
Intelligent Bio Solutions Inc. (INBS) Discusses FDA 510(k) Submission and Progress of Intelligent Fingerprinting Drug Screening System Transcript
Intelligent Bio Solutions Inc. (INBS) is a pioneering biotechnology company focused on delivering cutting-edge diagnostic solutions and biomarker-driven technologies, specifically designed for drug abuse testing and monitoring. Utilizing advanced scientific methodologies, INBS offers rapid and precise testing options that enhance clinical decision-making processes and improve patient outcomes. In a healthcare landscape increasingly reliant on innovative diagnostic tools, INBS is well-positioned to make substantial contributions to this evolving field, reinforcing its dedication to advancing healthcare quality and operational effectiveness.
| Revenue (TTM) | $4.22M |
| Gross Profit (TTM) | $2.05M |
| EBITDA | $-11.15M |
| Operating Margin | -346.00% |
| Return on Equity | -307.70% |
| Return on Assets | -76.20% |
| Revenue/Share (TTM) | $2.86 |
| Book Value | $1.90 |
| Price-to-Book | 1.06 |
| Price-to-Sales (TTM) | 1.34 |
| EV/Revenue | 0.877 |
| EV/EBITDA | -0.91 |
| Quarterly Earnings Growth (YoY) | 0.00% |
| Quarterly Revenue Growth (YoY) | 35.80% |
| Shares Outstanding | $3.32M |
| Float | $2.94M |
| % Insiders | 2.73% |
| % Institutions | 5.47% |
Volatility is currently contracting

Intelligent Bio Solutions Inc. (INBS) Discusses FDA 510(k) Submission and Progress of Intelligent Fingerprinting Drug Screening System Transcript

Management to discuss FDA 510(k) submission, clinical data, and commercial progress outside the U.S. Management to discuss FDA 510(k) submission, clinical data, and commercial progress outside the U.S.

NEW YORK, Sept. 09, 2026 (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 submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA), seeking regulatory clearance of its Intelligent Fingerprinting Drug Screening System (the “System”) for detection of the opiate codeine.

Multi-site clinical study delivers strong performance data for Intelligent Fingerprinting Drug Screening System Multi-site clinical study delivers strong performance data for Intelligent Fingerprinting Drug Screening System

$5 Million Upfront at Closing and $5 Million Tranche Warrant Callable by the Company Following FDA 510(k) Clearance of Intelligent Fingerprinting Drug Screening System $5 Million Upfront at Closing and $5 Million Tranche Warrant Callable by the Company Following FDA 510(k) Clearance of Intelligent Fingerprinting Drug Screening System

Reader installed base grew 22% year-over-year, driving a 35% increase in total consumable cartridges to over 100,000 units

Shares of Intelligent Bio Solutions Inc. (NASDAQ:INBS) are surging Monday afternoon after the medical technology company announced a significant regulatory milestone for its rapid testing unit.

Recertification aligns with the FDA's newly amended Quality Management System Regulation and supports the Company's regulatory strategy as it pursues FDA clearance Recertification aligns with the FDA's newly amended Quality Management System Regulation and supports the Company's regulatory strategy as it pursues FDA clearance

NEW YORK, Aug. 05, 2026 (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 completion of its Usability Study for the Intelligent Fingerprinting Drug Screening System, supporting its FDA 510(k) submission for U.S. market clearance for detection of the opiate codeine. The study was conducted in partnership with CenExel Clinical Research, Inc., following FDA guidance and ICH GCP (International Council for Harmonisation Good Clinical Practice) standards.

NEW YORK, Aug. 03, 2026 (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 completion of its Interference Study for the Intelligent Fingerprinting Drug Screening System. The study supports the Company's FDA 510(k) submission for U.S. market clearance for detection of the opiate codeine.
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