Pulmonx Reaches Multiple Milestones In Lung-Valve, Diagnostics Development
Executive Summary
Encouraging results from the IMPACT study of Pulmonx's Zephyr endobronchial valve in patients with homogenous emphysema – a population with almost no other options – is the latest in string of good news for the Silicon Valley company, which wants to create a new paradigm of personalized device therapy for pulmonary disease.
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US Market In Pulmonx' Sights Nine Years After Zephyr First Failure
Pulmonx is almost ready to submit the results of the pivotal LIBERATE trial of its Zephyr endobronchial valve to the US FDA. The data will support a premarket approval and the company hopes to bring the device, along with the Chartis patient-selection system, to the US market in 2018.
MnA round-up: AAA bags Atreus; Pulmonx acquires Aeris
Medtech M&A activity shows no sign of slowing down in the New Year, with two more deals. French nuclear imaging firm Advanced Accelerator Applications (AAA) has bought the remaining 49.9% stake in Canada’s Atreus Pharmaceuticals; while Pulmonx, a specialist in minimally-invasive treatments for pulmonary disorders, has acquired the assets of Aeris Therapeutics, including its AeriSeal foam-based lung sealant system for the treatment of emphysema.
Pulmonx buys Emphasys assets
Pulmonx is weighing the possibility of a new U.S. trial for the Emphasys EBV endobronchial valve for emphysema (formerly known as Zephyr) after acquiring the device and other assets of Emphasys Medical on May 13 for undisclosed terms. After nine years in the pipeline, Zephyr was found "not-approvable" by FDA following a negative advisory panel vote last December. Emphasys Medical subsequently put the technology on the auction block (1"The Gray Sheet" Feb. 23, 2009, p. 24). Pulmonx Executive VP and General Manager Niyazi Beyhan says his firm is considering a few options for Emphasys EBV, but will first focus on ramping up manufacturing to supply the valve to customers outside the U.S., where it has been sold since 2006. Palo Alto, Calif.-based Pulmonx touts the potential use of its 510(k)-pending Chartis collateral ventilation detection system to identify candidates best suited for endobronchial lung volume reduction procedures with Emphasys EBV