Intelligent Bio Solutions Concludes In-Clinic Testing for Clinical Study Plan, Advancing Toward FDA 510(k) Submission
Intelligent Bio Solutions Inc. (INBS)
Company Research
Source: GlobeNewswire
NEW YORK, Sept. 27, 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 the successful completion of in-clinic testing proposed to the FDA earlier this year in the Company’s clinical study plan. The clinical studies are a key element of the Company's 510(k) submission, designed to demonstrate the accuracy and reliability of its sweat-based testing method. The studies included a pharmacokinetic (PK) study, which aimed to demonstrate that the measurement of drugs in fingerprint sweat delivers results comparable or superior to other specimen matrices, such as blood, saliva and urine. In addition to the PK study, a method comparison and usability study was conducted to validate the accuracy of the Company's fingerprint sweat drug screening method in the hands of intended users. The clinical phase of the PK study concluded in Jun
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News
- 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
- Intelligent Bio Solutions Inc. Announces Progress Toward Completion of Clinical Study Plan Required for FDA 510(k) SubmissionGlobeNewswire
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