Intelligent Bio Solutions Initiates Additional Clinical Studies for FDA 510(k) Submission Supporting Planned Entry into Multi-Billion Dollar U.S. Market
Rhea-AI Summary
Intelligent Bio Solutions (Nasdaq: INBS) initiated clinical studies on Jan 28, 2026 to support an FDA 510(k) submission for its Intelligent Fingerprinting Drug Screening System targeting codeine detection.
The first cohort (40 adults) will use the DSR-Plus reader and fingerprint cartridges, include LC-MS/MS confirmation and predicate-device comparisons; full data analysis is expected by end of March 2026 for incorporation into the 510(k) package.
Positive
- Clinical study program commenced on Jan 28, 2026
- 40-subject first cohort to assess codeine detection cut-offs
- Full data analysis expected by end of March 2026
- 500,000 tests previously sold and used outside the U.S.
Negative
- First study limited to 40 adults, a small sample size
- Study results are pending and not yet in a 510(k)
- Current U.S. classification is Forensic Use Only, not cleared
Key Figures
Market Reality Check
Peers on Argus
INBS slipped 2.53% while sector peers were mixed: AIMD was highlighted in momentum scans with a 23.27% gain, NXL and NVNO were modestly negative, and ALUR rose 4.83%. With only one peer in momentum and no shared news, the move appears stock-specific.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 02 | Private placement closing | Negative | -17.2% | Closed $10M at-the-market private placement with warrants, funding 510(k) work. |
| Dec 31 | Private placement deal | Negative | +132.4% | $10M at-the-market private placement agreement with additional warrant coverage. |
| Dec 31 | Manufacturing partnership | Positive | +132.4% | New manufacturing partner expected to cut costs and expand reader capacity. |
| Dec 18 | Strategic alliance | Positive | +18.4% | Non-exclusive partnership to extend non-invasive testing into consumer health. |
| Dec 12 | Reverse stock split | Negative | -22.7% | 1-for-10 reverse split to address Nasdaq minimum bid price compliance. |
Recent news reactions mostly aligned with sentiment: partnerships and corporate actions often produced strong moves, with one notable divergence on a financing headline.
Over the past months, INBS executed a 1-for-10 reverse split and regained Nasdaq bid-price compliance. It then announced strategic partnerships to scale manufacturing and expand non-invasive screening technologies, which coincided with large positive price reactions around Dec 31, 2025. A subsequent $10.0M private placement produced a sharp selloff on Jan 2, 2026. Today’s clinical study launch extends the company’s 510(k)-focused U.S. entry strategy.
Regulatory & Risk Context
An effective S-3 resale registration filed on 2026-01-09 covers 6,896,550 shares tied to the December 31, 2025 financing. INBS will not receive proceeds from resales but could obtain up to about $18.87 million if related warrants are exercised for cash, while the large registered block may add resale overhang.
Market Pulse Summary
This announcement outlines a focused clinical program supporting an FDA 510(k) submission for codeine detection using INBS’s non-invasive fingerprint platform. It follows recent financing, a 1-for-10 reverse split, and a resale registration covering 6,896,550 shares, all of which shape the capital structure alongside clinical progress. Investors may watch enrollment, data readout by end of March 2026, and subsequent FDA interactions as key markers for the U.S. market entry plan.
Key Terms
liquid chromatography-tandem mass spectrometry medical
lc-ms/ms medical
AI-generated analysis. Not financial advice.
Clinical studies designed to support FDA clearance and planned commercial launch into the world’s largest drug screening market
Company anticipates full data analysis by the end of March 2026; data to be incorporated into FDA 510(k) submission package
NEW YORK, Jan. 28, 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 commencement of its clinical study program to support its new FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine.
As part of its clinical study program, the Company has again partnered with Cliantha Research, a leading clinical research organization, leveraging its extensive regulatory and clinical trial expertise.
The first clinical study will assess codeine detection cut-off levels in 40 adults at a single site. The study will utilize the Intelligent Fingerprinting Drug Screening Cartridge with the DSR-Plus fluorescence reader, together forming the Company's non-invasive Intelligent Fingerprinting Drug Screening System. Participants will receive controlled doses of codeine, with sample collection and analysis conducted to establish and verify optimal detection cut-off levels. The study design includes direct comparisons with a predicate FDA-cleared device to support the 510(k) regulatory pathway. Results will be corroborated via a liquid chromatography-tandem mass spectrometry (“LC-MS/MS”) analysis. This clinical approach is designed to support both the Company's U.S. regulatory pathway and commercial strategy to enter the U.S. market beyond the Forensic Use Only category.
The U.S. drug screening market represents a substantial commercial opportunity, generating several billions of dollars annually across workplace testing, criminal justice applications, pain management, and substance abuse treatment settings. The Company's non-invasive fingerprint-based technology offers significant advantages over traditional urine, oral fluid, and blood testing methods, including improved hygiene, ease of use, rapid results, and reduced collection costs.
"Obtaining FDA clearance for the U.S. market is a major opportunity for Intelligent Bio Solutions,” said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. "The U.S. drug screening market is the largest and most sophisticated in the world, and our Intelligent Fingerprinting technology is uniquely positioned to address unmet needs across multiple high-value segments, including workplace testing, clinical settings, and law enforcement applications. Initiating our clinical studies marks a pivotal moment for our company and the customers we aim to serve. This milestone reflects years of rigorous scientific development and dedication from our team. It will further demonstrate the proven performance of our technology, with over 500,000 tests already sold and used outside the U.S. We look forward to completing these trials and compiling the results as part of our overall FDA submission.”
Cliantha has initiated subject recruiting and screening, with the first testing cohort scheduled to begin on January 28, 2026, and full data analysis anticipated by the end of March 2026. The Company plans to incorporate this clinical data into its new FDA 510(k) submission package.
About Intelligent Bio Solutions Inc.
Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering intelligent, 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 the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the U.S. include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners.
For more information, visit: https://ibs.inc/
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefits from its partnerships and collaborations, and secure regulatory clearance or approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, actual results may differ materially from those expressed or implied by such statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” and “approximately,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those described in Intelligent Bio Solutions’ public filings with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of the date of this release. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Company Contact
Intelligent Bio Solutions Inc.
info@ibs.inc
Investor & Media Contact
Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com
FAQ
What clinical studies did Intelligent Bio Solutions (INBS) start on January 28, 2026?
When will Intelligent Bio Solutions (INBS) have clinical data for the FDA 510(k) submission?
How does Intelligent Fingerprinting technology factor into INBS's U.S. commercial plan?
What validation methods will Intelligent Bio Solutions (INBS) use in the codeine study?
Does Intelligent Bio Solutions (INBS) have prior commercial use of its tests outside the U.S.?
What market opportunity is INBS targeting with its FDA 510(k) program?
