Check-Cap Ltd (NASDAQ: MBAI)

Check-Cap Ltd is a clinical stage medical diagnostics company dedicated to improving colorectal cancer screening through its C Scan capsule based imaging system. The system consists of three components: an ingestible C Scan Cap that emits ultra low dose X rays while traveling through the gastrointestinal tract, a C Scan Track worn on the patient’s back to receive and store the transmitted data, and a C Scan View software that processes the data into two and three dimensional images of the colon lining. By avoiding the need for bowel cleansing or sedation, C Scan aims to address the low adherence rates seen with conventional colonoscopy, which is currently the gold standard for detecting precancerous polyps. The company notes that colorectal cancer is the third most commonly diagnosed cancer worldwide and that early detection of adenomatous polyps can prevent progression to invasive disease. Check Cap Ltd has received a Breakthrough Device designation from the U S Food and Drug Administration and holds a CE mark of conformity for the European Union, allowing distribution in those markets pending further clinical validation.

Check-Cap Ltd has not generated product sales to date and does not anticipate significant revenue in the near future. The company has financed its operations primarily through equity offerings, including the initial public offering on Nasdaq in February 2015, subsequent sales of ordinary shares and warrants, and the exercise of those warrants. Additionally, it has received non dilutive funding from the Israel Innovation Authority in the form of research and development grants. As a result of its focus on research and development and the decision to pause clinical activities in mid 2023, the company has reported net losses in recent years and an accumulated deficit, relying on continued access to capital markets to sustain operations.

The company does not report separate operating segments in its filings.

Check-Cap Ltd operates in the highly competitive field of colorectal cancer screening where established methods include optical colonoscopy, flexible sigmoidoscopy, computed tomography colonography and stool based immunochemical or DNA tests. Major competitors in the device space consist of Olympus, Pentax, Fujifilm, GE Healthcare, Siemens Healthineers, Philips and Toshiba, which provide endoscopic and imaging equipment with substantial financial resources and global distribution networks. In the non invasive stool test arena, companies such as Exact Sciences with its Cologuard product and Epigenomics AG offer alternatives that rely on biomarker detection rather than direct visualisation. Despite this competition, Check Cap Ltd believes its C Scan system offers a differentiated approach by combining low radiation exposure with a fully non invasive workflow that eliminates the need for bowel preparation or sedation, potentially improving patient compliance and expanding the addressable screening population. The company has also received a Breakthrough Device designation from the U S Food and Drug Administration, which is intended to facilitate expedited review and potential future clearance or approval of its technology.

Check-Cap Ltd intends to serve gastroenterology clinics, hospitals and ambulatory surgical centers that perform colorectal cancer screening, as well as the patients who undergo those examinations. The company has not disclosed specific customer names in its public filings, noting that its current activities are primarily pre commercial and focused on product development and clinical evaluation.