Intelligent Bio Solutions Begins Subject Dosing and Sampling for FDA 510(k) Pharmacokinetic (PK) Study for its Intelligent Fingerprinting Drug Screening Technology
Intelligent Bio Solutions Inc. (INBS)
Company Research
Source: GlobeNewswire
NEW 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 Ju
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News
- Intelligent Bio Solutions Concludes In-Clinic Testing for Clinical Study Plan, Advancing Toward FDA 510(k) SubmissionGlobeNewswire
- UK’s Largest Greenhouse Complex, Thanet Earth, Adopts Intelligent Bio Solutions’ Fingerprint Drug Test to Enhance Workplace SafetyGlobeNewswire
- Intelligent Bio Solutions Inc. Reports Fiscal 2024 Fourth Quarter and Full Year Financial Results and Operational HighlightsGlobeNewswire
- Intelligent Bio Solutions to Participate in the Sidoti Small-Cap Virtual Conference on September 18-19, 2024GlobeNewswire
- Intelligent Bio Solutions Inc. Announces Preliminary Full Fiscal Year 2024 Revenue Growth of 148% Year-Over-YearGlobeNewswire
INBS
Sec Filings
- 9/27/24 - Form 8-K
- 9/27/24 - Form 8-K
- 9/27/24 - Form 4
- INBS's page on the SEC website