ProUroScan – Regulatory Status

On April 27, 2012, the FDA approved the ProUroScan System for commercialization in the United States. The FDA clearance of the ProUroScan System with a single-use sensor probe was a key step in our plans to bring the system to market. During the course of the regulatory review process, the FDA issued an industry draft guidance document pertaining to cleaning and disinfecting reusable medical devices, which changed certain requirements needed for approval of the ProUroScan as a reusable device. Therefore, even though the probes were used multiple times during the clinical trials, we elected to classify the ProUroScan probe under review as a single-use disposable device in order to avoid any additional clearance delays that might have resulted from performing and documenting additional cleaning and disinfecting tests as required by the new FDA guidance. In order to achieve widespread utilization of the system, however, we need to gain regulatory approval of a multiple-use sensor probe that meets the requirements of the reusable medical devices draft guidance. We are currently in the process of finalizing a limited number of small changes to the probe designed to facilitate an effective cleaning and disinfection protocol. This will result in the submission of a new 510(k) application for FDA market clearance of the probe as a reusable device. We believe that this work and FDA 510(k) clearance can be done concurrently with the marketing scale-up activities outlined in the previous section.