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CardioGenesis Stock Suffers 71% Drop

Health: After FDA panel rejects new laser, O.C. firm has the day's worst fall on Wall Street.

July 11, 2001|From Bloomberg News

CardioGenesis Corp.'s stock suffered Tuesday's worst pummeling on Wall Street--losing 71% of its value--a day after the medical-device company revealed that a federal panel failed to back its latest laser treatment for heart patients.

Shares of the Foothill Ranch company plummeted $2.04 to close at 85 cents on Nasdaq, the largest percentage loss on U.S. markets Tuesday. During trading, the price had fallen to 76 cents a share.

CardioGenesis said it will continue to pursue Food and Drug Administration approval for its percutaneous myocardial revascularization, or PMR, laser system.

The device, called Axcis, is threaded through a blood vessel in the leg into the heart, where it blasts tiny holes to promote blood flow and relieve severe chest pain, or angina.

An FDA advisory panel voted 7 to 2 Monday against recommending the device. The panel said the benefits of the laser don't outweigh its risks, including death and heart-rhythm disturbances. Some panel members also expressed concern that a placebo effect might have obscured the company's trial results.

The agency usually follows the advice of its expert panels.

The company said it is disappointed with the panel's decision but noted that the panel recognized that PMR does provide symptomatic relief.

If the laser eventually wins FDA approval, it would be the first treatment in the U.S. for chronic chest pain that doesn't require surgeons to open a patient's chest, said CardioGenesis, formerly called Eclipse Surgical Technologies Inc.

Meantime, the company said it will step up growth efforts in Europe and Asia, where the product has been approved and is available. CardioGenesis also plans to focus its U.S. growth efforts on its TMR product, an FDA-approved laser device that treats cardiovascular disease during surgery.

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Dow Jones News was used in compiling this report.

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