Check-Cap has received approval from the Israeli Ministry of Health, the Medical Device Division (known as AMAR), to initiate commercial sales in Israel of the C-Scan system that received CE Mark approval in January 2018.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
"We are excited to receive approval from the Israeli Ministry of Health to initiate commercial sales in Israel of our C-Scan system,” Alex Ovadia, Chief Executive Officer of Check-Cap, said. “We believe that this approval reinforces the potential of the C-Scan system to increase CRC screening adherence and precancerous detection to ultimately reduce mortality by offering a preparation free, non-invasive and patient-friendly CRC screening option. We look forward to achieving our near-term planned milestones, which include commercializing the C-Scan system in Israel in the second quarter of 2019, pending extension of the AMAR approval and subject to engaging with a strategic partner and sufficient available capital."
The AMAR approval is valid until February 28, 2019 and its extension is subject to certain conditions detailed in the AMAR approval and the requirements of the Israeli Ministry of Health.