Shares of Check-Cap LTD (NASDAQ: CHEK) more than doubled this morning following the U.S. Food and Drug Administration's (FDA) approval of the Company’s C-Scan Device. The Pharmaceutical Company, based in Isfiya, Israel, dedicates its research to cancer detection technology. More specifically, the Company’s patented C-Scan device will help screen for colo-rectal cancer.
C-Scan could be game changing, as instead of patients undergoing a colonoscopy which is generally uncomfortable, they ingest a pill-like device that travels throughout the colon. The device uses ultra-low dose x-rays to scan the colon for polyps, clumps of cells that can potentially be cancerous. Patients can go about their daily routine as results are cloud-based, which allows doctors to analyze results from anywhere using a software called C-Scan View. The Company prides itself on C-Scan’s ability to provide its patients with comfort and convenience, requiring no preparation time or invasive operations.
C-Scan has been approved for clinical study in both Israel and the E.U., but until now was not approved in the U.S. However, the FDA has now approved Chek-Cap’s application for an Investigational Device Exemption (IDE) to begin trials in the U.S. After C-Scan’s approval, the Company’s CEO Alex Ovadia stated, “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.” Following the news, shares of CHEK traded as high as USD 4.24 and are currently up 110%, with trading volume reaching over 333 million shares today.