PK Study Successfully Demonstrates Fingerprint Sweat Provides Reliable Sample for Drug Detection

FDA 510(k) clearance would allow INBS technology to be introduced in the United States in 2025

NEW YORK, Nov. 13, 2024 (GLOBE NEWSWIRE) — Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company providing intelligent, rapid and non-invasive testing solutions , today announced strong initial results from its pharmacokinetic (PK) study required for a 510(k) submission to the FDA. Data from the PK study show that fingerprint sweat mimics the level and extent of codeine in blood and saliva. The study successfully demonstrated that sweat fingerprints provide a reliable sample matrix for drug detection, showing quantitative pharmacokinetic data closely aligned with blood, based on statistical comparisons performed at a confidence level of 95%.

“The close correlation of pharmacokinetic parameters in sweat and blood fingerprints highlights its robustness as a sampling approach. While independent data consistently supports this, our clinical study further reinforces these findings,” said Harry Simeonidis, President and CEO of Intelligent Bio Solutions. We are very pleased with the results of the PK study. This data highlights the potential for our technology to be widely adopted in safety-critical industries and beyond, marking an important achievement as we move toward FDA clearance in the United States.

The FDA’s 510(k) clearance would allow INBS to introduce its innovative drug screening technology to the U.S. market in 2025. The results of the pharmacokinetic study and other clinical data from the clinical study plan of the Company will be submitted as part of the Company’s 510(k) filing. , expected in the fourth calendar quarter of this year. INBS is well positioned to meet the growing demand for drug testing in the United States, particularly in safety-critical industries such as construction, mining and transportation, as well as in the health and safety sectors. law enforcement, drug treatment and forensics.

Results: mean codeine values ​​in whole blood, oral fluid and fingerprint sweat¹

The study results show that sweat fingerprints are a strong indicator of codeine ingestion. They further validate the ability of the INBS method to provide rapid and reliable drug screening through a simple fingerprint sweat sample, without invasive procedures.

The PK study, conducted in partnership with Cliantha Research, required a minimum of 36 subjects. The company successfully recruited 39 healthy adult subjects from diverse backgrounds, including varied genders, ages and ethnicities. The study compared levels of opiates detected in fingerprint sweat with those found in blood, oral fluid and urine samples after medically supervised administration of codeine. All fingerprint sweat samples collected using the INBS Intelligent Fingerprint Drug Screening System were analyzed by a validated and traceable liquid chromatography/tandem mass spectrometry (LC-MS) method. /MS), widely accepted as the gold standard for such studies.

About smart biological solutions

Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company providing innovative, rapid and non-invasive testing solutions. The company believes its intelligent fingerprint drug testing system will revolutionize wearable testing through sweat fingerprint analysis, which has the potential for broader applications in other areas. Designed as a hygienic and cost-effective system, the test detects recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine and cannabis. With sample collection in seconds and results in less than ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the United States include construction, manufacturing and engineering, transportation and logistics companies, drug treatment organizations and coroners.

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Forward-looking statements

Certain of the statements contained in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements contained in this press release include, but are not limited to, Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drugs and diagnostic tests, to realize commercial benefits from its partnerships and collaborations and to obtain regulatory approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in these forward-looking statements are reasonable as of the date they are made, the expectations may prove to be materially different from the results expressed or implied by these forward-looking statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terms such as “believes”, “estimates”, “anticipates”, “expects”, “plans”, “projects”, “intends” “, “potential”, “may”, “could”, “could”, “will”, “should”, “approximately” or other words that convey uncertainty as to future events or results to identify such statements These forward-looking statements are only predictions and involve known and unknown risks, uncertainties and other factors, included in Intelligent Bio Solutions’ public filings with the Securities and Exchange Commission. This release speaks only as of its date. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of this release. unforeseen events.

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¹ Urinary results are not included in this table. Due to the nature of urine sample collection, which depends on the individual’s need to urinate, samples cannot be collected at fixed intervals. Therefore, urine samples were collected ad libitum as often as possible..

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