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Financings In Brief

This article was originally published in The Gray Sheet

Executive Summary

Hansen Medical raises $39.4 mil.: Secondary stock offering of three million shares priced at $13.34 each on April 1 raises $39.4 million in net proceeds. The Mountain View, Calif., maker of the Sensei robotic catheter placement system will use the funds for sales and marketing, R&D, capital equipment, working capital, "general administrative activities ... and other general corporate purposes," the company says in a prospectus filed with the Securities and Exchange Commission. The company first went public in 2006 (1"The Gray Sheet" Nov. 20, 2006, p. 14). Morgan Stanley was the sole underwriter for the secondary offering

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Spiration IBV lung valve approved for post-surgical air leaks: Removable bronchial valve implant gains FDA humanitarian device exemption (HDE) approval Oct. 24 to treat prolonged air leaks that last at least seven days after a lobectomy, segmentectomy, or lung volume reduction surgery. The valve, which is inserted using a bronchoscope and intended to be removed within six weeks, allows air to flow in only one direction, preventing it from entering the affected areas but allowing air and mucus to escape, according to FDA. The device "may ease post-operative recovery," states Daniel Schultz, director of FDA's device center. The agency's HDE approval process is intended for devices that diagnose or treat conditions affecting less than 4,000 U.S. patients annually. Privately held, Redmond, Wash.-based Spiration notes that it also is conducting a pivotal study of the device for severe emphysema (1"The Gray Sheet" April 14, 2008, p. 10)

New Products In Brief

Spiration IBV lung valve approved for post-surgical air leaks: Removable bronchial valve implant gains FDA humanitarian device exemption (HDE) approval Oct. 24 to treat prolonged air leaks that last at least seven days after a lobectomy, segmentectomy, or lung volume reduction surgery. The valve, which is inserted using a bronchoscope and intended to be removed within six weeks, allows air to flow in only one direction, preventing it from entering the affected areas but allowing air and mucus to escape, according to FDA. The device "may ease post-operative recovery," states Daniel Schultz, director of FDA's device center. The agency's HDE approval process is intended for devices that diagnose or treat conditions affecting less than 4,000 U.S. patients annually. Privately held, Redmond, Wash.-based Spiration notes that it also is conducting a pivotal study of the device for severe emphysema (1"The Gray Sheet" April 14, 2008, p. 10)

Broncus Drug-Eluting Stent For Emphysema Slated To Debut In 2010

Broncus Technologies plans a mid-2010 U.S. launch of a minimally invasive emphysema treatment system that would rely on a drug-eluting stent to bypass collapsed airways in the lung

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