News blog
Lombard Medical Technologies
- BY: Andrew Hore |
- POSTED: 02/05/2012 |
Lombard Medical Technologies says that US FDA approval for its Aorfix medical device is unlikely to be gained until the fourth quarter of this year.
That is later than hoped because the FDA has asked for additional analysis of the clinical data. Lombard had talked about getting FDA approval be the summer. EU revenues of the Aorfix abdominal aortic aneurysm stent continue to grow but the US accounts for around 50% of the global market for the product so this approval is extremely important to Lombard.
Net cash was £7.5m at the end of 2011. Lombard believes that the £3m convertible loan issued to Investec earlier this year, along with what was already in the bank, will provide enough cash to cover the period until Aorfix gains FDA approval.
Once FDA approval is announced Lombard can raise the second tranche of cash from its 2010 fundraising and the Investec convertible will be paid back. The first tranche of the fundraising was £12.2m net of expenses and the second tranche will be £13.6m. The initial fundraising was at 0.7p a share.
Earlier this year there was a 200-for-one share consolidation in order to stop the stock being seen as a penny share and reduce the bid-offer spread. The second tranche will be priced at 140p a share – equivalent to 0.7p previously – or at the closing price on the day prior to the announcement that the FDA Milestone Requirements have been satisfied – broadly approval for product and labelling for certain specifications. This cash should be enough to finance the US launch of Aorfix.
Aorfix is an endovascular stent graft for the treatment of abdominal aortic aneurysms, which are a balloon-like enlargement of the aorta that can rupture and cause death. The selling point of Aorfix is that it can handle bends in the aorta. Lombard has also developed the Aorflex delivery system for Aorfix.
Lombard has applied for regulatory approval in Japan and a clinical study continues in France in order to gain approval for reimbursement.
Last year, sales in Germany more than trebled and sales in Italy more than doubled. The more mature UK market still grew revenues by 26%. Overall revenues grew from £3m to £4m in 2011, while the loss increased from £8.7m to £10.6m. There was a £850,000 write-off on an investment in another medical technology business.
House broker Canaccord Genuity forecasts a loss of £11.8m for 2012.
At 134p a share, Lombard is still valued at £28.4m.
Download the latest AIM Journal from http://www.hubinvest.com/AIMPDFApril2012_31.pdf
© 2024 Aim Micro. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
- Browse by issue
- All issues
- Popular tags
- All tags
- AIM Micro feeds
Keep up to date with articles published at AIMMicro.com. Subscribe to AIM Micro RSS Feeds
|