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JP Morgan Healthcare Conference In Brief

This article was originally published in The Gray Sheet

Executive Summary

FoxHollow files IDE for coronary indication: Plaque excision system manufacturer filed an IDE to resume a clinical trial studying the use of SilverHawk to treat coronary artery disease in type B and C bifurcation lesions on Jan. 9, the company announced at the JP Morgan Healthcare conference in San Francisco. The initial study, begun in Oct. 2002, was shelved in Dec. 2003 due to adverse events observed in a subset of the patients (1"The Gray Sheet" Nov. 1, 2004, p. 20). Enrollment for the 250-patient trial is expected to begin in the second quarter, interim CEO John Simpson, MD/PhD said. FoxHollow also plans to initiate a 100-patient randomized, controlled trial comparing treatment with SilverHawk to medical management for peripheral artery disease, the device's approved indication. The Redwood City, Calif. firm hopes the trial results will accelerate the firm's quest for profitability, a goal that has been delayed by an $11.4 mil. stock-based compensation expense this quarter related to the departure of CEO Robert Thomas Jan. 1 (2"The Gray Sheet" Jan. 9, 2006, p. 13)...
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