The Beat Goes On

WorldHeart Chairman Rod Bryden Unruffled By Rival's Move To Human Tests

By Bert Hill

The Ottawa Citizen with files from Bloomberg News

A major rival of World Heart Corp. has won U.S. approval to start human testing of an artificial heart product.

The stock price of Abiomed Inc. of Danvers, Massachusetts jumped 26 per cent yesterday when it announced that the U.S. government had approved tests in five humans.

WorldHeart, which won't start human testing of its own product until later this year at the earliest, failed last year in a lawsuit against Abiomed over what the Ottawa company said were stolen research secrets.

Yesterday, WorldHeart chairman Rod Bryden said he does not see Abiomed's approval as a setback in the race to market.

"We had been expecting them to start clinical testing since last summer," Mr. Bryden said. "The Abiomed product is a totally artificial heart, which we do not see as a competitor.

"We expect they will be successful in trials, and they will have a very valuable medical device."

About 400,000 Americans die of heart disease annually. The Canadian toll is about 40,000.

About half could survive if they could receive a human heart transplant or if they had access to devices to assist or replace their damaged organ. But only about 2,000 natural hearts are available for transplant annually in the U.S.

Abiomed plans to test its grapefruit-sized device, called the AbioCor, in patients who are at immediate risk of dying of heart failure.

Analysts said Abiomed's device -- if successful -- could one day be used in about 125,000 patients a year.

"There is going to be a tremendous shortage" of donor hearts, said Sam Chang, a Salomon Smith Barney analyst. "They are expecting to price this (device) at $75,000 to $100,000 -- and that's a $12- billion U.S. market, just in the U.S."

Shares in Abiomed jumped $4.69 to $23.06 in trading of 3.3 million, 18 times the stock's three-month average.

WorldHeart stock fell 25 cents to $11.75. Abiomed stock has risen 20 per cent in the past six months.

Like the WorldHeart device, Abiomed's product doesn't have to be hooked to any external wires or tubes. Surgeons remove most of a patient's heart, and stitch the AbioCor to a remaining bit of the upper chambers, or atria.

The WorldHeart product is designed to sit beside the weakened heart and keep blood flowing by mimicking the operation of the left ventricle.

Mr. Bryden said the WorldHeart product will be aimed at 85 per cent of the diseased heart market compared with only about 15 per cent for the Abiomed product.

However, if Abiomed gets U.S. approval, it could expect to capture a much bigger share of the market in the absence of competing assist products from WorldHeart or others.

The WorldHeart device has been dogged by technical problems that have delayed the start of human testing by more than a year.

To further complicate the situation, another U.S. company, Arrow International, leads WorldHeart in the race to get a heart-assist device ready for market and is conducting human tests in Europe.

Mr. Bryden said Arrow's LionHeart product is bulkier and more complex than the WorldHeart product.

WorldHeart still has to get Health Canada approval to start human testing. It expects to seek approval in the second quarter of this year and hopefully start human testing in the second half of the year.

WorldHeart plans to seek approval for trials in the United States and Europe in the second half of next year.

Copyright © 2001 Ottawa Citizen Group Inc.

This article posted February 4, 2001.