Pulmonary Device Companies Take It To The Streets - In Europe

Article preview from Start-Up - February 2011

For the past decade, venture capitalists have invested in companies that are developing new technologies to treat late-stage chronic obstructive pulmonary disorders.Despite hundreds of millions in venture capital dollars, the companies have made little progress in bringing these products to market in the US. But this band of start-ups is taking the fight to the streets - of Europe.

Pulmonary Device Companies Take It To The Streets - In Europe

Article preview from Start-Up - February 2011

For the past decade, venture capitalists have invested in companies that are developing new technologies to treat late-stage chronic obstructive pulmonary disorders such as emphysema, hoping to create a new line of devices to aid patients who can't draw enough oxygen from a single breath.Despite hundreds of millions in venture capital dollars, the companies have made little progress in bringing these products to market in the US.

But this band of start-ups is taking the fight to the streets – of Europe. The Food and Drug Administration hasn't given any chronic obstructive pulmonary disorder-oriented device broad access to the US market, although Spiration Inc. did obtain a Humanitarian Device Exemption for its IBV Valve System to control prolonged air leaks of the lung, or significant air leaks following lung surgery. European markets and regulators have been more accepting, as is typically the case. This has given pulmonology start-ups a chance to commercialize their devices abroad while pursuing approval from the FDA.

In the fourth quarter of last year, three companies – Aeris Therapeutics Inc., PneumRx Inc. and Rox Medical Inc. – launched commercial operations in Europe. PneumRx and Rox Medical each established European subsidiaries from which to sell its products, the RePneu Lung Volume Reduction Coil System and ROX Medical Anastomotic Coupler System, respectively. Aeris Therapeutics, which is selling its AeriSeal System, meanwhile is working through independent distributors. The three companies join Spiration, now a division of Olympus Corp., and privately held Pulmonx Inc. Both companies have been selling in Europe for over a year. Pulmonx sells its Zephyr bronchial valve and Chartis diagnostic system through its subsidiary in Germany and distributors in other European countries. Spiration, meanwhile, already had partnered with Olympus to sell its valve in Europe. It struck the deal before Olympus bought the entire company last year.

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