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Check-Cap Reports Initiation Of US Pivotal Trial
Check-Cap Reports Initiation Of US Pivotal Trial
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 (CRC), today announced the initiation of its U.S. pivotal trial of C-Scan® at Mayo Clinic in Rochester Minnesota.
The Company has successfully obtained Institutional review board (IRB) approval for the study and expects to promptly begin patient enrollment. Elizabeth Rajan, M.D., gastroenterologist, and professor of medicine at Mayo Clinic, will be the principal investigator of the study at this site.
"We are excited to announce the accomplishment of this important milestone in our path to demonstrate the potential of C-Scan to detect colorectal polyps before they may turn into cancer in the average-risk population," said Alex Ovadia, chief executive officer of Check-Cap. "We are pleased to have engaged with expert gastroenterologists at Mayo Clinic and continue to advance the participation of additional experienced clinical trial centers in this study. We have established a supply and distribution infrastructure and process of the C-Scan and our plan is to complete the calibration portion of the trial and begin the second statistically powered portion of the study during Q4 2022."
Mr. Ovadia continued, "Detecting precancerous polyps is needed to effectively prevent colorectal cancer. However, the acceptance of the colonoscopy procedure is low, in part due to the invasiveness of the procedure and bowel cleansing. We believe Check-Cap has the potential to reach those who are deterred by colonoscopy and to help improve colon cancer screening through a patient-friendly solution without the need of bowel cleaning, sedation, and fasting."
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 (CRC), today announced the initiation of its U.S. pivotal trial of C-Scan® at Mayo Clinic in Rochester Minnesota.
亞洲網加利福尼亞州聖何塞10月23日電推動C-SCAN®開發的臨牀階段性醫療診斷公司Check-Cap Ltd.(以下簡稱“公司”或“Check-Cap”)(納斯達克代碼:CHEKZ)今天宣佈,在明尼蘇達州羅切斯特市的梅奧診所啟動其C-SCAN®的美國關鍵試驗。
The Company has successfully obtained Institutional review board (IRB) approval for the study and expects to promptly begin patient enrollment. Elizabeth Rajan, M.D., gastroenterologist, and professor of medicine at Mayo Clinic, will be the principal investigator of the study at this site.
該公司已經成功地獲得了機構審查委員會(IRB)對這項研究的批准,並預計將迅速開始患者登記。醫學博士、胃腸病專家、梅奧診所醫學教授伊麗莎白·拉詹將擔任這項研究的首席研究員。
"We are excited to announce the accomplishment of this important milestone in our path to demonstrate the potential of C-Scan to detect colorectal polyps before they may turn into cancer in the average-risk population," said Alex Ovadia, chief executive officer of Check-Cap. "We are pleased to have engaged with expert gastroenterologists at Mayo Clinic and continue to advance the participation of additional experienced clinical trial centers in this study. We have established a supply and distribution infrastructure and process of the C-Scan and our plan is to complete the calibration portion of the trial and begin the second statistically powered portion of the study during Q4 2022."
Check-Cap首席執行官亞歷克斯·奧瓦迪亞説:“我們很高興地宣佈,在我們的道路上完成了這一重要的里程碑,展示了C-掃描在普通風險人羣中可能轉化為癌症之前發現結直腸息肉的潛力。”我們很高興與梅奧診所的胃腸病專家合作,並繼續推動更多經驗豐富的臨牀試驗中心參與這項研究。我們已經建立了C掃描的供應和分銷基礎設施和流程,我們的計劃是完成試驗的校準部分,並在2022年第四季度開始研究的第二個統計支持部分。
Mr. Ovadia continued, "Detecting precancerous polyps is needed to effectively prevent colorectal cancer. However, the acceptance of the colonoscopy procedure is low, in part due to the invasiveness of the procedure and bowel cleansing. We believe Check-Cap has the potential to reach those who are deterred by colonoscopy and to help improve colon cancer screening through a patient-friendly solution without the need of bowel cleaning, sedation, and fasting."
Ovadia先生繼續説:“檢測癌前息肉是有效預防結直腸癌所必需的。然而,結腸鏡檢查程序的接受度很低,部分原因是該檢查程序和腸道清潔的侵襲性。我們相信Check-Cap有潛力接觸到那些被結腸鏡檢查嚇倒的人,並通過一種患者友好的解決方案幫助改進結腸癌篩查,而不需要腸道清潔、鎮靜和禁食。”
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moomoo是Moomoo Technologies Inc.公司提供的金融資訊和交易應用程式。
在美國,moomoo上的投資產品和服務由Moomoo Financial Inc.提供,一家受美國證券交易委員會(SEC)監管的持牌主體。 Moomoo Financial Inc.是金融業監管局(FINRA)和證券投資者保護公司(SIPC)的成員。
在新加坡,moomoo上的投資產品和服務是通過Moomoo Financial Singapore Pte. Ltd.提供,該公司受新加坡金融管理局(MAS)監管(牌照號碼︰CMS101000) ,持有資本市場服務牌照 (CMS) ,持有財務顧問豁免(Exempt Financial Adviser)資質。本內容未經新加坡金融管理局的審查。
在澳大利亞,moomoo上的金融產品和服務是通過Futu Securities (Australia) Ltd提供,該公司是受澳大利亞證券和投資委員會(ASIC)監管的澳大利亞金融服務許可機構(AFSL No. 224663)。請閱讀並理解我們的《金融服務指南》、《條款與條件》、《隱私政策》和其他披露文件,這些文件可在我們的網站 https://www.moomoo.com/au中獲取。
在加拿大,透過moomoo應用程式提供的僅限訂單執行的券商服務由Moomoo Financial Canada Inc.提供,並受加拿大投資監管機構(CIRO)監管。
在馬來西亞,moomoo上的投資產品和服務是透過Moomoo Securities Malaysia Sdn. Bhd. 提供,該公司受馬來西亞證券監督委員會(SC)監管(牌照號碼︰eCMSL/A0397/2024) ,持有資本市場服務牌照 (CMSL) 。本內容未經馬來西亞證券監督委員會的審查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd.,Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc和Moomoo Securities Malaysia Sdn. Bhd., 是關聯公司。
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