Check-Cap Ltd., (Nasdaq: CHEK, CHEKW) a clinical stage medical diagnostics company engaged in the development of a preparation-free ingestible imaging capsule that utilizes low-dose X-rays for the screening for colorectal cancer, today announced receipt of a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application U.S. 13/825,018 entitled, "Estimation of Distances and Size of Lesions in the Colon with an Imaging Capsule." The patent broadly covers Check-Cap's investigational preparation-free endoscopy capsule with a colon imaging system for detecting colorectal cancer and clinically-significant pre-cancerous polyps, and outlines a method for measuring distances inside a patient's colon and optionally using the measurements to construct an image of the inside of the colon. Once granted, the patent is expected to be valid through 2031.
The Check-Cap imaging system consists of an ingestible capsule that transmits colon section measurements through a radio frequency (RF) link to a data recorder. The single-use, disposable capsule is approximately 34 millimeters long and 11.5 millimeters wide, making it similar in size to other capsule endoscopy products. It advances through the body by natural motility, painlessly capturing and continuously transmitting data reflecting the colon's internal surface with the help of a contrast agent before being excreted naturally within two to three days. Patients are able to continue their normal daily routines throughout the process including normal food intake. Upon test completion, gastroenterologists or radiologists can analyze the data from any computer in less than 10 minutes.
The Check-Cap imaging system requires no fasting or prior bowel cleansing as the imaging capsule employs X-rays for colon section measurements. The X-rays are ultra-low dose (with radiation exposure approximating that of a single chest X-ray) and allow for 3-dimensional imaging of the lining of the colon even when the capsule is surrounded by intestinal content. The ability to transmit a full 360-degree radius around the capsule is expected to allow for the detection of polyps including those located behind colon folds.
"We are encouraged to receive this Notice of Allowance for another patent that will extend intellectual property coverage of our proprietary endoscopy capsule technology in the United States, representing a significant milestone and protecting the significant R&D work we have done," said Guy Neev, chief executive officer, Check-Cap. "Although colon cancer can be classified as preventable or curable with the aid of early screening, many patients have been reluctant to undergo currently available procedures. We are encouraged by the early clinical evidence suggesting the ability to image the preparation-free human colon and are optimistic that the Check-Cap imaging system may be an acceptable option for millions of patients."
In late 2015, Check-Cap plans to file for a CE mark for the marketing and sale of the Company's endoscopy capsule in the European Union and expects to perform post-marketing studies in Europe following CE marking for the purpose of collecting additional clinical data to support market adoption. Check-Cap anticipates initiating a clinical trial for FDA approval during 2016.
More than one million new cases of colorectal cancer are reported each year worldwide, according to the World Cancer Research Fund International. The World Health Organization attributes 690,000 deaths annually to this cancer, which is the second leading cause of cancer-related deaths in the western world. Invasive colonoscopy, considered the gold standard for colorectal screening, requires thorough cleansing of the colon, which many patients find to be the most burdensome aspect of colon cancer screening.
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