The Miracle Business
Dr. Ken Gregory spins his futuristic research into business reality
by Alaina Buller
probably a safe bet that nothing makes Dr. Kenton Gregory as giddy as
a new discovery at the Oregon Medical Laser Center (OMLC). His eyes flash
with excitement while his ever-present grin stretches even further across
His enthusiasm is quite infectious, really. What looks like a simple
image of soap bubbles floating across a computer screen suddenly seems
And then comes the stream of superlatives: “I’m very impressed!
I think this is superb…this is out of the box…it’s nifty…it’s
This is the future of medical technology in the making. And it’s
all happening right here in Oregon thanks to Gregory and his staff.
“Things are hopping around here,” Gregory says. “Who’s
coming on tour today? Hopefully someone with lots of money.”
As the founder and director of OMLC at Providence St. Vincent Medical
Center since 1991, Gregory has had no shortages of exciting moments, beginning
with treating the first heart attack patient in medical history using
Gregory, a native Oregonian born in Salem, made the move to St. Vincent
from Harvard’s Massachusetts General Hospital with his colleague
Peter Block, who headed Harvard Medical School’s cardiology department.
Gregory brought with him the technology of laser thrombolysis, a procedure
used to instantly vaporize clots that cause heart attacks and strokes.
As soon as the technology was approved for a Food and Drug Administration
(FDA) clinical trial, the two cardiologists only needed to wait for the
“I can remember watching with Peter out the window because we had
notification that there was a patient in the full throws of a heart attack
being flown in from the Oregon Coast on a helicopter,” Gregory says. “I
can remember Peter and I staring out the window watching this helicopter
coming in and thinking, ‘Gosh, we’re going to light off a
very high-powered laser in somebody’s heart.’”
It had never been done before, and after years of lab testing and animal
testing it was the moment of truth.
“We see this helicopter come in. It’s really dramatic. You
go in and you’re so busy paying attention to every little thing
that you don’t have time to get worried. You just do your job. And
it worked. It was neat,” he says. “Thank God it worked.”
In the FDA Phase I trial, 20 patients were successfully treated, and
15 years later, the technology is in routine use in most major hospitals.
Ralph Shaw, a member of the Council of Trustees at St. Vincent Medical
Center, remembers the buzz Gregory created when he first started using
his technologies to treat patients in the early 90s. He was eager to assist
Gregory, so he helped create a second council, a board of trustees of
sorts, for the OMLC. Shaw was careful to include a variety of sources
on the board, including experts in business, politics, grant writing,
and health insurance.
“I went to the administration at St. Vincent and said, ‘I
think if Ken Gregory is as brilliant as I believe he is, we have to support
him in more than just giving him some support for his laser laboratory.’
Everybody was very enthusiastic,” Shaw says.
“This community, I find, responds very spontaneously and with great
enthusiasm if only people would ask them to help. In this case, what we
asked them to do was to create an environment which could become a much
bigger research and development organization — with an emphasis
The organization has grown into a team of about 30 experts and is now
a world leader in medical laser and biomaterials research. The center
is home to a confocal microscope — the most advanced microscope
of its kind and one of only a few in the United States — that allows
scientists to examine stem cells as living, growing objects in three dimensions.
The center is also the only one in the state to house a tissue engineering
and cell therapy center, or clean room. The clean room provides a pristine
environment that aids in the process of transferring new technologies
from the academic laboratory to production for clinical use.
With these advanced technologies and facilities, OMLC has stepped closer
to realizing the completion of several of their research studies —
one of which is laser tissue fusion. After almost 15 years of OMLC research,
and decades of research by others in the field, this laser technology
that seals and heals wounds in internal organs, instead of using needle
and thread, is ready to be tested on actual patients. Once again, Gregory
is waiting for the ideal patient.
“People have been trying to do that for 40 years. Even on Star
Trek with Captain Kirk they were always doing welding with lasers. Now
it looks so corny and unsophisticated,” Gregory says. “Anybody
who’s anybody in the laser business has tried their hand at it.
We’re just more persistent.”
And they’ve got the process down to a science — no pun intended.
The incision is coated with albumin, one of the dominant proteins found
in blood, and a sophisticated laser emitting a soft blue light is guided
over the wound. It takes less than a minute to seal a serious incision
that might otherwise have been fatal.
“We wanted to keep it as simple as possible so anyone can do it,”
Research Assistant Ted Moffitt says. “I’ve taught congressmen
and the former Miss America. If I can teach them how to do it, any surgeon
can do it.”
But as simple as this process may be, Gregory certainly realizes the
risk involved as he prepares to test any new technology on patients.
“My brother is a psychologist and he said, ‘Let’s see,
you’re doing something on a very high-risk patient that’s
never been done before, and it’s ultra high risk. Could you have
a more stressful job?’”
Gregory said the only job he thinks could be more stressful is to conduct
these procedures while someone is shooting at him. He knows people in
the military who have taken this daunting job, and he’s even been
offered a position in that field. But he happily replies, “My anthrax
vaccinations are not up to date fortunately.”
And of course these high-risk situations are preceded by heavy regulation
from the FDA. Gregory admits they’ve got a difficult job, and he
says he would not relish the thought of, like the FDA, being in charge
of tens of thousands of different drugs and devices.
Andrew Barofsky, one of the principle inventors of the elastin technology,
understands the need for rigorous investigations. “Whenever you’re
dealing with biological systems like the human body, it’s very complicated.
Stuff that works in the labs or in animals works very differently than
when you put them in the human body.”
The rigid testing process is divided up over time into several phases
once the initial lab and animal testing has proven positive. Sometimes
it can take 20 years for a device or drug to make it onto the market.
“I always say if I thought about how long it was going to take
me, I probably wouldn’t even start it,” Gregory says.
But Gregory has defied the odds yet again with his world-famous HemCon
chitosan bandage. Using chitosan, a compound found in shrimp shells, the
bandage is extremely effective at stopping severe external hemorrhaging.
Excessive blood loss is the leading cause of death of soldiers killed
in action, and this bandage was clearly a way to combat that problem.
The medical product was rushed through the FDA testing process and received
the second fastest approval in the FDA’s history.
OMLC discovered the positive effects of chitosan in March 2001, and he
presented the data for the first time at a military meeting held in Florida
on Sept. 11, 2001. In his original presentation, Gregory said he thought
he could get the bandage through the FDA in two to four years with about
$4 million. The meeting attendees were skeptical and told him it would
take closer to five years and $50 million. The military liked the idea
though and asked him to come back with a reasonable proposal.
Shortly after Gregory’s presentation that morning, they watched
the planes fly into the twin towers, and the tone changed.
“That’s when they said, we’re going to war with somebody,
we don’t know who, but it’s going to happen this year, and
[the bandage] needs to get out. They weren’t concerned with the
niceties of the FDA. That wasn’t a good excuse,” Gregory says.
“They said they need this, and they wanted to deploy with it. Afterward
they said we need this in one year, and we’ve got about $4-500,000.”
It’s a good thing the military recognized the capability of Gregory
and his staff because the chitosan bandage wasn’t always a popular
experiment around the lab.
“The staff was always saying this is the loser project. Why are
we doing this?” Gregory says.
OMLC was not the first to work on the hemorrhage control problem. Gregory
says people have been attempting to stop significant bleeding for thousands
of years. At another military meeting held at Fort Dietrich, Gregory even
attempted to convince the military to let others work on the bleeding
problem, while he continued his work on different projects.
“I was saying, ‘Well, that’s a really hard problem.
The Red Cross is working on that. They’ve been working on that since
World War II. They’ve got a whole building. They’ve got tens
of millions of dollars and a lot of smart people,’” he says.
“Then I realized 90 percent of my funding comes from the Army. When
your major patron wants you to do something you think, ‘How can
I say yes faster?’”
So he returned to his lab and asked Simon McCarthy, a chemist and principle
inventor of the bandage, to continue work on the chitosan project. The
other experiment McCarthy was hired for wasn’t ready yet, so Gregory
assigned him to the “loser bandage project” for the time being.
Once a successful bandage was developed, Gregory asked McCarthy if he
realized that his product was going to save thousands and thousands of
lives. McCarthy couldn’t comprehend the importance. Now McCarthy
is the executive vice president of research and development at HemCon
Inc., a company created by Gregory to manufacture the bandages.
“When you see a stroke patient who can’t move half their
body come in and then walk out of the hospital, or when you watch a blood
clot disappear in a couple minutes and the arteries open, or when you
see the people who come in with their stories of how they were bleeding
out on the battlefield and the bleeding stopped, it doesn’t get
much better than that. It makes you want to work harder,” Gregory
Every year Gregory invites military staff to a voluntary meeting to critically
look at the projects OMLC is undertaking. Two years ago at this meeting
he remembers hearing a young Marine captain tell his story about how the
HemCon bandage saved his life. At the time the captain was a tank commander
in Iraq. He stuck his head out of the tank for a moment and was hit in
the chin with a sniper bullet that blew his jaw bone and neck away. It
just so happened that someone had one of the bandages and slapped it on
his neck. The bleeding stopped and the captain was able to hold off the
Iraqis with a 9 mm.
“After ten operations he came back and told his story to my staff.
There wasn’t a dry eye in the place. He told this story about how
he saw his life spurting away and he was only going to live a minute longer,
and then next thing he’s got his normal life back now. So that had
a big impact,” Gregory says. “We had a reception at my house,
and he was the guest of honor. He had his medals all over the place, and
my mom posed with him.”
Involvement in the military has always been important to Gregory. He
says he has a lot of friends in the service and if they are willing to
put themselves in harm’s way, he will do anything he can to help
them. In 1996, Gregory and the OMLC research staff received a grant from
the Army to reconstruct arteries and other tissues using a protein called
elastin, a natural tissue protein that gives blood vessels, skin and lungs
“If you notice, there are not that many replacement parts for people.
That’s because most conventional plastics, glasses and metals don’t
really react well with the rest of your body,” Gregory explains.
“And so I thought I’ll see how Mother Nature makes her parts
and use the same materials. It doesn’t take rocket science.”
The elastin parts are intended to repair or replace an artery, skin,
ureter, or esophagus, and they would most often be welded to the affected
area using the laser tissue fusion. Gregory has taken the elastins through
the necessary pre-clinical trials, and he’s currently looking for
an industry partner to take them to the next step.
The next big medical project on Gregory’s plate is a biggie: limb
regeneration. Prior to the HemCon bandage, the death from bleeding in
the battlefield had not changed since the Civil War. Now, after this most
recent conflict, the death rate from bleeding has decreased for the first
time in military history. Now that Gregory is partially responsible for
bringing soldiers home, he wants to concentrate on giving them a normal
life once they’ve returned.
Gregory points out that about 20,000 men and women return with injuries
to their extremities. That’s 20,000 people whose lives may be forever
changed because their arms or legs are disfigured or dysfunctional. Gregory
thinks that’s too many people.
His theory is that before each soldier leaves for battle, he or she would
donate their own stem cells. Scientists will increase the number of stem
cells from a couple thousand to a hundred million and freeze them. Then
if necessary, these stem cells could be injected into the injured soldier
and help regrow heart cells, nerve cells or skeletal muscle cells.
OMLC is working closely with hospitals in Germany, the world leaders
in stem cell research, to develop this concept. German hospitals have
been regenerating hearts in patients for about six years, and they have
been more than willing to share their findings.
“If you go to a major German hospital and have a big heart attack
or part of your heart dies, before you go home they’ll give you
an injection of your own stem cells. Six weeks later your heart is partially
regenerated,” he says. “If you have a big heart attack in
Portland, that’s not going to happen. All of America is behind the
rest of the world because of stem cells. If you say stem cells here, you’re
killing babies and stuff like that.”
It certainly helps the process along when the military funds a project,
but the research is only half the battle when scientists are left to their
own devices to get a product on the market. As Gregory puts it, “Scientists
are bad businessmen. I’m living proof of that.”
He remembers trying to get a credit line for HemCon in the early stages
of the company. He met with the banker, showed him a video of the bandage
in action and really had him interested the company. The banker said,
“Well, what’s your ROI?” Gregory responded, “What’s
“You should have seen the banker’s face,” he says.
“We didn’t get the credit line.”
For this reason, Gregory has created the Oregon Biomedical Engineering
Institute (OBEI), a company that specializes in transferring technology
from the academic world to the business world. While OBEI will have a
laboratory to conduct research, its primary focus will be creating patents,
licensing and new companies. Gregory has hired scientists and people from
the business world to take on this task.
Gregory’s first choice to help form OBEI was Barofsky, who is now
its vice president and general counsel. In addition to his elastin research
at OMLC for five years, Barofsky also completed law school and business
school and worked at Schwabe, Williamson and Wyatt as a patent attorney.
“For me, it’s a little bit of a dream job. It allows me to
use the background that I have in all the different areas and professional
directions that I’m headed in. I get to sit in on science meetings,
help orchestrate business strategies and take care of some of the legal
aspects,” Barofsky says.
Both Gregory and Barofksy site the lack of business experience as the
main reason technologies often falter. Gregory compares the process to
attempting to span a large crevasse.
“Many of these technologies run full blast, and they go right over
like lemmings into a crevasse and never come up. It’s sad. I’ve
got some of my technologies down there as we speak,” he says. “It’s
a rare one that can get over that crevasse, from transferring it from
the academician to the guy in marketing or the guy in business development
or the CEO of a company.”
Many supporters believe that Gregory is one of that rare breed. Barofsky
says Gregory has the perfect combination of energy and personality, as
well as bright ideas in technology and research. Gerry Frank, a member
of the Providence Board of Trustees, says he is knowledgeable, down to
earth and able to communicate his technology so the average person can
Gregory says he’s just afraid the business guys will take his technology
and ruin it if he doesn’t keep a close eye.
But perhaps Gregory’s innovative spirit is best summed up by Shaw:
“Just because things have been done in a certain way doesn’t
mean that’s the only way to do them or the correct way to do them.
I think that characterizes the way Ken Gregory looks at things. He has
an extraordinarily inquiring mind, he has substantial confidence that
solutions can be accomplished, and he’s willing to accept the risk
of failure to accomplish big things.”
One Miracle, One Technology at a Time
Since 1991, the Oregon Medical Laser Center (OMLC) has created revolutionary
solutions to medical problems. The center expanded its original focus
of laser technology to include biomaterials research and tissue regeneration.
Prepare to be amazed by the innovations created by Dr. Kenton Gregory
and his staff.
OMLC is probably best known, nationally and internationally, for the chitosan
bandage, a breakthrough in hemorrhage control technology. Chitosan, found
in shrimp shells, adheres to red blood cells and quickly forms a clot
to stop massive external bleeding. With the military’s support,
the chitosan bandage received the second fastest approval in FDA history.
Developed in early 2001, the bandage was deployed for use in the Iraq
war in 2002. It was recently used at Providence St. Vincent Medical Center
to treat the first civilian trauma case. Gregory and his colleagues created
HemCon Inc. to manufacture the bandage.
Heart and Limb Regeneration
Still in the early stages of research, the heart and limb regeneration
program is Gregory’s way to help wounded soldiers return to a normal
life once they’ve come home. He hypothesizes that a soldier will
donate their own stem cells before being deployed, then scientists will
amplify these cells from a few thousand to a hundred million and freeze
them for safe keeping. If the soldier returns injured, their own cells
will be injected to regenerate muscles. Gregory has spent the past several
months campaigning to gain the military’s interest and support.
Elastin Replacement Tissue
Most conventional replacement parts are made from materials foreign to
the body and, therefore, do not react well when implanted. Gregory created
replacement tissues made from a natural material known as elastin, a tissue
protein responsible for the elasticity of blood vessels, skin and lungs.
OMLC scientists use these tissues to create replacement arteries and other
life-saving parts. OMLC began this project 12 years ago and is currently
performing the FDA-required pre-clinical trials.
Laser Tissue Fusion
Laser tissue fusion is used to instantly seal and heal tissue with a laser
light (where a needle and thread are not effective) in organs such as
the liver, kidney or spleen. Attempting to suture those areas is like
attempting to sew through Jello, Gregory says. The wound is coated with
albumin, a protein found in human blood, and a laser is used to heat the
albumin and seal the injury. After lengthy research — more than
10 years — OMLC plans to treat the first human patient with laser
tissue fusion technology in the near future.
Photodynamic Therapy (PDT) uses lasers to diagnose and treat cancerous
tissue. Patients are given light-activated drugs that are absorbed by
the cancer cells. A low-power light is then shined over the area killing
the cancerous cells and leaving the adjacent normal cells unharmed, often
resulting in a lack of chemotherapy effects. The OMLC was the first to
use this treatment in the Pacific Northwest. The FDA has approved the
use of PDT on several forms of cancer, and this technology is used routinely
in most major hospitals, Gregory says.
OMLC researchers are developing methods to scan blood or tissue using
light to detect disease. This technology could eliminate the need to remove
blood and tissue samples for testing. Several groups around the country
are developing laser light-based systems to diagnose various conditions.
Optical diagnostics for cancer developed by the OMLC are used locally
at Providence and OHSU. Gregory says the procedure is completely safe,
but they are still working to determine the accuracy.
Laser thrombolysis was the first use of laser energy to treat a heart
attack patient in medical history. The technology was created to instantly
remove blood clots in an artery using laser light, which then restores
blood flow without damaging the artery wall. This procedure was first
used in heart attack patients in 1991 and in stroke patients several years
later. The technology is now in routine clinical practice.
BrainstormNW - November 2006