Intelligent Bio Solutions Partners with Cliantha Research to Conduct Clinical Study as Part of FDA 510(k) Pathway
28 Febbraio 2024 - 2:30PM
Intelligent Bio Solutions Inc. ("INBS" or the "Company") (Nasdaq:
INBS), a medical technology company delivering intelligent, rapid,
non-invasive testing solutions, today announced its partnership
with Cliantha Research, a full-service Clinical Research
Organization (CRO), to perform a pharmacokinetic (PK) study forming
part of the Company’s FDA 510(k) clinical study plan.
The Company’s PK study will recruit 40 healthy
adult subjects under an IRB/EC and regulatory approved protocol and
compare the amounts of opiates in fingerprint sweat versus blood,
oral fluid and urine specimens following the medically supervised
administration of drugs. All fingerprint sweat, blood, oral fluid
and urine specimens will be analyzed by a validated, traceable
liquid chromatography mass spectrometry (LC-MS/MS) method, widely
accepted as the gold standard for such studies. The fingerprint
sweat specimen will be screened using INBS’ Intelligent
Fingerprinting Drug Screening System comprising the Intelligent
Fingerprinting Drug Screening Cartridge and DSR-Plus fluorescence
reader and compared to the LC-MS/MS results.
The start of the clinical study plan marks an
exciting milestone for the Company as it advances on its 510(k)
pathway. Harry Simeonidis, President and CEO at Intelligent Bio
Solutions, commented, “We are pleased to share news of our
partnership with Cliantha and progress on our 510(k) journey.
Initiating our clinical studies plan represents a critical
milestone for our organization. We have developed a detailed plan
that we are committed to executing, and while there is considerable
work ahead, we have taken the crucial first step in this process.
Our focus is on ensuring we remain on track for our planned entry
into the US market and expand access to our innovative screening
solution.” Dr Anne Marie Salapatek, Chief Scientific Officer and
Executive Vice President at Cliantha Research, stated, “At
Cliantha, we are excited to commence this rigorous and controlled
clinical trial to test this innovative device with potential to
provide rapid and non-invasive testing for opiates.”
In June 2023, the Company announced it had
received guidance from the FDA regarding the regulatory
classification of its Intelligent Fingerprinting Drug Screening
Cartridge. The FDA provisionally determined that the cartridge
falls within 21 CFR 862.3650, Opiate Test System, a Class II type
device that requires the submission of a pre-market notification
510(k) and the FDA’s clearance prior to marketing.
The Company intends to demonstrate through the
PK study that the fingerprint sweat measurement is a suitable proxy
for measurements obtained from blood, oral fluid, or urine
specimens to detect the presence of opiates. Recruitment and
screening of subjects for the PK study are anticipated to take
place in March and April 2024, with studies set to begin in May
2024. Sample analysis is projected to conclude by the end of June
2024.
About Cliantha
Cliantha Research Limited is a full-service,
global Clinical Research Organization (CRO) providing comprehensive
and integrated offerings in Clinical Endpoint Trials (Phase I –
IV), Bioequivalence (BA/BE) Studies, Safety/Phase I/ FIM
(SAD/MAD/POC) Studies, and those studies involving Personal
Healthcare products. Cliantha specializes in Nutraceutical
Products, Dermatology, Respiratory, Allergy, and Ocular trials.
Cliantha also offers a state-of-the-art Bioanalytical
Laboratory.
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 up to 130 indications,
ranging from glucose to immunological conditions and 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
Media Contact:
Cheryl BillsonComma
Communicationscheryl.billson@commacomms.com+44 (0)7791 720460
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