In the amended C-Scan pivotal trial design that Check-Cap Ltd. (CHEK:NASDAQ) submitted to the U.S. Food and Drug Administration, the medical diagnostics company added a second component which would be conducted before the existing part, H.C. Wainwright & Co. analyst Yi Chen reported. The added component would involve further calibrating the system and enhancing the algorithm for the U.S. population that is at average risk of developing polyps.
In the subsequent, second trial component, C-Scan performance would be compared to that of colonoscopy and analyzed for statistical significance.
Chen highlighted that with the previously conducted U.S. pivotal C-Scan study of 40 patients, neither serious events nor capsule retention occurred. Abdominal cramping was the most commonly reported side effect.
Patients were significantly (p=0.001) more likely to recommend the C-Scan than colonoscopy, which received scores of 4.1 and 2.8, out of 5, respectively.
"Bowel preparation is one of the most important deterrents to colorectal cancer screening," Chen wrote. "Therefore, C-Scan's preparation-free approach offers an accessible alternative that facilitates the detection of precancerous colorectal polyps and may increase screening rates in subjects who are at average risk for colorectal cancer."
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Disclosures for H.C. Wainwright & Co. LLC, Check-Cap Ltd., Jan. 14, 2022
This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules.
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H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
I, Yi Chen, Ph.D. CFA and Raghuram Selvaraju, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst’s household has a financial interest in the securities of Check-Cap Ltd. (including, without limitation, any option, right, warrant, future, long or short position).
As of December 31, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Check-Cap Ltd.
Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The Firm or its affiliates did receive compensation from Check-Cap Ltd. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Check-Cap Ltd. during the past 12 months.
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