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A Heart-Attack Detector To Beat Competitors? (washingtonpost.com)

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A Heart-Attack Detector To Beat Competitors?

Meridian Hopes New System Will Replace ECGs

_____Industry Watch_____

• Pharmaceuticals

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By Terence Chea

Washington Post Staff Writer

Wednesday, August 22, 2001; Page E05

A patient who arrives in a hospital emergency room complaining of chest

pain is usually hooked up to an electrocardiogram, or ECG, the standard

instrument for detecting heart attacks for nearly 60 years.

But today's ECG, also known as EKG, which uses 12 sensors to measure

electrical signals emitted by a patient's heart, is far from perfect. According

to some estimates, it fails to detect up to 60 percent of heart attacks because

it can't spot damage in several key areas of the heart.

" We've all known for some time that the 12-lead ECG is the best we had,

but it has important limitations, " said ph P. Ornato, a professor and the

chairman of emergency medicine at the Medical College of Virginia in Richmond.

Now a Columbia company hopes to cash in on the failings of the traditional

ECG. Meridian Medical Technologies Inc. awaits government approval to sell a new

version, the Prime ECG electrocardiac mapping system, which Ornato has been

testing for almost two years.

The Prime system is designed to detect heart attacks earlier and more

accurately than the standard ECG. It uses 80 sensors and sophisticated computer

software to translate the heart's electrical activity into colorful,

easy-to-read images that help doctors spot abnormalities.

Meridian officials believe the Prime system, though more costly than

current equipment, will one day become the standard test to detect heart attacks

and generate handsome profits for the five-year-old company, which has about 360

employees in Columbia, St. Louis and Northern Ireland.

Earlier this month, Meridian filed an application with the Food and Drug

Administration to market the Prime system in the United States. The Prime system

has already obtained approval in Europe, where marketing efforts are underway.

The company hopes the Prime system will be cleared for sale in this country

within six months.

With its application, Meridian submitted data from a major clinical study,

involving more than 800 patients at five test sites in the United States and the

United Kingdom. Although they have not released the results to the public,

company officials say the study shows the Prime system to be significantly more

effective at detecting heart attacks than the standard ECG.

" Based on the outcome of our clinical trials, we believe we have a claim

that the device is superior to the 12-lead ECG, " said H. ,

Meridian's president and chief executive.

Noble, a stock analyst at New York investment bank Fahnestock & Co.,

expects Meridian to win FDA clearance since the company needs to prove only that

its system is at least as effective as the standard ECG. The company's main

challenge will be persuading hospitals to switch from an established medical

standard to a less familiar, more expensive system, he said.

" The real issue is to convince the medical community, via clinical study

results, that the Prime ECG has a much better record than the 12-lead ECG at

detecting heart attacks, " said Noble, who has issued a " buy " rating on

Meridian's stock.

If the system wins FDA approval, Meridian will have to convince hospitals

and emergency room physicians that the Prime system will help them save more

lives and reduce long-term health-care costs by diagnosing heart attacks

earlier, offsetting the Prime system's higher cost.

Meridian is betting much of its future on the Prime system. Founded in

1996 from the merger of two medical-device companies, Meridian has become

profitable by selling drug-delivery systems to government agencies such as the

Department of Defense.

Meridian's main product, the EpiPen, is a drug-injection device used for

emergency treatment of allergic reactions and nerve-gas attacks, among other

uses. In its fiscal third quarter ended April 30, EpiPen sales rose 72 percent,

to $10.8 million, accounting for the bulk of the company's $14.8 million in

revenue and $764,000 in profit for the quarter.

But while its pharmaceutical products generate a steady stream of revenue,

company officials see the Prime system as its potential blockbuster. The company

has not issued specific revenue forecasts, but officials say revenue could grow

by multiples if the product is successful.

" This is obviously a very important product for our company, " said.

" Our pharmaceutical systems unit is growing and profitable, but the potential

home run is certainly Prime. We expect that in four to five years, this will be

our lead product. "

The Prime system addresses a huge medical need. Heart disease is among the

leading causes of death, and the company estimates more than 20 million patients

with heart-related chest pain are diagnosed in hospitals worldwide each year.

Heart attacks occur when the heart's blood supply is cut off or severely

restricted and heart muscle dies from lack of oxygen.

Despite medical advances, detecting heart attacks is far from an exact

science. Only one-third of chest-pain patients admitted for observation are

actually suffering from heart attacks or related ailments, a situation that

results in unnecessary hospital stays and delays in treatment, according to

studies cited in the New England Journal of Medicine.

In addition, as many as 160,000 Americans leave hospitals without needed

treatment due to missed diagnoses of heart attacks, the studies show. Many of

those patients die.

" The major challenge is to differentiate between people who are truly

having a heart attack and those who are having chest pains for other reasons, "

said.

Meridian believes the 12-lead ECG is partly to blame for the poor rates of

heart-attack detection. The standard ECG's 12 electrodes amplify the heart's

electrical signals and convert them into wave forms that doctors monitor for

signs of abnormal heart function. But the system can be difficult to interpret

and fails to detect many types of heart attacks.

The Prime system was designed by scientists at Meridian and the University

of Ulster in Belfast. Its 80 sensors wrap around a patient's torso like a vest,

offering a more complete view of the heart's electrical activity.

Beside monitoring the heart from more angles, the Prime system uses

specialized software to convert the information into two-dimensional color maps

that resemble Doppler radar weather images.

" One of the real innovations of the Prime system is the transformation of

data, " Ornato said. " The Prime system is processing that information and making

a pictorial display. It becomes very easy and very intuitive to see if something

is wrong. "

The company estimates the initial market for its system to be worth about

$2 billion. It remains to be seen how much of that market, if any, the company

will claim, but some analysts are optimistic.

" If they can demonstrate diagnostic superiority, then they should achieve

significant market penetration over the next few years, " Noble said. But he

adds, " It's not going to happen overnight. "

More stories on BIOTECH/MEDICAL online at Washtech.com.

© 2001 The Washington Post Company

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