• 16 Jul 2025
• Admin
• News Article

Avant Technologies and JV Partner, Ainnova, Complete Pivotal Meeting with U.S. FDA

Overview

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 the completion of its milestone meeting with the U.S. Food and Drug Administration (FDA). The pre-submission meeting allowed Ainnova and its Contract Research Organization (CRO), Fortrea, to present and discuss Ainnova's planned clinical trial for its Vision AI platform in the early detection of diabetic retinopathy and receive critical feedback from the FDA.

Ainnova Prepares U.S. Trial for Vision AI in Diabetic Retinopathy with FDA Support

• Ainnova's clinical trial will be conducted exclusively in the United States and focus solely on diabetic retinopathy. The FDA has now provided the Company with valuable guidance on its clinical protocol, the number and type of clinics Ainnova will need to conduct a successful clinical trial, the number of retinologists required to examine the images generated by Ainnova's Vision AI, etc.  
• With the FDA's recommendations, the Company can now actively plan for the total cost of conducting this planned clinical trial through to completion. Data from Ainnova's trial will support the Company's FDA 510(k) submission to obtain clearance from the FDA to market the Vision AI technology in the United States.

Statement from Vinicio Vargas, Chief Executive Officer at Ainnova

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 truly excited about this next phase. We're getting ready to begin data collection across primary care clinics in the U.S. with a study that is simple, yet rigorous - comparing our AI-based retinal screening to the readings of three retinologists.  
""This milestone not only brings us closer to validating our platform in the world's largest healthcare market, but it also paves the way for the upcoming approval of our new automated retinal camera, which we believe will be a game changer - making diabetic retinal screenings faster, more accessible, and available from virtually any point of care."" 

AAC Secures Global Rights for Ainnova Technology, Eyes U.S. Market Entry

• 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 clinical trial is 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.