Intelligent Bio Solutions Launches Clinical Study to Support FDA Submission
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 28 2026
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Should l Buy INBS?
Intelligent Bio Solutions 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. 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.
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Analyst Views on INBS
About INBS
Intelligent Bio Solutions Inc. is a medical technology company focused on developing and delivering intelligent, rapid, non-invasive testing and screening solutions. Its segment includes Commercially available Intelligent Fingerprinting Products and Development Stage Biosensor Platform Technology. Its product portfolio includes Intelligent Fingerprinting Platform that analyzes fingerprint sweat using a one-time cartridge and portable handheld reader, and a two-part system that consists of non-invasive, fingerprint sweat-based diagnostic testing products designed to detect drugs of abuse including opiates, cocaine, methamphetamines, benzodiazepines, cannabis, methadone, and buprenorphine. The Biosensor Platform is designed to detect multiple biological analytes by substituting the top enzyme layer of the biosensor to suit each analyte and to develop a range of Point of Care Tests, including the modalities of clinical chemistry, immunology, tumor markers, allergens, and endocrinology.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Intelligent Bio Solutions Expects Record Revenue Growth in Q2
- Revenue Growth Expectation: Intelligent Bio Solutions anticipates approximately $2.01 million in revenue for fiscal Q2 2026, reflecting a 36% year-over-year increase, indicating strong growth potential across all product categories.
- Surge in Reader Sales: Reader sales are expected to more than double year-over-year in Q2, which not only expands the installed base but also drives sustained recurring revenue, further solidifying the company's razor-razorblade business model.
- Comprehensive Product Growth: For the first half of fiscal 2026, cartridge sales are projected to increase by 38%, while other sales (accessories, training) are expected to rise by 10%, demonstrating the company's competitive strength and ongoing customer demand.
- Enhanced Market Confidence: The CEO emphasized that the ongoing customer adoption and demand for consumables lay a solid foundation for future revenue growth, which is expected to further enhance market share and bolster confidence in the commercial strategy.
See More
Intelligent Bio Solutions Launches Clinical Study for FDA Clearance
- Clinical Study Launch: Intelligent Bio Solutions has commenced its clinical study program to support the FDA 510(k) submission for its Intelligent Fingerprinting Drug Screening System, with full data analysis expected by the end of March 2026, marking a pivotal step for the company's entry into the U.S. market.
- Partnership with Cliantha: The company has partnered with Cliantha Research, leveraging their extensive regulatory and clinical trial expertise to ensure the study's effectiveness and compliance, thereby enhancing its competitive position in the market.
- Significant Market Potential: The U.S. drug screening market generates billions annually, and the company's non-invasive fingerprint technology offers superior hygiene and convenience compared to traditional urine and blood testing methods, which is expected to attract a broader customer base.
- Distinct Technological Advantages: With over 500,000 tests sold outside the U.S., the Intelligent Fingerprinting Drug Screening System demonstrates unique advantages across multiple high-value segments, such as workplace testing and law enforcement applications, further driving the company's global market expansion.
See More
Intelligent Bio Solutions (INBS) Partners with Syrma Johari MedTech, Stock Soars 132%
- Manufacturing Partnership: INBS's collaboration with Syrma Johari MedTech is expected to reduce annual production costs by 40% and increase gross margins by 20 percentage points while quadrupling manufacturing capacity, positioning the company for a U.S. market launch in 2026.
- Successful Private Placement: The company announced a private placement with two healthcare-focused institutional investors to issue 2.3 million shares of common stock, raising approximately $10 million, thereby strengthening its financial position for future business expansion.
- Strong Stock Surge: INBS stock closed up 132% on December 31, 2025, and surged 337% from the close on December 30, 2025, to January 9, 2026, becoming a favorite among retail traders, indicating robust market interest.
- Nasdaq Compliance Restored: On January 7, 2026, INBS was notified by Nasdaq that it regained compliance to trade, maintaining a closing bid price of $1.00 or higher for 14 consecutive trading days, which bolstered investor confidence.
See More
Intelligent Bio Solutions Reports 28% Revenue Growth in Q1
- Significant Revenue Growth: Intelligent Bio Solutions reported $1.11 million in revenue for Q1 2025, up from $0.8 million year-over-year, reflecting a more than 28% increase driven by rising demand for drug testing solutions in safety-critical sectors like logistics and transport.
- Financing for Expansion: The company closed a $10 million private placement in early 2026 at market price under Nasdaq rules, bolstering its cash position and providing capital to accelerate commercialization, expand distribution partnerships, and advance R&D initiatives.
- Fingerprint Drug Testing Platform: Its flagship Intelligent Fingerprinting Drug Testing System offers non-invasive screening through sweat collected from fingerprints, delivering results in minutes and detecting substances like opiates, methamphetamine, cocaine, and cannabis, focusing on impairment within a 16-24 hour window.
- Increased Market Attention: With improving quarterly revenue, fresh financing, and growing adoption of its fingerprint testing technology, Intelligent Bio Solutions saw its stock surge by 23% in pre-market trading, indicating strong market interest in its growth potential.
See More
Zentalis Pharmaceuticals (ZNTL) Surges 17.65% as Investors Renew Interest
- Zentalis Pharmaceuticals Surge: Zentalis Pharmaceuticals' stock rose 17.65% to $4.40 in after-hours trading, with no new news but bolstered by a corporate update on January 6, 2026, highlighting key milestones in its azenosertib development program, which has renewed investor confidence in its pipeline progress.
- LifeMD Secures Financing: LifeMD's stock climbed 12.18% to $4.33 following the announcement of a new senior secured revolving credit facility with Citizens Bank, providing up to $50 million in total availability, with $30 million committed, which is expected to support the company's organic growth initiatives.
- NanoViricides Attracts Speculative Interest: NanoViricides' stock advanced 11.11% to $1.24, drawing speculative interest in after-hours trading despite no new announcements, indicating ongoing market enthusiasm for biotech companies.
- Neurogene Participates in Healthcare Conference: Neurogene's stock increased 2.06% to $18.29 as the management team prepares to present at the 44th Annual J.P. Morgan Healthcare Conference, enhancing market expectations for its future developments.
See More
Intelligent Bio Solutions Closes $10 Million Private Placement with Institutional Investors
- Successful Financing: Intelligent Bio Solutions Inc. has completed a private placement with two healthcare-focused institutional investors, issuing 2,298,850 shares of common stock and associated warrants, expected to generate approximately $10 million in gross proceeds, thereby enhancing the company's liquidity for future growth.
- Clear Use of Proceeds: The funds raised will be allocated for working capital and general corporate purposes, including financing the 510(k) submission for FDA approval of its non-invasive Intelligent Fingerprinting Drug Screening System, indicating strong confidence in the product's market potential.
- Market Expansion Plans: The company intends to leverage the proceeds to further expand into international markets, particularly in sectors such as construction, manufacturing, and transport, showcasing its strategic positioning in safety-critical industries.
- Compliance Commitment: INBS has committed to filing a registration statement with the SEC within 10 days of the agreement to facilitate the resale of shares by investors, thereby enhancing investor confidence and ensuring compliance with securities laws.
See More
Intelligent Bio Solutions Expects Record Revenue Growth in Q2
- Revenue Growth Expectation: Intelligent Bio Solutions anticipates approximately $2.01 million in revenue for fiscal Q2 2026, reflecting a 36% year-over-year increase, indicating strong growth potential across all product categories.
- Surge in Reader Sales: Reader sales are expected to more than double year-over-year in Q2, which not only expands the installed base but also drives sustained recurring revenue, further solidifying the company's razor-razorblade business model.
- Comprehensive Product Growth: For the first half of fiscal 2026, cartridge sales are projected to increase by 38%, while other sales (accessories, training) are expected to rise by 10%, demonstrating the company's competitive strength and ongoing customer demand.
- Enhanced Market Confidence: The CEO emphasized that the ongoing customer adoption and demand for consumables lay a solid foundation for future revenue growth, which is expected to further enhance market share and bolster confidence in the commercial strategy.
See More
Intelligent Bio Solutions Launches Clinical Study for FDA Clearance
- Clinical Study Launch: Intelligent Bio Solutions has commenced its clinical study program to support the FDA 510(k) submission for its Intelligent Fingerprinting Drug Screening System, with full data analysis expected by the end of March 2026, marking a pivotal step for the company's entry into the U.S. market.
- Partnership with Cliantha: The company has partnered with Cliantha Research, leveraging their extensive regulatory and clinical trial expertise to ensure the study's effectiveness and compliance, thereby enhancing its competitive position in the market.
- Significant Market Potential: The U.S. drug screening market generates billions annually, and the company's non-invasive fingerprint technology offers superior hygiene and convenience compared to traditional urine and blood testing methods, which is expected to attract a broader customer base.
- Distinct Technological Advantages: With over 500,000 tests sold outside the U.S., the Intelligent Fingerprinting Drug Screening System demonstrates unique advantages across multiple high-value segments, such as workplace testing and law enforcement applications, further driving the company's global market expansion.
See More
Intelligent Bio Solutions (INBS) Partners with Syrma Johari MedTech, Stock Soars 132%
- Manufacturing Partnership: INBS's collaboration with Syrma Johari MedTech is expected to reduce annual production costs by 40% and increase gross margins by 20 percentage points while quadrupling manufacturing capacity, positioning the company for a U.S. market launch in 2026.
- Successful Private Placement: The company announced a private placement with two healthcare-focused institutional investors to issue 2.3 million shares of common stock, raising approximately $10 million, thereby strengthening its financial position for future business expansion.
- Strong Stock Surge: INBS stock closed up 132% on December 31, 2025, and surged 337% from the close on December 30, 2025, to January 9, 2026, becoming a favorite among retail traders, indicating robust market interest.
- Nasdaq Compliance Restored: On January 7, 2026, INBS was notified by Nasdaq that it regained compliance to trade, maintaining a closing bid price of $1.00 or higher for 14 consecutive trading days, which bolstered investor confidence.
See More
Intelligent Bio Solutions Reports 28% Revenue Growth in Q1
- Significant Revenue Growth: Intelligent Bio Solutions reported $1.11 million in revenue for Q1 2025, up from $0.8 million year-over-year, reflecting a more than 28% increase driven by rising demand for drug testing solutions in safety-critical sectors like logistics and transport.
- Financing for Expansion: The company closed a $10 million private placement in early 2026 at market price under Nasdaq rules, bolstering its cash position and providing capital to accelerate commercialization, expand distribution partnerships, and advance R&D initiatives.
- Fingerprint Drug Testing Platform: Its flagship Intelligent Fingerprinting Drug Testing System offers non-invasive screening through sweat collected from fingerprints, delivering results in minutes and detecting substances like opiates, methamphetamine, cocaine, and cannabis, focusing on impairment within a 16-24 hour window.
- Increased Market Attention: With improving quarterly revenue, fresh financing, and growing adoption of its fingerprint testing technology, Intelligent Bio Solutions saw its stock surge by 23% in pre-market trading, indicating strong market interest in its growth potential.
See More
Zentalis Pharmaceuticals (ZNTL) Surges 17.65% as Investors Renew Interest
- Zentalis Pharmaceuticals Surge: Zentalis Pharmaceuticals' stock rose 17.65% to $4.40 in after-hours trading, with no new news but bolstered by a corporate update on January 6, 2026, highlighting key milestones in its azenosertib development program, which has renewed investor confidence in its pipeline progress.
- LifeMD Secures Financing: LifeMD's stock climbed 12.18% to $4.33 following the announcement of a new senior secured revolving credit facility with Citizens Bank, providing up to $50 million in total availability, with $30 million committed, which is expected to support the company's organic growth initiatives.
- NanoViricides Attracts Speculative Interest: NanoViricides' stock advanced 11.11% to $1.24, drawing speculative interest in after-hours trading despite no new announcements, indicating ongoing market enthusiasm for biotech companies.
- Neurogene Participates in Healthcare Conference: Neurogene's stock increased 2.06% to $18.29 as the management team prepares to present at the 44th Annual J.P. Morgan Healthcare Conference, enhancing market expectations for its future developments.
See More
Intelligent Bio Solutions Closes $10 Million Private Placement with Institutional Investors
- Successful Financing: Intelligent Bio Solutions Inc. has completed a private placement with two healthcare-focused institutional investors, issuing 2,298,850 shares of common stock and associated warrants, expected to generate approximately $10 million in gross proceeds, thereby enhancing the company's liquidity for future growth.
- Clear Use of Proceeds: The funds raised will be allocated for working capital and general corporate purposes, including financing the 510(k) submission for FDA approval of its non-invasive Intelligent Fingerprinting Drug Screening System, indicating strong confidence in the product's market potential.
- Market Expansion Plans: The company intends to leverage the proceeds to further expand into international markets, particularly in sectors such as construction, manufacturing, and transport, showcasing its strategic positioning in safety-critical industries.
- Compliance Commitment: INBS has committed to filing a registration statement with the SEC within 10 days of the agreement to facilitate the resale of shares by investors, thereby enhancing investor confidence and ensuring compliance with securities laws.
See More
