Regulatory Update (5367C)
May 02 2012 - 2:00AM
UK Regulatory
TIDMLMT
RNS Number : 5367C
Lombard Medical Technologies PLC
02 May 2012
Press information
Lombard Medical Technologies PLC
("Lombard Medical" or "Company")
Regulatory Update
London, UK, 2 May 2012 - Lombard Medical Technologies PLC (AIM:
LMT), the specialist medical technology company focussed on
innovative vascular products, announces that it has received
feedback from the U.S. Food and Drug Administration ("FDA") as a
result of its 100 day review. This review is part of the process
for the pre-market approval ("PMA") application for Aorfix(TM) ,
the Company's flexible stent graft for the endovascular repair of
abdominal aortic aneurysms ("AAAs"). As previously announced the
PMA filing was accepted for review in January 2012.
As part of this review process the FDA has requested some
additional analyses of the existing clinical data set. The Company
is confident that it can provide such analyses to satisfy the FDA's
request, without the need for further patient enrolment into the
trial, and now anticipates FDA approval in the fourth quarter of
2012.
As noted in the Company's announcement on 9(th) March 2012, the
approval process with a regulatory authority such as the FDA can be
subject to delays beyond the control of the Company. To this end,
the Company strengthened its working capital position to ensure
financing would be available into 2013 should there be such a delay
in FDA approval beyond the third quarter of 2012 through the
issuance of GBP3m of convertible loan notes (CLNs). These proceeds,
together with the Company's existing cash resources, will be
applied towards general working capital purposes; to ensure that
the Company continues operating at current levels and preparations
for the US launch of Aorfix(TM) remain on track.
CEO of Lombard Medical Technologies, Simon Hubbert,
commented:
"We are encouraged by the progress made to date towards US
approval of Aorfix(TM). The questions now raised by the FDA look to
be readily addressable and we are confident that we remain on track
to receive US approval later this year."
- Ends -
About Lombard Medical
Lombard Medical Technologies PLC (AIM: LMT), is a medical device
company focused on device solutions for the $1.2 billion dollar per
annum abdominal aortic aneurysm (AAA) repair market. AAAs are a
balloon-like enlargement 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 600,000 new
cases are diagnosed. The market for endovascular stent grafts for
this application is expected to grow to $1.6 billion by 2015. The
Company's lead product, Aorfix(TM), is an endovascular stent graft
which has been specifically designed to solve the problems that
exist in treating complex tortuous anatomy which is often present
in advanced AAA disease. Aorfix(TM) is currently being
commercialised in the EU, and has been submitted to the FDA for
approval in the US.
The Company is headquartered in Oxfordshire, with operations in
Ayrshire and Phoenix, USA.
Further background on the Company can be found at
www.lombardmedical.com.
For further information:
Lombard Medical Technologies PLC Tel: 01235 750 800
Simon Hubbert, Chief Executive Officer
Ian Ardill, Chief Financial Officer
Canaccord Genuity Limited Tel : 020 7523 8000
Jamie Adams / Mark Dickenson / Lucy
Tilley
FTI Consulting Tel : 020 7831 3113
Simon Conway / Susan Quigley/ Victoria
Foster-Mitchell
This information is provided by RNS
The company news service from the London Stock Exchange
END
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