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LAS VEGAS - January 27, 2025 (NEWMEDIAWIRE) - 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 that Avant has started the budgeting process to fund Ainnova's upcoming interactions with the U.S. Food and Drug Administration (FDA). Ainnova will begin by 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, which will culminate with an FDA 510(k) submission to obtain clearance from the FDA to market its technology.
Ai-nova Acquisition Corp. (AAC), the ompany formed by the partnership between Avant and Ainnova to advance and commercialize Ainnova's technology portfolio, including its "Vision AI" platform and its versatile retinal cameras, has the licensing rights for this portfolio in the U.S., so the success of Ainnova's interactions with the FDA are paramount to marketing the technology portfolio in the United States.
For medical device applicants like Ainnova, the FDA's pre-submission program is useful to determine a clear regulatory pathway for the successful launch of the device, including the number of patients and the number of clinics needed to generate the necessary clinical data for the FDA to make an informed decision on Ainnova's Vision AI platform. For Avant, the presubmission meeting will help define a precise budget for the strategic partnership's entire FDA process.
Ainnova expects to submit its Pre-Sub application in the coming weeks and expects to meet with the FDA for its Pre-Sub 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 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.