Intelligent Bio Solutions Inc. Advances on FDA 510(k) Pathway with Biocompatibility Study Success
Intelligent Bio Solutions Inc. (Nasdaq: INBS) has successfully completed biocompatibility testing for its Intelligent Fingerprinting Drug Screening System, a important step in the FDA 510(k) regulatory clearance process. The study, conducted according to ISO 10993 standards, confirmed the safety of all system materials for medical device use. This milestone advances INBS closer to bringing its non-invasive drug testing technology to the U.S. market.
Key points:
- Biocompatibility testing included cytotoxicity, sensitization, and irritation tests
- FDA agreed that the proposed testing approach is adequate for future 510(k) submission
- INBS plans to submit the 510(k) package in Q4 2024
- The company aims to launch the product in the U.S. market in 2025
- Successful completion of biocompatibility testing for FDA 510(k) pathway
- Confirmation of safety for all system materials in medical device use
- FDA agreement on the adequacy of the proposed testing approach
- Planned 510(k) package submission in Q4 2024
- Targeted U.S. market launch in 2025
- None.
Insights
The successful completion of the biocompatibility study for Intelligent Bio Solutions Inc.'s (INBS) Intelligent Fingerprinting Drug Screening System is a significant milestone in the FDA 510(k) pathway. This indicates that the materials used in the device are safe for human use, which is a critical requirement for obtaining FDA clearance. The study, conducted in accordance with ISO 10993 standards, provides robust evidence that the product meets rigorous safety standards. This is particularly important in the medical technology sector, where patient safety is paramount. The approval from the FDA to proceed with this testing protocol suggests a strong likelihood that INBS will meet future regulatory requirements, potentially accelerating their time-to-market. For a retail investor, this development reduces some regulatory risks and could positively influence the company's future financial performance.
Understanding Biocompatibility and FDA 510(k): Biocompatibility testing assesses whether materials that come into contact with the body will cause any adverse reactions. This is important for medical devices as it ensures patient safety. The FDA 510(k) clearance process requires demonstrating that a new device is at least as safe and effective as a legally marketed device. Successfully meeting these requirements is a strong indicator of the company's product viability and market readiness.
In the short term, this development could boost investor confidence and the company's stock price due to reduced regulatory hurdles. In the long term, achieving FDA clearance will enable INBS to penetrate the U.S. market, potentially expanding its market share and revenue streams.
From a market perspective, the successful biocompatibility study completion positions Intelligent Bio Solutions Inc. strategically within the non-invasive drug testing market. As the first step towards FDA 510(k) clearance, this achievement not only de-risks the regulatory pathway but also signifies the company's commitment to adhering to stringent safety standards. This could enhance the company's reputation and attractiveness among potential customers and partners.
Market Potential: The non-invasive drug testing market is projected to grow due to increasing demand for reliable, quick and less intrusive testing methods. INBS's technology is at the forefront of this trend, offering a competitive edge over traditional drug testing methods. If the company successfully brings its Intelligent Fingerprinting Drug Screening System to market, it could capture a significant share of this growing market, driving revenue growth.
For investors, this development suggests a promising growth trajectory, assuming subsequent regulatory milestones are met. In the short term, positive sentiment could drive stock appreciation. In the long run, market entry and adoption could lead to substantial financial returns.
NEW YORK, July 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 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.inc
LinkedIn | Twitter
Investor & Media Contact:
Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com
FAQ
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