Avant Technologies and Ainnova Tech Advance Clinical Trial Protocol Following FDA Feedback

Rhea-AI Summary

Avant Technologies (OTCQB: AVAI) and its joint venture partner Ainnova Tech have announced updates to their clinical trial protocol following FDA feedback for their Vision AI platform. The revised protocol, focused on early detection of diabetic retinopathy, will be resubmitted to the FDA for review.

The companies are working through their Contract Research Organization, Fortrea, to advance the protocol that will enable initiation of a new clinical trial. The technology is being developed under Ai-nova Acquisition Corp. (AAC), a partnership between Avant and Ainnova, which holds worldwide licensing rights for Ainnova's technology portfolio.

Positive

• None.

Negative

• Clinical trial costs yet to be finalized
• FDA approval still pending for revised protocol
• Timeline for market entry remains uncertain

LAS VEGAS, July 29, 2025 /PRNewswire/ -- Avant Technologies Inc. (OTCQB: AVAI) ("Avant" or the "Company"), an emerging technology company developing healthcare solutions, and its Joint Venture partner, Ainnova Tech, Inc. (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced an update on the Company's clinical trial protocol following a recent pre-submission meeting with the U.S. Food and Drug Administration (FDA).  

Following its mid-July meeting with the FDA, Ainnova has revised its clinical trial protocol with the FDA's comments in mind. The new protocol will be resubmitted for FDA review to ensure compliance, which will mitigate potential costly errors in the development process for Ainnova's planned trial for its Vision AI platform in the early detection of diabetic retinopathy.  

Late last week, Ainnova's clinical development team met with Fortrea, the Company's Contract Research Organization, to present the updated protocol document. Upon approval, this protocol will pave the way for the initiation of a new clinical trial aligned with the revised guidelines.

"We are committed to meeting the highest regulatory standards, and we're confident that these protocol refinements will strengthen our path toward FDA 510(k) clearance," said 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.  "We anticipate finalizing the clinical trial budget soon, with estimated costs coming more into focus as we refine our protocol and navigate the process."

The company remains focused on advancing its innovative Vision AI platform to address the early detection of diabetic retinopathy, with the goal of achieving FDA 510(k) approval to obtain clearance from the FDA to market its Vision AI technology in the U.S. and deliver transformative solutions to the market.

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

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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

What is the status of Avant Technologies (AVAI) Vision AI platform FDA approval?

The company is currently revising its clinical trial protocol following FDA feedback and will resubmit it for review. They are pursuing FDA 510(k) clearance for early detection of diabetic retinopathy.

What is the purpose of Avant Technologies' Vision AI platform?

The Vision AI platform is designed for the early detection of diabetic retinopathy, aiming to revolutionize disease detection using artificial intelligence.

Who are the key partners in Avant Technologies' clinical trial development?

The key partners are Ainnova Tech (joint venture partner), Fortrea (Contract Research Organization), and Ai-nova Acquisition Corp. (AAC, the partnership entity holding licensing rights).

What markets will Avant Technologies' Vision AI platform be available in?

Through AAC, the company holds worldwide licensing rights for the technology portfolio, with initial focus on entering the U.S. market following FDA approval.

When will Avant Technologies begin its clinical trials for Vision AI?

The clinical trials will begin after the revised protocol receives FDA approval. The exact timeline is pending as the company is currently finalizing the protocol and budget.