FDA Clears HEPATIQ

HEPATIQReceives FDA Clearance  

 

December 19, 2014 03:54 PM Pacific Standard Time

 

IRVINE, Calif.--(BUSINESS WIRE)-- HEPATIQ LLC announced that
they received clearance from the United States Food & Drug Administration to market their
HEPATIQ™ software. HEPATIQ is a nuclear medicine
software application used to display and process liver-spleen images. The results obtained may be used as a tool by a nuclear physician in quantifying liver-spleen images.

 

HEPATIQ LLC is focused on diagnosing the severity of liver disease and predicting adverse clinical outcomes. Chronic liver disease is a slow and silent killer. It is widespread with about 15% prevalence globally. About 32,000 people die each year in the US from liver disease. For more information, please visit www.hepatiq.com.

 

The HEPATIQ software calculates PHM™ which precisely measures liver function. The HEPATIQ technology automates the Quantitative Liver Spleen Scan (QLSS™) that has been proven to be an accurate predictor of clinical outcomes in the recently concluded HALT-C trial.

 

“We are happy to have completed product development and achieved FDA clearance in less than 2½ years since the formation of the company,” said Dipu  Ghosh, Co-Founder and CEO of HEPATIQ LLC. “With this important milestone behind us, we look forward to helping physicians better manage the one billion plus people worldwide with liver disease.”


“As hepatologists, we have needed and searched for a reliable, precise method of measuring liver function that can be used in the clinical setting. Hepatic function is more important that hepatic fibrosis as hepatic function determines both the likelihood of clinical problems and patient survival,” said Dr. John Hoefs, Co-Founder and COO of HEPATIQ LLC. “We are very excited that this method will now be available to physicians and patients.”


Disclaimer

This press release contains forward-looking statements. These are based on current expectations and beliefs and are subject to numerous risks, uncertainties and change. The parties disclaim any obligation to update any forward-looking statement as a result of developments occurring after this
release.


Contacts


HEPATIQ LLC

(949) 250-1065 x124

Dipu Ghosh, MSEE, MBA.

Co-Founder & CEO

dghosh@hepatiq.com

or

John Hoefs, MD.

Co-Founder & COO

jhoefs@hepatiq.com