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

Rhea-AI Summary

Avant Technologies (OTCQB: AVAI) and its joint venture partner Ainnova Tech have completed a crucial pre-submission meeting with the FDA regarding their Vision AI platform for early detection of diabetic retinopathy. The meeting provided essential guidance for their upcoming U.S. clinical trial, including protocol requirements and necessary resources.

Through their joint venture company Ai-nova Acquisition Corp. (AAC), which holds worldwide licensing rights to Ainnova's technology portfolio, the companies are preparing to conduct data collection across U.S. primary care clinics. The study will compare their AI-based retinal screening against readings from three retinologists. The trial's success is crucial for obtaining FDA 510(k) clearance to market the technology in the United States.

Positive

• FDA provided clear guidance for clinical trial requirements and protocol
• Company holds worldwide licensing rights for the technology portfolio
• Planned automated retinal camera development could revolutionize diabetic screening accessibility
• Successful FDA clearance would unlock significant U.S. market potential

Negative

• Clinical trial costs and timeline yet to be determined
• FDA 510(k) clearance still pending and subject to successful trial completion

News Market Reaction

+3.97%

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+3.97% News Effect

On the day this news was published, AVAI gained 3.97%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

LAS VEGAS, July 15, 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 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'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.

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 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.

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

You can also follow us on social media at:

https://twitter.com/AvantTechAI 

https://www.linkedin.com/company/avant-technologies-ai  

https://www.facebook.com/AvantTechAI 

https://www.youtube.com/@AvantTechAI 

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

What was the outcome of Avant Technologies (AVAI) FDA meeting in July 2025?

The FDA provided crucial guidance on clinical trial protocols, including requirements for clinics and retinologists needed for testing Ainnova's Vision AI platform for diabetic retinopathy detection.

What is the purpose of AVAI's Vision AI clinical trial?

The clinical trial aims to validate the Vision AI platform by comparing AI-based retinal screening results to readings from three retinologists, supporting the FDA 510(k) submission for U.S. market clearance.

How will Avant Technologies' automated retinal camera impact healthcare?

The automated retinal camera is designed to make diabetic retinal screenings faster and more accessible, enabling screenings from virtually any point of care location.

What is the relationship between Avant Technologies and Ainnova Tech?

Avant Technologies and Ainnova Tech formed a joint venture company called Ai-nova Acquisition Corp. (AAC), which holds worldwide licensing rights for Ainnova's technology portfolio.

What regulatory approval is AVAI seeking from the FDA?

AVAI is seeking FDA 510(k) clearance to market their Vision AI technology for diabetic retinopathy detection in the United States.