Common Stock, $0.01 par value
- Symbol
- INBS
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 8.01, 9.01 · 8-K
Intelligent Bio Solutions Inc.
INBSNASDAQEQUITYCurrent
Regulation FD Disclosure · Other Events
Item 7.01 Regulation FD Disclosure. On September 9, 2026, Intelligent Bio Solutions Inc. (the “Company”) issued a press release (the “Press Release”) announcing the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA), seeking regulatory clearance of its Intelligent Fingerprinting Drug Screening System for the detection of the opiate codeine.…
Company context
Bio Solutions Inc. Intelligent Bio Solutions Inc. (Nasdaq: INBS) is a medical technology company delivering intelligent, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the U.S. include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners.
Current securities
Registered securities in this filing
INTELLIGENT BIO SOLUTIONS INC. · 8-K · Filed 2026-09-09
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item
7.01 Regulation FD Disclosure.
On
September 9, 2026, Intelligent Bio Solutions Inc. (the “Company”) issued a press release (the “Press Release”)
announcing the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA), seeking regulatory clearance
of its Intelligent Fingerprinting Drug Screening System for the detection of the opiate codeine. A copy of the press release is furnished
as Exhibit 99.1 to this Current Report on Form 8-K. The foregoing disclosure is qualified in its entirety by the full text of the Press
Release.
The
information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed
to be “filed” for the purpose of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall
it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, unless specifically
identified therein as being incorporated by reference.
Item 8.01Item 8.01 - Other Events
Item
8.01 Other Events.
On
September 9, 2026, the Company announced that
it had submitted its 510(k) premarket notification to the FDA seeking regulatory clearance of its Intelligent Fingerprinting Drug
Screening System for the detection of the opiate codeine.
Filed exhibits (1)
EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Intelligent Bio Solutions Submits FDA 510(k) Package for Intelligent Fingerprinting Drug Screening System, Seeking U.S. Market Clearance Submission package includes Method Comparison Study, which delivered accuracy above 98%, sensitivity above 94%, and 100% specificity across three independent U.S. clinical sites. NEW YORK, September 09, 2026 - Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA), seeking regulatory clearance of its Intelligent Fingerprinting Drug Screening System (the “System”) for detection of the opiate codeine. The submission represents the culmination of data from a structured, multi-study clinical program that the Company has executed throughout 2026, targeting entry into the multi-billion-dollar U.S. drug screening market. The Company’s 510(k) submission package includes a comprehensive body of clinical evidence generated in partnership with Cliantha Research and CenExel Clinical Resear…
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