Intelligent Bio Solutions Inc. Advances on FDA 510(k) Pathway with Biocompatibility Study Success
2024年7月18日 - 9:30PM
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 completion of biocompatibility testing of its
Intelligent Fingerprinting Drug Screening System, a pivotal phase
in the clinical study plan required for FDA 510(k) regulatory
clearance.
The biocompatibility study, conducted in
accordance with ISO 10993 standards, involved a thorough evaluation
of the system's materials that come into contact with human skin.
With the successful completion of the biocompatibility study, INBS
has confirmed that all materials used in its system, including the
Drug Screening Cartridge, Confirmatory Cartridge and the DSR-Plus
Reader, are safe for use in medical devices.
Harry Simeonidis, President and CEO at INBS,
commented, “This milestone is an important element of our FDA
510(k) pathway for regulatory clearance, and we are proud to
announce its completion. Our development team continues to execute
on our plan to meet FDA requirements for our Drug Screening System.
We are now poised to move forward with the next stages of our
clinical study plan and move closer to bringing our innovative
technology to the market.”
Rafael da Luz, Vice President of Regulatory
Affairs for INBS, added, “The planned biocompatibility testing
protocol included cytotoxicity, sensitization and irritation tests
conducted on drug screening system materials and was presented to
the FDA in November last year. Earlier this year, the FDA agreed
that the proposed testing approach would be adequate for a future
premarket 510(k) submission.”
The Intelligent Fingerprinting Drug Screening
System, which includes a drug screening cartridge, a DSR-Plus
reader, and a collection kit for laboratory analysis, is at the
forefront of non-invasive drug testing technology. The Company
expects to submit the 510(k) package in the fourth calendar quarter
of 2024, moving closer to its goal of bringing this innovative
technology to the U.S. market in 2025.
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
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