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

Rhea-AI Summary

Avant Technologies (OTCQB: AVAI) and its joint venture partner Ainnova Tech are preparing for a crucial FDA pre-submission meeting scheduled for July 7, 2025. The meeting will focus on discussing the planned clinical trial of Ainnova's Vision AI platform for early detection of diabetic retinopathy.

Through their partnership company Ai-nova Acquisition Corp. (AAC), which holds worldwide licensing rights to Ainnova's technology portfolio, the companies aim to determine critical trial parameters including the number of clinical sites and total patients needed. The pre-submission meeting will be instrumental in obtaining FDA 510(k) clearance to market the Vision AI technology in the United States.

The technology aims to address diabetic retinopathy, the leading cause of preventable blindness worldwide, with potential applications in early detection of other conditions such as Alzheimer's and cardiovascular disease through retinal screening. The FDA engagement is considered crucial for entering the U.S. market and unlocking significant commercial potential.

Positive

• Pre-submission FDA meeting secured for Vision AI platform development
• Worldwide licensing rights secured through AAC joint venture
• Technology addresses diabetic retinopathy, the leading cause of preventable blindness
• Platform has potential applications beyond diabetic retinopathy, including Alzheimer's and cardiovascular disease detection

Negative

• Exact clinical trial costs and timeline still undetermined
• FDA clearance process and requirements yet to be finalized
• Commercial success dependent on FDA approval and successful clinical trials

LAS VEGAS, June 30, 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 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 

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

When is Avant Technologies (AVAI) scheduled for their FDA pre-submission meeting?

The FDA pre-submission meeting is scheduled for Monday, July 7, 2025.

What is the purpose of AVAI's Vision AI platform?

The Vision AI platform is designed for the early detection of diabetic retinopathy, with potential applications in detecting other conditions like Alzheimer's and cardiovascular disease through retinal screening.

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

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

Who are the key partners involved in Avant Technologies' Vision AI development?

The key partners are Avant Technologies, Ainnova Tech (JV partner), Fortrea (Contract Research Organization), and their joint venture company Ai-nova Acquisition Corp. (AAC).

What is the market potential for AVAI's Vision AI technology?

The technology addresses the leading cause of preventable blindness worldwide, with significant commercial potential in the U.S. market pending FDA clearance.