Innovative Steps Towards FDA Approval by Intelligent Bio Solutions
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Progress in FDA Submission Preparation by Intelligent Bio Solutions
Intelligent Bio Solutions Inc. (Nasdaq: INBS), a notable player in the medical technology realm, is moving forward with its clinical study plan essential for FDA 510(k) submission. This announcement marks an essential milestone in the company’s aim to deliver innovative, rapid, and non-invasive testing solutions.
Partnership and Method Comparison Study
In a collaborative effort, Intelligent Bio Solutions has joined forces with CenExel for a method comparison study, an integral component of its clinical study plan. This study aims to recruit 135 healthy adult subjects across three sites following an IRB-approved protocol. It will compare the outcomes from fingerprint sweat opiate screening tests against results from a validated laboratory method using liquid chromatography-mass spectrometry (LC-MS/MS).
Enrollment and Study Progress
The company is pleased to report that it has successfully met approximately one-third of its enrollment targets for this important study. Activities conducted include screening, consenting, and collecting fingerprint sweat specimens. Additionally, the company has recently concluded the in-clinic portion of a pharmacokinetic (PK) study on opiates using human fingerprint sweat, and data analysis is currently underway.
Leadership Insights
Harry Simeonidis, President and CEO of Intelligent Bio Solutions, stated, "Our team is collaborating effectively with our CRO partner to stay on schedule with our plan. We are optimistic about completing the in-clinic part of the method comparison study by the end of September, which is pivotal for our 510(k) submission intended for the fourth quarter of the year." This determination reflects the company's commitment to advancing its innovative technologies.
Intelligent Fingerprinting Drug Screening System
The overarching goal of these clinical studies is to validate the Intelligent Fingerprinting Drug Screening System. The focus is on demonstrating that it is not only user-friendly but also provides accurate results for detecting opiates. This system represents a major shift in drug screening technology, harnessing the potential of fingerprint sweat analysis.
Revolutionizing Drug Testing
The Intelligent Fingerprinting Drug Screening System is designed to be hygienic and cost-effective. The technology enables rapid sample collection in seconds and yields results in under ten minutes. Such efficiency is particularly beneficial for employers in safety-critical sectors. Moreover, the company’s biosensor platform could expand to test for a variety of health indicators, encompassing both immunological conditions and infectious diseases.
Target Customer Segments
Intelligent Bio Solutions serves a diverse range of client sectors, including construction, manufacturing, logistics, drug rehabilitation programs, and forensic services. This broad applicability underscores the system's potential impact across various industries, promising enhanced safety and efficiency in drug screening processes.
About Intelligent Bio Solutions Inc.
Intelligent Bio Solutions Inc. is committed to leading advancements in medical testing technologies. The company's innovative approaches aim to reshape the landscape of portable testing through sophisticated methods that are both practical and effective.
Contact Information
For further inquiries:
Intelligent Bio Solutions Inc.
info@ibs.inc
For media and investor relations:
Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com
Frequently Asked Questions
What is the latest announcement from Intelligent Bio Solutions?
The company has made significant progress in completing its clinical study plan for FDA 510(k) submission.
Who is Intelligent Bio Solutions' partner for the clinical study?
The company has partnered with CenExel to conduct a method comparison study.
What technology does Intelligent Bio Solutions utilize for drug testing?
They use the Intelligent Fingerprinting Drug Screening System, which analyzes fingerprint sweat samples.
What are the benefits of their drug testing system?
The system is quick, hygienic, and provides results in under ten minutes, making it ideal for safety-critical industries.
Which sectors does Intelligent Bio Solutions serve?
They cater to construction, manufacturing, transport logistics, drug treatment organizations, and coroner services.
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