Avant Technologies and Ainnova Advance Toward FDA Clinical Trial with Selection of Top CRO
Avant Technologies (OTCQB:AVAI) and its partner Ainnova Tech have selected Fortrea as their Contract Research Organization (CRO) for upcoming FDA clinical trials. The trials will focus on seeking FDA approval for Ainnova's Vision AI platform, specifically for early detection of diabetic retinopathy.
Fortrea will assist in requesting a pre-submission FDA meeting expected in late March/early April 2025, followed by clinical studies and an FDA 510(k) submission. Through their joint venture, Ai-nova Acquisition Corp. (AAC), the companies hold licensing rights for the technology portfolio in the U.S., Canada, and Europe.
Additionally, Ainnova plans to seek FDA clearance for four recently acquired algorithms targeting early detection of cardiovascular risk, prediabetes and Type 2 diabetes, fatty liver disease, and chronic kidney disease.
Avant Technologies (OTCQB:AVAI) e il suo partner Ainnova Tech hanno selezionato Fortrea come il loro Organizzazione di Ricerca Contrattuale (CRO) per i prossimi studi clinici FDA. Gli studi si concentreranno sulla ricerca dell'approvazione FDA per la piattaforma Vision AI di Ainnova, specificamente per la rilevazione precoce della retinopatia diabetica.
Fortrea assisterà nella richiesta di un incontro pre-invio con la FDA, previsto per la fine di marzo/inizio aprile 2025, seguito dagli studi clinici e da una presentazione 510(k) alla FDA. Attraverso la loro joint venture, Ai-nova Acquisition Corp. (AAC), le aziende detengono diritti di licenza per il portafoglio tecnologico negli Stati Uniti, in Canada e in Europa.
Inoltre, Ainnova prevede di richiedere l'approvazione FDA per quattro algoritmi recentemente acquisiti mirati alla rilevazione precoce del rischio cardiovascolare, del prediabete e del diabete di tipo 2, della steatosi epatica e della malattia renale cronica.
Avant Technologies (OTCQB:AVAI) y su socio Ainnova Tech han seleccionado a Fortrea como su Organización de Investigación por Contrato (CRO) para los próximos ensayos clínicos de la FDA. Los ensayos se centrarán en buscar la aprobación de la FDA para la plataforma Vision AI de Ainnova, específicamente para la detección temprana de la retinopatía diabética.
Fortrea ayudará en la solicitud de una reunión de pre-sumisión con la FDA, prevista para finales de marzo/principios de abril de 2025, seguida de estudios clínicos y una presentación 510(k) a la FDA. A través de su empresa conjunta, Ai-nova Acquisition Corp. (AAC), las compañías poseen derechos de licencia para la cartera de tecnología en los EE. UU., Canadá y Europa.
Además, Ainnova planea buscar la autorización de la FDA para cuatro algoritmos recientemente adquiridos dirigidos a la detección temprana del riesgo cardiovascular, prediabetes y diabetes tipo 2, enfermedad del hígado graso y enfermedad renal crónica.
Avant Technologies (OTCQB:AVAI)와 파트너 Ainnova Tech가 곧 열릴 FDA 임상 시험을 위해 Fortrea를 계약 연구 기관(CRO)으로 선택했습니다. 이번 시험은 Ainnova의 Vision AI 플랫폼의 FDA 승인을 받기 위해, 특히 당뇨병성 망막병증의 조기 탐지에 초점을 맞춥니다.
Fortrea는 2025년 3월 말 또는 4월 초에 예정된 FDA 사전 제출 회의 요청을 지원하며, 그 후 임상 연구 및 FDA 510(k) 제출을 진행할 예정입니다. 이들 기업은 Ai-nova Acquisition Corp. (AAC)라는 합작 회사를 통해 미국, 캐나다, 유럽에서 해당 기술 포트폴리오에 대한 라이선스 권리를 보유하고 있습니다.
추가로, Ainnova는 심혈관 위험, 당뇨병 전단계 및 제2형 당뇨병, 지방간 질환 및 만성 신장 질환의 조기 탐지를 목표로 하는 최근 인수한 네 가지 알고리즘에 대해 FDA 승인을 요청할 계획입니다.
Avant Technologies (OTCQB:AVAI) et son partenaire Ainnova Tech ont choisi Fortrea comme leur Organisation de Recherche Contractuelle (CRO) pour les prochains essais cliniques de la FDA. Les essais se concentreront sur la recherche de l'approbation de la FDA pour la plateforme Vision AI d'Ainnova, spécifiquement pour la détection précoce de la rétinopathie diabétique.
Fortrea aidera à demander une réunion préliminaire avec la FDA prévue pour fin mars/début avril 2025, suivie d'études cliniques et d'une soumission 510(k) à la FDA. Grâce à leur co-entreprise, Ai-nova Acquisition Corp. (AAC), les entreprises détiennent des droits de licence pour le portefeuille technologique aux États-Unis, au Canada et en Europe.
De plus, Ainnova prévoit de demander une homologation de la FDA pour quatre algorithmes récemment acquis visant la détection précoce du risque cardiovasculaire, du prédiabète et du diabète de type 2, de la maladie du foie gras et de la maladie rénale chronique.
Avant Technologies (OTCQB:AVAI) und ihr Partner Ainnova Tech haben Fortrea als ihre Vertragliche Forschungsorganisation (CRO) für bevorstehende FDA-Klinikstudien ausgewählt. Die Studien konzentrieren sich darauf, die FDA-Zulassung für die Vision AI-Plattform von Ainnova zu beantragen, insbesondere zur frühzeitigen Erkennung von diabetischer Retinopathie.
Fortrea wird bei der Beantragung eines Pre-Submission-Meetings bei der FDA helfen, das für Ende März/Anfang April 2025 geplant ist, gefolgt von klinischen Studien und einer FDA 510(k)-Einreichung. Durch ihr Joint Venture, die Ai-nova Acquisition Corp. (AAC), halten die Unternehmen Lizenzen für das Technologieportfolio in den USA, Kanada und Europa.
Darüber hinaus plant Ainnova, die FDA-Zulassung für vier kürzlich erworbene Algorithmen anzustreben, die auf die frühzeitige Erkennung von kardiovaskulären Risiken, Prädiabetes und Typ-2-Diabetes, Fettleberkrankheit und chronischer Nierenerkrankung abzielen.
- Partnership with established CRO Fortrea to advance FDA approval process
- Extensive territorial licensing rights across U.S., Canada, and Europe
- Expansion of technology portfolio with four additional disease detection algorithms
- FDA approval process still in early stages with no guaranteed timeline for completion
- No assurance of successful FDA clearance
LAS VEGAS, NV / ACCESS Newswire / February 11, 2025 / Avant Technologies, Inc. (OTCQB:AVAI) ("Avant" or the "Company"), and its partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced the selection of Fortrea, a global provider of clinical development solutions to the life sciences industry, as the contract research organization (CRO) to conduct Ainnova's upcoming clinical studies to seek approval from the U.S. Food and Drug Administration (FDA) for Ainnova's Vision AI platform.
Fortrea will assist Ainnova in requesting a pre-submission meeting with the FDA for guidance on the clinical testing needed for its Vision AI platform in the early detection of diabetic retinopathy. After a pre-submission meeting, Fortrea will then work with Ainnova on its FDA submission and a subsequent clinical study before concluding with an FDA 510(k) submission to obtain clearance from the FDA to market its Vision AI platform.
The upcoming clinical studies are significant to Avant and its shareholders because of the partnership formed by Avant and Ainnova to advance and commercialize Ainnova's technology portfolio, including its Vision AI platform and its versatile retinal cameras. The joint venture formed by the two companies, Ai-nova Acquisition Corp. (AAC), has the licensing rights for this portfolio in the U.S., Canada, and Europe, so the success of Ainnova's clinical studies with the FDA will be vital to marketing the technology portfolio in the United States.
Ainnova's Chief Executive Officer, Vinicio Vargas, said of the selection, "We worked diligently to identify and select the right CRO to help us both engage the FDA and then conduct our clinical studies. Fortrea is an established and highly regarded full-service CRO with expertise in more than 20 therapeutic areas, and a CRO with an extensive portfolio of successfully completed clinical trials, including those involving both emerging and large biopharmaceutical, medical device, and diagnostic companies."
With Fortrea's guidance, Ainnova expects to submit its pre-submission application in the coming weeks and expects to meet with the FDA for its pre-submission meeting in late March/early April 2025. Additionally, Ainnova will also interact with the FDA to devise a plan to obtain clearance for four algorithms it recently acquired the exclusive licensing rights to, which include early detection for cardiovascular risk, prediabetes and Type 2 diabetes, fatty liver disease, and chronic kidney disease.
About Ainnova Tech, Inc.
Ainnova is a Nevada-based healthtech startup with headquarters in San Jose, Costa Rica, and Houston, Texas. Founded by an experienced and innovative team that is dedicated to leveraging artificial intelligence for early disease detection. Recognized with multiple global awards and renowned partnerships with hospitals and medical device companies, we proudly introduce VisionAI - our cutting-edge platform designed to prevent blindness and detect the early onset of diabetes. Explore how Ainnova is revolutionizing healthcare through advanced technology and proactive solutions.
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
Certain statements contained in this press release may constitute "forward-looking statements." Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website (http://www.sec.gov). In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company's ability to raise capital on acceptable terms, if at all, the Company's successful development of its products and the integration into its existing products and the commercial acceptance of the Company's products. The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date after the date of the press release.
Contact:
Avant Technologies, Inc.
info@avanttechnologies.com
SOURCE: Avant Technologies, Inc.
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FAQ
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What conditions will AVAI's new algorithms detect besides diabetic retinopathy?
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