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Abiomed Reports Progress on Heart Replacement by Jed Seltzer
NEW YORK, Nov 14 (Reuters) - ABIOMED Inc.(ABMD) on Tuesday reported positive early test results for its implantable heart system, and the company's stock soared on hopes it would make a full replacement heart available in the next few years.
"This would be a true breakthrough," said Salomon Smith Barney analyst Phil Nalbone. "We think they'll have the first successful fully implantable heart."
Shares of the company closed up $4-9/64, or about 17 percent, at $28-17/64 Tuesday on the Nasdaq. The stock's year-high is $41-11/16 and the 52-week low is $12-5/8.
The mechanical heart would be made from plastics and metals in a seamless package, precluding clotting or leakage.
The Danvers, Mass.-based company said it achieved a goal it set to test the durability and reliability of the heart system. Once the durability and reliability testing is completed in the laboratory, the company said it intends to apply for an investigational device exemption (IDE) to begin human trials.
Investigational status granted by the U.S. Food and Drug Administration is the first request to test a drug or device on humans, and follows successful animal studies that suggest the treatment could work in people.
ABIOMED's durability trials on the experimental heart are intended to determine "whether it's robust...whether it can endure the tests it will go through in the human body," Nalbone said.
HUMAN TRIALS IN 2001
Nalbone said he expects ABIOMED to begin human trials in early 2001.
Scientists have researched full mechanical hearts for decades and have even experimented with patients, but all attempts have been unsuccessful so far, Nalbone said.
Mechanical heart valves have been available for years, but an entire artificial or manufactured heart to place into humans remains elusive.
Nalbone said he believed the company would charge between $75,000 and $100,000 per heart. He added that tens of thousands of patients who suffer from heart failure need transplants or replacements, but there are only about 2,500 human donors each year.
In a research note Tuesday, Banc of America analyst Kurt Kruger said the device is a landmark discovery that would significantly benefit ABIOMED.
"We believe the demand for such a device will be immense as the scarcity of natural replacement hearts leaves as many as 100,000 patients a year with no viable clinical alternatives," Kruger wrote.
"The significance of this first ever product and our growing confidence that the first human implant of the device will occur in short order certainly justifies higher levels than the current market capitalization."
Transplant patients suffer from serious side effects of drugs intended to prevent the body from rejecting the new heart, but ABIOMED's system would not require such anti-rejection drugs, Nalbone said.
However, Nalbone said, patients with a mechanical heart would be exposed to the risk of mechanical failure or potential blood clotting.
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