Exclusive Japanese Partner Medico’s Hirata Anticipates Market Share
Gain Following Launch in Early 2017
OXFORDSHIRE, England--(BUSINESS WIRE)--Jan. 5, 2017--
Lombard Medical, Inc. (NASDAQ: EVAR), a medical device company focused
on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms
(AAAs), today announced approval from the Japanese Ministry of Health,
Labour and Welfare for its IntelliFlex™ Low Profile (LP) Delivery System
for the Aorfix™ Endovascular Stent Graft. Commercial launch will follow
reimbursement approval, which is anticipated in February 2017.
Aorfix with IntelliFlex is exclusively distributed by Medico's Hirata
Inc., one of Japan’s leading suppliers of vascular products with proven
expertise in building significant market share for AAA stent grafts.
This new and innovative delivery system is used in conjunction with the
Aorfix endovascular stent graft, the only AAA stent graft with global
regulatory approval to treat aortic neck angulation up to 90 degrees.
The IntelliFlex LP Delivery System features a low profile, compact and
ergonomic design that provides intuitive control of Aorfix during
deployment, even in challenging anatomy. The system features an
integrated exchange sheath allowing ancillary devices to be introduced
during the endovascular AAA procedure avoiding the need for sheath
exchanges thus potentially reducing blood loss, vessel trauma, procedure
cost and time.
Masataka Hirata, President of Medico’s Hirata Inc., said, “We have
enjoyed great success already with Aorfix in Japan and built our market
share to approximately 8% over the last two years. Now with the approval
of IntelliFlex, we believe we will significantly increase the usage of
this unique technology for the benefit of physician’s ease of use,
procedural outcomes and patients across the broadest range of AAA
“Japan is the world’s second largest standalone EVAR market and is both
strategically and financially important for us,” said Lombard Medical
CEO Simon Hubbert. “With our partner, Medico’s Hirata, we look forward
to providing Japanese physicians with the Aorfix stent graft, which has
outstanding clinical results, now delivered with the unique advantages
of the IntelliFlex LP Delivery System.”
The EVAR market in Japan is estimated at 10% of the global market and
has been growing at an average rate of approximately 18%. In Japan,
there are approximately 400 physicians at 200 clinics performing EVAR
and it is estimated that approximately 55% of Japanese AAA patients are
treated using this method.1
The Company is reporting preliminary revenue of $2.4 million for the
2016 fourth quarter and $12.1 million for the 2016 full year as compared
to the most recent guidance provided in August 2016 which reflected a
revenue floor of $13.0 million. Underlying this shortfall is the
Company’s previously stated strategy to exit the U.S. market and to
pursue cash conservation measures to bridge the business to the recently
announced transaction with MicroPort Scientific Corporation.
About Aorfix Endovascular Stent Graft
Aorfix is an endovascular stent graft system for treating infra-renal
aortic and aorto-iliac aneurysms, also known as abdominal aortic
aneurysms (AAAs). When placed within the aneurysm, Aorfix creates an
internal bypass of the aneurysm to reduce the risk of rupture. Aorfix is
the first and only endovascular stent graft with global approvals for
the treatment of patients with aortic neck angulations up to 90 degrees.
Aorfix features an exclusive helical and circular design that allows it
to conform to the natural contours of human anatomy, including aortic
necks with high angulations and iliac arteries with extreme bends.
Aorfix has been evaluated in three studies and used in more than 7,000
procedures worldwide. Aorfix has a CE Mark, Japan regulatory approval,
and received FDA approval in 2013.
About Abdominal Aortic Aneurysms (AAAs)
AAAs are balloon-like enlargements of the aorta which if left untreated,
may rupture and cause death. Approximately 4.5 million people are living
with AAAs in the developed world and each year more than 500,000 new
cases are diagnosed. In the U.S., aortic aneurysm disease is among the
leading causes of death and it is estimated that 1.5 million people have
an abdominal aortic aneurysm.
About Lombard Medical, Inc.
Lombard Medical, Inc. is an Oxfordshire, UK-based medical device company
focused on the $1.8bn market for minimally invasive treatment of
abdominal aortic aneurysms (AAAs). The Company has global regulatory
approval for Aorfix, an endovascular stent graft that has been
specifically designed to treat patients with the broadest range of AAA
anatomies, including aortic neck angulation up to 90 degrees. The
Company has also achieved CE Mark for the Altura® endograft system, an
innovative ultra-low profile endovascular stent graft that offers a
simple and predictable solution for the treatment of more standard AAA
anatomies. For more information, please visit www.lombardmedical.com.
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 April 29, 2016. 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.
1 Medtech Ventures: Aortic Intervention Market (2014)
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Source: Lombard Medical, Inc.
Lombard Medical, Inc.
Simon Hubbert, +44 (0)1235 750 800
William J. Kullback, +1-858-750-5245