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Energex System's Experimental Non-Pharmacological Treatment Exceeds Expectations in Reducing Liver Inflammation in Refractory Hepatitis C Patients.


EMERSON, N.J. -- Energex Systems, Inc. announced today that its experimental therapy known as HemoModulation was effective in reducing viral load and liver inflammation in non-responding Hepatitis C patients. The trial was conducted under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and  (IDE) that was granted by the Federal Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) in February 2006.

Hepatitis C (HCV HCV
abbr.
hepatitis C virus


HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus.
) is a viral infection of the liver and a major cause of chronic liver disease Chronic liver disease is a liver disease of slow process and persisting over a long period of time, resulting in a progressive destruction of the liver.

It includes amongst others:
  • Cirrhosis of the liver
  • Alcoholic liver disease
  • Chronic hepatitis C
, including cirrhosis and liver cancer, and is now recognized as the leading cause of liver transplantation in the United States. HCV is spread primarily by direct contact with human blood. The World Health Organization estimates that about 170 million people are infected with HCV, about 3% of the world's population. Approximately 5 million Americans are infected with HCV, and there are 8,000-10,000 such deaths each year in the United States.

The company's experimental treatment involves exposing a very small amount of an infected subject's blood (3-4%) to a very precise amount of ultra-violet light in the C band (UVC UVC ultraviolet C; see ultraviolet.
UVC Umbilical vein catheter, see there
), for a very precise amount of time. During the process, a percentage of any pathogen in the blood that is exposed to the UVC energy is inactivated inactivated

rendered inactive; the activity is destroyed.


inactivated viruses
treated so that they are no longer able to produce evidence of growth or damaging effect on tissue.
. After exposure, the blood carrying the inactive pathogen is returned to the patient through the same portal it was drawn from. The hypothesis is that UV-inactivated virus will serve as an autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism.

au·tol·o·gous
adj.
1.
 vaccine and stimulate the immune system of the subject against their own strain of virus. The process takes 20-30 minutes.

In this second trial conducted by the company, liver biopsies of the subjects were examined, graded and preserved for comparison to post treatment biopsies. Analysis and comparisons of the pre and post treatment biopsies established significant improvement in grades of inflammation of 3 of the 8 subjects (7-3, 7-4, 7-3) that completed treatment.

"Our pre-trial expectation was grade improvement in 1 of the 8 subjects and we clearly exceeded that expectation," said Thomas R. Petrie, the company's Director of Research, Development and Engineering.

Energex Systems is dedicated to improving patient quality of life by developing and commercializing novel technologies and processes that are intended to provide safer, more effective options to patients in areas with substantial unmet medical needs within the fields of immunotherapy, blood safety and musculoskeletal musculoskeletal /mus·cu·lo·skel·e·tal/ (-skel´e-t'l) pertaining to or comprising the skeleton and muscles.

mus·cu·lo·skel·e·tal
adj.
Relating to or involving the muscles and the skeleton.
 pain.
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Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jun 28, 2007
Words:380
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