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Intelligent Bio Solutions | 8-K: Current report

SEC announcement ·  Mar 1 06:05
Summary by Futu AI
On February 28, 2024, Intelligent Bio Solutions Inc., a medical technology company listed on Nasdaq under the symbol INBS, announced a partnership with Cliantha Research to conduct a pharmacokinetic study. This study is a key component of the company's FDA 510(k) clinical study plan, aiming to compare the levels of opiates in fingerprint sweat with those in blood, oral fluid, and urine after controlled drug administration. The study will involve 40 healthy adult subjects and utilize the company's Intelligent Fingerprinting Drug Screening System alongside LC-MS/MS analysis. The clinical study is a significant step in Intelligent Bio Solutions' strategy to enter the US market with its non-invasive drug screening technology. The company had previously received guidance from the FDA in June 2023, classifying its drug screening cartridge as a Class II device, which requires FDA clearance before marketing. The recruitment for the study is expected to occur in March and April 2024, with the study commencing in May and sample analysis concluding by the end of June 2024.
On February 28, 2024, Intelligent Bio Solutions Inc., a medical technology company listed on Nasdaq under the symbol INBS, announced a partnership with Cliantha Research to conduct a pharmacokinetic study. This study is a key component of the company's FDA 510(k) clinical study plan, aiming to compare the levels of opiates in fingerprint sweat with those in blood, oral fluid, and urine after controlled drug administration. The study will involve 40 healthy adult subjects and utilize the company's Intelligent Fingerprinting Drug Screening System alongside LC-MS/MS analysis. The clinical study is a significant step in Intelligent Bio Solutions' strategy to enter the US market with its non-invasive drug screening technology. The company had previously received guidance from the FDA in June 2023, classifying its drug screening cartridge as a Class II device, which requires FDA clearance before marketing. The recruitment for the study is expected to occur in March and April 2024, with the study commencing in May and sample analysis concluding by the end of June 2024.
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