Check-Cap (NASDAQ:CHEK) stock is heading higher on Monday after the company announced approval from the U.S. Food and Drug Administration (FDA) for one of its devices.
According to the company, the FDA has appvoed its Investigational Device Exemption (IDE) application for C-Scan. This is a medical device made by the company to detect polyps before they potentially become colorectal cancer.
Approval from the FDA means that Check-Cap can move forward with clinical studies of the device. It’s main use will be for people unable or unwilling to have a conoloscopy done to check for polyps.
One of the biggest advantages that C-Scan offers over a conoloscopy is convience. The disgnostic scan doesn’t require any preperation time from patients, which could make it a more accesible option.
The positive news for CHEK stock doesn’t stop there. The company also mentions that the FDA granted it Breakthrough Device Designation to C-Scan. This is for checking for polyps that are 1 cm of bigger in pateints with average risk that aren’t suitable for a colonoscopy.
Alex Ovadia, CEO of Check-Cap, said this about the news boosting CHEK stock up today.
“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.”
CHEK stock saw heavy trading this morning on the news. As of this writing, more than 222 million shares of the stock changed hands. For comparison, it’s daily average trading volume is 19.7 millino shares.
CHEK stock was up 125% as of Monday morning.
On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article.