Avant Technologies and Partner, Ainnova, Receive FDA Pre-Submission Meeting Date for Company's Vision AI Platform Technology
Avant Technologies (OTCQB: AVAI) and its joint venture partner Ainnova Tech have secured a pre-submission meeting with the FDA scheduled for July 7, 2025. The meeting will discuss their planned clinical trial for the Vision AI platform, designed for early detection of diabetic retinopathy. Through Ai-nova Acquisition Corp. (AAC), formed by the partnership, the companies aim to determine crucial trial parameters including the number of clinical sites, patient count, and protocol approval.
The meeting represents a significant step toward obtaining FDA 510(k) clearance for U.S. market entry. AAC holds worldwide licensing rights for Ainnova's technology portfolio, making successful FDA interactions crucial for commercialization in the United States market.
Avant Technologies (OTCQB: AVAI) e il suo partner in joint venture Ainnova Tech hanno ottenuto un incontro preliminare con la FDA programmato per il 7 luglio 2025. Durante l'incontro verrà discusso il loro piano di studio clinico per la piattaforma Vision AI, progettata per la diagnosi precoce della retinopatia diabetica. Attraverso Ai-nova Acquisition Corp. (AAC), costituita dalla partnership, le aziende intendono definire parametri fondamentali dello studio, come il numero di centri clinici, il numero di pazienti e l'approvazione del protocollo.
L'incontro rappresenta un passo importante verso l'ottenimento della certificazione FDA 510(k) per l'ingresso nel mercato statunitense. AAC detiene i diritti di licenza mondiali sul portafoglio tecnologico di Ainnova, rendendo essenziali interazioni di successo con la FDA per la commercializzazione negli Stati Uniti.
Avant Technologies (OTCQB: AVAI) y su socio en empresa conjunta Ainnova Tech han asegurado una reunión previa a la presentación con la FDA programada para el 7 de julio de 2025. En la reunión se discutirá el ensayo clínico planificado para la plataforma Vision AI, diseñada para la detección temprana de la retinopatía diabética. A través de Ai-nova Acquisition Corp. (AAC), creada por la asociación, las compañías buscan definir parámetros cruciales del ensayo, incluyendo el número de sitios clínicos, la cantidad de pacientes y la aprobación del protocolo.
La reunión representa un paso significativo hacia la obtención de la autorización FDA 510(k) para la entrada al mercado estadounidense. AAC posee los derechos de licencia mundial para el portafolio tecnológico de Ainnova, haciendo que las interacciones exitosas con la FDA sean esenciales para la comercialización en Estados Unidos.
Avant Technologies (OTCQB: AVAI)와 공동 벤처 파트너 Ainnova Tech는 FDA와의 사전 제출 회의를 2025년 7월 7일에 예정하고 있습니다. 이 회의에서는 당뇨병성 망막병증의 조기 발견을 위해 설계된 Vision AI 플랫폼의 임상 시험 계획에 대해 논의할 예정입니다. 파트너십을 통해 설립된 Ai-nova Acquisition Corp. (AAC)을 통해 두 회사는 임상 시험 장소 수, 환자 수, 프로토콜 승인 등 중요한 시험 매개변수를 결정하고자 합니다.
이번 회의는 미국 시장 진입을 위한 FDA 510(k) 승인 획득에 중요한 단계입니다. AAC는 Ainnova의 기술 포트폴리오에 대한 전 세계 라이선스 권리를 보유하고 있어, FDA와의 성공적인 협상이 미국 내 상용화를 위해 매우 중요합니다.
Avant Technologies (OTCQB : AVAI) et son partenaire en coentreprise Ainnova Tech ont obtenu une réunion de pré-soumission avec la FDA prévue pour le 7 juillet 2025. Cette réunion portera sur leur essai clinique prévu pour la plateforme Vision AI, conçue pour la détection précoce de la rétinopathie diabétique. Par le biais d’Ai-nova Acquisition Corp. (AAC), créée par ce partenariat, les entreprises visent à définir des paramètres cruciaux de l’essai, notamment le nombre de sites cliniques, le nombre de patients et l’approbation du protocole.
Cette réunion représente une étape importante vers l’obtention de l'autorisation 510(k) de la FDA pour l’entrée sur le marché américain. AAC détient les droits de licence mondiaux du portefeuille technologique d’Ainnova, rendant les interactions réussies avec la FDA essentielles à la commercialisation aux États-Unis.
Avant Technologies (OTCQB: AVAI) und sein Joint-Venture-Partner Ainnova Tech haben ein Vorab-Meeting mit der FDA für den 7. Juli 2025 vereinbart. In dem Treffen wird die geplante klinische Studie für die Vision AI-Plattform besprochen, die zur Früherkennung der diabetischen Retinopathie entwickelt wurde. Über die gemeinsam gegründete Ai-nova Acquisition Corp. (AAC) wollen die Unternehmen wichtige Studienparameter wie Anzahl der Studienzentren, Patientenzahl und Protokollgenehmigung festlegen.
Das Meeting stellt einen bedeutenden Schritt zur Erlangung der FDA 510(k)-Freigabe für den Markteintritt in den USA dar. AAC hält die weltweiten Lizenzrechte am Technologieportfolio von Ainnova, weshalb erfolgreiche Gespräche mit der FDA für die Kommerzialisierung in den USA entscheidend sind.
- Pre-submission meeting with FDA secured, indicating progress in regulatory pathway
- Company holds worldwide licensing rights for the technology portfolio
- Early FDA engagement could potentially expedite market entry
- FDA clearance not guaranteed and timeline for approval remains uncertain
- Clinical trial costs and timeline yet to be determined
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 are forever grateful for the opportunity to meet with the
"We will use this pre-submission meeting to determine a host of items, including the ideal number of clinical sites, the number of total patients needed, and to learn if the FDA will approve our protocol for the planned clinical trial. These are all crucial for both Avant and Ainnova in determining the exact costs and a timetable."
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 artificial intelligence in healthcare. With a focus on pushing the boundaries of what is possible in AI and machine learning, 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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