Intelligent Bio Solutions Receives Guidance from U.S. FDA on a Regulatory Pathway for Expansion into the United States for its Intelligent Fingerprinting Drug Screening Cartridge
28 Junho 2023 - 9:30AM
Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the
“Company”), a medical technology company delivering intelligent,
rapid, non-invasive testing solutions, today announced it has
received guidance from the U.S. Food and Drug Administration (the
“FDA”) regarding the regulatory classification of its Intelligent
Fingerprinting Drug Screening Cartridge. The FDA has 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 preliminary assessment, in response to the
Company’s March 2023 513(g) request for product classification,
provides a clear regulatory pathway for INBS as part of the
Company’s expansion strategy into the United States. The Company
intends to submit a 510(k) pre-market notification for its
proprietary Intelligent Fingerprinting Drug Screening Cartridge.
“We are pleased to receive the FDA’s preliminary
assessment for our Intelligent Fingerprinting Drug Screening
Cartridge, which is a key step in our expansion into the U.S.
market,” said Harry Simeonidis, President and CEO of Intelligent
Bio Solutions. “With its rapid collection time and portability, we
believe our intelligent drug screening technology will redefine how
U.S. workplaces approach testing by setting a new standard for drug
testing procedures that prioritizes the dignity of employees while
simultaneously enhancing operational efficiency for employers.”
The Intelligent Fingerprinting Drug Screening
System is designed to detect the presence of specific drugs and/or
their metabolites from fingerprint sweat. The system features a
small, tamper-evident drug screening cartridge onto which ten
fingerprint sweat samples are collected in less than a minute. The
tamper-proof cartridges are designed to screen for multiple drug
groups simultaneously, including combinations of opioids, cocaine,
methamphetamines, benzodiazepines, cannabis, methadone, and
buprenorphine, in an approach that offers a dignified,
non-invasive, and rapid drug screening solution. The application of
the technology in maintaining workplace safety has garnered
positive feedback from the Company’s growing customer base of over
350 clients in other countries, successfully deterring substance
abuse at work and ensuring employee well-being and compliance with
health and safety policies.
About Intelligent Bio Solutions
Inc.
Intelligent Bio Solutions Inc. (the "Company")
(Nasdaq: INBS) is a medical technology company delivering
intelligent, 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. This hygienic, and cost-effective system is
designed to screen for recent use of drugs commonly found in the
workplace, including opioids, 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 drug and diagnostic tests,
realize commercial benefit from its partnerships and
collaborations, and secure regulatory approvals (including
from the FDA), 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
Investor Contact:Valter Pinto, Managing
DirectorKCSA Strategic CommunicationsPH: (212)
896-1254INBS@kcsa.com
Media Contact:Cheryl BillsonComma
Communicationscheryl.billson@commacomms.com
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