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NEW YORK - Intelligent Bio Solutions Inc. (NASDAQ:INBS), a medical technology company with a market capitalization of $10.4 million that according to InvestingPro analysis appears undervalued, announced Wednesday it has submitted its Additional Information response to the U.S. Food and Drug Administration as part of the ongoing 510(k) clearance process for its fingerprint sweat-based drug screening technology.
The medical technology company expects a response from the FDA within six weeks as it maintains focus on entering the U.S. market later this year. With a solid gross profit margin of nearly 59% and more cash than debt on its balance sheet, the company appears positioned for this expansion, according to InvestingPro data.
The updated submission includes new data from cybersecurity testing, including penetration and electromagnetic compatibility testing. According to the company, 10,000 hours were dedicated to collecting new data, resulting in 23 test reports and over 100 supporting attachments totaling more than 1,900 pages.
"The quality, depth, and regulatory alignment of our current submission represents a significant advancement," said Peter Passaris, Vice President of Product Development at Intelligent Bio Solutions, in a press release statement.
The company also reported it has reaffirmed the accuracy of its technology using advanced quantification methods, including human eccrine sweat testing with an Ultra-Micro Balance scale to detect and analyze sweat volumes in a single fingerprint.
Intelligent Bio Solutions is seeking FDA clearance for its opiate test system for codeine. The company’s non-invasive drug screening technology is currently used across more than 450 accounts in 24 countries, supporting workplace, law enforcement and justice sectors through 18 global distribution partners.
The fingerprint-based system screens for recent use of drugs including opiates, cocaine, methamphetamine, and cannabis, with sample collection taking seconds and results available in under ten minutes. While the company posted revenue growth of 3.87% in the last twelve months, analysts tracked by InvestingPro anticipate stronger sales growth ahead, with 8 additional exclusive ProTips available for subscribers.
In other recent news, Intelligent Bio Solutions Inc. has secured a significant contract with a major public transport operator in London to implement its fingerprint-based drug screening technology across 14 operational sites. The company is also advancing its FDA submission process by collecting new data that reinforces the security and performance of its Intelligent Fingerprinting Drug Screening System, with plans to submit findings to the FDA. Additionally, Intelligent Bio Solutions has expanded its global reach through a new distribution agreement with SMARTOX to market its SmarTest Patch drug detection product internationally, excluding the United States and Canada.
The SmarTest Patch, a recent addition to the company’s non-invasive drug testing lineup, offers continuous drug detection through sweat over a 7 to 10-day period. In corporate developments, Intelligent Bio Solutions has amended executive contracts, adjusting the non-compete obligations for its President and CEO, Harry Simeondis, and CFO, Spiro Sakiris. These amendments introduce a tiered structure for post-employment restrictions and expand the scope of non-compete clauses. These strategic moves reflect the company’s ongoing efforts to enhance its product offerings and operational footprint.
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