Record quarterly revenue of $1.11 million, an increase of 32% sequentially and 28% year-over-year, driven by consumable cartridge sales and customer base expansion Gross profit margins increased 690 basis points year-over-year to 46.6%, reflecting improved operational efficiency and greater revenue percentage from higher margin cartridge sales NEW YORK, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intellige ...

Core Viewpoint - Intelligent Bio Solutions Inc. is focused on obtaining FDA clearance for its innovative fingerprint sweat-based drug screening technology, with a response expected within six weeks, aiming for U.S. market entry in 2025 [1][4]. Company Developments - The company submitted an Additional Information response to the FDA, which includes new positive data that enhances its 510(k) submission and validates the technology's security and performance [1][4]. - The updated submission involved extensive cybersecurity testing, dedicating 10,000 hours to data collection, resulting in 23 detailed test reports and over 1,900 pages of documentation [2][4]. - The technology has been reaffirmed for accuracy using advanced quantification methods, confirming its capability to detect minute sweat volumes from a single fingerprint [3][4]. Market Strategy - Securing FDA clearance is a top priority for the company as it seeks to enter the multi-billion-dollar U.S. market, which presents significant commercial opportunities [4]. - The company's non-invasive drug screening technology is already in use across more than 450 accounts in 24 countries, with a growing international presence supported by 18 global distribution partners [4][5]. - The technology is designed for rapid testing, providing results in under ten minutes, making it suitable for safety-critical industries such as construction, manufacturing, and law enforcement [5].