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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,医疗科技公司Intelligent Bio Solutions Inc.在纳斯达克上市(股票代码INBS)并宣布与全国临床研究站点网络CenExel合作。该合作是Intelligent Bio Solutions的FDA 510(k)临床研究计划中进行方法比较临床研究的一部分。该研究旨在招募三个站点的135名健康成年受试者,以比较指纹排汗鸦片筛查测试和液相色谱质谱法(LC-MS/MS)方法的结果。该公司总裁兼首席执行官Harry Simeonidis表示,对于计划在该年第四季度提交的FDA申请的进展充满信心。研究是证明Intelligent Fingerprinting Drug Screening System精确性的关键步骤,该系统包括药物筛查盒和荧光读数仪,用于无创鸦片检测。该公司最近完成了关于人类指纹汗液中鸦片药物动力学的临床研究,将于2024年8月开始方法比较研究。
2024年8月1日,医疗科技公司Intelligent Bio Solutions Inc.在纳斯达克上市(股票代码INBS)并宣布与全国临床研究站点网络CenExel合作。该合作是Intelligent Bio Solutions的FDA 510(k)临床研究计划中进行方法比较临床研究的一部分。该研究旨在招募三个站点的135名健康成年受试者,以比较指纹排汗鸦片筛查测试和液相色谱质谱法(LC-MS/MS)方法的结果。该公司总裁兼首席执行官Harry Simeonidis表示,对于计划在该年第四季度提交的FDA申请的进展充满信心。研究是证明Intelligent Fingerprinting Drug Screening System精确性的关键步骤,该系统包括药物筛查盒和荧光读数仪,用于无创鸦片检测。该公司最近完成了关于人类指纹汗液中鸦片药物动力学的临床研究,将于2024年8月开始方法比较研究。
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