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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INBS
News
- Intelligent Bio Solutions to Participate in the Noble Capital Markets’ 20th Annual Emerging Growth Equity ConferenceGlobeNewswire
- Intelligent Bio Solutions Announces Positive Results of PK Study, a Key Milestone on Path to FDA 510(k) SubmissionGlobeNewswire
- Intelligent Bio Solutions Reports Fiscal 2025 First Quarter Financial Results and Operational HighlightsGlobeNewswire
- Intelligent Bio Solutions Partners with B2i Digital to Amplify Investor OutreachGlobeNewswire
- Intelligent Bio Solutions Announces Preliminary Unaudited Fiscal 2025 First Quarter Revenue ResultsGlobeNewswire
INBS
Sec Filings
- 11/20/24 - Form 8-K
- 11/14/24 - Form SC
- 11/14/24 - Form SC
- INBS's page on the SEC website