We’re developing the ClariCore™ Biopsy System for optimizing in vivo prostate tissue classification. Consisting of a controllable, single-use handpiece with integrated fiber optics and a companion console, this system will provide spectral analysis to rapidly classify whether tissue is normal or suspicious. We plan to conduct Phase 1 and 2 clinical trials, then apply for, and obtain, FDA approval upon successful completion of the trials.

Initial proof of concept.

To prove the initial concept, we conducted a Human Feasibility Pilot Study in 2012 with 13 patients at the University of Colorado Hospital. This study exceeded all expectations.

  • In-vivo and ex-vivo core samples demonstrated high correlation with optical responses
  • Proved feasibility of automated tissue classification in patients with prostrate cancer

Getting from here to your biopsy room.

We are working with the FDA on both the clinical and regulatory strategy to support commercialization of the ClariCore Biopsy System. Central to our journey are the extensive clinical trials we are conducting to ensure the safety and reliability of our system. We expect to submit the results of these studies to the FDA, with the goal of obtaining market clearance for the ClariCore Biopsy System.