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.
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