Intelligent Bio Solutions Successfully Completes Recruitment and Begins Subject Screening for FDA 510(k) Pharmacokinetic (PK) Study
29 Maggio 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 the
successful recruitment and commencement of screening for subjects
in its pharmacokinetic (PK) study, a critical component of the
Company's FDA 510(k) regulatory pathway for clearance.
Harry Simeonidis, President and CEO at INBS,
commented, "As we navigate the FDA 510(k) regulatory pathway, we
are proud to announce the successful recruitment and commencement
of screening for subjects in our PK study, a key milestone in our
clinical study plan. Our dedicated team has worked tirelessly to
ensure the study's design meets the rigorous standards set by the
FDA. As we continue to make strides in our clinical study plan, we
look forward to completing the screening phase, proceeding to the
next phase of the plan, and moving closer to bringing our
innovative technology to the market."
The PK study will provide a more thorough
understanding of opiate metabolism, distribution, and excretion,
particularly in human sweat. The study will collect and analyze
human fingerprint sweat specimens and compare the results with
other specimen matrices: blood, saliva, and urine.
"We appreciate the ongoing collaborative effort
and diligence of our CRO partner, Cliantha Research, in executing
this study," said Daniel Brown, Head of Clinical Affairs at INBS.
"We look forward to analyzing the laboratory results soon."
The Intelligent Fingerprinting Drug Screening
System, which includes a drug screening cartridge, a DSR-Plus
fluorescence reader, and a collection kit for laboratory analysis,
is at the forefront of non-invasive drug testing technology. The
Company expects subject screening for the PK study to be completed
in June 2024.
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.incLinkedIn | Twitter
Investor & Media
Contact:
Valter Pinto, Managing Director KCSA
Strategic Communications PH: (212)
896-1254 INBS@kcsa.com
Grafico Azioni Intelligent Bio Solutions (NASDAQ:INBS)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Intelligent Bio Solutions (NASDAQ:INBS)
Storico
Da Giu 2023 a Giu 2024