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Intelligent Bio Solutions Begins Subject Dosing and Sampling for FDA 510(k) Pharmacokinetic (PK) Study for its Intelligent Fingerprinting Drug Screening Technology
Pharmacokinetic study is key step on path to expansion into US market NEW YORK, June 18, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq:
About this update from Intelligent Bio Solutions Inc.
[{"type":"text","content":"Pharmacokinetic study is key step on path to expansion into US market\nNEW YORK, June 18, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (\"INBS\" or the \"Company\"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced that it is entering the next phase of its planned 510(k) submission to the FDA. The Company has successfully completed subject screening for its Pharmacokinetic (PK) Study and will begin dosing and sampling study subjects today. INBS’ PK study is a key step towards the Company’s planned 510(k) submission to the FDA during the fourth quarter of this year. FDA clearance is required to show that INBS’ fingerprint drug screening technology is safe and effective and would result in the Company’s ability to enter the substantial US market, currently planned for the first half of 2025. INBS aims to complete the dosing and sampling of the recruited subjects by the end of June 2024, with a review of the PK study results expected to be finalized by the end of July 2024. The PK study will provide insights into the metabolism, distribution, and excretion of opiates, with a specific focus on human sweat. The study will gather and analyze fingerprint sweat samples and compare the results with blood, saliva, and urine samples. Peter Passaris, INBS’ Vice President of Product Development, commented, \"We look forward to commencing the next phase of our PK study this week. A lot of work and planning has gone into reaching this stage, and I am proud of our progress so far.\" INBS' first-of-its-kind fingerprint drug screening technology uses fingerprint sweat to provide a quick, hygienic, and easy-to-use method for drug testing, delivering results in just minutes. This unique approach tests for common drugs of abuse, including cocaine, cannabis, methamphetamine, and opiates. About Intelligent Bio Solutions Inc. Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering innovative, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for recent use of drug...