NEW YORK - Intelligent Bio Solutions Inc. (NASDAQ: INBS), a medical technology firm, has reported promising initial results from a Pharmacokinetic (PK) study, a critical step toward seeking FDA 510(k) clearance for its non-invasive drug screening system. The study found that fingerprint sweat can reliably indicate the presence of codeine, closely mirroring the drug's levels in blood and saliva.
The company's PK study, which compared the detection of opiates in fingerprint sweat to that in blood and oral fluid, demonstrated a strong correlation of PK parameters at the 95% confidence level. This suggests that fingerprint sweat is a robust sample matrix for drug detection. The study involved 39 healthy adult participants of diverse demographics and utilized the Intelligent Fingerprinting Drug Screening System alongside LC-MS/MS analysis, a highly regarded standard for such assessments.
Harry Simeonidis, President and CEO of INBS, expressed satisfaction with the study's outcomes, emphasizing the potential for the technology's adoption in safety-critical industries and beyond. The company plans to submit its 510(k) application in the fourth quarter of this year, aiming to introduce its drug screening technology to the U.S. market in 2025.
INBS's technology is designed to offer a hygienic, cost-effective, and rapid testing solution, screening for drugs such as opiates, cocaine, methamphetamine, and cannabis. The system promises to deliver results in under ten minutes from a simple fingerprint sweat sample, which could be particularly useful for employers in industries where safety is paramount.
The company's existing clientele outside the U.S. spans sectors including construction, manufacturing, transport, and drug rehabilitation. The information in this article is based on a press release statement from Intelligent Bio Solutions Inc.
In other recent news, Intelligent Bio Solutions Inc. has been making significant strides in its operations. The medical technology firm reported an 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. The company also announced a strategic expansion in Saudi Arabia, projecting a rise in global sales by 15% year-on-year.
In addition, Intelligent Bio Solutions has entered into a strategic partnership with B2i Digital to enhance its investor relations and spotlight its patented technology. The collaboration is expected to strengthen the company's market presence in anticipation of its product launch in the U.S. market in 2025.
Moreover, the company has made significant progress in its FDA 510(k) submission process for its sweat-based drug testing method. The completion of the in-clinic testing phase marks a significant milestone in the company's quest to obtain FDA clearance.
Intelligent Bio Solutions has also secured Pyrotek Pty Ltd as a new client, which plans to implement the company's drug testing solution across its Australian operations. Furthermore, the company announced a $3 million stock offering with Ladenburg Thalmann & Co. Inc., aimed at funding working capital and other corporate purposes.
Lastly, Intelligent Bio Solutions awarded a significant number of fully vested shares to its top executives, including CEO Harry Simeonidis and CFO Spiro Sakiris, as part of its 2024 compensation analysis and evaluation. These are the recent developments from Intelligent Bio Solutions Inc.
InvestingPro Insights
As Intelligent Bio Solutions Inc. (NASDAQ: INBS) progresses towards FDA 510(k) clearance for its innovative drug screening system, investors may find additional context from recent financial data and analyst insights valuable.
According to InvestingPro data, INBS has shown significant revenue growth, with a 55.29% increase in the last twelve months as of Q1 2023. This aligns with the company's technological advancements and potential market expansion. However, it's important to note that despite this growth, the company is not currently profitable, with an operating income margin of -328.8% for the same period.
InvestingPro Tips highlight that INBS holds more cash than debt on its balance sheet, which could provide financial flexibility as it pursues FDA clearance and potential U.S. market entry in 2025. Analysts anticipate sales growth in the current year, possibly reflecting optimism about the company's drug screening technology and its market potential.
Investors should be aware that INBS has experienced significant price volatility. While the stock has shown strong returns over the last week (27.63%) and month (30.2%), it has fallen significantly over the past year (-69.03%). This volatility may reflect both the company's progress in product development and the inherent risks associated with pre-revenue medical technology firms.
For 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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