Avant Technologies and Ainnova Tech Announce Enhanced Patient Recruitment Strategy Ahead of FDA Clinical Trial

Rhea-AI Summary

Avant Technologies (OTCQB: AVAI) and its joint venture partner Ainnova Tech have announced an enhanced patient recruitment strategy for their upcoming FDA clinical trial of the Vision AI platform, designed for early detection of diabetic retinopathy. The study will be conducted across 8-10 U.S. clinical sites, targeting approximately 1,000 multiethnic patients with diabetes.

The companies will collaborate with Fortrea, a renowned Contract Research Organization specializing in ophthalmology studies. The trial will focus on community clinics and primary care facilities rather than specialized centers to gather real-world data. This strategic approach aims to support the company's FDA 510(k) submission for Vision AI, with Ai-nova Acquisition Corp. (AAC) holding worldwide licensing rights for Ainnova's technology portfolio.

Positive

• None.

Negative

• FDA 510(k) approval still pending and subject to successful clinical trial results
• Significant resources required to conduct large-scale clinical trial across multiple sites

LAS VEGAS, Aug. 12, 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 that Ainnova is refining its patient recruitment strategy for the Company's planned clinical trial for its Vision AI platform in the early detection of diabetic retinopathy. Ainnova will work directly with Fortrea, a globally recognized Contract Research Organization (CRO) renowned for its expertise in ophthalmology studies and medical device trials, following the guidance the Company received from its recent meeting with the U.S. Food and Drug Administration (FDA). 

The planned clinical study, which will be performed in 8-10 clinical sites around the U.S., will prioritize the recruitment of approximately 1,000 multiethnic patients, with a focus on individuals living with diabetes. By targeting community clinics and primary care facilities rather than specialized ophthalmology centers, Ainnova aims to capture real-world data that reflects the diverse population affected by diabetic retinopathy. This strategic approach ensures the study aligns with the practical realities of diabetes care, providing robust and relevant data to support the Company's FDA 510(k) submission.

"We are excited to move forward with an enhanced patient recruitment process," 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. "By focusing on community clinics and targeting a multiethnic group of around 1,000 diabetic patients, we aim to ensure that our study accurately represents the diverse population affected by diabetic retinopathy. 

"Working with Fortrea, an expert CRO in ophthalmology, allows us to confidently navigate this process with a partner that shares our commitment to quality and efficiency. We are getting closer to initiating a clinical study that will significantly contribute to obtaining FDA 510(k) approval and making our Vision AI platform a crucial tool in early disease detection."

Ainnova's collaboration with Fortrea underscores its commitment to conducting a rigorous and inclusive clinical study. By leveraging Fortrea's deep expertise in ophthalmology and medical device trials, Ainnova is well-positioned to deliver high-quality data to support the regulatory approval process to market Vision AI, a platform poised to transform early disease detection for diabetic patients worldwide, in the United States.

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.

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SOURCE Avant Technologies Inc.

FAQ

What is the scope of Avant Technologies (AVAI) and Ainnova Tech's clinical trial for Vision AI?

The clinical trial will involve 1,000 multiethnic patients across 8-10 U.S. clinical sites, focusing on individuals with diabetes for early detection of diabetic retinopathy.

Who is conducting the clinical trial for AVAI's Vision AI platform?

The trial will be conducted by Fortrea, a globally recognized Contract Research Organization (CRO) specializing in ophthalmology studies and medical device trials.

What are the potential market opportunities for AVAI's Vision AI platform?

Through AAC, the company holds worldwide licensing rights for Ainnova's technology portfolio, with successful FDA approval potentially unlocking significant commercial opportunities in the U.S. market.

How is AVAI ensuring diverse representation in their Vision AI clinical trial?

The trial will recruit patients from community clinics and primary care facilities rather than specialized centers, targeting a multiethnic patient population to ensure diverse representation.

What regulatory approval is AVAI seeking for their Vision AI platform?

The company is pursuing FDA 510(k) approval for their Vision AI platform, which requires successful completion of the clinical trial and submission of supporting data.