Koios Medical

Executive Summary

Koios Medical is a US-based medical technology company that has developed an FDA-cleared and CE-marked AI-powered clinical decision support platform, Smart Ultrasound®, to assist radiologists in diagnosing breast and thyroid cancer from ultrasound images. Founded in 2014 and headquartered in Buffalo, New York, the company's software analyzes suspicious lesions, improving diagnostic accuracy and reducing false positives. By integrating seamlessly into existing ultrasound workflows, Koios Medical aims to enhance efficiency and confidence in cancer detection, addressing a critical need in radiology where skill variability can impact outcomes. The platform has been validated in multiple clinical studies and is deployed in clinical settings, offering a scalable solution that can be used with any ultrasound system. Koios Medical operates in the rapidly growing AI diagnostics market, where demand for non-invasive, cost-effective cancer screening tools is rising. Its key differentiators include proprietary algorithms trained on large, diverse datasets and regulatory approvals in both the US and Europe, positioning it for commercial expansion. The company is likely pursuing additional indications, such as liver or ovarian cancer, and exploring partnerships with ultrasound manufacturers and healthcare systems to broaden adoption. With a conviction score of 65, Koios demonstrates meaningful commercial traction and a clear path to growth, though financial details and larger commercial scale remain unverified.

Upcoming Catalysts (preview)

• Q1 2027FDA clearance for additional ultrasound indication (e.g., liver lesions)60% success
• Q4 2026Publication of prospective multicenter clinical study in a leading radiology journal70% success
• H2 2026Strategic partnership with a top ultrasound OEM or large health system50% success