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Endocare Gains Clearance For Benign Breast Tumor Therapy; Malignant Next

This article was originally published in The Gray Sheet

Executive Summary

Endocare will follow up its FDA 510(k) clearance of the Visica minimally invasive cryoablation system for benign breast tumors with a submission for malignant tumors.

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Financings In Brief

Stereotaxis raises $20.1 mil.: Firm tabs $20.1 million in net proceeds from a private placement stock offering for marketing, R&D and working capital. The offering includes approximately 1.9 million common stock shares at $10.50 each. Stereotaxis, which makes magnetic interventional navigation systems for cardiac catheterization labs, generated revenue of $27.2 million in 2006 - an 81% jump from the prior year. A net loss for the year of $45.7 million compares to a loss of $43.6 million a year earlier. As of year-end 2006, the firm had $37 million in cash on hand. On March 1, the firm announced the start of its HEAL HF trial to evaluate its Niobe system for magnetic navigation to multiple potential pacing sites and optimization of left ventricular lead placement to treat heart failure. Stereotaxis went public in 2004 (1"The Gray Sheet" Sept. 27, 2004, p. 12)...

Financings In Brief

Stereotaxis raises $20.1 mil.: Firm tabs $20.1 million in net proceeds from a private placement stock offering for marketing, R&D and working capital. The offering includes approximately 1.9 million common stock shares at $10.50 each. Stereotaxis, which makes magnetic interventional navigation systems for cardiac catheterization labs, generated revenue of $27.2 million in 2006 - an 81% jump from the prior year. A net loss for the year of $45.7 million compares to a loss of $43.6 million a year earlier. As of year-end 2006, the firm had $37 million in cash on hand. On March 1, the firm announced the start of its HEAL HF trial to evaluate its Niobe system for magnetic navigation to multiple potential pacing sites and optimization of left ventricular lead placement to treat heart failure. Stereotaxis went public in 2004 (1"The Gray Sheet" Sept. 27, 2004, p. 12)...

Breast Tumor Ablation Study Parameters To Be Reviewed By FDA Panel

Clinical trial criteria for studying percutaneous breast tumor removal devices will be explored by FDA's General & Plastic Surgery Devices Panel during a July 24 meeting in Gaithersburg, Md

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