The company expects to start the US main test in late 2021
ISFIYA, Israel, March 15, 2021 / PRNewswire / – Check-Cap Ltd. (the “Company” or “Check-Cap”) (NASDAQ: CHEK), (NASDAQ: CHEKZ), a clinical diagnostic medical company that promotes the development of C-Scan® , the first and only patient-friendly screening test, without preparation, to detect polyps before they turn into colorectal cancer (CRC), announced today that the US Food and Drug Administration (FDA) has approved the Investigative Device Exemption (IDE ) of the Company), allowing Check-Cap to initiate a fundamental study of C-Scan in the USA. The C-Scan is intended for candidates with a medium risk of CRC and who are weak candidates for colonoscopy or declining colonoscopy, or who have had an incomplete colonoscopy for optical colonoscopy. The main study will assess the safety and performance of the C-Scan, as well as the patient’s compliance with the C-Scan.
“IDE approval is a significant milestone for Check-Cap. Now with IDE in hand, we intend to enter the last phase of demonstrating the clinical potential of C-Scan in the USA, with the ultimate goal of commercialization in this important market, “said Alex Ovadia, CEO of Check-Cap. “We are in active discussions with several clinical centers as part of our preparations to start the main study in late 2021. In parallel, as previously announced, we will continue to optimize C-Scan performance and the patient experience through additional clinical data collection in Israeli locations. To that end, we are preparing to start a study in Israel in more than 10 clinical centers to enroll up to 250 medium-risk patients. “
Mr. Ovadia continued: “We are also pleased to announce that the FDA has approved the company’s innovative device designation for the intended use of identifying candidates within the medium-risk population who are at high risk of polyps equal to or greater than 1 cm and are poor candidates for colonoscopy. We believe this highlights the FDA’s recognition of C-Scan as an alternative method to address the significant unmet need for patient-friendly CRC screening, in particular because it allows the detection of colorectal polyps before they turn into cancer.
In addition, the updated American College of Gastroenterology (ACG) CRC screening guidelines published in March 2021, recommend colon capsules as an option for CCR screening in people who do not want or cannot undergo a colonoscopy or Fecal Immunochemical Test (FIT). Since screening for precancerous polyps offers an opportunity for early intervention and cancer prevention, C-Scan can be considered an option for these individuals, if approved. “
To learn more about Check-Cap and C-Scan, visit the company’s website at www.check-cap.com.
About colorectal cancer
Every year, about 935,000 deaths occur as a result of colorectal cancer (CRC) and more than 1.9 million new cases are identified. CCR usually begins as precancerous polyps or abnormal growths in the colon or rectum, which can be present for up to 10 years before progressing to invasive cancer. As a result, screening for polyps before they develop into cancer is the most direct method for preventing CCR. Despite evidence that standard colonoscopy screening can prevent RCC, adherence remains low due to necessary intestinal preparation, invasiveness and, in some communities, limited access. Most of the patient-friendly CRC screening tests currently available, or about to enter the market, such as fecal or liquid biopsy tests, are designed primarily to detect cancer and demonstrate low sensitivity in the detection of precancerous polyps. As such, they do not necessarily provide patients with the time window to prevent the disease. There is, therefore, an unmet medical need for non-invasive screening methods that can detect precancerous polyps.
About Check-Cap
Check-Cap is a medical diagnosis company in clinical stage with the objective of redefining colorectal cancer (CRC) screening by introducing C-Scan®, the first and only screening test without patient friendly preparation to detect polyps before that they turn into colorectal cancer to allow early intervention and cancer prevention. The company’s disruptive capsule-based screening technology aims to significantly increase adherence to screening worldwide and help millions of people stay healthy through preventive CRC screening. C-Scan uses an ultra-low dose X-ray capsule, an integrated positioning, control and recording system, as well as proprietary software to generate a 3D map of the colon’s inner lining as it travels naturally along the gastrointestinal tract. C-Scan is non-invasive and does not require sedation. Unlike other capsule technologies, it does not require intestinal preparation, allowing patients to continue their daily routine without interruption. C-Scan is not intended to replace colonoscopy. A positive C-Scan result should be followed by colonoscopy.
Legal notice regarding forward-looking statements
This press release contains “forward-looking statements”. Words like “can”, “should”, “could”, “would”, “foresee”, “potential”, “continue”, “wait”, “anticipate”, “future”, “intend”, “plan,” “believes”, “esteem” and similar expressions, as well as forward-looking statements, generally mean forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be an accurate indication of when such performance or results will be achieved. Forward-looking statements are based on information that the Company has when these statements are made or management’s good faith belief at that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to be material. different from those expressed or suggested by the forward-looking statements. For a discussion of these and other risks that may cause such differences and that may affect the making of forward-looking statements, see “Forward-looking statements” and “Risk factors” in the Company’s Annual Report on Form 20-F for the year ended December 31, 2019 and other filings with the Securities and Exchange Commission (SEC). Investors and bondholders should read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company does not undertake any obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Investor Contacts
Irina Koffler
LifeSci Advisors, LLC
646,970,4681
[email protected]
Meirav Gomeh-Bauer
LifeSci Advisors, LLC
+972 (0) -54-476-4979
[email protected]
Media contact
Monica Rouco Molina
Senior Account Executive
LifeSci Communications
[email protected]
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SOURCE Check-Cap Ltd.