Asthmatx Inc. hasn't taken any chances in its seven-year pursuit of a Premarket Approval of its Alair Bronchial Thermoplasty System as a treatment for the most severe cases of asthma . In 2007, the company withdrew its plans to attempt an IPO in a rocky market and accepted a $50 million investment from Olympus Medical Systems Group, a division of Olympus Corp., in exchange for 15% of the company. [See Deal][See Deal] ( See "Asthmatx Breathes Easier," IN VIVO, October 2007. Also see "Asthmatx Breathes Easier" - In Vivo, 1 October, 2007.) Earlier on, the company wanted to leave nothing up to an advisory panel's discretion so it negotiated a rigorous clinical trial regimen for its catheter and bronchoscope, putting the Alair system through four separate clinical trials, with three of them randomized and controlled, just to prove beyond a doubt that the device worked.
The hard work paid off. Last fall, an FDA panel found the results of the trial to be conclusive enough...
