Avant Technologies and Partner, Ainnova, Receive FDA Pre-Submission Meeting Date for Company's Vision AI Platform Technology

Rhea-AI Summary

Avant Technologies (OTCQB: AVAI) and its joint venture partner Ainnova Tech have secured a pre-submission meeting with the FDA scheduled for July 7, 2025. The meeting will discuss their planned clinical trial for the Vision AI platform, designed for early detection of diabetic retinopathy. Through Ai-nova Acquisition Corp. (AAC), formed by the partnership, the companies aim to determine crucial trial parameters including the number of clinical sites, patient count, and protocol approval.

The meeting represents a significant step toward obtaining FDA 510(k) clearance for U.S. market entry. AAC holds worldwide licensing rights for Ainnova's technology portfolio, making successful FDA interactions crucial for commercialization in the United States market.

Positive

• Pre-submission meeting with FDA secured, indicating progress in regulatory pathway
• Company holds worldwide licensing rights for the technology portfolio
• Early FDA engagement could potentially expedite market entry

Negative

• FDA clearance not guaranteed and timeline for approval remains uncertain
• Clinical trial costs and timeline yet to be determined

LAS VEGAS, May 6, 2025 /PRNewswire/ -- 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 the U.S. Food and Drug Administration (FDA) 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.

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."

"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.

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 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.

More information about Avant can be found at https://avanttechnologies.com 

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Forward-Looking Statements

Certain statements contained in this press release may constitute "forward-looking statements."  Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact.  Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website (http://www.sec.gov).  In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company's ability to raise capital on acceptable terms, if at all, the Company's successful development of its products and the integration into its existing products and the commercial acceptance of the Company's products.  The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change.  However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.  These forward-looking statements should not be relied upon as representing the Company's views as of any date after the date of the press release.

Contact: 
Avant Technologies, Inc.
info@avanttechnologies.com

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SOURCE Avant Technologies Inc.

FAQ

When is Avant Technologies (AVAI) scheduled to meet with the FDA for their Vision AI platform?

Avant Technologies and Ainnova are scheduled to meet with the FDA on July 7, 2025, for a pre-submission meeting regarding their Vision AI platform for diabetic retinopathy detection.

What is the purpose of AVAI's FDA pre-submission meeting?

The meeting aims to determine clinical trial parameters, including the number of clinical sites, total patients needed, and protocol approval for their Vision AI platform's diabetic retinopathy detection technology.

What type of FDA clearance is Avant Technologies seeking for their Vision AI platform?

Avant Technologies and Ainnova are seeking FDA 510(k) clearance to market their Vision AI platform technology in the United States.

What is the target medical condition for AVAI's Vision AI platform?

The Vision AI platform is designed for the early detection of diabetic retinopathy.

Who owns the licensing rights for Ainnova's technology portfolio?

Ai-nova Acquisition Corp. (AAC), formed by the partnership between Avant and Ainnova, holds the worldwide licensing rights for Ainnova's technology portfolio.