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Intelligent Bio Solutions’ FDA Clearance Process Remains on Track for 2025 U.S. Launch
GlobeNewswire· 2025-03-25 13:00
Core Viewpoint - Intelligent Bio Solutions Inc. is progressing towards the FDA clearance for its Intelligent Fingerprint Drug Screening System, aiming for a U.S. market launch in 2025, specifically targeting opiate testing for codeine [1][2][5]. FDA Clearance Process - The company submitted its 510(k) premarket notification to the FDA on December 18, 2024, marking a significant milestone for entering the U.S. market [2]. - The FDA classified the system as a Class II device, requiring a 510(k) submission, which initiated a 90-day review period [2][4]. - The FDA has issued an Additional Information (AI) request, pausing the review clock, and the company is currently addressing this request [4]. Performance Data - The 510(k) submission included performance data showing a 94.1% accuracy rate and validation studies indicating that fingerprint sweat is a reliable sample matrix for drug detection [3]. - The pharmacokinetic (PK) study results align closely with blood data, demonstrating the system's reliability and usability [3]. Market Potential - The company is preparing for a significant entry into the multi-billion-dollar U.S. market in 2025 and is also pursuing FDA clearance for additional drug classes [4]. - The Intelligent Fingerprinting Drug Screening System is designed for rapid, non-invasive testing, with results available in under ten minutes, making it suitable for safety-critical industries [6]. Global Presence - The company's full panel test is already adopted in 19 countries with over 400 accounts globally, indicating a strong international presence [4].
Intelligent Bio Solutions' FDA Clearance Process Remains on Track for 2025 U.S. Launch
Newsfilter· 2025-03-25 13:00
Core Viewpoint - Intelligent Bio Solutions Inc. is progressing towards the FDA clearance for its Intelligent Fingerprint Drug Screening System, aiming for a U.S. market launch in 2025, specifically targeting opiate testing for codeine [1][2][5]. FDA Clearance Process - The company submitted its 510(k) premarket notification to the FDA on December 18, 2024, which is classified as a Class II device requiring a 510(k) submission [2]. - The FDA has initiated a 90-day review period for the submission, which may extend to three to six months or longer if additional data is requested [4]. Performance Data and Validation - The 510(k) submission included performance data showing a 94.1% accuracy rate and validation studies indicating that fingerprint sweat is a reliable sample matrix for drug detection [3]. - The quantitative pharmacokinetic data aligns closely with blood analysis, demonstrating the system's reliability and usability [3]. Market Potential - The company is preparing to enter the multi-billion-dollar U.S. market in 2025 and is also pursuing FDA clearance for additional drug classes [4]. - The Intelligent Fingerprint Drug Screening System is designed for rapid, non-invasive testing, with results available in under ten minutes, making it suitable for safety-critical industries [6]. Global Presence - The company's full panel test is already adopted in 19 countries with over 400 accounts globally, indicating a strong international presence [4].
Intelligent Bio Solutions to Expand U.S. IP Portfolio with Expected Patent Grant
GlobeNewswire· 2025-03-20 12:30
Core Insights - Intelligent Bio Solutions Inc. (INBS) is set to receive its sixth patent in the U.S., enhancing its intellectual property portfolio related to its Intelligent Fingerprinting Drug Testing Solution [1][2] - The patent will protect INBS's lateral flow technology, crucial for its market entry strategy in the U.S. drug screening market [2][3] - The demand for non-invasive drug testing solutions is increasing as industries focus on workplace safety and compliance, positioning INBS favorably for market transformation [3] Company Overview - Intelligent Bio Solutions Inc. specializes in rapid, non-invasive testing solutions, particularly through its Intelligent Fingerprinting Drug Screening System, which analyzes fingerprint sweat [5] - The system screens for commonly used drugs in the workplace, including opiates, cocaine, methamphetamine, and cannabis, with results available in under ten minutes [5] - Current customer segments outside the U.S. include construction, manufacturing, transport, drug treatment organizations, and coroners [5]
Intelligent Bio Solutions to Participate in the iAccess Virtual Best Ideas Spring Conference on March 25th and 26th
GlobeNewswire News Room· 2025-03-11 12:30
Company Overview - Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company focused on delivering innovative, rapid, non-invasive testing solutions [3] - The company’s Intelligent Fingerprinting Drug Screening System utilizes fingerprint sweat analysis, aiming to revolutionize portable testing with potential applications in various fields [3] - The system is designed to be hygienic and cost-effective, screening for recent drug use, including opiates, cocaine, methamphetamine, and cannabis [3] Conference Participation - The management team of Intelligent Bio Solutions Inc. will participate in the iAccess Alpha Virtual Best Ideas Spring Conference on March 25 and 26, 2025 [1] - The presentation is scheduled for March 25th at 11:00 a.m. ET, with one-on-one meetings available during the conference [2] Target Markets - Current customer segments outside the US include construction, manufacturing, engineering, transport and logistics firms, drug treatment organizations, and coroners [3]
Intelligent Bio Solutions Inc. Announces Closing of $3.0 Million Public Offering of Common Stock and Full Exercise of the Underwriter's Option to Purchase Additional Shares of Common Stock
GlobeNewswire News Room· 2025-02-21 21:05
Core Viewpoint - Intelligent Bio Solutions Inc. has successfully closed a public offering of 1,500,000 shares at a price of $2.00 per share, raising approximately $3.0 million in gross proceeds [1]. Company Overview - Intelligent Bio Solutions Inc. is a medical technology company focused on delivering innovative, rapid, non-invasive testing solutions. The company aims to transform portable testing through its Intelligent Fingerprinting Drug Screening System, which analyzes fingerprint sweat for drug use [5]. - The system is designed to be hygienic and cost-effective, screening for drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. It allows for sample collection in seconds and provides results in under ten minutes, making it a valuable tool for employers in safety-critical industries [5]. Offering Details - The public offering included the full exercise of the underwriter's option to purchase an additional 195,652 shares, which contributed to the total gross proceeds [1]. - Ladenburg Thalmann & Co. Inc. acted as the sole bookrunning manager for the offering [2]. - The offering was conducted under a shelf registration statement filed with the SEC, which was declared effective in April 2022 [3].
Intelligent Bio Solutions Inc. Announces Closing of $3.0 Million Public Offering of Common Stock and Full Exercise of the Underwriter's Option to Purchase Additional Shares of Common Stock
Newsfilter· 2025-02-21 21:05
Core Viewpoint - Intelligent Bio Solutions Inc. has successfully closed a public offering of 1,500,000 shares at a price of $2.00 per share, raising approximately $3.0 million in gross proceeds [1]. Company Overview - Intelligent Bio Solutions Inc. is a medical technology company focused on delivering innovative, rapid, non-invasive testing solutions. The company aims to transform portable testing through its Intelligent Fingerprinting Drug Screening System, which analyzes fingerprint sweat [5]. - The testing system screens for recent drug use, including opiates, cocaine, methamphetamine, and cannabis, and is designed to be hygienic and cost-effective, providing results in under ten minutes [5]. - Current customer segments outside the U.S. include construction, manufacturing, engineering, transport and logistics, drug treatment organizations, and coroners [5]. Offering Details - The public offering included the full exercise of the underwriter's option to purchase an additional 195,652 shares, contributing to the total gross proceeds [1]. - Ladenburg Thalmann & Co. Inc. served as the sole bookrunning manager for the offering [2]. - The offering was conducted under a shelf registration statement filed with the SEC, which was declared effective in April 2022 [3].
Intelligent Bio Solutions Inc. Announces Pricing of $2.6 Million Public Offering of Common Stock
GlobeNewswire· 2025-02-20 13:30
Core Viewpoint - Intelligent Bio Solutions Inc. has announced a public offering of 1,304,348 shares of common stock at a price of $2.00 per share, aiming for gross proceeds of approximately $2.6 million before expenses [1][2]. Group 1: Offering Details - The offering is managed by Ladenburg Thalmann & Co. Inc. as the sole bookrunning manager [2]. - The company has granted the underwriter a 45-day option to purchase an additional 195,652 shares at the public offering price [2]. - The offering is expected to close on or about February 21, 2025, subject to customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for working capital and general corporate purposes [3]. Group 3: Company Overview - Intelligent Bio Solutions Inc. specializes in medical technology, focusing on rapid, non-invasive testing solutions [4]. - The company’s Intelligent Fingerprinting Drug Screening System analyzes fingerprint sweat to detect recent drug use, targeting industries such as construction, manufacturing, and transport [4]. - The testing system is designed to be hygienic and cost-effective, providing results in under ten minutes, which is beneficial for safety-critical industries [4].
Intelligent Bio Solutions Inc. Announces Proposed Public Offering of Common Stock
GlobeNewswire· 2025-02-19 21:42
Company Overview - Intelligent Bio Solutions Inc. is a medical technology company focused on delivering innovative, rapid, non-invasive testing solutions [5] - The company’s Intelligent Fingerprinting Drug Screening System utilizes fingerprint sweat analysis for drug testing, targeting common workplace substances such as opiates, cocaine, methamphetamine, and cannabis [5] - The testing system is designed to be hygienic and cost-effective, providing results in under ten minutes, which is beneficial for employers in safety-critical industries [5] Public Offering Announcement - Intelligent Bio Solutions Inc. has announced the commencement of an underwritten public offering of shares of its common stock, with all shares being offered by the company itself [1] - The offering is subject to market conditions, and there is no assurance regarding the completion, size, or terms of the offering [1] - Ladenburg Thalmann & Co. Inc. is acting as the sole bookrunning manager for this offering, which is made under a shelf registration statement filed with the SEC [2] Regulatory and Contact Information - A preliminary prospectus supplement and accompanying prospectus will be filed with the SEC and will be available on the SEC's website [3] - Interested parties can obtain copies of the prospectus by contacting Ladenburg Thalmann & Co. Inc. directly [3] - Company contact information includes an email address for inquiries [7] and a dedicated investor and media contact [8]
GBS(INBS) - 2025 Q2 - Quarterly Results
2025-02-13 22:15
CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of Earliest Event Reported): February 6, 2025 INTELLIGENT BIO SOLUTIONS INC. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K (State of Incorporation) (Commission File Number) Delaware 001-39825 82-1512711 (IRS employer identification no.) 135 West, 41 Street, 5th Floor New York, NY 10036 (Address of principal execut ...
GBS(INBS) - 2025 Q2 - Quarterly Report
2025-02-13 13:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) Commission File Number 001-39825 Intelligent Bio Solutions Inc. (Exact name of Registrant as specified in its Charter) Delaware 82-1512711 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) Intelligent Bio Solutions Inc., 135 West, 41 Street, 5FloorNew YorkNY 10036 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: ...