Check-Cap touts interim post-CE Mark C-Scan study results

Check-Cap (NSDQ:CHEK) today released interim results from the post-CE Mark approval study of its C-Scan system version 3, touting the device’s ability to detect polyps in un-prepped colons.

The Israel-based company’s C-Scan system is designed as an alternative to standard colon cancer screening methods. The system uses an ingestible, ultra-low dose X-ray capsule and a wireless tracking system to return structural information on the lumen of the colon to create 2D and 3D maps.

The study aimed to assess the safety and clinical performance of the C-Scan system version 3 in detecting polyps, Check-cap said. Data came from 31 evaluable patients, the company added.

Results indicated that the C-Scan version 3 had a sensitivity of 76% and a specificty of 80% in detecting polyps, with results confirmed through colonoscopies, Check-Cap said. The company said that analysis of the results were performed by independent, blinded expert investigators.

“We are excited to unveil the multidimensional screening capabilities of the C-Scan system. We believe that the encouraging interim results from our ongoing post CE approval study demonstrate a significant progress in the clinical performance of C-Scan compared with previously communicated CE study results for our patient-friendly, and preparation free colon-cancer screening device. These results were achieved through the continuous improvements in cross-system algorithms, while maintaining C-Scan’s strong safety profile. As our post CE approval study continues, with final results planned in 2Q/19 on a more substantial number of patients, we look forward to delivering on our near-term milestones for the remainder of 2018 and forward, including the establishment of the GE manufacturing line and regulatory path in the United States towards the expected initiation of our U.S. pilot trial in 4Q/18,” CEO Alex Ovadia said in a press release.

“I believe that these interim clinical results demonstrate the C-Scan system’s potential to become a meaningful colon cancer prevention device. Despite the large body of evidence suggesting that polyp detection and removal can decrease CRC incidence and mortality, the screening adherence among target population is still relatively low. By maintaining this level of clinical performance, C-Scan has the ability to influence screening adherence for those who are unable to undergo a colonoscopy or are unwilling to choose standard CRC screening tests for precancerous polyp detection or stool collection (known to be less effective for precancerous polyp detection) due to common barriers such as unpleasant bowel preparation requirements, invasiveness or stool collection. C-Scan continuously supports the promise to provide a patient-friendly option that could potentially increase CRC screening rates and save lives,” principal investigator Dr. Nadir Arber of the Tel-Aviv Sourasky Medical Center said in a prepared statement.

In May, Check-Cap said that it closed an offering of Series C shares and warrants, raising approximately $20.2 million in total.

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