HepQuant Announces Approval of Fourth Investigational Device Exemption Application
HepQuant SHUNT™ Liver Diagnostic Kit for use in a clinical study in subjects with Alcoholic Hepatitis
DENVER (September 14, 2017) — HepQuant, LLC, a Greenwood Village, Colorado-based company with a unique, patented and patent-pending technology for evaluating the liver in patients with chronic liver disease, today announced that its fourth application for an Investigational Device Exemption (“IDE”) for its HepQuant SHUNT™ Liver Diagnostic Kit has been approved by the Food and Drug Administration (“FDA”) for use in a Phase 1 clinical study in subjects with Non-Alcoholic Steatohepatitis with Fibrosis.
Founder and Chief Executive Officer of HepQuant, LLC, Dr. Gregory T. Everson noted that the clinical trial is an important next step to potentially advance the treatment of patients with fibrotic livers due to NASH. “There is a significant need for a minimally invasive liver health test to assess evolving therapeutic solutions. We look forward to continuing to work with the FDA on developing and providing a robust liver health test to help physicians assess their patients.”
An IDE allows an investigational device, in this case the HepQuant SHUNT™ Liver Diagnostic Kit, to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application submission to FDA.
HepQuant products are investigational combination drug / diagnostic devices and have not yet been evaluated or approved by the US Food and Drug Administration (FDA) for commercial sale. They are currently available for investigational use via the FDA IDE application process. For additional information, please visit our website at www.hepquant.com.
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