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Lombard Medical Technologies (EVAR) Flagship Product Meets Unmet Need in Treatment of Abdominal Aortic Aneurysms

Lombard Medical Technologies is a medical technology company specializing in developing, manufacturing, and marketing endovascular stent-grafts to repair aortic aneurysms. The company’s lead product, Aorfix™, is the only abdominal aortic aneurysm (AAA) stent-graft approved by the U.S. FDA for the treatment of AAAs with angulation of up to 90°at the neck of the aneurysm.

AAAs are the 13th leading cause of death in the United States and the 10th leading cause of death in U.S. men aged 65 years and older. Current treatment options involve invasive open surgical repair, or less invasive endovascular aortic repair (EVAR). Medtech Ventures pegs the global EVAR market at approximately $1.4 billion in 2013, with the U.S. market estimated at approximately $680 million.

“Tortuous anatomy” affects roughly 20-30% of patients suffering from AAA; Aorfix is specifically targeted at this segment of the market. In contrast to rigid design of competitor products, Aorfix has a coil design that provides flexibility for use in patients with tortuous anatomies that cannot be satisfactorily treated with other licensed stent grafts. In addition, competitor products are typically only licensed for use in aneurysms with proximal neck angulations of up to 60°. There are no EVAR devices other than Aorfix approved by the FDA to treat AAAs with high angle neck anatomy of greater than 60°.

Lombard Medical Technologies formally launched the U.S. roll-out of Aorfix in November 2013, and anticipates receiving regulatory approval to market Aorfix in Japan in 2014.

The company is also developing a stent-graft system to treat thoracic aortic aneurysms (TAAs), which are aneurysms similar to AAAs but located in the thoracic aorta. According to Medtech Ventures, the worldwide TAA market was valued at approximately $380 million in 2013, and is estimated to grow to more than $480 million by 2018.

To achieve its goal of becoming a profitable company within three years, Lombard Medical Technologies has established four key business objectives: increase commercial revenues in Europe principally through the expansion of its sales and marketing infrastructure; obtain regulatory approval for Aorfix in the U.S. and to launch the product in the U.S. with a direct sales force; expand the size range for Aorfix and make enhancements to its delivery system to ensure the product remains competitive in terms of profile and ease of use; and make operational efficiency improvements to increase capacity and improve gross margins.

Lombard Medical Technologies is listed on the London Stock Exchange under the ticker symbol “LMT.” The company today initiated its initial public offering (IPO) for listing on the Nasdaq exchange, offering 3.6 million shares priced at $15-$18 per share for a total offer amount of $75.2 million.

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