Lombard Medical Suspends United States Operations to Focus on Europe and International Markets

August 22, 2016—Lombard Medical, Inc. announced a significant operational restructuring, as well as an exploration of strategic alternatives in its report of financial results and business highlights for the second quarter and the 6 months ended June 30, 2016.

The company is discontinuing the funding of commercial operations in the United States and will instead solely focus resources on growing revenue in Europe, Japan, and other key international markets. 

Lombard stated that it is taking this course, in part, because the US Food and Drug Administration is requiring additional clinical data to support the application for approval of the company’s IntelliFlex delivery system and thereby significantly extending the timeline for potential approval in the United States.

Lombard advised that it is allocating its resources to exclusively support the new Altura endovascular stent graft for the repair of abdominal aortic aneurysm and the recently CE Mark–approved IntelliFlex LP delivery system for its Aorfix endovascular stent graft in the European Union, Japan, and other key international markets. The Aorfix sales force in the United States has been eliminated, and the majority of commercial operations have transitioned to the company’s facility in the United Kingdom.

The company reported that second quarter 2016 global revenue was $3.8 million, representing a 30.1% sequential increase from $2.9 million in the first quarter of 2016. Additionally, revenue from both the Altura and Aorfix endovascular stent grafts in Lombard’s European direct sales markets in the United Kingdom, Germany, and the Netherlands grew 20.9% sequentially and 42.6% year-over-year. 

Further financial details are available online from the company’s news release for investors.

The company expects to see continued sales growth for the Altura with its introduction into new centers in Europe along with the launch of the new IntelliFlex delivery system for Aorfix.

In order to enhance shareholder value, the company’s board of directors has engaged an investment bank to begin a process of exploring strategic alternatives, including a potential sale of the company or disposition of certain assets, as well as distribution or other strategic partnerships. There are no assurance that Lombard will enter into any strategic or financing transaction in connection with this process, stated the company.

In March 2014, Lombard Medical—which was then headquartered in Oxfordshire, United Kingdom—announced its plans for an initial public offering on the NASDAQ exchange. The company subsequently moved its corporate headquarters to Irvine, California, while maintaining the Oxfordshire location for manufacturing operations and outside-United States administrative offices. 

In July 2015, the Altura device was acquired when Lombard Medical bought Silicon Valley, California-based manufacturer, Altura Medical.

In early 2016, Lombard Medical announced the initial procedures and subsequent launch of the Altura endovascular stent. In June, the company announced European approval for the Aorfix IntelliFlex delivery system and began commercialization soon after that.

On June 16, the company announced that the Altura ALTITUDE Global Registry will be conducted in Europe to evaluate the use of Altura in real-world procedures, with a planned enrollment of 1,000 patients starting in late 2016.

In May, positive 30-day clinical results were reported on 57 patients who were implanted with Altura. Throughout the year, data on the company’s devices were presented at SITE 2016: the International Symposium on Endovascular Therapeutics in Barcelona, Spain; the 2016 Japanese Society for Vascular Surgery Annual Meeting in Tokyo, Japan; and the 2016 Vascular Annual Meeting of the Society for Vascular Surgery Annual Meeting in National Harbor, Maryland.