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company profile (Energex Systems) http://www.regenerationnet.com/node/1330 
and http://www.energexsystems.com/index.htm   check out the 'about us' part.
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'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