Intelligent Bio Solutions Concludes In-Clinic Testing for Clinical Study Plan, Advancing Toward FDA 510(k) Submission
September 27 2024 - 8:30AM
Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the
“Company”), a medical technology company delivering intelligent,
rapid, non-invasive testing solutions, today announced the
successful completion of in-clinic testing proposed to the FDA
earlier this year in the Company’s clinical study plan. The
clinical studies are a key element of the Company's
510(k) submission, designed to demonstrate the accuracy and
reliability of its sweat-based testing method.
The studies included a pharmacokinetic (PK)
study, which aimed to demonstrate that the measurement of drugs in
fingerprint sweat delivers results comparable or superior to other
specimen matrices, such as blood, saliva and urine. In addition to
the PK study, a method comparison and usability study was
conducted to validate the accuracy of the Company's
fingerprint sweat drug screening method in the hands of intended
users.
The clinical phase of the PK study concluded in
June 2024, with all laboratory analyses completed and data
currently under review. The method comparison and
usability studies, carried out across three sites,
involved 135 subjects who were randomly dosed with codeine and then
tested using the Company's drug screening system. The accuracy of
the screening system results will be assessed relative to a
traceable, laboratory-based reference method. “Executing these
clinical studies required diligence and collaboration across
multiple functions within Intelligent Bio Solutions and our CRO
partners, CenExel and Cliantha,” said Daniel Brown, Head of
Clinical Affairs at INBS.
“Completion of these in-clinic studies marks a
significant achievement for our team and brings us closer to our
goal of obtaining FDA 510(k) Notification clearance,” said Harry
Simeonidis, President and CEO at INBS. “The early feedback on
results from these studies demonstrates the potential of our
fingerprint-based testing method to provide a non-invasive,
reliable alternative to traditional drug testing methods and
address the needs of diverse sectors, including workplaces and
government agencies.”
With the in-clinic testing phase now complete,
INBS is preparing for the next steps in its FDA submission process.
Achieving FDA clearance will enable the Company to market its
product as a clinically validated tool, paving the way for adoption
in the US and potentially transforming the landscape of drug
screening. The Company expects clinical data analysis to be
completed in the fourth calendar quarter of 2024 and to submit the
510(k) package during the same quarter.
About Intelligent Bio Solutions
Inc.
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
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