Quantason has developed protocols for two rounds of clinical studies. The protocols have been developed based on the American College of Radiology Imaging Network (ACRIN) - www.acrin.org - studies and guidelines:
- Pilot Study: Designed to commence following completion of a series of clinical-grade IDUS™ alpha prototypes designed for clinical validation and efficacy. The study will be conducted in one center and involve a limited number (< 30) of women. The pilot study will commence 21-24 months following the closing of the current investment round.
- Two-Center Clinical Study: Designed to commence following completion of the Pilot Study and development of a series of fully-integrated IDUS™ beta prototypes for statistical analyses, FDA submission, and workflow and compliance assessment. The commercial IDUS™ systems will be developed 40-48 months following the closing of the current investment round.