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.

InterCure Inc., 214 Carnegie Center, Suite 300,

Princeton 08540-6237. Paul Sheils, CEO. 609-799-7599; fax,

609-799-7690.

Consumer number: 877-988-9388. Www.InterCure.com and

www.resperate.com.

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

www.unimedical.com

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

www.zargis.com

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

echocathinc@echocathinc.com

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

www.i-stat.com

Corrections or additions?


This page is published by PrincetonInfo.com

— the web site for U.S. 1 Newspaper in Princeton, New Jersey.

Facebook Comments