Clairity Raises $43 Million in Series B to Launch First FDA-Authorized AI Platform for Breast Cancer Risk Prediction

With backing from leading healthcare investors, Clairity accelerates its mission to predict and prevent breast cancer and expand into cardiovascular disease

Clairity, Inc., an AI-driven precision health company pioneering image-based risk prediction, today announced the closing of a $43 million Series B financing. The funds will be used to commercialize the company's product, Clairity Breast, the first FDA-authorized artificial intelligence platform that predicts a woman's five-year risk of breast cancer directly from a routine mammogram, and to advance development of Clairity Breast 3D and Clairity Heart, Clairity's next offering focused on predicting cardiovascular risk from the same routine imaging exam.

The round was led by ACE Global Equity and Santé Ventures, with continued participation from the Breast Cancer Research Foundation (BCRF) and several new investors. The strong commitment from the syndicate reflects broad confidence in Clairity's mission to transform how breast cancer is found, managed, and ultimately prevented, and in the power of the company's AI platform to extend into other areas of population health.

The new funding will allow Clairity to accelerate U.S. commercialization, expand partnerships with leading imaging centers and health systems, and drive continued development of Clairity's broader predictive health platform.

Following the successful FDA authorization of Clairity Breast and its initial rollout to marquee health systems, the company is expanding its pipeline to include new AI-based predictive offerings for other major diseases, leveraging the same deep learning framework on which Clairity Breast was built. The Series B financing will also support reimbursement initiatives and partnerships aimed at making Clairity Breast accessible across community imaging centers nationwide.

"For decades, we have relied on mammography to detect cancer only after it is visible," said Connie Lehman, MD, PhD, Founder of Clairity. "With Clairity Breast, we can now use the same images to predict who may be at risk over the next five years, supporting earlier intervention, fewer late-stage diagnoses, and more lives saved. This is the future of breast cancer care: predictive, personalized, and preventive."

"Our fundraising is about more than capital; it's about momentum," said Jeff Luber, Clairity's President and CEO. "With FDA authorization in hand and commercial partnerships underway, Clairity Breast is poised to redefine how the world approaches breast cancer. We're proud to stand at the forefront of a paradigm shift—from detection to prevention—and to deliver technology that empowers women and their doctors to predict risk to support action before cancer starts."

"Clairity represents a rare combination of scientific rigor, regulatory validation, and transformative clinical impact," said Gabriella Antici, Partner and Chief Investment Officer, ACE Global Equity. "Predictive imaging is the next frontier in oncology, and Clairity Breast is the first real-world embodiment of that promise."

"BCRF has long believed that prevention is the ultimate cure," said Donna McKay, President and CEO, Breast Cancer Research Foundation. "Clairity's technology embodies that vision, turning existing imaging infrastructure into a proactive tool for risk stratification toward earlier interventions that can save lives. We're proud to continue supporting their work as they bring this innovation to women everywhere."

"Santé is proud to support Clairity in advancing a new era of predictive breast health," said Kevin Lalande, Founding Managing Director and Chief Investment Officer of Santé Ventures. "By pairing clinically validated AI with scalable access channels, Clairity exemplifies the type of innovation that can help drive better outcomes for patients and greater cost efficiency across the healthcare system."

"Clairity's work represents exactly the kind of innovation we need in healthcare, where data and AI move us from reacting to disease to preventing it," said Joe Kiani, Founder and Executive Chairman of Willow Laboratories, and Founder of global medical technology company, Masimo (NASDAQ:MASI). "By transforming routine imaging into a window of prediction, Clairity empowers physicians and patients alike to act earlier, which should lead to better outcomes." Mr. Kiani joins Clairity as investor and board member.

TCB Capital Advisors ("TCB") served as exclusive financial advisor to Clairity with respect to the Series B financing.

About Clairity, Inc.

Clairity is an AI-powered precision health company transforming medical imaging into a predictive tool for early risk assessment. Its flagship product, Clairity Breast, is the first FDA-cleared platform to estimate a woman's five-year breast cancer risk directly from a routine mammogram. By shifting care from detection to prevention, Clairity empowers health systems, radiologists, and women to act earlier, save lives, and lower the overall cost of cancer care.

For more information, visit www.clairity.com.

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Investor Contact: Jenna Barton; [email protected]