James H. Miller, president of Meridian Medical Technologies Inc., told an investor conference meeting in Washington this week that he sees strong growth opportunities for the company in the cardiopulmonary market and estimated that sales for a new diagnostic device could top $50 million annually five years from now.
The Columbia-based medical equipment company, which makes pre-filled automatic injectors for treating allergies and the effects of chemical warfare, has developed a device that can detect a heart attack and pinpoint where the trouble is occurring.
The disposable vest-like device contains electrodes that collect and transmit data on the electrical impulses of the heart to a computer system that can determine with 80 percent accuracy whether a person is having or about to have a heart attack, according to Meridian.
Meridian is seeking marketing clearance for the device in Europe, and it plans to seek Food and Drug Administration approval to bring the product to the U.S. market next year.
The company claims the product is three times more accurate in diagnosing heart attacks than electrocardiograms, or ECGs, which are used now to help diagnose heart attacks.
If successful in getting marketing clearances, the company hopes Prime ECG would replace ECGs as the standard diagnostic device, Miller said in an interview after the Technology Investor Conference.
Meridian, said Miller, plans to market the device first to hospital emergency rooms.
He said the company has its eye on the 20 million people who visit doctors' offices and emergency rooms worldwide complaining of chest pain. The United States accounts for half of them. About 1 million of the patients are diagnosed as having a heart attack.
The company hopes to receive clearance by the end of the year to market Prime ECG in Europe, Miller said.
The executive projects that the company, which had 1997 sales of $41 million, could generate sales of $50 million to $70 million from its Prime ECG device once marketing approvals are obtained in the United States and Europe.
"The total market potential is probably $1 billion, but we're being conservative and estimating that we'll get just a portion of that," said Miller. "With any new product introduction, you first have to educate people about how important it is."
Meridian expects to complete construction by January of a new manufacturing facility in Northern Ireland where the device will be made.
The company is also working on other diagnostic devices, based on the technology behind Prime ECG. These include a monitor that can be used at home by people with a history of heart trouble.
The "Cardio Beeper" device, about the size of a portable tape player such as a Walkman, is being designed to transmit circulatory data by phone to doctors' offices so patients can be monitored without office visits.
Meanwhile, he said, the company has committed $2 million to improving quality controls at its St. Louis factory, where its line of auto-injectors for the allergy and military markets is made.
In May the company recalled 1 million of its epinephrine-loaded EpiPen and EpiPen Jr. injectors because of a production defect. That recall continues, said Miller. The company took a $2.2 million charge for recall costs in its second quarter.
In July a distributor for EpiPen and EpiPen Jr. said it was recalling injectors sold in Switzerland because it found the same defect.
Pub Date: 8/08/98