Intelligent Bio Solutions Announces Positive Results of PK Study, a Key Milestone on Path to FDA 510(k) Submission
13 Novembre 2024 - 2:30PM
Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the
"Company"), a medical technology company delivering intelligent,
rapid, non-invasive testing solutions, today announced strong
initial results from its Pharmacokinetic (PK) study required for an
FDA 510(k) submission. The data from the PK study shows that
fingerprint sweat mimics the rate and extent of codeine in blood
and saliva. The study successfully demonstrated that fingerprint
sweat provides a reliable sample matrix for drug detection, showing
quantitative PK data closely aligned to blood, based on statistical
comparisons made at the 95% confidence level.
"The close correlation of PK parameters in
fingerprint sweat and blood highlights its robustness as a sampling
approach. While independent data has consistently supported this,
our clinical study further reinforces these findings,” said Harry
Simeonidis, President and CEO of Intelligent Bio Solutions. “We are
very pleased with the PK study results. This data highlights the
potential for our technology to achieve widespread adoption in
safety-critical industries and beyond, marking a significant
achievement as we advance toward FDA clearance in the United
States."
FDA 510(k) clearance would enable INBS to
introduce its innovative drug screening technology to the US market
in 2025. The PK study results and other clinical data from the
Company's clinical study plan will be submitted as part of the
Company's 510(k) submission, expected in the fourth calendar
quarter of this year. INBS is well-positioned to meet the
increasing demand for drug testing in the United States,
particularly in safety-critical industries like construction,
mining, and transportation, as well as in law enforcement, drug
rehabilitation, and forensic sectors.
Results: Average Codeine Values in Whole
Blood, Oral Fluid and Fingerprint
Sweat1
The study results show that fingerprint sweat is
a strong indicator of codeine ingestion. They further validate the
ability of 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 varying genders, ages, and ethnicities. The
study compared the levels of opiates detected in fingerprint sweat
with those found in blood, oral fluid, and urine samples following
the medically supervised administration of codeine. All fingerprint
sweat specimens collected using INBS' Intelligent
Fingerprinting Drug Screening System, were analyzed by a validated,
traceable liquid chromatography/tandem mass spectrometry
(LC-MS/MS) method, widely accepted as the gold standard for such
studies.
About Intelligent Bio
Solutions
Intelligent Bio Solutions Inc. (NASDAQ: INBS) is
a medical technology company delivering innovative, 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 US include construction, manufacturing and engineering,
transport and logistics firms, drug treatment organizations, and
coroners.
For more information,
visit: http://www.ibs.inc/
Forward-Looking Statements
Some of the statements 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
in this press release include, without limitation, Intelligent Bio
Solutions Inc.'s ability to successfully develop and commercialize
its drug and diagnostic tests, realize commercial benefit from its
partnerships and collaborations, and secure regulatory approvals,
among others. Although Intelligent Bio Solutions Inc. believes that
the expectations reflected in such forward-looking statements are
reasonable as of the date made, expectations may prove to have been
materially different from the results expressed or implied by such
forward-looking statements. Intelligent Bio Solutions Inc. has
attempted to identify forward-looking statements by terminology,
including "believes," "estimates," "anticipates," "expects,"
"plans," "projects," "intends," "potential," "may," "could,"
"might," "will," "should," "approximately" or other words that
convey uncertainty of future events or outcomes to identify these
forward-looking statements. These statements are only predictions
and involve known and unknown risks, uncertainties, and other
factors, included in Intelligent Bio Solutions' public filings
filed with the Securities and Exchange Commission. Any
forward-looking statements contained in this release speak 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 unanticipated events.
Company Contact:
Intelligent Bio Solutions
Inc.info@ibs.incLinkedIn | Twitter
Investor & Media
Contact:
Valter Pinto, Managing DirectorKCSA Strategic
CommunicationsPH: (212) 896-1254INBS@kcsa.com
1 Urine results are not included in this chart.
Due to the nature of urine sample collection, which depends on an
individual's need to urinate, samples cannot be collected at fixed
intervals. Therefore, urine specimens were collected on an ad-lib
basis as frequently as possible.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/6806ebb4-b738-4c65-b0a0-e6a4c1dc9626
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