Guest guest Posted November 23, 2004 Report Share Posted November 23, 2004 http://www.bio.com/industryanalysis/industryanalysis_news.jhtml?cid=6500010 Energex System's Experimental Non-Pharmicalogical Treatment Promising in Reducing Viral Load in Hepatitis C Patients 11/22/04 -- Energex Systems, Inc. announced today that preliminary results of its Hepatitis C clinical trial have shown consistent and drastic reductions in viral load in trial participants treated with its Hemo-Modulator technology. The trial is being conducted under an Investigational Device Exemption (IDE) that was granted by the Federal Food and Drug Administration (FDA) in October, 2004. Hepatitis C is a viral infection of the liver and a major cause of acute hepatitis and chronic liver disease, 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. Energex's experimental treatment involves exposing a very small amount of an infected subjects blood (3-4%) to a very precise amount of ultra-violet light in the C band (UVC), for a very precise amount of time, explained Petrie, the developer of the technology and Director of Engineering at Energex Systems. " During treatment, a percentage of any pathogen in the blood that is exposed to the UVC energy is inactivated. After exposure, the blood carrying the inactive pathogen is returned to the patient through the same portal it was drawn from. The result, we believe, is a stimulation of the immune system " , said Petrie. The process takes 20-30 minutes. In the trial, non-responders to Interferon/Ribaviran are administered 3 PCR tests before treatment, on days 1,8, and 15. The average of the tests is the baseline that post-treatment tests are compared to. After the blood draw on day 15, the 1st treatment is administered, followed by the 2nd treatment on day 17. Prior to the 3rd treatment on day 20, the first post-treatment PCR test is administered and the result is compared to the baseline. The 4th and 5th treatments are administered on days 25 and 30 respectively. On day 33 the 1st PCR test after the last treatment is administered and compared to the baseline. Additional PCR tests are administered on days 57, 64 and 71 and the average of the tests is compared to the baseline. Preliminary results at day 33, established viral load reductions of 56, 91 and 96 percent in the 1st three trial participants. " When you consider that we are treating non-responders; the average viral load reduction of the 1st three participants was in excess of 81% in just a 17-day period, and there have been no adverse events, I believe it goes a long way in validating our belief that our Hemo-Modulator technology will soon become the treatment of choice for Hepatitis C and other RNA type viruses " said J. Fagan, President of Energex Systems. We are excited about the potential that our technology has to manage this hard-to-treat disease, to reduce the cost of care, and to provide a better quality of life for the millions that suffer from it. We are committed to expending whatever resources are necessary to see that this technology continues through the research and approval processes, and that it is accepted by the medical community as the treatment of choice for this potentially life threatening disease " , said Fagan. Energex Systems is dedicated to developing medical technologies and therapies with an emphasis on the treatment of conditions unmet by present day therapies and reducing the cost of care. Source: Energex Systems, Inc. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 23, 2004 Report Share Posted November 23, 2004 http://www.bio.com/industryanalysis/industryanalysis_news.jhtml?cid=6500010 Energex System's Experimental Non-Pharmicalogical Treatment Promising in Reducing Viral Load in Hepatitis C Patients 11/22/04 -- Energex Systems, Inc. announced today that preliminary results of its Hepatitis C clinical trial have shown consistent and drastic reductions in viral load in trial participants treated with its Hemo-Modulator technology. The trial is being conducted under an Investigational Device Exemption (IDE) that was granted by the Federal Food and Drug Administration (FDA) in October, 2004. Hepatitis C is a viral infection of the liver and a major cause of acute hepatitis and chronic liver disease, 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. Energex's experimental treatment involves exposing a very small amount of an infected subjects blood (3-4%) to a very precise amount of ultra-violet light in the C band (UVC), for a very precise amount of time, explained Petrie, the developer of the technology and Director of Engineering at Energex Systems. " During treatment, a percentage of any pathogen in the blood that is exposed to the UVC energy is inactivated. After exposure, the blood carrying the inactive pathogen is returned to the patient through the same portal it was drawn from. The result, we believe, is a stimulation of the immune system " , said Petrie. The process takes 20-30 minutes. In the trial, non-responders to Interferon/Ribaviran are administered 3 PCR tests before treatment, on days 1,8, and 15. The average of the tests is the baseline that post-treatment tests are compared to. After the blood draw on day 15, the 1st treatment is administered, followed by the 2nd treatment on day 17. Prior to the 3rd treatment on day 20, the first post-treatment PCR test is administered and the result is compared to the baseline. The 4th and 5th treatments are administered on days 25 and 30 respectively. On day 33 the 1st PCR test after the last treatment is administered and compared to the baseline. Additional PCR tests are administered on days 57, 64 and 71 and the average of the tests is compared to the baseline. Preliminary results at day 33, established viral load reductions of 56, 91 and 96 percent in the 1st three trial participants. " When you consider that we are treating non-responders; the average viral load reduction of the 1st three participants was in excess of 81% in just a 17-day period, and there have been no adverse events, I believe it goes a long way in validating our belief that our Hemo-Modulator technology will soon become the treatment of choice for Hepatitis C and other RNA type viruses " said J. Fagan, President of Energex Systems. We are excited about the potential that our technology has to manage this hard-to-treat disease, to reduce the cost of care, and to provide a better quality of life for the millions that suffer from it. We are committed to expending whatever resources are necessary to see that this technology continues through the research and approval processes, and that it is accepted by the medical community as the treatment of choice for this potentially life threatening disease " , said Fagan. Energex Systems is dedicated to developing medical technologies and therapies with an emphasis on the treatment of conditions unmet by present day therapies and reducing the cost of care. Source: Energex Systems, Inc. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 23, 2004 Report Share Posted November 23, 2004 http://www.bio.com/industryanalysis/industryanalysis_news.jhtml?cid=6500010 Energex System's Experimental Non-Pharmicalogical Treatment Promising in Reducing Viral Load in Hepatitis C Patients 11/22/04 -- Energex Systems, Inc. announced today that preliminary results of its Hepatitis C clinical trial have shown consistent and drastic reductions in viral load in trial participants treated with its Hemo-Modulator technology. The trial is being conducted under an Investigational Device Exemption (IDE) that was granted by the Federal Food and Drug Administration (FDA) in October, 2004. Hepatitis C is a viral infection of the liver and a major cause of acute hepatitis and chronic liver disease, 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. Energex's experimental treatment involves exposing a very small amount of an infected subjects blood (3-4%) to a very precise amount of ultra-violet light in the C band (UVC), for a very precise amount of time, explained Petrie, the developer of the technology and Director of Engineering at Energex Systems. " During treatment, a percentage of any pathogen in the blood that is exposed to the UVC energy is inactivated. After exposure, the blood carrying the inactive pathogen is returned to the patient through the same portal it was drawn from. The result, we believe, is a stimulation of the immune system " , said Petrie. The process takes 20-30 minutes. In the trial, non-responders to Interferon/Ribaviran are administered 3 PCR tests before treatment, on days 1,8, and 15. The average of the tests is the baseline that post-treatment tests are compared to. After the blood draw on day 15, the 1st treatment is administered, followed by the 2nd treatment on day 17. Prior to the 3rd treatment on day 20, the first post-treatment PCR test is administered and the result is compared to the baseline. The 4th and 5th treatments are administered on days 25 and 30 respectively. On day 33 the 1st PCR test after the last treatment is administered and compared to the baseline. Additional PCR tests are administered on days 57, 64 and 71 and the average of the tests is compared to the baseline. Preliminary results at day 33, established viral load reductions of 56, 91 and 96 percent in the 1st three trial participants. " When you consider that we are treating non-responders; the average viral load reduction of the 1st three participants was in excess of 81% in just a 17-day period, and there have been no adverse events, I believe it goes a long way in validating our belief that our Hemo-Modulator technology will soon become the treatment of choice for Hepatitis C and other RNA type viruses " said J. Fagan, President of Energex Systems. We are excited about the potential that our technology has to manage this hard-to-treat disease, to reduce the cost of care, and to provide a better quality of life for the millions that suffer from it. We are committed to expending whatever resources are necessary to see that this technology continues through the research and approval processes, and that it is accepted by the medical community as the treatment of choice for this potentially life threatening disease " , said Fagan. Energex Systems is dedicated to developing medical technologies and therapies with an emphasis on the treatment of conditions unmet by present day therapies and reducing the cost of care. Source: Energex Systems, Inc. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 23, 2004 Report Share Posted November 23, 2004 http://www.bio.com/industryanalysis/industryanalysis_news.jhtml?cid=6500010 Energex System's Experimental Non-Pharmicalogical Treatment Promising in Reducing Viral Load in Hepatitis C Patients 11/22/04 -- Energex Systems, Inc. announced today that preliminary results of its Hepatitis C clinical trial have shown consistent and drastic reductions in viral load in trial participants treated with its Hemo-Modulator technology. The trial is being conducted under an Investigational Device Exemption (IDE) that was granted by the Federal Food and Drug Administration (FDA) in October, 2004. Hepatitis C is a viral infection of the liver and a major cause of acute hepatitis and chronic liver disease, 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. Energex's experimental treatment involves exposing a very small amount of an infected subjects blood (3-4%) to a very precise amount of ultra-violet light in the C band (UVC), for a very precise amount of time, explained Petrie, the developer of the technology and Director of Engineering at Energex Systems. " During treatment, a percentage of any pathogen in the blood that is exposed to the UVC energy is inactivated. After exposure, the blood carrying the inactive pathogen is returned to the patient through the same portal it was drawn from. The result, we believe, is a stimulation of the immune system " , said Petrie. The process takes 20-30 minutes. In the trial, non-responders to Interferon/Ribaviran are administered 3 PCR tests before treatment, on days 1,8, and 15. The average of the tests is the baseline that post-treatment tests are compared to. After the blood draw on day 15, the 1st treatment is administered, followed by the 2nd treatment on day 17. Prior to the 3rd treatment on day 20, the first post-treatment PCR test is administered and the result is compared to the baseline. The 4th and 5th treatments are administered on days 25 and 30 respectively. On day 33 the 1st PCR test after the last treatment is administered and compared to the baseline. Additional PCR tests are administered on days 57, 64 and 71 and the average of the tests is compared to the baseline. Preliminary results at day 33, established viral load reductions of 56, 91 and 96 percent in the 1st three trial participants. " When you consider that we are treating non-responders; the average viral load reduction of the 1st three participants was in excess of 81% in just a 17-day period, and there have been no adverse events, I believe it goes a long way in validating our belief that our Hemo-Modulator technology will soon become the treatment of choice for Hepatitis C and other RNA type viruses " said J. Fagan, President of Energex Systems. We are excited about the potential that our technology has to manage this hard-to-treat disease, to reduce the cost of care, and to provide a better quality of life for the millions that suffer from it. We are committed to expending whatever resources are necessary to see that this technology continues through the research and approval processes, and that it is accepted by the medical community as the treatment of choice for this potentially life threatening disease " , said Fagan. Energex Systems is dedicated to developing medical technologies and therapies with an emphasis on the treatment of conditions unmet by present day therapies and reducing the cost of care. Source: Energex Systems, Inc. Quote Link to comment Share on other sites More sharing options...
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