New SmiLe company N23 Health shows strong clinical results with AI-supported portable mammography solution

N23 Health, a femtech company developing AI support for portable breast cancer screening equipment, has been accepted into the incubator program at SmiLe Venture Hub. Ongoing clinical studies show highly promising results, where the combination of AI and ultrasound performs at levels comparable to physician assessments.

N23 Health’s solution combines commercially available portable ultrasound devices with a proprietary app that provides AI support and guidance during breast examinations. The aim is to make breast cancer screening more accessible, including for women living far from advanced hospitals and healthcare facilities.

The company is currently completing the second phase of a clinical study involving 5,000 women in Ethiopia. Women in whom suspicious lumps were identified through physical examination were subsequently examined using N23 Health’s AI-assisted portable ultrasound solution.

According to the company, results from the first phase of the study show that Ethiopian nurses, supported by the company’s AI solution, identified suspected cancer at levels comparable to Swedish radiologists. In parallel, a clinical study is being conducted in Malmö, Sweden, where Swedish radiologists have evaluated the technology, which has so far shown highly promising results.

Once both studies are completed, the company will have sufficient clinical data to move forward towards MDR approval, representing a step towards market entry.

The AI model is based on research by Kristina Lång, physician and researcher at Lund University. She recently published the largest randomized controlled study to date on AI support in mammography in the scientific journal The Lancet.

“We want to make breast cancer screening accessible to everyone. We plan to launch the product in Europe and other parts of the world, but we are starting in Africa because the need is significant, there is openness towards AI-based healthcare, and the route to market is shorter. We are very excited to continue developing the company with support from SmiLe,” says Lisa Falco, CEO of N23 Health, who previously has experience from developing successful femtech companies.

“N23 Health combines strong science with a clear understanding of where the need is greatest. By expanding access to breast cancer screening in underserved markets, the team is addressing an important healthcare challenge while building a company with significant potential. We are pleased to welcome Lisa and her team to SmiLe,” says Kush Punyani, CBO and business coach, SmiLe Venture Hub.