Soteria Medical B.V.

Soteria Medical B.V. is a specialized medical device manufacturer focused on MRI-guided in-bore prostate biopsy solutions. The company has developed a proprietary Remote Controlled Manipulator (RCM)—a fully MRI-compatible robotic device for precision prostate interventions. The RCM enables real-time, near real-time targeting of suspicious prostate lesions within the MRI bore, significantly improving diagnostic accuracy for prostate cancer detection and reducing the need for multiple unnecessary biopsy cores. The RCM system addresses key clinical challenges: it delivers high diagnostic accuracy (reported 70% prostate cancer detection rates), reduces procedure duration (typically under 30 minutes), minimizes patient discomfort by eliminating general anesthesia, and improves specimen quality for pathological analysis. The device features intuitive planning software and remote needle-guide positioning, enabling radiologists to perform precise, guided biopsies with minimal patient motion and reduced in-bore time. Soteria Medical's technology has been validated by leading radiologists across multiple institutions in Europe (Spain, Italy, Netherlands, France, Norway), with testimonials emphasizing clinical safety, diagnostic efficiency, and positive patient experience compared to transrectal ultrasound (TRUS) guidance. The company's offering is positioned for hospital radiology departments and diagnostic imaging centers specializing in urologic oncology and prostate cancer diagnosis. Recent market recognition includes CMS introduction of dedicated CPT codes (55713, 55714) for in-bore MR-guided prostate biopsy, reflecting clinical differentiation and reimbursement support in the US market. Soteria Medical is an active participant in major medical imaging conferences (ECR).