Intelligent Bio Solutions Achieves Milestone in Clinical Testing
Intelligent Bio Solutions Progress in FDA Study Phase
Intelligent Bio Solutions Inc. (NASDAQ: INBS) has recently marked a significant milestone by completing essential in-clinic testing as part of its FDA 510(k) submission process. This achievement is crucial for validating the precision and dependability of its unique drug testing approach that utilizes sweat analysis. As part of this endeavor, clinical studies were performed, including a pharmacokinetic (PK) study and additional usability and method comparison evaluations.
Pharmacokinetic Study Success
The PK study, finalized in mid-2024, aimed to demonstrate the effectiveness of measuring drugs in fingerprint sweat, showing that this approach could match or surpass traditional methods like blood, saliva, and urine testing. In this phase of research, 135 participants were involved at three different testing locations, providing valuable data to compare the results against laboratory standards.
Team Contributions and Early Feedback
According to Daniel Brown, the Head of Clinical Affairs at Intelligent Bio Solutions, this phase required extensive collaboration among various team members to ensure its success. Harry Simeonidis, President and CEO, expressed that this completion brings them closer to obtaining FDA clearance. Initial feedback indicates that the fingerprint-based drug testing method may offer a reliable, non-invasive option for drug screening, catering to several sectors.
Looking Ahead: Next Steps for FDA Submission
The company is now strategically preparing for the subsequent steps in its FDA submission strategy. They expect detailed clinical data analysis to be finished in late 2024, with plans to submit the 510(k) application around the same time.
Technology Impact on Various Industries
Intelligent Bio Solutions' innovative technology facilitates rapid and hygienic drug screening through fingerprint sweat analysis. This system promises results in less than ten minutes and is currently operational in selected international markets. This would serve essential industries where safety is of utmost importance, such as construction, transport, and logistics.
Recent Business Developments
The conclusion of this in-clinic testing phase is a significant triumph for Intelligent Bio Solutions as they aim for FDA clearance, allowing for the marketing of their product as a clinically validated tool within the U.S.
Further to this, the company has initiated a $3 million stock offering through a partnership with Ladenburg Thalmann & Co. Inc., aimed at raising funds for working capital and other corporate needs. Notably, INBS has highlighted an impressive revenue growth of 80% for their fiscal third quarter and an outstanding 193% increase over the first nine months of the fiscal year, largely attributed to a surge in product orders.
Expansion and Strategic Partnerships
In addition to the financial successes, Intelligent Bio Solutions has deployed over 1,000 drug screening devices, exhibiting a remarkable 65% growth from the previous year, along with a 20% rise in cartridge sales. Significant advancements in the FDA approval journey have been made, including the successful completion of biocompatibility testing processes.
Recent expansions in the UK market saw their drug screening systems used by three major retailers. Moreover, a new collaboration with a European transport provider will further bolster their market position. Notably, the company has witnessed executive changes, leading to salary increases for CEO Harry Simeonidis and CFO Spiro Sakiris in light of board member Lawrence Fisher's passing.
Funding and Future Growth Potential
With approximately $10.1 million secured through a private placement transaction, Intelligent Bio Solutions is also proud to announce a newly granted European patent for its DSR-Plus Cartridge Reader, entrenching their technological advancement in the market.
Frequently Asked Questions
What is Intelligent Bio Solutions working on currently?
Intelligent Bio Solutions is focused on completing its FDA 510(k) submission process for its sweat-based drug testing technology.
How does the fingerprint sweat analysis work?
The technology measures drugs present in fingerprint sweat, aiming for a non-invasive and effective alternative to traditional drug testing methods.
What recent financial achievements has the company accomplished?
Intelligent Bio Solutions reported an 80% increase in revenue for the fiscal third quarter and a remarkable 193% boost for the nine months ending earlier this year.
What industries could benefit from this technology?
This technology has potential applications in various sectors, including construction, transportation, and logistics, where safety is paramount.
Has the company made any notable partnerships recently?
Yes, Intelligent Bio Solutions has partnered with major British retailers and a significant European transport provider to expand its market reach.
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