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NEW YORK - Intelligent Bio Solutions Inc. (NASDAQ:INBS), a micro-cap healthcare company with a market capitalization of $17 million that according to InvestingPro analysis is currently trading below its Fair Value, announced Wednesday that the U.S. Food and Drug Administration (FDA) has requested the company submit a new 510(k) notification for its Intelligent Fingerprinting Drug Screening System.
The company initially filed its 510(k) premarket notification in December 2024, receiving an Additional Information request with over 70 items in February 2025. After submitting responses in August 2025, INBS received feedback indicating that while most responses were satisfactory, the FDA requires additional information through a new submission. The company, which generated $3.05 million in revenue over the last twelve months with a gross margin of 41%, has seen its stock rise over 10% in the past week despite the regulatory hurdles.
"The FDA’s feedback provides constructive clarity on the additional information it requires to advance our application," said Harry Simeonidis, President and CEO at Intelligent Bio Solutions.
The company attributed the extensive review process to the innovative nature of its technology, noting it is a "first-of-its-kind device with no comparable cleared or approved sweat-based product currently on the market." InvestingPro data reveals that while INBS is actively pursuing innovation, it faces financial challenges, including rapid cash burn and short-term obligations exceeding liquid assets.
INBS expects to provide investors with an updated timeline for FDA clearance within ten days. The company is currently consulting with specialized FDA advisors to evaluate the regulator’s questions.
The Intelligent Fingerprinting Drug Screening System is designed to detect recent use of opiates, cocaine, methamphetamine, and cannabis through fingerprint sweat analysis, with results available in under ten minutes.
While pursuing U.S. regulatory clearance, INBS continues to expand its commercial activities internationally in sectors including construction, manufacturing, transport, mining, and drug treatment organizations, according to the company’s press release statement. Analysts tracked by InvestingPro anticipate sales growth in the current year, with revenue projected to increase by 7.6% in fiscal year 2026. For more detailed analysis and 10+ additional ProTips about INBS’s financial health and market position, visit InvestingPro.
In other recent news, Intelligent Bio Solutions Inc. has made significant strides with its fingerprint-based drug screening technology. The company has submitted additional information to the U.S. Food and Drug Administration as part of the 510(k) clearance process, anticipating feedback within six weeks. Reinforcing this submission, Intelligent Bio Solutions has collected new test data to support the security and performance of its drug screening system, with findings to be submitted in August. Meanwhile, the company has secured a contract with a major London public transport operator to implement its drug screening technology across 14 sites, serving over one million passengers daily. Expanding its global footprint, Intelligent Bio Solutions has entered into a distribution agreement with Texas-based SMARTOX to distribute the SmarTest Patch internationally, outside the U.S. and Canada. This patch, which has been added to the company’s non-invasive drug testing lineup, can continuously detect drugs through sweat over a 7 to 10-day period. The company continues to focus on enhancing its offerings, including completing cybersecurity and electromagnetic compatibility testing to ensure system resilience.
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