INBSPhases
Intelligent Bio Solutions Initiates Clinical Study Supporting FDA Clearance and Planned U.S. Market Entry
Intelligent Bio Solutions Inc. has initiated an Interference Study to support its FDA 510(k) submission for its Intelligent Fingerprinting Drug Screening System. This study, conducted in partnership with CenExel Clinical Research, aims to validate the system's accuracy in the presence of common substances. Results are expected by mid-July 2026 and will be included in the FDA submission package.
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Intelligent Bio Solutions Commences Multi-Site Method Comparison Study for FDA 510(k) Submission
Intelligent Bio Solutions Inc. has commenced a multi-site Method Comparison Study to support its FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System. The study aims to validate the system's accuracy and performance in real-world workplace settings, involving 135 participants. Results will be included in the FDA submission package, expected by July 2026.
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Intelligent Bio Solutions Reports Fiscal Third Quarter Revenue Growth of 46% Year-over-Year
Intelligent Bio Solutions Inc. reported a 46% increase in revenue for the fiscal third quarter, driven primarily by a 59% rise in cartridge sales. The company achieved a gross profit margin of 50.5%, reflecting enhanced operational efficiencies. With nine-month revenue reaching $3.07 million, INBS is well-positioned for growth as it approaches key FDA regulatory milestones.
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Intelligent Bio Solutions Advances Upcoming FDA 510(k) Submission, Successfully Completes Penetration Testing with No Major Vulnerabilities Identified
Intelligent Bio Solutions Inc. has successfully completed penetration testing as part of its FDA 510(k) submission, identifying no major vulnerabilities. The company has also implemented security upgrades to enhance its drug testing technology. These developments are expected to strengthen its regulatory submission and open new revenue opportunities in the U.S. drug screening market.
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Intelligent Bio Solutions Strengthens European IP Portfolio with Eighth Patent Grant
Intelligent Bio Solutions Inc. has received its eighth European patent, enhancing its intellectual property portfolio related to fingerprint sweat drug testing technology. The new patent focuses on contextualizing chemical analysis with fingerprint deposition volume, improving the interpretation of test results. This advancement reinforces the company's market position and supports its innovative, non-invasive testing solutions.
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Intelligent Bio Solutions Successfully Manufactures and Ships First Readers with New Partner, Accelerating Scale and Driving Gross Margin Expansion in Anticipation of Planned U.S. Entry
Intelligent Bio Solutions Inc. has successfully manufactured and shipped its first drug screening readers in collaboration with Syrma Johari, marking a significant step towards scaling production. The partnership is expected to yield over 40% in annual production cost savings and improve gross margins by approximately 20 percentage points. The company has also doubled its in-house production capacity for lateral flow test strips, enhancing its operational capabilities ahead of its planned U.S. market entry in 2026.
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Intelligent Bio Solutions Partners with Bouygues UK, Part of Multi-Billion Dollar Global Construction Giant Bouygues Construction, for UK Drug Testing Rollout
Intelligent Bio Solutions Inc. has partnered with Bouygues UK to implement its fingerprint drug screening technology across 13 project sites in the UK. This collaboration marks a shift from third-party testing to an in-house solution, emphasizing hygiene, efficiency, and cost savings. The partnership is seen as a foundation for potential future expansions within Bouygues' global operations.
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Intelligent Bio Solutions Reports Record Fiscal Second Quarter Revenue Growth of 48% with Reader Sales Surging 104% Year-Over-Year
Intelligent Bio Solutions Inc. reported a 48% increase in revenue for the fiscal second quarter of 2026, driven by a 104% surge in reader sales. The company achieved a gross profit margin of 49%, up from 39% the previous year. With total revenue exceeding $2 million in the first half of the fiscal year, INBS is building a sustainable business model focused on non-invasive drug testing solutions.
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Intelligent Bio Solutions Expects to Report Fiscal Second Quarter 2026 Revenue Growth of Approximately 48% Year-Over-Year, Surpassing $2 Million in Total Revenue for First Half of Fiscal Year
Intelligent Bio Solutions Inc. anticipates a 48% revenue growth for fiscal Q2 2026, exceeding $2 million in total revenue for the first half of the fiscal year. The company reports significant growth in reader sales, expected to more than double year-over-year. This growth is attributed to an expanding customer base and a robust product offering, reinforcing their recurring revenue model.
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Intelligent Bio Solutions Initiates Additional Clinical Studies for FDA 510(k) Submission Supporting Planned Entry into Multi-Billion Dollar U.S. Market
Intelligent Bio Solutions Inc. has launched clinical studies to support its FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System, aimed at detecting codeine. The studies will assess detection cut-off levels and are expected to conclude by March 2026. This initiative positions the company to enter the lucrative U.S. drug screening market, leveraging its non-invasive technology.
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Intelligent Bio Solutions Announces Closing of $10.0 Million Private Placement Priced At-the-Market Under Nasdaq Rules
Intelligent Bio Solutions Inc. has successfully closed a $10 million private placement with institutional investors, issuing approximately 2.3 million shares and associated warrants. The funds will be used for working capital, including a 510(k) submission to the FDA for their Intelligent Fingerprinting Drug Screening System. The company aims to expand its market presence internationally.
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Intelligent Bio Solutions Announces New Manufacturing Partnership to Strengthen Global Production Capability and Increase Margins
Intelligent Bio Solutions Inc. has announced a strategic partnership with Syrma Johari MedTech to enhance its manufacturing capabilities. This collaboration aims to improve gross margins by approximately 20 percentage points and significantly increase production capacity. The partnership is expected to bolster supply chain resilience as INBS prepares for its U.S. market entry in 2026.
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Intelligent Bio Solutions Announces $10.0 Million Private Placement Priced At-the-Market Under Nasdaq Rules
Intelligent Bio Solutions Inc. has announced a private placement to raise approximately $10 million by issuing shares and warrants. The placement is priced at $4.35 per share and is expected to close on January 2, 2026. The proceeds will be used for working capital and general corporate purposes, with an agreement to file a registration statement with the SEC.
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