Avant Technologies and JV Partner, Ainnova, Prepare for Key FDA Milestone with Next Week's Pre-Submission Meeting
June 30 2025 - 8:00AM
InvestorsHub NewsWire
LAS VEGAS, NV -- June 30, 2025 -- InvestorsHub NewsWire -- Avant
Technologies Inc. (OTCQB:
AVAI) (“Avant” or the “Company”), and its JV partner, Ainnova
Tech, Inc., (Ainnova), a leading healthcare technology company
focused on revolutionizing early disease detection using artificial
intelligence (AI), today announced that Ainnova and its Contract
Research Organization, Fortrea, will use this week to make final
preparations for the company’s pre-submission meeting with the U.S.
Food and Drug Administration (FDA) next week.
The pre-submission meeting with Ainnova’s executives and its CRO
is set for Monday, July 7. The FDA meeting will allow the Company
to discuss its planned clinical trial of Ainnova’s Vision AI
platform in the early detection of diabetic retinopathy. These
meetings will give the team the direction it needs for a successful
clinical trial and to support the Company’s FDA 510(k) submission
to obtain clearance from the FDA to market the Vision AI technology
in the United States.
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, said,
“We’re approaching a key milestone. We’ve been preparing thoroughly
with the support of an experienced CRO and expert regulatory
advisors, and we’re optimistic about the
outcome.
“Diabetic retinopathy is the number one cause of preventable
blindness worldwide. That’s unacceptable - and we believe
technology can change that. But this is just the beginning. Retinal
screening offers a gateway to detecting many systemic conditions
early - like Alzheimer’s, cardiovascular disease, and
more.
“We’re committed to pushing the boundaries of preventive care,
improving both life expectancy and quality of life for people
around the world. That’s the mission behind everything we
do.”
Ainnova will use this pre-submission meeting to determine a host
of items, including the ideal number of clinical sites, the number
of total patients needed, and to learn if the FDA will approve the
clinical trial protocol for the planned trial. These are all
crucial for both Avant and Ainnova in determining the exact costs
and a timetable.
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 interactions with the FDA are 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
You can also follow us on social media at:
https://twitter.com/AvantTechAI
https://www.linkedin.com/company/avant-technologies-ai
https://www.facebook.com/AvantTechAI
https://www.youtube.com/@AvantTechAI
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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