Lombard Medical Technologies

www.lombardmedical.com TICKER: LMT     EXCHANGE: L

Lombard Medical is focused on the development, manufacturing and commercialisation of innovative endovascular aortic repair (EVAR) devices such as abdominal and thoracic aortic aneurysms (AAA & TAC respectively). The lead product, 'Aorfix' for AAA is a synthetic aortic abdominal bifurcated stent-graft, marketed in Europe through direct sales in the UK and in Germany and through a network of local distributors supported by clinical specialists from Lombard Medical in the rest of Continental Europe. In the US 'Aorfix' is in the final stages of the regulatory approval, having filed five of the six Pre-Market Approval (PMA) filings and having received approval for the first three PMA modules. Aorfix has been designed to also address complex and tortuous aneurysmal or iliac anatomy including those with high-angle-neck angulations (up-to 90degrees), that are normally referred to open surgery as they are not currently covered by marketed devices, allowing Lombard Medical to cater for a larger number of aneurysms.

LATEST REPORTS

 
Turning the corner
Published: Apr 14 2009

Substantial progress in recent months: advancing Aorfix trials, raising funds and controlling costs

Sales traction visible in 2008 results

Despite significant equity diliution, fair value per share still seen at multiples of current levels

 
Breathing space
Published: Jan 12 2009

The combination of a cost cutting exercise started in Q3 2008 (aimed at bringing annual cash burn below £6m) and the £6.1m (£5.6m net) fundraising just announced is enabling Lombard Medical to continue operations for the next 12 months. Critically this allows them to concentrate on the completion of the Aorfix US clinical trial (PYTHAGORAS) which is expected in mid-2009, with possible approval in the early part of 2011, although some caution ought be applied to the timing of these events given the challenging nature of the patients' anatomy.
 
Cash infusion
Published: Oct 02 2008

£1.4m (net) raised via Convertible Loan Notes

Talks ongoing regarding possible substantial investment from Middle East bank

Operational progress with international trials

 
Strong signals from the radar
Published: Jul 30 2008

Aorfix FDA trial recruitment on target 

Clinical evidence strengthening brand acceptance for all angulations

Refinancing required for commercialisation

 
Turning a corner
Published: Mar 26 2008

Raised £15m to fund commercialisation

Improved terms for Aorfix US trial approved by FDA

Loading and manufacturing problems now resolved stock levels at all time high

Successful disposal of EndoArt
 
Interim results; strengthened and focused
Published: Sep 21 2007

US trials proceeding with 17 of 20 centres signed

Lombard's case strengthened for stents use in all aneurysms, not just >60°

Successful acquisition of Culzean Medical

 
Newsflow turns positive
Published: Jul 24 2007

Management redefining operational and financial strategies following turbulent 18 months

3 new research collaboration agreements in polymer coating division

Proposed changes to pivotal AAA trial accepted by FDA

Lombard Medical's share value seen in 28p-42p range (on differing risk factors) post financing

ARCHIVE

2007
Clinical Procedures recommenced; Good news
Published: Jan 30 2007

  • Refix Endostapler now CE marked
  • Distribution and licensing deal with Medtronic worth up to US$8m
  • Design of US Aorfix trial changed and speeded up
  • Fair value of 47p vs current 34p, with significant newsflow expected
2006
Lombard Medical; well placed to grow
Published: Oct 02 2006

  • Unique product in a growing market, endorsed by medical community
  • Strong pipeline of products
  • Profitability expected in 2009
  • Fair value/share 89p vs current 77p