Check-Cap (NSDQ:CHEK) said it finalized a manufacturing line transfer implementation and qualification with the healthcare business at General Electric (NYSE:GE) for its C-Scan system, a preparation-free ingestible scanning capsule-based system designed to prevent colorectal cancer. The C-Scan system is in the midst of a pilot clinical trial at the New York University School of Medicine and […]
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Check-Cap signs second trial site, beats Street on Q1 loss
Check-Cap (NSDQ:CHEK) said today that Mayo Clinic (Rochester, Minn.) has signed on as the second trial site in the U.S. pilot study of the company’s C-Scan colorectal cancer-screening system. The single-arm study to evaluate the safety and usability of the X-ray-enabled, cancer-screening capsule will enroll up to 45 adults considered to be at average risk […]
Check-Cap’s cancer screening capsule will have U.S. study
Check-Cap (NSDQ:CHEK) said its X-ray-enabled, colorectal cancer-screening capsule will have a pilot study in the United States. The Isfiya, Israel-based startup makes the C-Scan System, an ingestible capsule used to detect precancerous polyps without the need for laxatives or an invasive procedure. The C-Scan system uses an ultra-low dose X-ray capsule, an integrated positioning, control, and recording system, and proprietary […]
Check-Cap raises $8m
Check-Cap (NSDQ:CHEK) said today that it inked a direct registered offering deal worth approximately $7.5 million to support the continued development of its C-Scan system. 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 […]
Check-Cap wins conditional IDE approval for C-Scan pilot study
Check-Cap (NSDQ:CHEK) said today it won conditional approval from the FDA for its investigational device exemption application to launch a pilot study of its C-Scan system. 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 […]
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 […]
Check-Cap closes $20m Series C
Check-Cap (NSDQ:CHEK) said yesterday it closed an offering of Series C shares and warrants, raising approximately $20.2 million in total. In the offering, the Isfiya, Israel-based company floated approximately 3.2 million units for $5.50 per unit, with each unit in the offering consisting of a single ordinary share or ordinary share equivalent and a Series C […]
Check-Cap prices $18m offering
Check-Cap (NSDQ:CHEK) late last week announced an upcoming offering looking to raise approximately $17.5 million. In the offering, the Isfiya, Israel-based company will look to float approximately 3.2 million units for $5.50 per unit. Each unit in the offering consists of a single ordinary share or ordinary share equivalent and a Series C warrant to purchase one […]
Check-Cap initiates 1-for-12 reverse split
Check-Cap (NSDQ:CHEK) said that earlier this month it initiated a 1-for-12 reverse stock split as it looked to regain compliance with the NASDAQ stock market’s minimum bid pricing requirement. With the move, which was effected on April 4, the Israel-based company put a single share into the hands of every shareholder for each 12 shares they held […]
Check-Cap wins CE Mark for C-Scan diagnostic capsule
Check-Cap (NSDQ:CHEK) said today it won CE Mark approval in the European Union for its C-Scan ingestible sensor capsule designed for colorectal cancer screening. 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 […]
Check-Cap seeks CE Mark for C-Scan diagnostic capsule
Check-Cap (NSDQ:CHEK) said today that it filed for CE-Mark registration of its C-Scan ingestible capsule, designed for preparation-free, colorectal cancer screening. Data used to support the EU regulatory submission showed that C-Scan had a 44% sensitivity in the 45 study participants included in an analysis for polyps, with 89% specificity. The company reported that sensitivity strongly […]
