Lombard Medical product receives US approval for commercial sale

Lombard Medical, the AIM-listed medical technology firm focused on innovative vascular products, has announced that its Aorfix product has been approved for commercial sale in the US.

Aorfix, the company's flexible stent graft for the endovascular repair of abdominal aortic aneurysms (AAAs) was found by the US Food and Drug Administration (FDA) to treat a larger patient population than competing devices.

Lombard said: "Independent market research suggests that the U.S. market for the repair of AAAs is worth over $600m per annum, is forecast to grow at approximately 8.0% per annum."

The approval triggers receipt of the £14.1m second tranche of the two-tranche placing and subscription for funds, which will be used to launch Aorfix in the US. It also triggers the company's ability to draw down $2.5m from the $5.0m loan facility granted by its exclusive distribution partner in Japan, Medico's Hirata Inc.

"FDA approval of Aorfix is a major milestone for the company and sets the stage for the next chapter in the company's growth," said Lombard's Chief Executive Simon Hubbert.

"I would like to thank all of our employees, investigators and clinical advisors for their support and hard work, without which development and approval of Aorfix would not have been possible."

"We look forward to launching Aorfix in the U.S. through our own sales force and are confident of securing a meaningful share of this growing market."