NEW YORK - Intelligent Bio Solutions Inc. (NASDAQ: INBS), a medical technology firm, has announced the successful completion of biocompatibility testing for its drug screening system, marking a significant step toward FDA 510(k) regulatory clearance. The testing, which complies with ISO 10993 standards, ensures that the system's materials are safe for medical use.
Harry Simeonidis, President and CEO of INBS, stated, "This milestone is an important element of our FDA 510(k) pathway for regulatory clearance." Rafael da Luz, Vice President of Regulatory Affairs, added that the FDA had previously agreed to the proposed testing approach for a premarket 510(k) submission.
The Intelligent Fingerprinting Drug Screening System, which is designed for non-invasive drug testing through fingerprint sweat analysis, is expected to be submitted for FDA review in the fourth quarter of 2024, aiming for a U.S. market launch in 2025.
The system includes a drug screening cartridge, a DSR-Plus reader, and a collection kit for laboratory analysis, offering a quick and hygienic method for detecting drugs such as opiates, cocaine, methamphetamine, and cannabis.
The technology is anticipated to be a valuable tool for employers in safety-critical industries, with sample collection in seconds and results available in under ten minutes. INBS's broader biosensor platform is also being developed to test for various indications, including immunological conditions and communicable diseases.
INBS serves customer segments including construction, manufacturing, transport, drug treatment organizations, and coroners. This press release statement serves as the basis for the information provided.
In other recent news, medical technology firm Intelligent Bio Solutions Inc. (INBS) has seen significant growth in its operations and market presence. The company reported an 80% surge in revenue for its fiscal third quarter and a 193% increase for the nine months ending March 31, 2024, primarily driven by a substantial uptick in product sales.
INBS also expanded its UK customer network, introducing its Intelligent Fingerprinting Drug Screening System to three major British retailers, and secured a new partnership with a major European transport provider to implement its drug screening system in the United Kingdom.
Recently, INBS showcased its drug screening technology at The Health & Safety Event 2024 in the United Kingdom, indicating high interest from industry leaders. The company also discussed a pilot program to introduce the technology in Chile's hospitals and emergency services.
Moreover, INBS secured approximately $10.1 million in funding through a private placement transaction, allocated for advancing clinical trials and market expansion efforts.
The company was granted a new European patent for its DSR-Plus Cartridge Reader, enhancing its intellectual property portfolio across 17 European countries. These recent developments reflect the company's continued growth and market presence. It's important to note that all information is based on press releases from Intelligent Bio Solutions Inc. and analysts' analysis.
InvestingPro Insights
As Intelligent Bio Solutions Inc. (NASDAQ: INBS) takes strides towards FDA 510(k) regulatory clearance, the financial landscape of the company provides an essential perspective for investors. The company holds a market capitalization of 5.72 million USD, which indicates its relative size in the industry. Despite the positive developments in its regulatory journey, INBS has experienced significant volatility in its stock price, as reflected by a 93.57% decline in the 1-year total return. This level of volatility is a critical factor for potential investors to consider.
Analysts have projected sales growth for INBS in the current year, which is a promising sign against the backdrop of a 247.42% revenue growth in the last twelve months as of Q3 2024. This growth momentum is noteworthy, especially when considering the company's innovative drug screening system that is poised for FDA review. Still, it is important to note that INBS currently holds a negative P/E ratio of -0.16, which suggests that the company has not been profitable over the last twelve months.
InvestingPro Tips highlight that while INBS holds more cash than debt, which is a positive indicator of financial health, the company is also quickly burning through cash. Additionally, the company does not pay a dividend to shareholders, which may influence investment decisions for those seeking regular income streams. For investors interested in a deeper dive into the financials and future outlook of INBS, there are 11 additional InvestingPro Tips available, which can be accessed at https://www.investing.com/pro/INBS. To explore these insights further, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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