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Capsule

SEC qualification enables ProteusDxTM to raise capital, drive FDA clearances, and accelerate commercialization of AI-enhanced GI diagnostics

The capital raised will support our FDA roadmap, commercialization efforts, and long-term vision of targeted capsule therapeutics.” - Ernie LeeDANVILLE, CA, UNITED STATES, September 16, 2025 /EINPresswire / -- ProteusDxTM by FirstVitals^®, an innovator in AI-enhanced capsule endoscopy and targeted drug delivery, today announced that the U.S. Securities and Exchange Commission (SEC) has qualified its Regulation A+ offering, enabling the company to raise capital from both accredited and retail investors.

This SEC qualification marks a significant milestone in the company's mission to transform gastrointestinal (GI) health through advanced, patient-friendly diagnostics and therapeutics. The Regulation A+ framework allows ProteusDxTM by FirstVitals^® to broaden access to its investment opportunity while pursuing key clinical, regulatory, and commercialization initiatives.

Strategic Use of Funds
Proceeds from the offering are intended to accelerate:
. FDA Clearance Efforts: Advancing regulatory submissions for the ProteusDxTM capsule endoscopy platform and AI-assisted interpretation tools.
. Commercialization: Launching initial pilots in physician practices and expanding awareness of non-invasive capsule endoscopy for patients.
. AI Innovation: Enhancing proprietary modules such as Lesion Mapping, Bleed Detection, and Inflammation Scoring Metrics.
. ProteusTxTM Development: Expanding into targeted drug delivery applications, beginning with equine gastric ulcers and extending into human therapeutics.

Leadership Commentary
"Receiving SEC qualification for our Regulation A+ offering is a transformative milestone for the ProteusDxTM platform," said Ernie G. Lee, Founder & CEO of FirstVitals. "This approval enables us to invite a broader community of investors to join our mission of making GI diagnostics and treatments more accessible, accurate, and patient-friendly. The capital raised will support our FDA roadmap, commercialization efforts, and long-term vision of targeted capsule therapeutics."

Investment Access
Interested investors can learn more and participate in the qualified offering at: . Company website:

About ProteusDxTM by FirstVitals^®

ProteusDxTM by FirstVitals^® is an advanced, AI-powered capsule endoscopy platform redefining how gastrointestinal health is assessed and managed. The platform delivers a patient-friendly alternative to invasive procedures, enabling accurate GI visualization, early detection of lesions, ulcers and polyps, and long-term monitoring. Through the integration of artificial intelligence, ProteusDxTM enhances diagnostic accuracy while supporting providers with actionable insights.

Future innovations include ProteusTxTM, a targeted drug delivery capsule, and expansion into veterinary applications, addressing gastric ulcers in horses and GI health in companion pets. Anchored within the Test2Treat ecosystem, ProteusDxTM by FirstVitals^® is committed to improving accessibility, accuracy, and patient outcomes while driving investor value through scalable technology and future regulatory milestones.

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Disclaimer: This press release does not constitute an offer to sell or a solicitation of an offer to buy securities. The offering is made only by means of the offering circular qualified by the SEC. Investors should read the offering circular and related risk factors before investing.

AJ Daly
ProteusDxTM
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