Medstone Gallstone Unit Rejected
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A physician advisory panel to the Food and Drug Administration refused Thursday to recommend Medstone International Inc.’s lithotripsy technology for treatment of gallstones, an FDA spokeswoman said.
The Irvine company already has approval to sell its lithotripters for treatment of kidney stones and wanted to penetrate the larger market for gallstone treatment. Lithotripters use shock waves to disintegrate stones.
Thursday’s decision was considered a significant setback for Medstone, as evidenced by the reaction on Wall Street. Medstone’s stock fell to an all-time low of $10.50 a share in heavy trading, down from $12 a share Wednesday.
The reasons behind the panel’s decision were not disclosed. FDA spokeswoman Susan Cruzan said more details about the decision will be released in a few days.
Cruzan said the FDA rarely gives approval for a product without the panel’s concurrence.
Medstone officials were not available for comment Thursday after attending an all-day public hearing before the FDA advisory panel in Washington.
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