Avant Technologies and JV Partner, Ainnova, Prepare for Key FDA Milestone with Next Week's Pre-Submission Meeting
Avant Technologies (OTCQB: AVAI) and its joint venture partner Ainnova Tech are preparing for a crucial FDA pre-submission meeting scheduled for July 7, 2025. The meeting will focus on discussing the planned clinical trial of Ainnova's Vision AI platform for early detection of diabetic retinopathy.
Through their partnership company Ai-nova Acquisition Corp. (AAC), which holds worldwide licensing rights to Ainnova's technology portfolio, the companies aim to determine critical trial parameters including the number of clinical sites and total patients needed. The pre-submission meeting will be instrumental in obtaining FDA 510(k) clearance to market the Vision AI technology in the United States.
The technology aims to address diabetic retinopathy, the leading cause of preventable blindness worldwide, with potential applications in early detection of other conditions such as Alzheimer's and cardiovascular disease through retinal screening. The FDA engagement is considered crucial for entering the U.S. market and unlocking significant commercial potential.
Avant Technologies (OTCQB: AVAI) e il suo partner in joint venture Ainnova Tech si stanno preparando per un incontro pre-sottomissione fondamentale con la FDA, previsto per il 7 luglio 2025. L'incontro sarà incentrato sulla discussione della sperimentazione clinica pianificata della piattaforma Vision AI di Ainnova per la diagnosi precoce della retinopatia diabetica.
Attraverso la loro società in partnership Ai-nova Acquisition Corp. (AAC), che detiene i diritti di licenza mondiali sul portafoglio tecnologico di Ainnova, le aziende mirano a definire parametri critici della sperimentazione, inclusi il numero di siti clinici e il totale dei pazienti necessari. L'incontro pre-sottomissione sarà fondamentale per ottenere l'autorizzazione FDA 510(k) per commercializzare la tecnologia Vision AI negli Stati Uniti.
La tecnologia punta a contrastare la retinopatia diabetica, principale causa di cecità prevenibile a livello globale, con potenziali applicazioni anche nella diagnosi precoce di altre patologie come l'Alzheimer e le malattie cardiovascolari tramite screening retinico. Il coinvolgimento della FDA è considerato essenziale per l'ingresso nel mercato statunitense e per sbloccare un significativo potenziale commerciale.
Avant Technologies (OTCQB: AVAI) y su socio en empresa conjunta Ainnova Tech se están preparando para una reunión crucial de pre-sumisión con la FDA programada para el 7 de julio de 2025. La reunión se centrará en discutir el ensayo clínico planificado de la plataforma Vision AI de Ainnova para la detección temprana de la retinopatía diabética.
A través de su empresa conjunta Ai-nova Acquisition Corp. (AAC), que posee los derechos de licencia mundial de la cartera tecnológica de Ainnova, las compañías buscan determinar parámetros críticos del ensayo, incluyendo el número de sitios clínicos y el total de pacientes requeridos. La reunión de pre-sumisión será clave para obtener la autorización FDA 510(k) para comercializar la tecnología Vision AI en Estados Unidos.
La tecnología está dirigida a la retinopatía diabética, la principal causa de ceguera prevenible a nivel mundial, con aplicaciones potenciales en la detección temprana de otras enfermedades como el Alzheimer y enfermedades cardiovasculares mediante el cribado retinal. La interacción con la FDA es considerada fundamental para ingresar al mercado estadounidense y desbloquear un importante potencial comercial.
Avant Technologies (OTCQB: AVAI)와 공동 벤처 파트너 Ainnova Tech는 2025년 7월 7일로 예정된 중요한 FDA 사전 제출 회의를 준비하고 있습니다. 이 회의에서는 당뇨병성 망막병증 조기 발견을 위한 Ainnova의 Vision AI 플랫폼 임상 시험 계획에 대해 논의할 예정입니다.
세계적인 라이선스 권리를 보유한 파트너사 Ai-nova Acquisition Corp. (AAC)를 통해 양사는 임상 시험에 필요한 임상 기관 수와 총 환자 수 등 중요한 시험 파라미터를 결정하는 것을 목표로 하고 있습니다. 이 사전 제출 회의는 Vision AI 기술을 미국 시장에 출시하기 위한 FDA 510(k) 승인 획득에 중요한 역할을 할 것입니다.
이 기술은 전 세계적으로 예방 가능한 실명의 주요 원인인 당뇨병성 망막병증을 해결하는 것을 목표로 하며, 망막 스크리닝을 통해 알츠하이머 및 심혈관 질환과 같은 다른 질환의 조기 발견에도 적용될 가능성이 있습니다. FDA와의 협력은 미국 시장 진출과 상당한 상업적 잠재력 확보에 있어 매우 중요하다고 평가됩니다.
Avant Technologies (OTCQB : AVAI) et son partenaire en coentreprise Ainnova Tech se préparent pour une réunion pré-soumission cruciale avec la FDA, prévue le 7 juillet 2025. Cette réunion portera sur l'essai clinique prévu de la plateforme Vision AI d'Ainnova pour la détection précoce de la rétinopathie diabétique.
Par le biais de leur société commune Ai-nova Acquisition Corp. (AAC), qui détient les droits de licence mondiaux du portefeuille technologique d'Ainnova, les entreprises visent à définir les paramètres clés de l'essai, notamment le nombre de sites cliniques et le nombre total de patients nécessaires. La réunion pré-soumission sera déterminante pour obtenir l'autorisation FDA 510(k) permettant la commercialisation de la technologie Vision AI aux États-Unis.
Cette technologie vise à traiter la rétinopathie diabétique, principale cause mondiale de cécité évitable, avec des applications potentielles pour la détection précoce d'autres pathologies telles que la maladie d'Alzheimer et les maladies cardiovasculaires via le dépistage rétinien. L'engagement avec la FDA est considéré comme essentiel pour pénétrer le marché américain et libérer un potentiel commercial important.
Avant Technologies (OTCQB: AVAI) und sein Joint-Venture-Partner Ainnova Tech bereiten sich auf ein entscheidendes FDA-Vorabtreffen vor, das für den 7. Juli 2025 geplant ist. Das Treffen wird sich auf die geplante klinische Studie der Vision AI-Plattform von Ainnova zur Früherkennung der diabetischen Retinopathie konzentrieren.
Über ihr gemeinsames Unternehmen Ai-nova Acquisition Corp. (AAC), das die weltweiten Lizenzrechte am Technologieportfolio von Ainnova hält, wollen die Unternehmen wichtige Studienparameter festlegen, darunter die Anzahl der klinischen Standorte und die Gesamtzahl der benötigten Patienten. Das Vorabtreffen wird entscheidend sein, um die FDA 510(k)-Zulassung für die Vermarktung der Vision AI-Technologie in den USA zu erhalten.
Die Technologie zielt darauf ab, die diabetische Retinopathie, die weltweit führende Ursache für vermeidbare Erblindung, zu bekämpfen, mit potenziellen Anwendungen zur Früherkennung anderer Erkrankungen wie Alzheimer und Herz-Kreislauf-Erkrankungen durch Netzhautuntersuchungen. Die Zusammenarbeit mit der FDA gilt als entscheidend für den Eintritt in den US-Markt und die Erschließung eines erheblichen kommerziellen Potenzials.
- Pre-submission FDA meeting secured for Vision AI platform development
- Worldwide licensing rights secured through AAC joint venture
- Technology addresses diabetic retinopathy, the leading cause of preventable blindness
- Platform has potential applications beyond diabetic retinopathy, including Alzheimer's and cardiovascular disease detection
- Exact clinical trial costs and timeline still undetermined
- FDA clearance process and requirements yet to be finalized
- Commercial success dependent on FDA approval and successful clinical trials
The pre-submission meeting with Ainnova's executives and its CRO is set for Monday, July 7. The FDA meeting will allow the Company to discuss its planned clinical trial of Ainnova's Vision AI platform in the early detection of diabetic retinopathy. These meetings will give the team the direction it needs for a successful clinical trial and to 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 approaching a key milestone. We've been preparing thoroughly with the support of an experienced CRO and expert regulatory advisors, and we're optimistic about the outcome.
"Diabetic retinopathy is the number one cause of preventable blindness worldwide. That's unacceptable—and we believe technology can change that. But this is just the beginning. Retinal screening offers a gateway to detecting many systemic conditions early—like Alzheimer's, cardiovascular disease, and more.
"We're committed to pushing the boundaries of preventive care, improving both life expectancy and quality of life for people around the world. That's the mission behind everything we do."
Ainnova 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 the clinical trial protocol for the planned 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 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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