James D. Utterback

Invention by Marvin Sackner MD

Michael Coyle

Corrections

Corrections or additions?

This article by Barbara Fox was prepared for the July 16, 2003

edition of U.S. 1 Newspaper. Minor corrections were made on July 23

All rights reserved.

How Are You? The Vest Knows

Like Santa Claus, this gadget sees you when you’re

sleeping and knows when you’re awake. It can also measure your

movement,

the amount of air you take in with every breath, the number of times

you breathe in a minute, your activity level, your heart beat, when

you cough — and that’s not all. It can record your posture and

correlate all this with information on your symptoms and moods at

any given moment. You wear it as a vest.

New at Princeton Overlook is VivoMetrics, the company that makes this

gadget, called the LifeShirt System, and sells it to pharmaceutical

firms for clinical trials. The LifeShirt is one of the company’s

continuous

ambulatory monitoring products and services that can collect, analyze,

and report physiologic data gathered during everyday activities. Cost:

$500 to $5,000 per person per trial, depending on how much information

is needed for that particular study.

Taking a shower is the only activity that the LifeShirt does

not accurately identify and that’s because it can’t get wet. (The

vest can, nevertheless, be washed if you remove the cable.)

So far the company has put shirts on 1,020 subjects and done 67

studies,

most paid for by universities. Zurich researchers, for instance, did

a study on mountain sickness and a scientist at Brown is using the

shirts to study autism. Pharmaceutical firms have done three clinical

trials and are in the process of doing two more. And because the vest

can simultaneously measure breathing patterns and heart rate, it can

be used to study sleep apnea, which has just been found to have a

high correlation with heart failure.

Having raised $26 million to date, VivoMetrics is on the verge of

completing its third round of investment with Credit Suisse First

Boston and plans to be profitable by the mid point of next year.

Boston-based

Perceptive Informatics (PRXL) signed an agreement to market the

LifeShirt

System last month. "We would certainly plan to go public, when

the market conditions make sense," says James D. Utterback,

president

of the pharmaceutical research division.

"We have a unique product with a large market opportunity to grow

in the clinical trials space," says Utterback, "and our other

vertical markets could expand." These might include health care,

academic research, the military, and such applications as

rehabilitation,

professional sports, and training. "We’ve had it worn by

professional

athletes, including Indy race car drivers," he says.

Top Of Page
James D. Utterback

Utterback grew up in Greenwich, Connecticut, where his father was

an entrepreneur and founder of one of the country’s largest dairy

conglomerates. After majoring in psychology and economics from

Washington

& Lee University (Class of 1977), he earned a master’s degree in

industrial

psychology at Virginia Polytechnic Institute and has completed

executive

courses at Harvard Business School. He has worked for GE Medical

Systems,

Rhone-Poulenc Rorer Pharmaceuticals in Africa, and was corporate

senior

vice president and operating president at Carnegie Center-based

Covance.

where he built Most recently he was CEO of Boston-based PHT

Corporation,

which provided E-clinical services to healthcare organizations. He

and his wife live in Newtown, PA, and have three children. Utterback

joined VivoMetrics in April, 2002, and has six employees now.

The earliest employees hired helped Utterback find his space, 2,000

square feet at Princeton Overlook, and the office officially opened

on June 1. Utterback expects to grow the staff into "the mid

teens"

by the end of next year. "Why here? Because the pharmaceutical

industry is centered in the northeast corridor," says Utterback.

Paul Kennedy, president and CEO, remains in the headquarters office

in Ventura, CA, as does Andrew Behar, COO.

Top Of Page
Invention by Marvin Sackner MD

VivoMetrics’ technology, called respiratory inductants

plethysmography, has been used in more than 1,000 hospitals over the

past 30 years, but this is the first time it has been used as part

of a garment for ambulatory patients. It was invented by Marvin

Sackner MD (Temple University, Class of 1953, and Jefferson Medical

School).

Sackner created a system for measuring respiratory tidal volume in

intensive care units and put this technology into a shirt, but he

resisted attempts to market it. Behar, his son-in-law, commissioned

the marketing study that persuaded Sackner to license the technology.

At the time Behar had a multimedia technology company with his wife,

Sara. The company’s first funding came from friends and family, and

when an article on the technology ran in the Economist, checks started

pouring in.

The LifeShirt System might eventually go wireless, but right now the

information gets downloaded to a recording device and transmitted

over the Internet in encrypted form. To accumulate so much information

so quickly with so little aggravation to the patient could be very

valuable for pharmaceutical companies that want to hasten their

clinical

trials.

The business plan calls for VivoMetrics to lend the garments to

researchers

for preliminary studies, but eventually they may have to buy the vests

for the trials they conduct. VivoMetrics sells not just the vest but

also its data capturing services; it analyzes the data on complex

physiological measures. "We are experts at signal processing

detection,

data capture analysis, and miniaturization technologies," says

Utterback. "We have no direct competitor — it’s a highly

patented

product."

The LifeShirt is exponentially more powerful than the traditional

Holter monitor that records electrocardiagram data for a 24-hour

period.

It combines cardio pulmonary data with an electronic patient diary

and a two axis accelerometer that gives body position and estimates

energy expenditure, core temperature, and CO2 output, and it turns all

this into objective data.

Top Of Page
Michael Coyle

"We are creating an environment where a patient is viewed in terms

of a 24-hour cardio-pulmonary kinetic profile," explains Michael

Coyle, vice president of clinical development (Butler University,

Class of 1992, with a PhD from Indiana University). "It gives us

insight into

how a person’s physiology functions during clinical trials and

correlates

that with activity. Now we have an objective data point in addition

to the subjective data that is traditionally unreliable."

Depression trials that ask questions like "How sleepy are you?

How happy are you" are perfect examples of how a high placebo

response rate can skew a study. It is well known that, for depression

trials, the placebo response rate is more than 50 percent, says Coyle.

He believes the LifeShirt can help screen the appropriate patients

into a trial and look for physiological changes made by a drug.

How to choose patients for these trials? "Depressed people sigh

a lot," he says. In contrast to normal people, whose at-rest

breath

is fairly constant, depressed people change their pattern with every

breath. "To select the right patients into a depression study,

you would want to be sure they would have `tidal volume instability’

or erratic breath patterns."

Coyle points out that a drug company may have an efficacious drug

but not enough power in its study to demonstrate that. But if the

company testing a depression drug can couple its findings with an

objective physiological marker, it can reduce the placebo response.

"You can’t fake your physiology," says Coyle. "You can

fill out a diary falsifying your mood, but you can’t change

cardio-pulmonary

response to a drug."

VivoMetrics, 100 Overlook Center, Princeton.

609-919-9810;

fax, 609-919-9811. Www.vivometrics.com

Top Of Page
Corrections

VivoMetrics offered corrections that have been made in the article

above: COO Andrew Behar lives in Ventura, California, not New York.

Marvin Sackner has an MD degree. The device’s two-axis accelerometer

does not give energy expenditure, core temperature, and CO2 output —

it estimates them. And, instead of "creating an environment where a

patient has a 24-hour cardio-pulmonary kinetic profile" the

sentence should read "creating an environment where the patient is

viewed in terms of a 24-hour cardio-pulmonary kinetic profile.


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