Shares of medical diagnostics company Check-Cap (NASDAQ: CHEK) are surging premarket on Monday after it announced that the U.S. Food and Drug Administration (FDA) approved its Investigational Device Exemption (IDE) application, permitting Check-Cap to begin a study of C-Scan in the US.
Check-Cap's share price has gained 122%, trading at $3.41 following the news. For the year to date, its shares are up 232.6%.
C-Scan is to be used on patients at average risk for colorectal cancer (CRC) and poor candidates for colonoscopy or decline colonoscopy. The pivotal study will evaluate the safety and performance of C-Scan as well as compliance.
“The IDE approval is a significant milestone for Check-Cap. Now with IDE in hand, we aim to enter the last phase of demonstrating the clinical potential of C-Scan in the U.S., with the ultimate goal of commercialization in this important market,” said Alex Ovadia, CEO of Check-Cap.
“We are in active discussions with a number of clinical sites as part of our preparations to begin the pivotal study in late 2021,” added Ovadia.