• Intelligent Bio Solutions remains on track for a 2025 U.S. launch of its non-invasive Intelligent Fingerprinting Drug Screening System.
• The company’s FDA 510(k) submission included validation studies showing 94.1% accuracy in detecting opiates through fingerprint sweat.
• INBS is already active in 24 countries, with over 450 commercial accounts globally, and adoption growing across diverse industries, including logistics, mining, retail, and marine operations.
• The firm is expanding its distributor network to support localized growth ahead of its U.S. market entry.

Intelligent Bio Solutions (NASDAQ: INBS), a medical technology company specializing in rapid, non-invasive testing solutions, is preparing for its expected U.S. launch in 2025, as it is progressing through the FDA clearance process for its Intelligent Fingerprinting Drug Screening System. The non-invasive device, which detects recent drug use via fingerprint sweat, is gaining international traction for its speed, portability, and ability to integrate into a range of safety-critical environments.

On Dec. 18, 2024, INBS submitted a 510(k) premarket notification to the U.S. Food and Drug Administration, seeking clearance for its opiate test system for codeine (https://ibn.fm/YVRNE). The FDA classified the system as a Class II medical device, which requires this form of submission. As of March 2025, the FDA has issued an Additional Information (“AI”) request, a standard part of the review process that pauses the 90-day review clock while the company prepares its response.

The 510(k) filing includes data from method comparison and pharmacokinetic studies. INBS reported a 94.1% accuracy rate in its performance evaluations and emphasized that fingerprint sweat provides a viable and statistically consistent alternative to blood for drug detection. According to the company, these findings support its plans to launch the platform in the U.S. and expand the system’s testing panel to additional drug classes over time.

“We appreciate the thoroughness of the FDA’s process, which aligns with our expectations. As we await FDA clearance, we remain confident in the strength of our data, which demonstrates the accuracy, reliability, and usability of our technology,” said Harry Simeonidis, President and CEO of INBS. “We are actively preparing for our planned U.S. launch in 2025, where we see significant opportunities to revolutionize drug screening with our non-invasive, rapid testing solution.”

Outside the U.S., INBS continues to expand its commercial footprint, reflecting rising global demand for drug screening technologies that can deliver fast, reliable results without the logistical challenges of traditional methods. As of May 2025, the company reported more than 450 active accounts across 24 countries, with 35 new clients added in the third fiscal quarter alone (https://ibn.fm/CgnKV).

Growth is being driven by industries where on-site, rapid testing is critical. INBS has seen adoption in sectors including transportation, engineering, logistics, mining, and, most recently, luxury marine operations in Europe. In Australia, the technology has gained traction in remote testing programs, waste management, and retail, including implementation by a major e-commerce brand.

To support expansion, INBS is building out its distributor network, which now spans 19 countries through 18 regional partners. The company is also preparing to offer collected testing services, aimed at organizations that require centralized testing capacity for high volumes.

The fingerprint-based screening system delivers results in under ten minutes and does not require specialist medical personnel to administer. This ease of use, combined with its compact form factor and accuracy, makes it attractive to organizations managing distributed or mobile workforces.

Doug Heath, INBS’s Vice President of Global Sales, said the technology is resonating with clients seeking a simpler and faster alternative to traditional urine or saliva tests. “Traditional testing methods aren’t keeping up with operational demands – our solution is,” Heath said. “Industries are moving quickly to adopt a system that’s fast, diverse in its capabilities, and easy to implement.”

For more information, visit the company’s website at https://ibs.inc.

NOTE TO INVESTORS: The latest news and updates relating to INBS are available in the company’s newsroom at https://ibn.fm/INBS

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