Business
Check-Cap Reports Second Quarter 2020 Financial Results and Corporate Highlights
IDE submission to the FDA for C-Scan® planned for the end of 2020; Initiation of a U.S. pivotal study planned for 2021 ISFIYA, Israel, Aug. 6, 2020
About this update from Check-cap Ltd.
[{"type":"text","content":"IDE submission to the FDA for C-Scan® planned for the end of 2020; Initiation of a U.S. pivotal study planned for 2021\n\n\nISFIYA, Israel, Aug. 6, 2020 /PRNewswire/ -- Check-Cap Ltd. (the \"Company\" or \"Check-Cap\") (NASDAQ: CHEK), (NASDAQ: CHEKZ), a clinical stage medical diagnostics company advancing the development of C-Scan®, the first and only patient-friendly preparation-free screening test to detect polyps before they may transform into colorectal cancer, today announced financial results for the second quarter and six months ended June 30, 2020.\n \n \nSecond Quarter and Recent Highlights:\nStrengthened balance sheet through gross proceeds of $16.3 million in registered direct offerings and a private placement of ordinary shares in the first half of 2020, followed by $9.6 million in a warrant exercise financing in July 2020. Company believes that it has sufficient capital to fund its ongoing operations and plans for at least the next 12 months. \nInvestigational Device Exemption (IDE) submission to the FDA planned for the end of 2020, with initiation of a U.S. pivotal study of C-Scan planned for 2021. \n\"I am happy with the progress we made during the first six months of 2020 and delighted to observe our team's commitment despite the ongoing global COVID-19 crisis. While some of the measures we took at the beginning of the pandemic slowed our anticipated progress, we have resumed near normal operations, including resuming ongoing collection of clinical data in Israel in the third quarter of 2020, and have been successfully adapting ourselves to the dynamic environment,\" said Alex Ovadia, chief executive officer of Check-Cap. \"We anticipate IDE submission to the FDA by the end of 2020 and continue to refine and advance C-Scan to support initiation of a U.S. pivotal study in 2021. This includes establishing manufacturing capacity, quality infrastructure and collection of substantial additional data on device usability.\"\nMr. Ovadia added, \"We have strengthened our ability to achieve corporate objectives with a total of $25.8 million raised during 2020. As a result, and despite these challenging times, we believe that we are well-positioned to fund our ongoing operations well into 2021, including our plans toward the initiation of the pivotal U.S. trial, while exploring partnerships with potential strategic industry...