Aa
HEMO MODULATOR
I am new here and i was wondering if anyone new or is discussing the new trial treatment with the
Hemo Modulator by Energex sytems. I think it is really promising.
My brother in Pa. Built the guys house who is one of the chief inventors of the thing.
It always amazes me how something so cool and simple gets lost in the shuffle of big drug companies putting there self interest over the publics health. Virtually no side effects, using your own blood as the serum.
I mean come on a no brainer right. I was actually asked to do a trial of this in Ca. The guy Denny Losko told my brother he would send me the info on what is required to sign up for the trials.
I still have not enough info and was wondering if anyone had more info than what there parent site offers.
http://www.energexsystems.com/about.htm
Like tesla call it conspiratory but i could go on and on about it.
Dan
Hemo Modulator by Energex sytems. I think it is really promising.
My brother in Pa. Built the guys house who is one of the chief inventors of the thing.
It always amazes me how something so cool and simple gets lost in the shuffle of big drug companies putting there self interest over the publics health. Virtually no side effects, using your own blood as the serum.
I mean come on a no brainer right. I was actually asked to do a trial of this in Ca. The guy Denny Losko told my brother he would send me the info on what is required to sign up for the trials.
I still have not enough info and was wondering if anyone had more info than what there parent site offers.
http://www.energexsystems.com/about.htm
Like tesla call it conspiratory but i could go on and on about it.
Dan
Hey ,
Thanks for the reply. yea small world. I will try and find out if he can get intouch with him to get he scoop and aask him about Tom.
Dan
Thanks for the reply. yea small world. I will try and find out if he can get intouch with him to get he scoop and aask him about Tom.
Dan
This was supposed to be a vast improvement of the other Ultraviolet Blood Irradiation machines that have been in use by some alternative MDs. I guess that would be the Knott macine mentioned in your post. I was also interested in this study, and have periodically checked for updates, but there has been no further information since the 2004 announcements. My guess is that the results were not promising, or we'd all be hooking up to one of those machines.
Small world... I also talked to the designer of this machine (a fellow named Tom) several years ago and he sounded very positive about the possibilities. Anyway, if you find out more info, please post it.
Small world... I also talked to the designer of this machine (a fellow named Tom) several years ago and he sounded very positive about the possibilities. Anyway, if you find out more info, please post it.
This is some info i got but i have not heard update and my bro is not in communical with the guy anymore...'Old' light tech gets update in Energex hepatitis C fight
By Don Long
Medical Device Daily Managing Editor
Developmental firm Energex Systems (Emerson, New Jersey) reported this week that it has received conditional approval from the FDA to use its experimental Hemo-Modulator technology in a clinical trial to treat patients suffering from hepatitis C.
The initial trial with 10 subjects who have failed all other conventional therapies will be conducted at Eisenhower Medical Center (Rancho Mirage, California), with enrollment to be launched next month, said Thomas Fagan, president of Energex.
Fagan told Medical Device Daily that the company needs only approval of the trial by an institutional review board and other minor adjustments in protocol to launch the trial. With expected success in the 10-patient study, Energex will then carry out larger trials, and it has a projected application filing with the FDA at around 18 months.
The Hemo-Modulator system is a non-pharmaceutical technology that uses ultraviolet (UV) light that works both to inactivate the virus that causes hepatitis C while also "jump-starting" the immune system, according to Thomas Petrie, the system's developer.
The use of UV light to inactivate viruses is actually an "old technology," developed in the 1930s as a way to kill viruses, Petrie told Medical Device Daily. In particular, he says that something called a "Knott machine" was "put together based on [the structure] of germicidal properties" and had shown some efficacy in a virus-killing application. But that effort was then substantially sidetracked by the development of antibiotics, he said.
And then, "Nine years ago, this science was brought to my attention by someone motivated by their own health," Petrie said. "But there was very little information about it, just mostly anecdotal research," he noted. He then went "back into the physics of it and built [the Hemo-Modulator] from the ground up."
In operation, the machine is a closed-loop system involving the extraction of a precise amount of blood from the patient, collecting it in a bag and then passing it through a coil where it is irradiated with UV light in the C band (UVC) "for a precise amount of time," according to an Energex statement. After the exposure to the UVC, the blood is then recirculated back into a bag and returned to the patient's body at the same point it was drawn from.
From 3% to 4% of blood, no more than 250 cc are extracted, and the whole process takes "from six to eight minutes," Petrie said.
In the initial trial, patients will be treated five times a week over a two- or three-week period.
The expected result of the UVC exposure is to inactivate a certain amount of hepatitis C pathogens in the blood, he said. While the mechanism of action is yet to be fully known, Petrie referred to one of Einstein's laws of light that, in general, "if something absorbs a photon from light, it will have a reaction." The C band of UV light, he says, is a "low invisible light with a bandwidth of about 254 nanometers" that is "extremely germicidal" and able to produce "a biological change."
Put another way, he said that the light disrupts the viral cell and it "becomes stupid - disrupted in its normal course, it can't replicate, it can't do anything. If [these viruses] can't replace themselves, they'll die off in a few hours."
A concomitant effect of the light treatment, he says, is to mobilize the immune system, further protecting against the virus.
As to whether the company will seek a 510(k) or premarket approval (PMA) - assuming strong trial results - "is a question we're asking ourselves," Fagan said.
He noted that because the Hemo-Modulator is based on uses of a light system commercialized in the past, "technically, we believe we're entitled to a 510(k)" in a grandfathering process. But he said that to support the robustness of the technology and "for protection, we're leaning toward a PMA."
Prior to clinical trial application, the system was tested in the lab using a viral equivalent to hepatitis C in blood samples, because, he noted, no animal model has yet been devised for this sort of test.
The system was tested on a variety of other viruses, Fagan said, but the company targeted hepatitis C because of potential value of the application, the large size of the effected population and the unmet need that the Hemo-Modulator can address. He quoted World Health Organization (Geneva, Switzerland) data indicating 170 million infected worldwide and up to 10,000 deaths from HCV in the U.S. each year.
The Hemo-Modulator is the second product for the company, with Energex in 1999 winning FDA clearance for a radiofrequency device that treats temporal mandibular joint dysfunction (TMJ, or simply jaw dysfunction), a product of joint inflammation that can cause considerable pain. While it "sells well," that market is fairly limited, Fagan acknowledged.
Additionally, Energex is on the verge of completing a study to use its RF system to treat osteoarthritis, an opportunity offering "huge market sales," Fagan said.
But the "big bang" for the company, you might say, is the Hemo-Modulator. Fagan unhesitatingly projects it as a $2 billion to $3 billion revenue producer in the hepatitis C application and "north of $10 billion" when expanded to a variety of other applications.
What those applications are he wouldn't specify in detail, except to note, "We're only starting with hepatitis C. This will treat any RNA virus. If it's an RNA virus, we can effectively and safely treat it."
Nor would he lay out his hand when asked about possible applications for general blood decontamination - but then said, "if you call me back in two months, we may have a very interesting story for you."
And if there is a barometer for success, he pointed to investor interest, saying the company is currently turning investors away.
"This is a very, very interesting technology," said Fagan. "It's valuable, it's real, and shareholders are very excited about it. We're building either to do a major IPO [initial public offering] or to partner with a major company."
Published: June 18, 2004
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By Don Long
Medical Device Daily Managing Editor
Developmental firm Energex Systems (Emerson, New Jersey) reported this week that it has received conditional approval from the FDA to use its experimental Hemo-Modulator technology in a clinical trial to treat patients suffering from hepatitis C.
The initial trial with 10 subjects who have failed all other conventional therapies will be conducted at Eisenhower Medical Center (Rancho Mirage, California), with enrollment to be launched next month, said Thomas Fagan, president of Energex.
Fagan told Medical Device Daily that the company needs only approval of the trial by an institutional review board and other minor adjustments in protocol to launch the trial. With expected success in the 10-patient study, Energex will then carry out larger trials, and it has a projected application filing with the FDA at around 18 months.
The Hemo-Modulator system is a non-pharmaceutical technology that uses ultraviolet (UV) light that works both to inactivate the virus that causes hepatitis C while also "jump-starting" the immune system, according to Thomas Petrie, the system's developer.
The use of UV light to inactivate viruses is actually an "old technology," developed in the 1930s as a way to kill viruses, Petrie told Medical Device Daily. In particular, he says that something called a "Knott machine" was "put together based on [the structure] of germicidal properties" and had shown some efficacy in a virus-killing application. But that effort was then substantially sidetracked by the development of antibiotics, he said.
And then, "Nine years ago, this science was brought to my attention by someone motivated by their own health," Petrie said. "But there was very little information about it, just mostly anecdotal research," he noted. He then went "back into the physics of it and built [the Hemo-Modulator] from the ground up."
In operation, the machine is a closed-loop system involving the extraction of a precise amount of blood from the patient, collecting it in a bag and then passing it through a coil where it is irradiated with UV light in the C band (UVC) "for a precise amount of time," according to an Energex statement. After the exposure to the UVC, the blood is then recirculated back into a bag and returned to the patient's body at the same point it was drawn from.
From 3% to 4% of blood, no more than 250 cc are extracted, and the whole process takes "from six to eight minutes," Petrie said.
In the initial trial, patients will be treated five times a week over a two- or three-week period.
The expected result of the UVC exposure is to inactivate a certain amount of hepatitis C pathogens in the blood, he said. While the mechanism of action is yet to be fully known, Petrie referred to one of Einstein's laws of light that, in general, "if something absorbs a photon from light, it will have a reaction." The C band of UV light, he says, is a "low invisible light with a bandwidth of about 254 nanometers" that is "extremely germicidal" and able to produce "a biological change."
Put another way, he said that the light disrupts the viral cell and it "becomes stupid - disrupted in its normal course, it can't replicate, it can't do anything. If [these viruses] can't replace themselves, they'll die off in a few hours."
A concomitant effect of the light treatment, he says, is to mobilize the immune system, further protecting against the virus.
As to whether the company will seek a 510(k) or premarket approval (PMA) - assuming strong trial results - "is a question we're asking ourselves," Fagan said.
He noted that because the Hemo-Modulator is based on uses of a light system commercialized in the past, "technically, we believe we're entitled to a 510(k)" in a grandfathering process. But he said that to support the robustness of the technology and "for protection, we're leaning toward a PMA."
Prior to clinical trial application, the system was tested in the lab using a viral equivalent to hepatitis C in blood samples, because, he noted, no animal model has yet been devised for this sort of test.
The system was tested on a variety of other viruses, Fagan said, but the company targeted hepatitis C because of potential value of the application, the large size of the effected population and the unmet need that the Hemo-Modulator can address. He quoted World Health Organization (Geneva, Switzerland) data indicating 170 million infected worldwide and up to 10,000 deaths from HCV in the U.S. each year.
The Hemo-Modulator is the second product for the company, with Energex in 1999 winning FDA clearance for a radiofrequency device that treats temporal mandibular joint dysfunction (TMJ, or simply jaw dysfunction), a product of joint inflammation that can cause considerable pain. While it "sells well," that market is fairly limited, Fagan acknowledged.
Additionally, Energex is on the verge of completing a study to use its RF system to treat osteoarthritis, an opportunity offering "huge market sales," Fagan said.
But the "big bang" for the company, you might say, is the Hemo-Modulator. Fagan unhesitatingly projects it as a $2 billion to $3 billion revenue producer in the hepatitis C application and "north of $10 billion" when expanded to a variety of other applications.
What those applications are he wouldn't specify in detail, except to note, "We're only starting with hepatitis C. This will treat any RNA virus. If it's an RNA virus, we can effectively and safely treat it."
Nor would he lay out his hand when asked about possible applications for general blood decontamination - but then said, "if you call me back in two months, we may have a very interesting story for you."
And if there is a barometer for success, he pointed to investor interest, saying the company is currently turning investors away.
"This is a very, very interesting technology," said Fagan. "It's valuable, it's real, and shareholders are very excited about it. We're building either to do a major IPO [initial public offering] or to partner with a major company."
Published: June 18, 2004
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