Intelligent Bio Solutions Inc.

Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company pioneering innovative, non-invasive, real-time point-of-care testing solutions. The company's Intelligent Fingerprinting Drug Testing Solution is transforming the traditional drug testing landscape through fingerprint sweat analysis. This rapid, cost-effective, and highly accurate solution plays a critical role in safeguarding workplaces across high-risk industries, including transportation, mining, construction, and manufacturing. The technology is designed to detect drug use within a 16-24 hour period, aiming to ensure employees are ‘fit for work’ at the time of testing and reducing risks associated with potential impairment. The company has over 450 active accounts across 24 countries.

The company's Drug Testing Solution comprises a two-part drug screening system for on-site screening, and a confirmatory drug test kit and procedure for confirmatory lab testing. The Intelligent Fingerprinting Drug Screening System consists of single-use, tamper-proof Drug Screening Cartridges (for sample collection) and the portable Drug Screening Reader for analysis. 

The System simplifies drug screening by delivering results in under ten minutes from a quick fingerprint sweat sample, removing the need for more invasive urine, saliva or blood tests. With over 1,000 readers deployed globally, the System has proven reliable and efficient, particularly in safety-critical industries where quick decisions and operational efficiency are vital. The System screens for major drugs of abuse, including opiates, cocaine, methamphetamine, and cannabis.

Looking ahead, Intelligent Bio Solutions is poised to significantly impact the US market. The company submitted its 510(k) pre-market application to the United States Food and Drug Administration (FDA) in December 2024. A 510(k) is a pre-market submission made to the FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device already approved by the FDA. If the FDA agrees, the device can be sold without undergoing the more stringent Premarket Approval (PMA) process. The company intends to enter the US market in 2025 with its advanced drug screening technology.

FDA 510(k) clearance will pave the way for the company's anticipated product launch in the first half of 2025, unlocking substantial growth potential in a market increasingly focused on rapid, non-invasive testing technologies. With stringent regulatory requirements and a heightened focus on workplace safety, the company is well-positioned to meet these demands with its innovative solution.

Source: Company Documents

See the Intelligent Fingerprinting Drug Screening System in Action

Watch this brief 1-minute video to learn how Intelligent Bio Solutions’ innovative Drug Screening System simplifies testing, delivering fast, accurate results through non-invasive fingerprint sweat analysis.

Source: Company Documents

Growing Drug Consumption

The global landscape of drug consumption continues to evolve, marked by significant increases in use across multiple substances. The United Nations Office on Drugs and Crime (UNODC) World Drug Report 2024 reveals that over 292 million people used drugs globally in 2022, reflecting a steady rise over the past decade. Cannabis remains the most widely used drug, with over 228 million users, making up around 4% of the global population. While opioids have a smaller user base of 60 million, they are one of the deadliest drug categories, with fentanyl and other potent synthetic opioids associated with high levels of drug-related mortality in North America. The use of stimulants remains high, with approximately 30 million people using amphetamine-type stimulants (ATS) such as methamphetamine, and 23.5 million people using cocaine. Both substances are contributing to growing public health concerns as their use expands across multiple regions.

This rise in drug consumption, driven by social, economic, and health factors, underscores the growing demand for robust drug screening solutions. As more individuals face the consequences of drug misuse, the need for fast, non-invasive, and reliable testing becomes critical, not just in workplace settings but across society at large. Intelligent Bio Solutions is positioned to meet this growing demand through its innovative drug screening technology, offering an effective solution for organizations looking to combat drug misuse with minimal disruption to their operations.

Source: Company Documents

Drug Use in the Workplace

Workplace drug use is a significant issue, as more than 70% of adults abusing alcohol or illicit drugs in the US are employed¹. In safety-critical industries such as construction, transportation, and manufacturing, this can lead to a higher risk of accidents, absenteeism, and lower productivity. Testing programs across these industries employ traditional testing methods that can be time-consuming, invasive, and costly. Intelligent Bio Solutions offers a rapid, non-invasive alternative with its Intelligent Fingerprinting Drug Screening System, helping organizations identify potential safety risks quickly and efficiently, reducing the risk of drug-related workplace accidents.

¹ Centers for Disease Control and Prevention, Mental Health, Alcohol Use, and Substance Use Resources for Workers and Employers

Source: Company Documents

USA Market Potential

The US drug screening products market is projected to reach $14.9 billion by 2030², driven by stricter regulations, a focus on workplace safety, demand for faster testing technologies, and growth in substance abuse cases. With its December 2024 FDA 510(k) pre-market submission and anticipated US launch in 2025, Intelligent Bio Solutions is well-positioned to capture a significant market share. The company's unique fingerprint sweat-based drug screening technology addresses the demand for faster, more convenient testing, disrupting the traditional testing landscape.

² Research And Markets’ ‘Drug Screening - Global Strategic Business Report’

Source: Company Documents

Simpler Drug Testing

Intelligent Bio Solutions is revolutionizing drug testing with its Intelligent Fingerprinting Drug Screening System, which uses fingerprint sweat to detect recent drug use. Unlike traditional methods that require urine, saliva, or blood samples, this system provides a fast, non-invasive alternative, allowing organizations to maintain workplace safety without the discomfort and biohazard risks associated with other testing methods. The System screens for commonly abused drugs, including opiates, cocaine, methamphetamine, and cannabis, making it ideal for industries where safety is paramount. The technology is hygienic and cost-effective and delivers results in less than ten minutes, minimizing downtime and ensuring quick decision-making.

The two-part Drug Screening System consists of single-use, tamper-proof Drug Screening Cartridges (for sample collection) and the portable Drug Screening Reader for analysis. This simple collection method eliminates the need for trained personnel and specialized facilities, reducing cost and complexity. Additionally, its compact, portable design allows for easy deployment across various locations, enabling organizations to conduct on-site drug tests anywhere and anytime, regardless of size or location.

Source: Company Documents

How It Works

The Intelligent Fingerprinting Drug Screening System uses advanced technology to detect recent drug use through fingerprint sweat analysis. The Drug Screening Cartridge uses lateral flow assay technology and fluorescence-labeled antibodies to selectively detect specific drugs and drug metabolites in the eccrine sweat collected from fingerprints. Metabolites are chemicals produced by the body’s metabolic processes when a substance is ingested or injected. Detection of specific metabolites in body fluids, such as fingertip sweat, can indicate recent drug use.

Ten fingerprint sweat samples (one from each finger) are collected onto the Drug Screening Cartridge sample application pad in a process that takes less than a minute. If drug metabolites are present in the sweat, the antibodies in the cartridge will bind to them. As these antibodies attach to the drug metabolites, they emit a fluorescent signal, invisible to the naked eye but detectable by the DSR-Plus Reader. The Reader then scans the cartridge and analyzes the strength of the fluorescent signal, providing a clear and accurate result in under ten minutes.

Because the system is highly sensitive to even small amounts of drug metabolites, it ensures high accuracy. Unlike traditional urine or saliva tests, which can be invasive and lengthy to process, the Intelligent Fingerprinting Drug Screening System allows for quick, non-invasive testing. In cases where further confirmation is needed, samples can be sent for laboratory testing. Speed, reliability, and ease of use make the System ideal for workplace safety and compliance, particularly in industries where rapid decision-making is essential.

Source: Company Documents

Competitive Advantages

Intelligent Bio Solutions' Intelligent Fingerprinting Drug Testing Solution offers several advantages over traditional drug testing solutions, such as urine and saliva tests. It provides a quick, non-invasive, and hygienic alternative, making it an appealing option for organizations in safety-critical industries.

Below are nine important competitive advantages of the Intelligent Fingerprinting Drug Testing Solution:

1. A Complete Drug Testing Solution

The comprehensive Drug Testing Solution includes training of nominated personnel, a two-part system for on-site screening, and a confirmatory drug test kit and procedure for when a non-negative screening result requires lab confirmation.

2. Non-Invasive Testing

Unlike urine and saliva tests, which can be uncomfortable and require sample collection in private settings, the fingerprint-based method is entirely non-invasive. Fingerprint sweat samples are collected in just a few seconds, reducing discomfort for the individual being tested and protecting their privacy and dignity.

3. Faster Results

Traditional drug tests, especially those involving urine samples, can often take hours or even days to organize, collect and process. In contrast, the Intelligent Fingerprinting Drug Screening System takes minutes, from sample collection to delivering results, providing organizations with immediate insights. This speed is particularly crucial for safety-critical industries where rapid decision-making is essential, such as transportation, construction, and manufacturing.

4. Hygienic and Convenient

Collecting urine or saliva samples can introduce biohazard risks that require special handling and disposal procedures. The fingerprint sweat collection method is non-biohazardous and does not require specialized storage or disposal, making the process far more convenient and hygienic. The Intelligent Fingerprinting Drug Screening System reduces the complexity of drug testing programs and minimizes the potential for cross-contamination.

5. Reduced Risk of Tampering

Urine and saliva samples are susceptible to tampering or substitution, which can compromise the integrity of drug tests. The fingerprint sweat collection method is far more difficult to manipulate due to the System’s tamper-evident cartridges, providing organizations with greater confidence in the accuracy and reliability of test results. 

6. Wider Applicability and Portability

The Drug Screening Reader is portable and easy to use in various environments, from on-site workplace testing to more remote locations. This portability allows for more flexible and scalable testing programs than traditional methods requiring trained personnel and designated collection areas. The ability to conduct tests anytime and anywhere gives organizations greater control and flexibility in their drug testing processes.

7. Comparable Accuracy

While traditional methods like urine and saliva testing have been the standard choices for drug testing, the Intelligent Fingerprinting Drug Screening System provides a comparable level of accuracy, ensuring reliable results. Its sensitivity to drug metabolites in fingerprint sweat ensures that even small traces of drugs are detected, making it a competitive and reliable option for workplace drug screening.

8. Cost Savings

The Intelligent Fingerprinting Drug Screening System is more cost-effective than traditional drug testing methods due to the time savings involved in the testing process. Traditional methods often involve additional expenses for specialized facilities, trained personnel, and biohazardous material disposal. The System requires minimal training and no special collection facilities, eliminating the need for complex disposal procedures. With faster results and batch testing capability, organizations save time and resources by avoiding the delays and administrative burdens associated with traditional methods and lab-based testing.

Other Drug Testing Systems

The Intelligent Fingerprinting Drug Screening System is the only commercially available platform to use fingerprint sweat analysis for drug testing. Most testing methods rely on urine, saliva, or blood samples. Intelligent Bio Solutions uniquely provides this combination of non-invasive testing, speed, and portability.

Source: Company Documents

Current Accounts Base

Intelligent Bio Solutions has a diverse and growing accounts base spanning multiple industries and regions. The company's Intelligent Fingerprinting Drug Screening System is deployed across 24 countries and 450+ active account sites in key industries such as construction, transportation, manufacturing, and engineering. These industries are highly safety-sensitive, making the fast, non-invasive nature of the System particularly valuable in reducing risk and maintaining compliance with workplace safety standards.

The company's product footprint continues to grow, with significant penetration in the United Kingdom, Europe and, more recently, Asia Pacific. High-profile accounts include businesses in safety-critical sectors and organizations focused on drug treatment and rehabilitation. These partnerships demonstrate the versatility and scalability of the technology. As a testament to the System’s reliability, many accounts report substantial improvements in the efficiency and effectiveness of their drug testing programs.

Source: Company Documents

Account Testimonials highlight how the non-invasive sweat-based testing method has significantly reduced costs and the discomfort and privacy concerns typically associated with urine or saliva testing. Employers in safety-critical sectors have praised the System’s speed and portability, allowing them to conduct on-site testing with minimal disruption to operations while maintaining high workplace safety standards.

Source: Company Documents

Regulatory Strategy

Intelligent Bio Solutions has developed a comprehensive regulatory strategy to ensure that its Intelligent Fingerprinting Drug Testing Solution meets the necessary standards for global markets. The company submitted its 510(k) pre-market application to the US Food and Drug Administration (FDA) in December 2024. This critical milestone aims to demonstrate that the company's Intelligent Fingerprinting Drug Screening System is equivalent to existing, legally marketed devices. The company anticipates launching its product in the US market in 2025.

In addition to its FDA efforts, Intelligent Bio Solutions adheres to stringent quality standards in other regions. The company is ISO 13485:2016 certified, an international standard that ensures compliance with medical device regulations for manufacturing, design, and quality management. This certification is essential for selling medical devices in markets such as the US, Canada, Europe, Japan, Singapore, Malaysia, and Saudi Arabia, further solidifying the company's global presence.

To support its entry into new regions, the company has also established partnerships with regulatory bodies and laboratories to ensure compliance with local regulations. These efforts are integral to the company's expansion strategy, enabling it to introduce its innovative technology to a growing number of markets while maintaining the highest quality and safety standards.

R&D and Innovation Pipeline

The company is focused on enhancing the Drug Screening Reader with improved connectivity and user interface upgrades, allowing for seamless data integration with healthcare systems. These developments will further strengthen Intelligent Bio Solutions’ position as a leader in workplace safety and healthcare diagnostics, providing adaptable solutions for a range of industries and applications.

Sales & Distribution Strategy

Intelligent Bio Solutions has developed a multifaceted sales and distribution strategy designed to scale its operations globally and capitalize on the growing demand for rapid, non-invasive drug testing solutions. The company employs a combination of direct sales efforts and strategic partnerships to penetrate key markets, particularly in the United Kingdom, Europe, and Australia. These safety-conscious regions present significant opportunities for the company's Intelligent Fingerprinting Drug Testing Solution.

The company's direct sales team focuses on building relationships with employers in safety-critical industries, such as construction, mining, manufacturing and engineering, transport, and logistics. By targeting these sectors, the company ensures that its Solution is positioned where the need for fast, reliable drug testing is paramount. The sales team is trained to demonstrate how the Intelligent Fingerprinting Drug Screening System can streamline operations and reduce the risks associated with workplace drug use, particularly by highlighting its speed, non-invasive nature, and cost-effectiveness.

In addition to direct sales, Intelligent Bio Solutions leverages strategic distribution partnerships to expand its footprint in regions where local knowledge and networks are essential for market entry. These partnerships with established distributors enable the company to reach smaller organizations and markets that would otherwise be difficult to access through direct sales alone. By partnering with distributors who understand regional regulatory requirements, the company ensures smooth market entry and compliance with local standards.

The company's ongoing commitment to regulatory approvals is essential to its sales and distribution strategy. As it prepares for its anticipated launch in the US in 2025, Intelligent Bio Solutions is looking into a distribution network to ensure the product is available to a broad range of industries. This strategy is complemented by a focus on scalability, with the company investing in account support and training infrastructure to support growth in both direct and indirect sales channels. Through this approach, Intelligent Bio Solutions is working to establish itself as the go-to provider for rapid, non-invasive, and cost-effective drug testing in multiple global markets.

Intellectual Property Protection

Intelligent Bio Solutions has a robust intellectual property (IP) portfolio to protect its cutting-edge fingerprint sweat-based technology, ensuring a competitive advantage in the rapidly evolving drug testing and diagnostics market. The company has obtained patents in the US, United Kingdom, Europe, Australia, Japan, China, and Canada, securing legal protection in critical markets where demand for non-invasive testing is expected to grow. These patents cover multiple facets of the company's technology, from core diagnostic methodologies to device innovations, providing a comprehensive defense against competitors.

At the heart of Intelligent Bio Solutions’ IP portfolio are patents related to its lateral flow test strips, cartridge technology, and lateral flow test strip reader, all of which are integral to the company's commercial products. The company holds a primary patent, filed in 2014, which covers the broad concept of using lateral flow strips in diagnostic testing. This patent is projected to remain in force until 2034-2035, securing long-term protection for one of the company's most critical innovations.

In addition to the core cartridge technology, Intelligent Bio Solutions has protected the Drug Screening Reader, the device responsible for analyzing fingerprint sweat samples and generating test results. The patent related to this reader ensures the company controls the core hardware that powers its Intelligent Fingerprinting Drug Screening System. Another primary patent covers the Confirmation Cartridge, further solidifying the company's stronghold on the testing process and the tools required to carry it out. With patents lasting through 2040-2041, Intelligent Bio Solutions is well-positioned to maintain exclusivity in the market, shielding its products from reverse engineering or duplication by larger players looking to enter the non-invasive diagnostics space.

The company's complete patent suite covers virtually all aspects of fingerprint diagnostics, including chemistry, screening cartridge technology, collection cartridge technology, fingerprint quantitation, fingerprint-controlled medication dispensers, lab testing of fingerprints, accessories, and lateral flow test strip readers. 

Financial Overview

Intelligent Bio Solutions is positioned for sustained growth, with revenue increasing significantly as its innovative drug screening technology gains traction. For the fiscal year ending June 30, 2024, the company's revenues were $3.11 million, a 148% year-over-year growth from $1.26 million in fiscal 2023. This strong performance reflects the growing adoption of the company's Intelligent Fingerprinting Drug Testing Solution across key industries such as construction, transportation, and manufacturing.

The company's balance sheet provides the resources necessary to fuel continued expansion. As of June 30, 2024, the company had Cash and cash equivalents of $6.30 million, up from $1.54 million the previous year. The company's strong working capital positions it to sustain its operations and invest in areas such as product development, geographical expansion, and regulatory compliance to drive future growth.

Source: Company Documents