Avant Technologies, Inc , and its JV partner, Ainnova Tech, a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence announced that the U.S. Food and Drug Administration has scheduled its pre-submission meeting with Ainnova’s executives and its CRO, Fortrea, for July 7, 2025, to discuss a range of items related to the Company’s planned clinical trial of its Vision AI platform in the early detection of diabetic retinopathy.
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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 U.S. FDA to discuss our planned clinical trial. These meetings will give us the direction that we’ll need for success and to support our FDA 510(k) submission to obtain clearance from the FDA to market our technology in the U.S.”
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“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 U.S., where the FDA regulates drug and medical device development, so the success of Ainnova’s interactions with the FDA are paramount to marketing the technology portfolio in the United States. Entering the U.S. market will unlock significant commercial potential, and this early engagement with the FDA ensures AAC can do so with speed, credibility, and a validated product.
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Source – PR Newswire
