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NEW YORK - Intelligent Bio Solutions Inc. (NASDAQ: INBS), a medical technology firm with a market capitalization of $6.07 million, has announced the submission of a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its Intelligent Fingerprinting Drug Screening System. According to InvestingPro data, the company's stock has experienced significant volatility, currently trading at $1.38, down about 66% year-to-date. The system, which promises to deliver rapid and non-invasive drug screening through fingerprint sweat analysis, aims to enter the US market in 2025.
The company's submission to the FDA includes performance data and validation studies that highlight the system's 94.1% accuracy in drug detection. This includes a method comparison study and a Pharmacokinetic (PK) study that supports the reliability of fingerprint sweat as a sample matrix for drug detection, with results closely aligned to blood at the 95% confidence level. The company maintains a healthy gross profit margin of 48.31% and has shown impressive revenue growth of 55.29% in the last twelve months, as reported by InvestingPro.
The Intelligent Fingerprinting Drug Screening System is designed to detect drugs of abuse such as opiates, cocaine, methamphetamine, and cannabis, via sweat from the fingertips and provide results within ten minutes. This could offer benefits in safety-critical industries like construction, mining, and transportation, as well as applications in law enforcement, drug rehabilitation, and forensic sectors.
Harry Simeonidis, President and CEO at INBS, stated, "The submission of our 510(k) application to the FDA is an impactful moment for all of us at Intelligent Bio Solutions." He emphasized the team's agility in executing clinical studies and analyzing data, expressing excitement about the potential growth and transformative impact on the drug screening market.
The company has already seen adoption of its system in international markets, where it has been recognized for delivering cost savings, operational efficiencies, and rapid results with minimal disruption. Entry into the US market, one of the largest for drug screening, could provide significant opportunities for revenue growth and market share acquisition for INBS.
The press release also contained forward-looking statements regarding the company's ability to commercialize its drug screening system, secure regulatory approvals, and realize commercial benefits from partnerships and collaborations. These statements involve risks and uncertainties, and the company has made no commitment to update any forward-looking statements following the date of the press release. InvestingPro analysis suggests the stock is currently undervalued, though investors should note that the company holds more cash than debt on its balance sheet, providing some financial flexibility. InvestingPro subscribers have access to 8 additional key insights about INBS, along with detailed financial metrics and Fair Value calculations.
This news 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 company raised about $250,802 through stock sales, facilitated by Ladenburg Thalmann & Co. Inc. This capital is expected to support ongoing research and development efforts. The company has also 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.
In a promising development, Intelligent Bio Solutions has reported initial results from a Pharmacokinetic study, a crucial step toward FDA 510(k) clearance for its non-invasive drug screening system. The company has also entered into a strategic partnership with B2i Digital to enhance its investor relations and spotlight its patented technology.
Furthermore, Intelligent Bio Solutions has secured Pyrotek Pty Ltd as a new client, which plans to implement the company's drug testing solution across its Australian operations. The company also announced a $3 million stock offering with Ladenburg Thalmann & Co. Inc., aimed at funding working capital and other corporate purposes. These are some of the recent developments from Intelligent Bio Solutions Inc.
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