Avant Technologies and Ainnova Begin Designing Clinical Trial Protocol for Company's Vision AI Platform
Avant Technologies (OTCQB: AVAI) and its partner Ainnova Tech have initiated the design of clinical trial protocols for their Vision AI platform, focusing on early detection of diabetic retinopathy. The companies are preparing for a pre-submission meeting with the FDA scheduled for mid-May 2025, which will guide the clinical testing requirements for their 510(k) clearance application.
An ophthalmologist has been hired to assist in drafting the trial protocol requirements requested by their Contract Research Organization (CRO), Fortrea. The technology is being developed through Ai-nova Acquisition Corp. (AAC), a joint venture holding global licensing rights to Ainnova's technology portfolio, including the Vision AI platform and retinal cameras.
The FDA pre-submission program will help determine the regulatory pathway, including patient and clinic requirements for clinical data generation, and enable Avant to establish a precise budget for the FDA process.
Avant Technologies (OTCQB: AVAI) e il suo partner Ainnova Tech hanno avviato la progettazione dei protocolli per le sperimentazioni cliniche della loro piattaforma Vision AI, concentrandosi sulla diagnosi precoce della retinopatia diabetica. Le aziende si stanno preparando per un incontro pre-sottomissione con la FDA previsto per metà maggio 2025, che guiderà i requisiti per i test clinici necessari per la loro domanda di autorizzazione 510(k).
È stato assunto un oftalmologo per assistere nella redazione dei requisiti del protocollo di prova richiesti dalla loro Organizzazione di Ricerca Contrattuale (CRO), Fortrea. La tecnologia è in fase di sviluppo tramite Ai-nova Acquisition Corp. (AAC), una joint venture che detiene i diritti di licenza globali sul portafoglio tecnologico di Ainnova, inclusa la piattaforma Vision AI e le fotocamere retiniche.
Il programma di pre-sottomissione della FDA aiuterà a determinare il percorso normativo, inclusi i requisiti per pazienti e cliniche per la generazione di dati clinici, e consentirà ad Avant di stabilire un budget preciso per il processo FDA.
Avant Technologies (OTCQB: AVAI) y su socio Ainnova Tech han iniciado el diseño de los protocolos de ensayos clínicos para su plataforma Vision AI, centrándose en la detección temprana de la retinopatía diabética. Las empresas se están preparando para una reunión de pre-sumisión con la FDA programada para mediados de mayo de 2025, que guiará los requisitos de pruebas clínicas para su solicitud de autorización 510(k).
Se ha contratado a un oftalmólogo para ayudar en la redacción de los requisitos del protocolo del ensayo solicitados por su Organización de Investigación por Contrato (CRO), Fortrea. La tecnología se está desarrollando a través de Ai-nova Acquisition Corp. (AAC), una empresa conjunta que posee los derechos de licencia global sobre el portafolio tecnológico de Ainnova, incluida la plataforma Vision AI y las cámaras retinianas.
El programa de pre-sumisión de la FDA ayudará a determinar la vía regulatoria, incluidos los requisitos para pacientes y clínicas para la generación de datos clínicos, y permitirá a Avant establecer un presupuesto preciso para el proceso de la FDA.
Avant Technologies (OTCQB: AVAI)와 그 파트너 Ainnova Tech는 당뇨병성 망막병증의 조기 발견에 중점을 둔 Vision AI 플랫폼의 임상 시험 프로토콜 설계를 시작했습니다. 두 회사는 2025년 5월 중순으로 예정된 FDA와의 사전 제출 회의를 준비하고 있으며, 이는 510(k) 승인 신청을 위한 임상 시험 요구 사항을 안내할 것입니다.
그들의 계약 연구 기관(CRO)인 Fortrea의 요청에 따라 시험 프로토콜 요구 사항을 작성하는 데 도움을 줄 안과 의사가 고용되었습니다. 이 기술은 Ai-nova Acquisition Corp. (AAC)를 통해 개발되고 있으며, 이는 Ainnova의 기술 포트폴리오에 대한 글로벌 라이센스 권리를 보유한 합작 투자입니다. 여기에는 Vision AI 플랫폼과 망막 카메라가 포함됩니다.
FDA의 사전 제출 프로그램은 규제 경로를 결정하는 데 도움이 될 것이며, 임상 데이터 생성을 위한 환자 및 클리닉 요구 사항을 포함하고 Avant가 FDA 프로세스에 대한 정확한 예산을 설정할 수 있도록 합니다.
Avant Technologies (OTCQB: AVAI) et son partenaire Ainnova Tech ont lancé la conception des protocoles d'essai clinique pour leur plateforme Vision AI, axée sur la détection précoce de la rétinopathie diabétique. Les entreprises se préparent à une réunion de pré-soumission avec la FDA prévue pour la mi-mai 2025, qui orientera les exigences des tests cliniques pour leur demande d'autorisation 510(k).
Un ophtalmologiste a été engagé pour aider à rédiger les exigences du protocole d'essai demandées par leur Organisation de Recherche Contractuelle (CRO), Fortrea. La technologie est développée par le biais de Ai-nova Acquisition Corp. (AAC), une coentreprise détenant les droits de licence mondiaux sur le portefeuille technologique d'Ainnova, y compris la plateforme Vision AI et les caméras rétiniennes.
Le programme de pré-soumission de la FDA aidera à déterminer le chemin réglementaire, y compris les exigences pour les patients et les cliniques pour la génération de données cliniques, et permettra à Avant d'établir un budget précis pour le processus de la FDA.
Avant Technologies (OTCQB: AVAI) und sein Partner Ainnova Tech haben mit der Gestaltung der klinischen Prüfprotokolle für ihre Vision AI-Plattform begonnen, die sich auf die frühzeitige Erkennung von diabetischer Retinopathie konzentriert. Die Unternehmen bereiten sich auf ein vorläufiges Treffen mit der FDA vor, das für Mitte Mai 2025 angesetzt ist und die klinischen Testanforderungen für ihren 510(k)-Genehmigungsantrag leiten wird.
Ein Augenarzt wurde eingestellt, um bei der Ausarbeitung der von ihrer Vertragsforschungsorganisation (CRO), Fortrea, angeforderten Prüfprotokollanforderungen zu helfen. Die Technologie wird über Ai-nova Acquisition Corp. (AAC) entwickelt, ein Joint Venture, das die globalen Lizenzrechte am Technologieportfolio von Ainnova hält, einschließlich der Vision AI-Plattform und der retinalen Kameras.
Das vorläufige Programm der FDA wird helfen, den regulatorischen Weg zu bestimmen, einschließlich der Anforderungen für Patienten und Kliniken zur Generierung klinischer Daten, und es Avant ermöglichen, ein genaues Budget für den FDA-Prozess festzulegen.
- Partnership with established healthcare tech company Ainnova Tech
- Global licensing rights secured through joint venture AAC
- Progress toward FDA regulatory pathway with pre-submission meeting scheduled
- Product still in early regulatory phase, requiring full clinical trials
- No immediate revenue generation until FDA clearance is obtained
- Additional funding may be needed for clinical trials and FDA process
Ainnova has hired an ophthalmologist, who is assisting in drafting the requirements for the clinical trial protocol that the Company's Contract Research Organization (CRO), Fortrea, has requested. Upon completion of the protocol, Ainnova will work with its CRO to prepare and send all the documentation to the FDA for its upcoming pre-submission meeting. A clinical trial protocol is a detailed, written plan that outlines the objectives, design, methodology, and organization of a clinical research project, ensuring the safety of participants and the integrity of data collected. The Company expects its pre-submission meeting with the FDA to occur in midMay 2025.
Ai-nova Acquisition Corp. (AAC), the Company formed by the partnership between Avant and Ainnova to advance and commercialize Ainnova's technology portfolio, including its Vision AI platform and its versatile retinal cameras, has the global licensing rights for this portfolio, so the success of Ainnova's interactions with the FDA are paramount to marketing the technology portfolio in
For medical device applicants like Ainnova, the FDA's pre-submission program is useful to determine a clear regulatory pathway for the successful launch of the device, including the number of patients and the number of clinics needed to generate the necessary clinical data for the FDA to make an informed decision on Ainnova's Vision AI platform. For Avant, the presubmission meeting will help define a precise budget for the strategic partnership's entire FDA process.
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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Forward-Looking Statements
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Contact:
Avant Technologies, Inc. info@avanttechnologies.com
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SOURCE Avant Technologies Inc.
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