John Vandermosten

- Intelligent Bio Solutions Inc. (INBS) has provided an updated timeline for the anticipated **FDA 510(k) clearance** for its Intelligent Fingerprinting Drug Screening System for opiate codeine.  **[1725430_0001493152-25-015068_ex99-1.htm:0]** 
- The company plans to commence **clinical studies** to gather additional supporting data, with these studies scheduled to conclude in the **first half of 2026**.  **[1725430_0001493152-25-015068_ex99-1.htm:0]** 
- INBS anticipates receiving FDA 510(k) clearance in the **second half of 2026**.  **[1725430_0001493152-25-015068_ex99-1.htm:0]** 
- The Intelligent Fingerprinting Drug Screening System is currently adopted by **over 450 accounts in 24 countries** and has 18 distribution partners, with ongoing commercial operations outside the U.S..  **[1725430_0001493152-25-015068_ex99-1.htm:0]**

Intelligent Bio Solutions Updates FDA 510(k) Clearance Timeline

- Intelligent Bio Solutions Inc. (INBS) announced on **September 17, 2025**, that the FDA requires the company to **resubmit a new 510(k) notification** for its Intelligent Fingerprinting Drug Screening System.  **[1725430_0001493152-25-013836_ex99-1.htm:0]** **[1725430_0001493152-25-013836_form8-k.htm:1]** 
- This decision follows INBS's initial submission in **December 2024** and a response to an FDA Additional Information request in **August 2025**.  **[1725430_0001493152-25-013836_ex99-1.htm:0]** 
- The FDA's request for a new submission is due to the device being a **first-of-its-kind sweat-based product** with no comparable cleared or approved alternatives on the market.  **[1725430_0001493152-25-013836_ex99-1.htm:0]** 
- INBS expects to provide an investor update with an **updated timeline for FDA clearance within the next ten days**.  **[1725430_0001493152-25-013836_ex99-1.htm:0]** **[1725430_0001493152-25-013836_form8-k.htm:1]**

INTELLIGENT BIO SOLUTIONS (INBS)