinopathie diabétique. Cette réunion a fourni des orientations essentielles pour leur prochain essai clinique aux États-Unis, notamment les exigences du protocole et les ressources nécessaires.
Par l’intermédiaire de leur société en coentreprise Ai-nova Acquisition Corp. (AAC), qui détient les droits de licence mondiaux sur le portefeuille technologique d’Ainnova, les entreprises se préparent à collecter des données dans des cliniques de soins primaires aux États-Unis. L’étude comparera leur dépistage rétinien basé sur l’IA aux lectures de trois rétinologues. Le succès de cet essai est crucial pour obtenir l’autorisation FDA 510(k) afin de commercialiser la technologie aux États-Unis.
Avant Technologies (OTCQB: AVAI) und ihr Joint-Venture-Partner Ainnova Tech haben ein wichtiges Vorab-Meeting mit der FDA bezüglich ihrer Vision AI-Plattform zur Früherkennung der diabetischen Retinopathie abgeschlossen. Das Treffen lieferte wesentliche Leitlinien für die bevorstehende klinische Studie in den USA, einschließlich Protokollanforderungen und notwendiger Ressourcen.
Über ihr Joint-Venture-Unternehmen Ai-nova Acquisition Corp. (AAC), das die weltweiten Lizenzrechte am Technologieportfolio von Ainnova hält, bereiten die Unternehmen die Datenerhebung in US-amerikanischen Primärversorgungszentren vor. Die Studie wird das KI-basierte retinalen Screening mit den Auswertungen von drei Retinologen vergleichen. Der Erfolg der Studie ist entscheidend für die Erlangung der FDA 510(k)-Zulassung zur Vermarktung der Technologie in den USA.
- FDA provided clear guidance for clinical trial requirements and protocol
- Company holds worldwide licensing rights for the technology portfolio
- Planned automated retinal camera development could revolutionize diabetic screening accessibility
- Successful FDA clearance would unlock significant U.S. market potential
- Clinical trial costs and timeline yet to be determined
- FDA 510(k) clearance still pending and subject to successful trial completion
Ainnova's clinical trial will be conducted exclusively in
With the FDA's recommendations, the Company can now actively plan for the total cost of conducting this planned clinical trial through to completion. Data from Ainnova's trial will support the Company's FDA 510(k) submission to obtain clearance from the FDA to market the Vision AI technology in
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, said, "We're truly excited about this next phase. We're getting ready to begin data collection across primary care clinics in the
"This milestone not only brings us closer to validating our platform in the world's largest healthcare market, but it also paves the way for the upcoming approval of our new automated retinal camera, which we believe will be a game changer - making diabetic retinal screenings faster, more accessible, and available from virtually any point of care."
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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