Lombard Medical exits U.S. market, shares jump

Lombard Medical Technologies (NSDQ:EVAR) said yesterday that it’s bailing out of the U.S. market after an FDA decision requiring a 50-patient clinical study of its Intelliflex low-profile delivery system for the Aorfix stent graft. Lombard said it eliminated its U.S. sales force and moved most of its commercial operations to its U.K. facility, significantly reducing its cash burn. Irvine, Calif.-based Lombard said it plans to focus exclusively on the European Union, Japan and other “key” international markets. The company in June won CE Mark approval in the European Union for the IntelliFlex device. “In the U.S., the FDA is requiring additional clinical data to support the application for U.S. approval of the IntelliFlex delivery system. This pushes the potential approval timeline out significantly. We have, therefore, decided to discontinue funding commercial operations in the U.S. at this time and instead solely focus our resources on growing revenue in Europe, Japan and other key international markets where we are able to benefit from the enhanced Aorfix delivery system as well as the direct and synergistic effect of Altura,” CEO Simon Hubbert said in prepared remarks. “Our shift in geographical commercial focus is starting to deliver strong sales growth in the Western Europe direct markets as Altura gains traction. We expect to see this growth accelerate as we expand Altura into new centers. We are very encouraged by the physici...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Endoscopic / Arthroscopic MassDevice Earnings Roundup Stent Grafts Wall Street Beat Lombard Medical Technologies Source Type: news