Intelligent Bio Solutions Partners with CenExel to Conduct Clinical Study as Part of FDA 510(k) Pathway
01 Agosto 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 its
partnership with CenExel, a nationwide clinical research site
network, to perform a method comparison clinical study as part of
the Company’s FDA 510(k) clinical study plan.
The Company’s method comparison study will
recruit 135 healthy adult subjects across three sites under an
IRB-approved protocol and compare the results of fingerprint sweat
opiate screening tests to the results from a validated, traceable
liquid chromatography mass spectrometry (LC-MS/MS) method, widely
accepted as the gold standard for such studies.Harry Simeonidis,
President and CEO of Intelligent Bio Solutions, commented, “We are
pleased to announce our partnership with CenExel and the initiation
of the method comparison study, marking the final phase in our
clinical study plan. Over the past two months, we have made
substantial progress and are steadily getting closer to filing our
510(k) submission with the FDA. We remain on track for our planned
submission to the FDA in the fourth quarter of this calendar year.
I commend our dedicated team and clinical study partners for their
immense effort and commitment to ensuring the smooth execution of
our clinical study plan.” Stuart Goldblatt, Chief Executive Officer
at CenExel, stated, “CenExel is excited to commence this clinical
trial to test this innovative device with the potential to provide
rapid and non-invasive testing for opiates.”
The Company recently completed the in-clinic
portion of a pharmacokinetic (PK) study on opiates in human
fingerprint sweat. Through the method comparison study, the Company
intends to demonstrate that the Intelligent Fingerprinting Drug
Screening System, which comprises the Intelligent Fingerprinting
Drug Screening Cartridge and DSR-Plus fluorescence reader, performs
accurately in the hands of intended users to detect the presence of
opiates. The Company plans to commence the method comparison study
in August 2024.
About CenExel
CenExel provides unparalleled medical and
scientific support in the design and execution of clinical trials.
CenExel’s therapeutic area focus, attention to detail, and
auxiliary services assure quality, reliable results and help it to
consistently achieve and exceed patient recruitment goals. CenExel
Centers of Excellence have conducted thousands of studies, the
variety and complexity of which have resulted in a vast depth of
experience and insight for the Principal Investigators and research
staff in each facility. The CenExel Centers of Excellence deliver
the engagement, expertise, and results to ensure clients achieve
their clinical research goals.
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
Director KCSA Strategic Communications PH: (212)
896-1254 INBS@kcsa.com
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