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
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
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
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.
Perceptive Informatics (PRXL) signed an agreement to market the
System last month. "We would certainly plan to go public, when
the market conditions make sense," says James D. Utterback,
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
professional sports, and training. "We’ve had it worn by
athletes, including Indy race car drivers," he says.
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
& Lee University (Class of 1977), he earned a master’s degree in
psychology at Virginia Polytechnic Institute and has completed
courses at Harvard Business School. He has worked for GE Medical
Rhone-Poulenc Rorer Pharmaceuticals in Africa, and was corporate
vice president and operating president at Carnegie Center-based
where he built Most recently he was CEO of Boston-based PHT
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
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.
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
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
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
The business plan calls for VivoMetrics to lend the garments to
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
data capture analysis, and miniaturization technologies," says
Utterback. "We have no direct competitor — it’s a highly
The LifeShirt is exponentially more powerful than the traditional
Holter monitor that records electrocardiagram data for a 24-hour
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.
"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
how a person’s physiology functions during clinical trials and
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
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
response to a drug."
fax, 609-919-9811. Www.vivometrics.com
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.
Corrections or additions?
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