Intelligent Bio Solutions Begins Subject Dosing and Sampling for FDA 510(k) Pharmacokinetic (PK) Study for its Intelligent Fingerprinting Drug Screening Technology
Intelligent Bio Solutions (Nasdaq: INBS) is advancing its 510(k) FDA submission with a Pharmacokinetic (PK) study for its fingerprint drug screening technology. After completing subject screening, the company will start dosing and sampling subjects today, aiming to finish by June 2024. The study focuses on how opiates are metabolized, distributed, and excreted, particularly through human sweat. Results are expected by late July 2024. FDA clearance, targeted for 4Q 2024, would allow INBS to enter the US market by 1H 2025. The technology offers quick, non-invasive drug testing for substances like cocaine, cannabis, methamphetamine, and opiates.
- INBS is progressing with its FDA 510(k) submission, a important step for US market entry.
- The PK study aims to be completed promptly, with results expected by the end of July 2024.
- Successful FDA clearance would enable market entry in the first half of 2025.
- The technology offers a non-invasive, quick, and hygienic drug testing method.
- Focus on common drugs of abuse, including cocaine, cannabis, methamphetamine, and opiates.
- Completion of the dosing and sampling phase is not guaranteed by June 2024.
- Delays in FDA clearance could impact the planned US market entry by 1H 2025.
- The PK study's success depends on gathering and analyzing accurate data from various biological samples.
- Potential competitive challenges in the US market could affect market penetration.
Insights
Intelligent Bio Solutions' advancement into the pharmacokinetic (PK) study phase for its fingerprint drug screening technology is worth noting. Pharmacokinetics is the study of how a drug is absorbed, metabolized, distributed and excreted in the body. By focusing on human sweat as the medium for drug detection, INBS is addressing a notable gap in current drug testing methods, which often rely on blood, saliva and urine samples.
This study's importance lies in its potential to revolutionize the drug testing industry by offering a more non-invasive, rapid and hygienic alternative. The meticulous comparison of results from sweat with traditional methods will be critical in establishing this technology's reliability and validity. If successful, this could drastically change workplace drug testing, law enforcement procedures and even clinical settings, providing a clear competitive advantage.
Looking ahead, the finalization of the PK study by July 2024 and a potential FDA 510(k) clearance in the fourth quarter of the year are key milestones. Investors should monitor these timelines closely as they represent significant de-risking events. The entry into the US market, tentatively planned for the first half of 2025, could significantly boost INBS' market presence and revenue streams.
The strategic implications of this development for Intelligent Bio Solutions are substantial. The US drug testing market is both extensive and lucrative and gaining FDA clearance could position INBS as a key player. The fingerprint drug screening technology's appeal primarily lies in its speed and ease of use, which are critical in high-turnover settings like workplaces and law enforcement.
The company's ability to provide results within minutes could disrupt the current market, which predominantly uses slower and more invasive methods. This technology’s convenience could also appeal to sectors that require frequent drug testing, providing INBS with a broad customer base.
However, investors should consider the competitive landscape. While INBS has a unique product, the drug testing market has entrenched players with established technologies. Therefore, the company's marketing and sales strategies post-FDA approval will be important to its success. Market penetration rates and customer adoption will be key metrics to watch after the expected market entry in 2025.
Pharmacokinetic study is key step on path to expansion into US market
NEW YORK, June 18, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced that it is entering the next phase of its planned 510(k) submission to the FDA. The Company has successfully completed subject screening for its Pharmacokinetic (PK) Study and will begin dosing and sampling study subjects today.
INBS’ PK study is a key step towards the Company’s planned 510(k) submission to the FDA during the fourth quarter of this year. FDA clearance is required to show that INBS’ fingerprint drug screening technology is safe and effective and would result in the Company’s ability to enter the substantial US market, currently planned for the first half of 2025.
INBS aims to complete the dosing and sampling of the recruited subjects by the end of June 2024, with a review of the PK study results expected to be finalized by the end of July 2024. The PK study will provide insights into the metabolism, distribution, and excretion of opiates, with a specific focus on human sweat. The study will gather and analyze fingerprint sweat samples and compare the results with blood, saliva, and urine samples.
Peter Passaris, INBS’ Vice President of Product Development, commented, "We look forward to commencing the next phase of our PK study this week. A lot of work and planning has gone into reaching this stage, and I am proud of our progress so far."
INBS' first-of-its-kind fingerprint drug screening technology uses fingerprint sweat to provide a quick, hygienic, and easy-to-use method for drug testing, delivering results in just minutes. This unique approach tests for common drugs of abuse, including cocaine, cannabis, methamphetamine, and opiates.
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
FAQ
What is the significance of INBS' Pharmacokinetic study?
When will INBS complete its dosing and sampling for the PK study?
What drugs does INBS' fingerprint drug screening technology test for?
When are the results of the PK study expected?
What is the planned timeline for INBS to enter the US market?
