Aug. 6 at 6:05 PM
Intelligent Bio Solutions (Nasdaq:
$INBS) has submitted comprehensive Additional Information to the FDA, strengthening its 510(k) package and supporting the clearance process for its fingerprint sweat-based drug screening system. This updated submission features extensive new data supporting the platform’s security and performance, positioning the company for its anticipated U.S. market entry in 2025.
Intelligent Bio Solutions Inc. (NASDAQ:
$INBS) is a B2i Digital Featured company. View INBS’s comprehensive profile at https://b2idigital.com/intelligent-bio-solutions.
Over 10,000 hours were dedicated to compiling the data for the company’s updated submission. INBS conducted rigorous cybersecurity assessments, including penetration testing and electromagnetic compatibility testing, confirming the system’s reliability in diverse operating conditions. The comprehensive package delivered to the FDA contained 23 technical reports with over 100 supporting documents, 1,900 pages and 7,800+ lines of data.
Harry Simeonidis, President & CEO of Intelligent Bio Solutions, stated: “Securing FDA clearance has been a top priority as we look to bring our fingerprint sweat-based solution to more markets, particularly those with significant commercial potential, such as the multi-billion-dollar U.S. market. The data we have gathered reflects the outstanding work of our R&D team, whose technical expertise has strengthened the case for our technology’s accuracy and reliability.”
Please read the full news release at this link: https://investors.ibs.inc/news/news-details/2025/Intelligent-Bio-Solutions-Strengthens-FDA-510k-Package-with-New-Cybersecurity-and-Performance-Data-Ahead-of-Planned-U-S--Market-Launch/default.aspx
Led by CEO Harry Simeonidis and CFO Spiro Sakiris, INBS is advancing hygienic, rapid, and cost-effective fingerprint sweat-based testing worldwide.
The company’s non-invasive, patented technology delivers results in under ten minutes and now supports more than 450 accounts across 24 countries in the workplace safety, law enforcement, drug treatment, and forensics markets. Its experienced global management team includes Anna Turkington, Ghanshyam Poudel, Taylor Doherty, Daniel Brown, Doug Heath, Sugam Pokharel, Victoria Gavrilenko, Rafael da Luz, MBA, Callistus Sequeira, Derek Mapoli MBus, and Peter Passaris.
For investor inquiries, visit https://investors.ibs.inc or contact Valter Pinto at
[email protected], KCSA Strategic Communications.
Disclosure: David Shapiro, CEO of B2i Digital, personally purchased in the open market and currently owns shares of unrestricted INBS stock, in line with B2i Digital’s practice of investing alongside its Featured Companies. This post is not intended to solicit the sale of INBS or any security, and it is not intended to offer any opinion on INBS as an investment. Conduct your own research and consult with your own professional advisors prior to making any investment decisions. See the complete Disclosure in the Risks and Disclosures section of https://b2idigital.com/disclaimer.
