OXFORDSHIRE, England--(BUSINESS WIRE)--Sep. 26, 2017--
Lombard Medical, Inc. (NASDAQ: EVAR), a developer, manufacturer and
marketer of endovascular abdominal aortic aneurysm (AAA) endovascular
repair products, today announced the full commercial launch in Japan of
its new low-profile IntelliFlex™ LP delivery system for the Aorfix™ AAA
The new delivery system, used to deliver Lombard’s Aorfix AAA stent
graph, is exclusively marketed in Japan by Osaka-based Medico’s Hirata,
Inc., a leading supplier of medical devices for the Japanese healthcare
Clinical cases confirming the performance and ease-of-use of the
IntelliFlex LP delivery catheter in complex aortic aneurysm anatomies
were presented at the 12th Annual Japanese Endovascular
Symposium on August, 23, 2017, by Makoto Sumi, M.D., of Saitama
Cardiovascular and Respiratory Center for Vascular Surgery.
“After a carefully controlled release of Lombard’s new delivery catheter
for Aorfix, positive first-hand customer experience is increasing demand
in our domestic market. We are confident that the investment made by
Lombard in the technology -- and our firm in sales and marketing -- will
pay dividends in terms of increased sales for the balance of 2017 and
beyond,” said Masataka Hirata, president of Medico’s Hirata. “In
addition, early data from the Medico’s-sponsored Japanese clinical study
(JANIS) recently presented at the Japanese Society for Vascular Surgery
independently confirmed the excellent clinical data in the clinical
study which led to Lombard’s FDA approval (PYTHAGORAS).”
Details on the PYTHAGORAS U.S. clinical study can be found in the July
edition of the Journal of Vascular Surgery (McGillicuddy et al. J Vasc
Surg. 2017 Jul; 66(1):71-78) and on the internet at https://doi.org/10.1016/j.jvs.2016.12.063.
Kurt Lemvigh, CEO of Lombard, commented, “Japan is perhaps the most
demanding market in the world in terms of quality of products and
clinical outcomes. In any market, especially Japan, it is imperative
that all aspects of any manufacturer’s AAA system function perfectly and
without fail, given the critical nature of repairing a person’s
abdominal aortic aneurysm. It’s no secret Lombard has had its challenges
in the past, and has paid the price in terms of the value of its
publicly-traded shares. However, we have an excellent portfolio that is
highly competitive and thanks to Medico’s Hirata’s efforts and the
quality of Aorfix, we are winning market share every month in Japan. Our
clinical results are second-to-none and have withstood the test of time.
Now we can deliver Aorfix with a low-profile, easy to use catheter and
without any fuss factor. Moreover, by focusing on our U.K. home market
and the fast-growing AAA markets in Japan and China, we believe we can
achieve cash flow breakeven and profitability on rather modest revenue.
The operational turnaround at Lombard is tangible. We fully expect that
by leveraging our broad technology portfolio, supporting our implanting
physicians, and working diligently with our partners Medico’s Hirata in
Japan and MicroPort Scientific in China, we can secure a bright future
for our Company.”
About Medico’s Hirata, Inc.
Founded in 1918, Medico's Hirata Inc. is a leading supplier and
developer of medical device products for the Japanese healthcare
industry. Hirata has extensive industry experience for the treatment of
abdominal aortic aneurysms, complementing its portfolio of innovative
minimally invasive devices in the field of vascular intervention. The
AAA market in Japan is estimated at about 10 percent of the AAA global
market and has been growing at an average rate of more than 15 percent
over the last five years. In Japan, there are over 400 physicians at
more than 200 clinics now performing AAA.
About Lombard Medical, Inc.
Lombard Medical, Inc. based in Oxfordshire, U.K., develops, manufactures
and markets an innovative range of minimally invasive abdominal aortic
aneurysm endovascular repair products. For more information, please
This announcement contains forward-looking statements that reflect the
Company’s current expectations regarding future events. These
forward-looking statements generally can be identified by the use of
words or phrases such as “believe,” “expect,” “future,” “anticipate,”
“look forward to,” “intend,” “plan,” “foresee,” “may,” “should,” “will,”
“estimates,” “outlook,” “potential,” “optimistic,” “confidence,”
“continue,” “evolve,” “expand,” “growth” or words and phrases of similar
meaning. Statements that describe objectives, plans or goals also are
forward-looking statements. Forward-looking statements are subject to
risks, management assumptions and uncertainties. Actual results could
differ materially from those projected herein and depend on a number of
factors, including the success of the Company’s research and development
and commercialization strategies, the uncertainties related to the
regulatory process and the acceptance of the Company’s products by
hospitals and other medical professionals, the uncertainty of estimated
revenues and profits, the uncertainty of current domestic and
international economic conditions that could adversely affect the level
of demand for the Company’s products and increased volatility in foreign
exchange rates, the inability to raise additional funds, and the risks,
uncertainties and other factors described under the heading “Risk
Factors” in the Company’s Form 20-F filed with the Securities and
Exchange Commission dated May 1, 2017. Readers are urged to consider
these factors carefully in evaluating the forward-looking statements.
The forward-looking statements included herein are made only as of the
date of this report and the Company undertakes no obligation to update
these statements in the future.
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Source: Lombard Medical, Inc.
Lombard Medical, Inc.
Kurt Lemvigh, +44 (0)1235 750 800