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Intelligent Bio Solutions | 8-K: Current report

Intelligent Bio Solutions | 8-K: Current report

Intelligent Bio Solutions | 8-K:重大事件
美股SEC公告 ·  08/01 17:17
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On August 1, 2024, Intelligent Bio Solutions Inc., a medical technology company listed on NASDAQ under the symbol INBS, announced a partnership with CenExel, a nationwide clinical research site network. This collaboration is to conduct a method comparison clinical study as part of Intelligent Bio Solutions' FDA 510(k) clinical study plan for its drug screening system. The study aims to recruit 135 healthy adult subjects across three sites to compare the results of fingerprint sweat opiate screening tests with those from a liquid chromatography mass spectrometry (LC-MS/MS) method. The company's President and CEO, Harry Simeonidis, expressed confidence in the progress towards the FDA submission planned for the fourth quarter of the year. The study is a critical step in demonstrating the accuracy of the Intelligent Fingerprinting Drug Screening System, which includes a drug screening cartridge and a fluorescence reader, intended for non-invasive opiate detection. The company recently completed an in-clinic pharmacokinetic study on opiates in human fingerprint sweat and is set to commence the method comparison study in August 2024.
On August 1, 2024, Intelligent Bio Solutions Inc., a medical technology company listed on NASDAQ under the symbol INBS, announced a partnership with CenExel, a nationwide clinical research site network. This collaboration is to conduct a method comparison clinical study as part of Intelligent Bio Solutions' FDA 510(k) clinical study plan for its drug screening system. The study aims to recruit 135 healthy adult subjects across three sites to compare the results of fingerprint sweat opiate screening tests with those from a liquid chromatography mass spectrometry (LC-MS/MS) method. The company's President and CEO, Harry Simeonidis, expressed confidence in the progress towards the FDA submission planned for the fourth quarter of the year. The study is a critical step in demonstrating the accuracy of the Intelligent Fingerprinting Drug Screening System, which includes a drug screening cartridge and a fluorescence reader, intended for non-invasive opiate detection. The company recently completed an in-clinic pharmacokinetic study on opiates in human fingerprint sweat and is set to commence the method comparison study in August 2024.
2024年8月1日,納斯達克上市的醫療技術公司Intelligent Bio Solutions Inc.,(標的INBS)宣佈與全國性的臨床研究機構網絡CenExel合作。這項合作旨在進行一項方法比較臨床研究,作爲Intelligent Bio Solutions公司針對其藥物篩選系統的FDA 510(k)臨床研究計劃的一部分。該研究旨在在三個地點招募135名健康成年受試者,比較指紋汗液阿片篩選檢測和液相色譜質譜( LC-MS/MS)方法的結果。公司總裁兼首席執行官Harry Simeonidis 對於該公司計劃在年底提交FDA審批的進展表示信心。該研究是展示Intelligent Fingerprinting藥物篩選系統的準確性的關鍵一步,該系統包括藥物篩選芯片和熒光讀數器,用於非侵入式的阿片檢測。公司最近已完成一項關於人類指紋汗液中阿片藥代動力學的臨床研究,並將於2024年8月開始進行方法比較研究。
2024年8月1日,納斯達克上市的醫療技術公司Intelligent Bio Solutions Inc.,(標的INBS)宣佈與全國性的臨床研究機構網絡CenExel合作。這項合作旨在進行一項方法比較臨床研究,作爲Intelligent Bio Solutions公司針對其藥物篩選系統的FDA 510(k)臨床研究計劃的一部分。該研究旨在在三個地點招募135名健康成年受試者,比較指紋汗液阿片篩選檢測和液相色譜質譜( LC-MS/MS)方法的結果。公司總裁兼首席執行官Harry Simeonidis 對於該公司計劃在年底提交FDA審批的進展表示信心。該研究是展示Intelligent Fingerprinting藥物篩選系統的準確性的關鍵一步,該系統包括藥物篩選芯片和熒光讀數器,用於非侵入式的阿片檢測。公司最近已完成一項關於人類指紋汗液中阿片藥代動力學的臨床研究,並將於2024年8月開始進行方法比較研究。
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