Avant Technologies and JV Partner, Ainnova, Prepare for Key FDA Milestone with Next Week's Pre-Submission Meeting

Globe and Mail

30-06-2025

LAS VEGAS , June 30, 2025 /CNW/ -- Avant Technologies, Inc. (OTCQB: AVAI) ("Avant" or the "Company"), and its JV partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced that Ainnova and its Contract Research Organization, Fortrea, will use this week to make final preparations for the company's pre-submission meeting with the U.S. Food and Drug Administration (FDA) next week.
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 the United States .
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 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.
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 Vision AI – 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 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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