Intelligent Bio Solutions Begins Subject Dosing and Sampling for FDA 510(k) Pharmacokinetic (PK) Study for its Intelligent Fingerprinting Drug Screening Technology
18 Giugno 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 that it is
entering the next phase of its planned 510(k) submission to the
FDA. The Company has successfully completed subject screening for
its Pharmacokinetic (PK) Study and will begin dosing and sampling
study subjects today.
INBS’ PK study is a key step towards the
Company’s planned 510(k) submission to the FDA during the fourth
quarter of this year. FDA clearance is required to show that INBS’
fingerprint drug screening technology is safe and effective and
would result in the Company’s ability to enter the substantial US
market, currently planned for the first half of 2025.
INBS aims to complete the dosing and sampling of
the recruited subjects by the end of June 2024, with a review of
the PK study results expected to be finalized by the end of July
2024. The PK study will provide insights into the metabolism,
distribution, and excretion of opiates, with a specific focus on
human sweat. The study will gather and analyze fingerprint sweat
samples and compare the results with blood, saliva, and urine
samples.
Peter Passaris, INBS’ Vice President of Product
Development, commented, "We look forward to commencing the next
phase of our PK study this week. A lot of work and planning has
gone into reaching this stage, and I am proud of our progress so
far."
INBS' first-of-its-kind fingerprint drug
screening technology uses fingerprint sweat to provide a quick,
hygienic, and easy-to-use method for drug testing, delivering
results in just minutes. This unique approach tests for common
drugs of abuse, including cocaine, cannabis, methamphetamine, and
opiates.
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
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. Additionally, the Company's biosensor
platform has the potential to test for various indications, ranging
from immunological conditions to communicable diseases. The
Company's current customer segments 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.inc LinkedIn | Twitter
Investor & Media Contact:Valter Pinto,
Managing DirectorKCSA Strategic CommunicationsPH: (212)
896-1254INBS@kcsa.com
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