The single-arm study to evaluate the safety and usability of the X-ray-enabled, cancer-screening capsule will enroll up to 45 adults considered to be at average risk for polyps and colon cancer. It began last month.
The C-Scan system uses an ultra-low dose X-ray capsule, an integrated positioning, control, and recording system, and proprietary software to generate a 3D map of the inner lining of the colon without the need for laxatives or an invasive procedure. It received approval from Israel’s Ministry of Health Medical Device division (AMAR) and the CE Mark in 2018. AMAR recently gave the Isfiya, Israel-based startup an extension to begin commercial sales of C-Scan in Israel, valid until March 31, 2020.
“We are thrilled to collaborate with Mayo Clinic as a part of our U.S. pilot study of the C-Scan system,” said Check-Cap CEO Alex Ovadia in a news release. “Together with the continued progress being made at our first trial site, the New York University School of Medicine, we are advancing this study, and look forward to final results later this year as we prepare for a U.S. pivotal study.”
Check-Cap also reported first-quarter earnings today, just slightly beating analysts’ per-share earnings projections. The company said it lost $3.146 million in the quarter ended March 31, 2019, compared with a loss of $2.127 million in the same quarter last year. It also increased R&D spending by 44% to $3.6 million during the quarter.
It posted a per-share net loss of 0.44¢, besting Q1 2018’s $1.27 net loss and analysts’ consensus of -0.46¢. Investors reacted by sending CHEK stock down 6% to $2.18 per share at the close.
In February, the company inked a direct registered offering deal worth approximately $7.5 million to advance the clinical development of C-Scan in the U.S.
“We believe the availability of a patient-friendly, preparation-free colon cancer screening alternative such as C-Scan can fundamentally alter the screening and prevention paradigm and significantly increase screening rates globally, leading to improved outcomes for patients while creating long-term value for our shareholders,” Ovadia said.