AAC announces updated clinical trial protocol

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Joint venture partners Avant Technologies and Ainnova Tech recently announced updated clinical trial protocol for the company following a recent pre-submission meeting with the US Food and Drug Administration (FDA), according to a press release.¹

Anniva has revised its clinical trial protocol following its mid-July meeting with the FDA. The new protocol, which will be re-submitted for FDA review, will “mitigate potential costly errors in the development process for Ainnova’s planned trial for its Vision AI platform.”

The new Vision AI platform is used for early detection of diabetic retinopathy, and the company has the goal of achieving FDA 510(k) approval, which would lead to clearance from the FDA to market its Vision AI technology in the US.

“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,” Vinicio Vargas, Chief Executive Officer at Ainnova and a member of the Board of Directors of Ai-nova Acquisition Corp (AAC), said in a press release.

AAC is the company formed by the partnership between Avant and Ainnova. It has the worldwide licensing rights for Ainnova’s technology portfolio, which includes the US, where the FDA regulates drug and medical device development. Entering the US market will allow AAC to reach higher commercial potential, “and this early engagement with the FDA ensures AAC can do so with speed, credibility, and a validated product,” a press release said.

“We anticipate finalizing the clinical trial budget soon, with estimated costs coming more into focus as we refine our protocol and navigate the process,” Vargas said.

Reference:

1. Avant Technologies Inc. Avant Technologies and Ainnova Tech Advance Clinical Trial Protocol Following FDA Feedback. Prnewswire.com. Published July 29, 2025. Accessed August 4, 2025. https://www.prnewswire.com/news-releases/avant-technologies-and-ainnova-tech-advance-clinical-trial-protocol-following-fda-feedback-302516042.html