Other Circulatory Device Firms
Corrections or additions?
This article by Kathleen McGinn Spring was prepared for the
August 29, 2001 edition of U.S. Newspaper. All rights reserved.
A Breath of Hypertension Relief
A digital plastic device, shaped like a Walkman,
but quite a bit fatter, could possibly become a must-have piece of
exercise equipment for the health conscious (health obsessed?) Baby
Boomer. Called RESPeRATE, the machine is not designed to strengthen
abs or even to give the good old cardio vascular system a workout.
No, RESPeRate, retailing at $399 and available only by prescription
— at least for now — is designed to lower blood pressure by
giving a good workout to the 60,000 miles of small blood vessels that
snake through the human body.
The device was invented by Benjamin Gavish, an Israeli biophysicist,
who noticed that blood vessels in a healthy person are limber,
oscillating
nicely, but that those in a person with hypertension are much more
rigid. Exercising those vessels, he reasoned, would keep them in
shape.
In 1994 he came up with a device to do just that, and set about
forming
a company to test and market them. His son, Erez Gavish, left a career
as an industrial engineer to help his father found InterCure, the
company that has run RESPeRATE through trials that have won the device
marketing approval from the FDA.
Gavish senior, the son of an Israeli industrialist who manufactured
batteries, holds the title of chief scientific officer. His son, one
of three children in a family of scientists, serves as executive vice
president of the Carnegie Center-based InterCure. A resident of
Manhattan’s
Upper West Side, the younger Gavish, whose wife, Maya, is studying
architecture at Columbia, holds an undergraduate degree from Techion
College in Israel and an MBA from the University of Israel. He has
just moved the company’s headquarters from lower Broadway, near Wall
Street, to 214 Carnegie Center, where it has six employees, but room
for quite a few more. Research and development remains in Israel,
where the company was founded, and where it has 13 employees. In June,
in preparation for raising a significant amount of capital, it
received
$3.5 million from its major investors.
Gavish says RESPeRate is the first device ever cleared by the FDA
for use in treating hypertension, a disease that affects 50 million
Americans and is a contributing factor in heart attack, congestive
heart failure, and stroke. The device reduces blood pressure through
measuring respiration rate and cueing users to reduce that rate. Doing
so for just a few minutes a day strengths the circulatory system and
lowers blood pressure.
A disease that has devastating effects, hypertension can be difficult
to treat because it generally has no symptoms. Those afflicted —
one quarter of Americans — feel so well that they often stray
from treatments their physicians prescribe. It is estimated that
hypertension
is not under control in 70 percent of the people who have it.
The first line of treatment against hypertension often is diet —
an endeavor with an overall long-term failure rate of between 95 and
99 percent, according to a recent article on stomach reduction surgery
in the New Yorker magazine — and exercise, an activity some
patients
take to, and others put right up there with dental surgery.
When diet and exercise fail to lower blood pressure to an acceptable
level — under 140 over 90 — doctors often prescribe
medication.
While spending 10 minutes a day with RESPeRATE is lots easier than
forgoing a slice of birthday cake or jogging around Lake Carnegie,
"it’s not as easy as popping a pill," says Gavish. But, he
says, pills are far from a surefire cure for hypertension. For one
thing, there are side effects, the nastiest of which include dizziness
and impotence. And, says Gavish, "60 percent of people on
medication
for hypertension stop taking it within six months."
Even when patients are scrupulous about diet and
exercise,
and swallow all of their pills too, hypertension still may elude
control.
"Then the doctor is faced with the decision of prescribing more
medicine," says Gavish, who hopes his device will become an
alternative
to another fistful of pills.
Careful to refer to RESPeRATE as "adjunctive," Gavish says
it is not meant to be used alone. "We don’t want to be perceived
as an alternative," he says. "We want to be a mainstream
therapy
that is non-drug."
Most individuals participating in tests of the device take some sort
of blood pressure medicine, and a good number watch their diets, and
exercise too. InterCure wants its device to be a prescribed to people
like these as part of a holistic approach to lowering blood pressure.
This stance appears to be part of a strategy to have the device
included
as a standard, widely-used, weapon in a multi-pronged attack on
hypertension.
RESPeRATE is unique, says Gavish, and is protected by patents here
and abroad. In his opinion, it would not be easy for a competitor
to muscle in to this niche.
While the company goes to great pains to tout its product as just
one part of hypertension therapy, it is possible to use the device
by itself. Gavish, a jogger who has not yet reached middle age, admits
to strapping it on three times a week. "Who knows if it is
preventative?"
he says. But it is easy and painless — and relaxing too —
so he figures, why not?
Painless and easy — fun, really — to use, some believe
RESPeRATE,
and devices like it, might become too popular. Chris Taconet,
president
of Mednet Healthcare Technologies, says "There are so many
hypertensive
patients out there, that if Medicare approved ambulatory blood
pressure
devices — and there are other monitors out there — just about
anybody could be put on the device, and it might be
overprescribed."
Mednet, with offices in Ewingville Business Park, develops devices
that monitor heart activity over the phone.
While over-prescription could be a problem HMOs might worry about
down the line, Intercure’s concern is having its device perceived
as a serious — and effective — remedy for high blood pressure.
RESPeRATE’s effects are real — and significant — says Gavish.
The average drop in blood pressure registered by those using the
device
is 12 over 8. That would mean that a blood pressure reading of 160
over 100 came down to 148 over 92. The first number is systolic
pressure,
and the second is diastolic pressure. A reading of 120 over 80 is
optimal; up to 130 over 85 is normal; and a reading of more than 140
over 90 signals hypertension.
To put RESPeRATE’s effect into perspective, Gavish says banishing
salt from a diet will result, on average, in a drop of 4 over 2
points,
and exercise will lower a reading by 6 over 2. "Anything over
5 points, doctors are ecstatic," says Gavish.
Gavish is positioning RESPeRATE as serious therapy, yet, he says,
"I was afraid people would say `Oh, this is just another
relaxation
method.’" To beat critics to the punch, the company conducted
a series of randomized, double blind studies in which the placebo
was a Walkman loaded with a 10 minute relaxation tape. After working
with RESPeRATE, or listening to the soothing tape, participants
recorded
their blood pressure, and took the results to their doctors, who did
not know which device they were using. In every study — six in
all so far — RESPeRATE lowered blood pressure more than the music
did. On average, the relaxation tapes resulted in an 8.4 over 4.2
point drop versus a 12.41 over 7.8 point drop with RESPeRATE.
An explanation, Gavish says, is that, typically, when people work
at slowing their breathing they become anxious and achieve the
opposite
result. RESPeRATE relies on aural cues to lead users to slow breathing
down to a rate of fewer than 10 breaths a minute, a rate that gives
blood vessels a workout that keeps them limber, and able to move blood
efficiently.
Most people take 16 or 17 breaths a minute, but when I hooked myself
up to RESPeRATE, Gavish was surprised to see I was taking only 4.8
breaths. "Are you doing yoga?" he asked, as I sat a foot or
two from RESPeRATE with the pocket watch-sized breath detector
strapped
comfortably across my chest and over my shirt. I just said
"No,"
not bothering to explain that, upon being hooked up to the little
machine — non-threatening though it is — I had probably sucked
myself into my doctor’s office mode; quiet and watchful, waiting for
a needle — or something worse — to come into view.
Gavish and I chatted a bit, and soon I was taking 16.7 breaths per
minute. Taking the measure of the number of my respirations, and of
their pattern, a cartoon man on RESPeRATE’s LCD shot out arrows
indicating
when I should inhale, and then exhale. A little dot above cartoon
man’s head acted as a further inhale prompt. After I had followed
the cartoon’s lead for a few seconds, Gavish directed me to close
my eyes and listen to the sounds in the earphones I had put on after
strapping on the breathing monitor.
It sounded vaguely like ecclesiastical music to me, but Gavish
insisted
it was not music at all, but rather "just sounds." Without
coaching, the music (It did sound like music to me.) led me to inhale
on a note that, even to my tin ear, was distinctly higher than the
rest. I then held the breath as the notes descended. At my first try,
I must say that I did feel some anxiety about missing the high note
and inhaling late, but despite that initial unease, my rate of
breathing
did fall steadily from 16.7 down to 10 in the three minutes or so
that I was hooked up.
Patients are directed to use the machine for 10 to 15 minutes in the
evening, and to take their blood pressure in the morning. The goal
is not to retrain one’s breathing. A normal breathing rate will kick
in as soon as the exercise is over — and that is fine. The effect,
says Gavish lasts all day. This is one way in which the machine
resembles
exercise. No one jogs all day, yet 30 to 60 minutes of jogging
produces
benefits in terms of speeded up metabolism, increased lung capacity,
and strengthened heart beat that lasts long after the jogger returns
to his chair.
The device and the digital blood pressure monitor that comes with
it record data from each session, which can then be uploaded into
a computer. "You can’t cheat," says Gavish. There is no way
for a doctor to know whether his patient did eat just one slice of
pizza, take all his pills, or jog the full way around the track. An
advantage of his machine, says Gavish, is that if a patient skips
some sessions the doctor will know.
Having proved to the satisfaction of the FDA that RESPeRATE does in
fact reduce blood pressure, the next step is getting it on the market.
Physicians can write prescriptions for RESPeRATE now, but the product
will not be officially launched until later in the year. Gavish says
InterCure is being exceedingly careful in building a pre-launch base
for the product. It is trying hard for acceptance among physicians
by attending medical conferences, publishing papers, and assembling
a scientific advisory board that includes Henry Black, the dean of
research at Rush Medical College in Chicago, who sits on the editorial
board of the Journal of Hypertension, and Thomas Pickering, director
of the integrative and behavioral cardiology program at Mt. Sinai
School of Medicine in New York City.
In May, in preparation for the official launch of its product,
InterCure
hired a new CEO, Paul Sheils. While Sheils, former CEO of Medscape
and vice president for information services at Dow Jones, has
substantial
management and technology experience, a post-college bike trip played
a big part in landing him his current position. "After I graduated
from Williams in 1976, I traveled on bike in Europe," he says.
Along the way he spent two months on a kibbutz in Isreal, and, he
says, that experience was one of the things that made him attractive
to his new employer.
Sheils’ group was responsible for launching Dow Jones Interactive,
and he says leaving to head Medscape, an Internet resource for
doctors,
was "a big step." He grew Medscape, now headquartered in
Oregon,
from 20 to 300 people and developed CBS HealthWatch, a consumer
website.
Both were successful, going public, and then being sold — in
mid-2000
to MedicaLogic — just before the Internet landed in Intensive
Care. "We hit the height of the market, and suffered the downturn
of the market," he says. Asked if he sold his Medscape stock,
now trading at 31 cents a share, Sheils replies, "Not enough of
it."
Sheils grew up in New York City, earned a law degree
from Fordham, and lives in Yardley with his wife, Theresa, and their
four children, the oldest of whom is a student at Williams. Princeton
is a good spot for InterCure, he says, because of its pharm country
location, which puts it close to companies that could become ideal
business partners, perhaps taking over some or all of the marketing
of its RESPeRATE device.
Like Gavish, Sheils take pains to emphasize that RESPeRATE is not
a toy for anxious Boomers. "We want to maintain a high health
profile," he says. "This is a treatment. We need a high
medical
positioning."
The company is setting its device out as a treatment for blood
pressure,
but Sheils says it is equally well suited for dozens of other disease
conditions. Lowering respiration rate can be a treatment for
everything
from congestive heart failure to asthma to panic attacks. After
RESPeRATE
is established as a hypertension therapy, the company plans to take
on other disease states. The machine will be customized for each.
"With congestive heart failure," Sheils says, "there are
low blood oxygen levels." Proper breathing raises those levels,
and a RESPeRATE for that purpose, he says, would most likely be
packaged
with a pulse oxymeter to allow patients to monitor progress.
While the company is convinced it needs credibility with the medical
establishment to achieve substantial sales, it plans to go directly
to the consumer, too. Sheils says the company applied to the FDA for
approval of its device on a prescription only basis initially, but
in August will seek approval to sell it directly to consumers over
the counter. Articles in consumer magazines, including Prevention
and Health, already have touted its benefits to consumers.
The company hopes consumers will drive sales by ripping out ads or
articles and taking them along on visits to their doctors, perhaps
prompting the physicians to write out prescriptions. This tactic not
only could produce sales, but also could raise physicians’ awareness
of the device.
An obstacle the company faces is that the $399 cost of the device
package — estimated life, five years — is not covered by
medical
insurance. The company will lobby health insurance companies, asking
that the device be covered. Sheils points out that the cost is no
greater than the typical co-pay for five years worth of hypertension
drugs. Yet, as he and Gavish both have said, the device will not be
a substitute for drugs in many cases. Still, the recent profusion
of radio ads for full body CAT scans and day-long physicals as a way
for the affluent to head off any and all life threatening diseases,
bodes well for RESPeRATE sales, at least among the
we-plan-to-live-forever
crop of Boomers approaching the age at which hypertension worries
often move to center stage.
It is not unusual for Israeli medical technology companies to
establish
a sales and administrative office in on the East Coast, but InterCure
has a compelling reason for doing so, especially given the fact that
its product is not covered by insurance. "This product has strong
consumer appeal," says Gavish. "The United States is the world
leader of the consumer movement. Consumers in Europe are more
conservative
than in the U.S." And the States not only has adventuresome
consumers,
but has a good number of somewhat elderly consumers who know their
way around the Internet. "You don’t find that in Europe, or in
Israel," says Gavish, who plans to make the Internet an important
part of its marketing strategy.
InterCure, which began, Gavish says, as "a garage operation,"
has raised approximately $10 million to date. Investors include
"wealthy
Israeli angels," Mizrahi Investors, a group with an affiliation
to one of Israel’s largest banks, and Palladin Capital in New York
City. (The Mizrahi group was responsible for the June funding.) The
Gavish family retains ownership of about 40 percent of the company.
The company is preparing for major growth next year when its product
is launched. But with RESPeRate still making the rounds of medical
conferences to build its pre-launch reputation, Gavish already is
planning an exit strategy. In fact, he says the company chose a U.S.
location — and more specifically a Princeton location — with
a lucrative exit in mind.
"If you succeed in the U.S., it is good for an exit strategy,"
says Gavish. Options include going public, or being bought out, or
possibly licensed out. In either of the latter scenarios, a
pharmaceutical
company would be the likely suitor. While Gavish is thinking ahead,
he says he expects that he and his new bride will remain in the United
States for at least four or five years.
After that, he may be ready to leave, whether or not InterCure is
moving toward an exit strategy. As an adolescent, Gavish accompanied
his father to Champaign-Urbana, Illinois, where he was doing post-doc
work at the University of Illinois. The younger Gavish attended junior
high in Illinois, and, years later, the culture shock lingers.
"In Israel, I was very sheltered," he says. "Thirteen
year olds did not get pregnant, take drugs, use alcohol." In his
American junior high all of these activities were commonplace.
Gracious
and tactful, Gavish adds, "But that was years ago, things may
have changed. And things are different in Israel now, too."
If Gavish’s carefully thought out business strategy is successful,
treatment of hypertension — a condition that is thought to be
responsible for more deaths than the next seven most common causes
of death combined — will be a little different too. In a best-case
scenario for InterCure, its digital breathing coach will soon sit
alongside jogging shoes, books on heart healthy eating, and bottles
of blood pressure medicine in the kitchens of Boomers determined to
keep the Grim Reaper at bay.
Princeton 08540-6237. Paul Sheils, CEO. 609-799-7599; fax,
609-799-7690.
Consumer number: 877-988-9388. Www.InterCure.com and
Top Of Page
Other Circulatory Device Firms
Mednet Healthcare Technologies, 100 Ludlow Drive,
Ewingville Business Park, Ewing 08628; trans-telephonic laboratory
for over the telephone heart monitoring and receiving station products
— arrhythmia monitoring, pacemakers. Founded 1989. Frank Movizzo,
CEO.
800-222-2842 800-840-6937
Zargis Medical Corp., 755 College Road East,
Princeton 08540; advanced diagnostic products and services to detect
heart abnormalities. Founded 2001. Ray Watrous, chief technology
officer.
609-734-6596 609-734-6565
EchoCath Inc. (ECHTU), 4326 Route 1 North, Box
7224, Princeton 08543-7224; high tech medical devices, including an
ultrasound-guided angioplasty catheter. Frank DeBernardis, president.
609-987-8400 609-987-1019
i-STAT Corporation (STAT), 104 Windsor Center
Drive, East Windsor 08520; diagnostic blood analysis equipment
manufacturing.
Founded 1984. William P. Moffitt, president and CEO. Staff size: 150.
609-443-9300 609-443-9310
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