NEW YORK - Intelligent Bio Solutions Inc. (NASDAQ:INBS), a medical technology firm, announced today the completion of crucial in-clinic testing as part of its FDA 510(k) submission process. The clinical studies, which are integral to the company's efforts to validate the accuracy and reliability of its sweat-based drug testing method, concluded with a pharmacokinetic (PK) study and additional method comparison and usability studies.
The PK study, completed in June 2024, aimed to show that the measurement of drugs in fingerprint sweat can be as effective, if not more so, than traditional methods such as blood, saliva, and urine. The subsequent studies involved 135 subjects across three sites and sought to verify the accuracy of the company's testing system against a laboratory-based reference.
Daniel Brown, Head of Clinical Affairs at INBS, highlighted the collaborative efforts required to execute these studies, while President and CEO Harry Simeonidis emphasized the achievement as a step closer to FDA clearance. Early feedback suggests the fingerprint-based method could offer a non-invasive and reliable alternative for drug screening in various sectors.
The company is now preparing for the next stages of its FDA submission, with clinical data analysis expected to be completed in the fourth quarter of 2024 and the 510(k) package submission anticipated within the same timeframe.
Intelligent Bio Solutions' technology, which allows for rapid and hygienic drug screening through fingerprint sweat analysis, is poised to serve industries where safety is paramount, such as construction, transport, and logistics. The system provides results in under ten minutes and is already in use in select markets outside the U.S.
The completion of the in-clinic testing phase marks a significant milestone for Intelligent Bio Solutions in its quest to obtain FDA clearance, which would enable the company to market its product as a clinically validated tool in the U.S.
This information is based on a press release statement from Intelligent Bio Solutions Inc.
In other recent news, Intelligent Bio Solutions Inc. has announced a $3 million stock offering in an agreement with Ladenburg Thalmann & Co. Inc. This move allows for the sale of common stock to fund working capital and other corporate purposes. The company also reported a significant 80% increase in revenue for the fiscal third quarter and a 193% rise for the nine months ending March 31, 2024, primarily due to a surge in product sales.
In addition, the firm installed over 1,000 drug screening readers, marking a 65% growth from the previous year, and reported a 20% increase in cartridge sales. Alongside these developments, Intelligent Bio Solutions has made significant strides in the FDA approval process for its drug screening system, successfully completing biocompatibility testing.
The company also expanded its UK customer network, introducing its drug screening system to three major British retailers, and secured a new partnership with a major European transport provider. Executive changes within the company have seen substantial salary increases for CEO Harry Simeonidis and CFO Spiro Sakiris, following the passing of board member Lawrence Fisher.
Lastly, Intelligent Bio Solutions secured approximately $10.1 million in funding through a private placement transaction and was granted a new European patent for its DSR-Plus Cartridge Reader. These are the recent developments from Intelligent Bio Solutions Inc.
InvestingPro Insights
As Intelligent Bio Solutions Inc. (NASDAQ:INBS) progresses through its FDA 510(k) submission process, investors may find value in examining the company's financial metrics and market performance. According to InvestingPro data, INBS has shown impressive revenue growth, with a 147.58% increase in the last twelve months as of Q4 2024. This aligns with the company's recent clinical achievements and potential market expansion.
However, it's crucial to note that INBS is currently not profitable, with an operating income margin of -330.46% for the same period. This reflects the company's significant investment in research and development, including the recently completed clinical studies.
InvestingPro Tips highlight that while INBS holds more cash than debt on its balance sheet, it is quickly burning through cash. This financial position is typical for biotech companies in the pre-approval stage and underscores the importance of the ongoing FDA submission process for the company's future.
The stock's recent performance has been volatile, with a strong 54.17% return over the last month, contrasting with a 58.43% decline over the past six months. This volatility may be attributed to investor reactions to clinical progress and regulatory milestones.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for INBS, providing deeper insights into the company's financial health and market position.
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