Avant Technologies and Ainnova Advance Toward FDA Clinical Trial with Selection of Top CRO
Rhea-AI Summary
Avant Technologies (OTCQB:AVAI) and its partner Ainnova Tech have selected Fortrea as their Contract Research Organization (CRO) for upcoming FDA clinical trials. The trials will focus on seeking FDA approval for Ainnova's Vision AI platform, specifically for early detection of diabetic retinopathy.
Fortrea will assist in requesting a pre-submission FDA meeting expected in late March/early April 2025, followed by clinical studies and an FDA 510(k) submission. Through their joint venture, Ai-nova Acquisition Corp. (AAC), the companies hold licensing rights for the technology portfolio in the U.S., Canada, and Europe.
Additionally, Ainnova plans to seek FDA clearance for four recently acquired algorithms targeting early detection of cardiovascular risk, prediabetes and Type 2 diabetes, fatty liver disease, and chronic kidney disease.
Positive
- Partnership with established CRO Fortrea to advance FDA approval process
- Extensive territorial licensing rights across U.S., Canada, and Europe
- Expansion of technology portfolio with four additional disease detection algorithms
Negative
- FDA approval process still in early stages with no guaranteed timeline for completion
- No assurance of successful FDA clearance
LAS VEGAS, NV / ACCESS Newswire / February 11, 2025 / Avant Technologies, Inc. (OTCQB:AVAI) ("Avant" or the "Company"), and its partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced the selection of Fortrea, a global provider of clinical development solutions to the life sciences industry, as the contract research organization (CRO) to conduct Ainnova's upcoming clinical studies to seek approval from the U.S. Food and Drug Administration (FDA) for Ainnova's Vision AI platform.
Fortrea will assist Ainnova in requesting a pre-submission meeting with the FDA for guidance on the clinical testing needed for its Vision AI platform in the early detection of diabetic retinopathy. After a pre-submission meeting, Fortrea will then work with Ainnova on its FDA submission and a subsequent clinical study before concluding with an FDA 510(k) submission to obtain clearance from the FDA to market its Vision AI platform.
The upcoming clinical studies are significant to Avant and its shareholders because of the partnership formed by Avant and Ainnova to advance and commercialize Ainnova's technology portfolio, including its Vision AI platform and its versatile retinal cameras. The joint venture formed by the two companies, Ai-nova Acquisition Corp. (AAC), has the licensing rights for this portfolio in the U.S., Canada, and Europe, so the success of Ainnova's clinical studies with the FDA will be vital to marketing the technology portfolio in the United States.
Ainnova's Chief Executive Officer, Vinicio Vargas, said of the selection, "We worked diligently to identify and select the right CRO to help us both engage the FDA and then conduct our clinical studies. Fortrea is an established and highly regarded full-service CRO with expertise in more than 20 therapeutic areas, and a CRO with an extensive portfolio of successfully completed clinical trials, including those involving both emerging and large biopharmaceutical, medical device, and diagnostic companies."
With Fortrea's guidance, Ainnova expects to submit its pre-submission application in the coming weeks and expects to meet with the FDA for its pre-submission meeting in late March/early April 2025. Additionally, Ainnova will also interact with the FDA to devise a plan to obtain clearance for four algorithms it recently acquired the exclusive licensing rights to, which include early detection for cardiovascular risk, prediabetes and Type 2 diabetes, fatty liver disease, and chronic kidney disease.
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 VisionAI - 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
SOURCE: Avant Technologies, Inc.
View the original press release on ACCESS Newswire
FAQ
When is AVAI's FDA pre-submission meeting scheduled for Vision AI platform?
What territories does AVAI have licensing rights for the Vision AI platform?
What conditions will AVAI's new algorithms detect besides diabetic retinopathy?
Which CRO has AVAI selected for their FDA clinical trials?
What type of FDA submission is AVAI planning for the Vision AI platform?
