Lombard will distribute its stent graft system through Medico's Hirata and will roll out commercial sales of the device after securing reimbursement approval, which the company hopes to receive in September.
"Japan is a substantial EVAR market--both strategically and financially--
Regulatory blessings help Lombard cash in on a growing market and keep a leg up on the competition. In Japan, the EVAR sector is estimated at $140 million or 10% of the global market in 2013 and has been climbing at an average rate of 18% over the last 5 years, the company said in a statement. Globally, the market for abdominal aortic aneurysm repair rings in at $1.4 billion. Lombard expects U.S. demand for EVAR devices to grow 7% annually over the next 5 years, it said in an F-1 filing.
The approval also comes at a critical moment for the company, as it continues to build upward momentum after filing an IPO. In April, Lombard revived plans to go public with a $55 million NASDAQ debut. The company first filed confidential IPO documents in January. In its first quarter after going public, the company reported a 104% jump in global sales of its Aorfix stent.
Meanwhile, Lombard faces some stiff competition in the Japanese stent graft market from larger device outfits. In May, Boston Scientific ($BSX) rolled out its next-generation drug-eluting coronary stent system in Japan as a way to kick-start revenue growth. The company touts its Promus Premier stent as a safer, more cost-effective option that can reach more challenging artery disease lesions by using a dual-layer balloon and special catheter.
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