The company expects to begin the US nuclear trial in late 2021
ISFIYA, Israel, 15 March 2021 / PRNewswire / – Check-Cap Ltd. (the “Company” or “Check-Cap”) (NASDAQ: CHEK), (NASDAQ: CHEKZ), a clinical-stage medical diagnostic enterprise that promotes the development of C-Scan® , the first and only patient-friendly, preparation-free screening test to detect polyps before they can turn into colorectal cancer (CRC), announced today that the US Food and Drug Administration (FDA) has approved the company’s Exemption for IUDs) application, which allows Check-Cap to launch a core study of C-Scan in the US. C-Scan is intended for candidates who have an average risk for CRC and who are weak candidates for colonoscopy or colonoscopy, or who have an incomplete optical colonoscopy. The core study will evaluate the safety and performance of C-Scan, as well as compliance with C-Scan.
“IDE approval is an important milestone for Check-Cap. Now with IDE in hand, we strive to enter the final phase to demonstrate the clinical potential of C-Scan in the US, with the ultimate goal of commercialization in this important market, said Alex Ovadia, CEO of Check-Cap. “We are engaged in active discussions with a number of clinical sites as part of our preparations to begin the core study at the end of 2021. At the same time, as previously communicated, we will continue to optimize the performance and patient experience of C-Scan by through additional clinical data collection on Israeli sites, therefore we are preparing to start a study Israel in more than ten clinical sites to enroll up to 250 patients at average risk. ‘
Mr. Ovadia continues: ‘We are also pleased to announce that the FDA has approved the company’s breakthrough device for its intended use to identify candidates within the average risk population who are at increased risk for polyps equal to or greater than 1 cm and which weak candidates for colonoscopy. We believe this underscores the FDA’s recognition of C-Scan as an alternative method of addressing the significant unmet need for patient – friendly CRC screening, especially as it enables the detection of colorectal polyps before they can become cancerous.
In addition, updated CRC screening guidelines from the American College of Gastroenterology (ACG) have been published on March 2021, recommends colon capsules as an option for CRC screening in people who are unwilling or unable to undergo a colonoscopy or Fecal Immunochemical Test (FIT). Since screening for pre-cancerous polyps provides the opportunity for early intervention and prevention of cancer, C-Scan can be considered as an option for those individuals, if approved. ‘
For more information on Check-Cap and C-Scan, visit the company’s website at www.check-cap.com.
About colorectal cancer
Every year, nearly 935,000 deaths from colorectal cancer (CRC) occur and more than 1.9 million new cases are identified. CRC usually begins as precancerous polyps or abnormal growths in the colon or rectum, which can be present for up to ten years before developing into invasive cancer. As a result, screening for polyps before they become cancer is the most direct method of preventing CRC. Despite evidence that standard examinations by colonoscopy may prevent CRC, compliance remains due to the required bowel preparation, invasiveness, and in some communities limited access. Most patient-friendly CRC screening tests currently available, or ready to enter the market, such as fecal or liquid biopsy tests, are primarily designed to detect cancer and show a low sensitivity in the detection of pre-cancerous polyps. As such, they do not necessarily provide patients with the time period to precede the disease. Thus, there is an unmet medical need for non-invasive screening methods that can detect pre-cancerous polyps.
About Check-Cap
Check-Cap is a clinical-stage medical diagnostic company that aims to redefine colorectal cancer screening (CRC) with the launch of C-Scan®, the first and only patient-friendly preparation-free screening test to detect polyps before they can be in colorectal cancer. alter. to enable early intervention and prevention of cancer. The company’s disruptive capsule-based screening technology aims to significantly increase compliance worldwide and help millions of people stay healthy through preventative 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 inner lining of the colon while naturally along the digestive tract move. C-Scan is non-invasive and requires no sedation. Unlike other capsule technologies, it is not necessary to prepare the bowel, which allows the 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 “power,” “must,” “could,” “would,” “predict,” “potential,” “continue,” “expect,” “expect,” “future,” “plan,” “plan , “” believe, “” estimates “and similar expressions, as well as statements in future tense, often indicate forward-looking statements. Forward-looking statements should not be read as a guarantee of future achievements or results, and may not be accurate indications of when such achievements or results will be achieved. Forward-looking statements are based on information the company has when making those statements, or the management’s good faith at that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in 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 realization of forward-looking statements, please refer to the “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 filing with the Securities and Exchange Commission (SEC). Investors and security holders are requested to read these documents free of charge on the SEC website, http://www.sec.gov. The Company accepts no obligation to publicly update or revise its forward-looking statements due to 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
Mónica Rouco Molina
Senior Account Manager
LifeSci Communication
[email protected]
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SOURCE Check-Cap Ltd.