Full Press Release Details
Bio Solutions Inc. Advances on FDA 510(k) Pathway with Biocompatibility Study Success
YORK, 18 July, 2024 - 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.
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
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."
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."
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.
Intelligent Bio Solutions Inc.
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.
more information, visit: http://www.ibs.inc/
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.
Pinto, Managing Director