LAS VEGAS, NV / ACCESS Newswire / March 25, 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 that the Company has started designing its clinical trial protocol ahead of a pre-submission meeting with the U.S. Food and Drug Administration (FDA). The pre-submission meeting is to request guidance on the clinical testing needed for its Vision AI platform in the early detection of diabetic retinopathy, and Ainnova's clinical trial will culminate in the submission of an FDA 510(k) to obtain clearance from the regulatory agency to market its technology.
Ainnova has hired an ophthalmologist, who is assisting in drafting the requirements for the clinical trial protocol that the Company's Contract Research Organization (CRO), Fortrea, has requested. Upon completion of the protocol, Ainnova will work with its CRO to prepare and send all the documentation to the FDA for its upcoming pre-submission meeting. A clinical trial protocol is a detailed, written plan that outlines the objectives, design, methodology, and organization of a clinical research project, ensuring the safety of participants and the integrity of data collected. The Company expects its pre-submission meeting with the FDA to occur in midMay 2025.
Ai-nova Acquisition Corp. (AAC), the Company formed by the partnership between Avant and Ainnova to advance and commercialize Ainnova's technology portfolio, including its Vision AI platform and its versatile retinal cameras, has the global licensing rights for this portfolio, so the success of Ainnova's interactions with the FDA are paramount to marketing the technology portfolio in the United States.
For medical device applicants like Ainnova, the FDA's pre-submission program is useful to determine a clear regulatory pathway for the successful launch of the device, including the number of patients and the number of clinics needed to generate the necessary clinical data for the FDA to make an informed decision on Ainnova's Vision AI platform. For Avant, the presubmission meeting will help define a precise budget for the strategic partnership's entire FDA process.
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.
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SOURCE: Avant Technologies
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