Question · Q2 2015
Matt Keeler from Credit Suisse inquired about the company's commercial expectations, including the timeline to achieve full commercial coverage, and asked how CureXcell's clinical data would resonate with physicians compared to competitors' claims from smaller studies.
Answer
President & CEO Nissim Mashiach outlined a commercial launch timeline for early 2018, following a BLA filing in H2 2016 and a 10-month FDA review. CFO Mark Page noted that dialogue with CMS would begin in 2016. CMO Mike Molyneaux emphasized that their reimbursement cycle would be faster than typical MedTech products due to rigorous FDA-approved trial data. Regarding competition, Dr. Molyneaux stated that physicians view their rigorous Phase III trial as the 'next great hope' and understand its superiority over smaller, non-blinded studies. Mr. Mashiach highlighted CureXcell's ease of use as a key differentiator.