$INBS Intelligent Bio Solutions Successfully Completes Recruitment and Begins Subject Screening for FDA 510(k) Pharmacokinetic (PK) Study
https://www.globenewswire.com/news-release/20...Study.html
NEW YORK, May 29, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"
, a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the successful recruitment and commencement of screening for subjects in its pharmacokinetic (PK) study, a critical component of the Company's FDA 510(k) regulatory pathway for clearance.
Harry Simeonidis, President and CEO at INBS, commented, "As we navigate the FDA 510(k) regulatory pathway, we are proud to announce the successful recruitment and commencement of screening for subjects in our PK study, a key milestone in our clinical study plan. Our dedicated team has worked tirelessly to ensure the study's design meets the rigorous standards set by the FDA. As we continue to make strides in our clinical study plan, we look forward to completing the screening phase, proceeding to the next phase of the plan, and moving closer to bringing our innovative technology to the market."
The PK study will provide a more thorough understanding of opiate metabolism, distribution, and excretion, particularly in human sweat. The study will collect and analyze human fingerprint sweat specimens and compare the results with other specimen matrices: blood, saliva, and urine.
"We appreciate the ongoing collaborative effort and diligence of our CRO partner, Cliantha Research, in executing this study," said Daniel Brown, Head of Clinical Affairs at INBS. "We look forward to analyzing the laboratory results soon."
The Intelligent Fingerprinting Drug Screening System, which includes a drug screening cartridge, a DSR-Plus fluorescence reader, and a collection kit for laboratory analysis, is at the forefront of non-invasive drug testing technology. The Company expects subject screening for the PK study to be completed in June 2024.
https://www.globenewswire.com/news-release/20...Study.html
NEW YORK, May 29, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"
, a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the successful recruitment and commencement of screening for subjects in its pharmacokinetic (PK) study, a critical component of the Company's FDA 510(k) regulatory pathway for clearance. Harry Simeonidis, President and CEO at INBS, commented, "As we navigate the FDA 510(k) regulatory pathway, we are proud to announce the successful recruitment and commencement of screening for subjects in our PK study, a key milestone in our clinical study plan. Our dedicated team has worked tirelessly to ensure the study's design meets the rigorous standards set by the FDA. As we continue to make strides in our clinical study plan, we look forward to completing the screening phase, proceeding to the next phase of the plan, and moving closer to bringing our innovative technology to the market."
The PK study will provide a more thorough understanding of opiate metabolism, distribution, and excretion, particularly in human sweat. The study will collect and analyze human fingerprint sweat specimens and compare the results with other specimen matrices: blood, saliva, and urine.
"We appreciate the ongoing collaborative effort and diligence of our CRO partner, Cliantha Research, in executing this study," said Daniel Brown, Head of Clinical Affairs at INBS. "We look forward to analyzing the laboratory results soon."
The Intelligent Fingerprinting Drug Screening System, which includes a drug screening cartridge, a DSR-Plus fluorescence reader, and a collection kit for laboratory analysis, is at the forefront of non-invasive drug testing technology. The Company expects subject screening for the PK study to be completed in June 2024.
