The succesful LOM AGM for the 2004 financial results was held on Friday 30th December. [LMT will likely hold their AGM for 2005 results in late Q2 '06] The AGM was a chance to meet the new team running LMT. The new CEO and FD are sharp and focussed, which is good news. The CEO whilst at Boston built up his segment from $50M sales p/a to $200M p/a. One senses he sees the opportunity to do likewise with the market cap of LMT.

The portfolio of opportunity remains the same but by way of a recap:-

Grafts

AAA grafts (Aortic)
Boston has extended their agreement to allow further time to evaluate the Aorfix graft. With this area being very litigious [threat of board members of US company Guidant going to jail.] and the difficulties thrown up by TriVascular a small AAA graft company which they recently purchased their desire to cover all bases is understandable. Boston will have to set up and train a sales force to sell the graft so it is a major decision for them. If they can make up their mind by summer LMT are in contact with other major suppliers who wish to distribute the AAA graft outside the US.

The US FDA has conditionally approved the AAA graft IDE to allow a US trial called PYTHAGORUS to begin very soon. Initially a few tens of 1st Generation grafts will be implanted at which stage the FDA will review and then if everything is okay allow the 2nd Gen graft to be used and the scope of the trial to be widened to grafts with angulated necks greater than 60 degrees. There will be 275 grafts used in cases with angulation less than 60 degrees and 110 grafts for cases greater than 60 degrees angulation. The upside is that the clinical centres who have signed up for the trial will pay for the grafts which retail at $10-$12k each. With discounts LMT might achieve $9-$10K. All grafts are expected to be implanted in 2006 therefore LMT can look forward to an income of around $3.5M this year from the US. If the clinical centres require additional grafts then LMT can continue to sell them until FDA approval comes through so similar income may be available in 2007 and 2008.There are no grafts in the EU capable of dealing with angulated and although the Aorfix is not yet approved it is already finding use in compassionate cases.

The rights for the US market have still to be licensed, but clearly Boston is the frontrunner. To obtain the best price LMT will no doubt show they have other interested parties who are keen to step in if they should falter.

TAA Grafts (Thoracic)
Now that money is available clinical trials are expected to start in Europe and the US. The TAA market could be worth $500-$1000M in the next years 3. The size of the market depends on the capability of the graft which will be demonstrated by clinical trial results. A sales partner has still to be appointed.

Staplers
LMT has at least 3 versions of their stapler
Open stapler for use in surgery
Endovascular stapler for use in fixing AAA grafts that have moved or heart tissue valves
GI stapler - subject of a deal with Wilson Cook some years back

The value focus is currently on the Endovascular stapler with FDA 510(k) and CE mark approvals awaited. Distribution deals are likely to be interesting and lucrative.

Polymers
Polybiomed are working
with a US major on multidrug delivery using their polymer
with an EU stent company on multidrug delivery using their polymer
with a major biotech on delivery of an innovative restenosis drug
on a gel wound dressing
on a coated urinary catheter


Unquoted investments
Investments continue to be made into Endoart to protect their shareholding, but its value has been written down to nil in the most recent accounts I have seen. The two events do not seem consistent. Perhaps it will be revalued in the accounts for the year just ended.

Vascular Concepts is making money in the Indian drug eluting coronary stent market. It is still seeking investment to break into the EU and US markets.

Stock overhang?
It is interesting to note that at IPO there were no stock sales apart from that held by the new non-executive director. As the company strategy has evolved over the years it has divested businesses such as AME and DMC and dropped a number of directors and executives along the way. All of these will have shareholdings and may now be sitting watching and wondering if they should sell now they have the opportunity. At the AGM it was reported that presentations had been made to 42 institutions from across Europe of which 24 had subscribed for shares with one taking 10% of those on offer. Raising 26M is a big achievement - but more money was on offer.

With Code holding the price any stock sold may just be ending up in the hands of institutions that didn't get in at the offer. We also know the way that many IPO's work - not all the good news comes out at IPO which allows a flow of news to follow which puts some air into the price and a comfort zone to those that invested.

There is a new executive team under the Chairman, the brokers Nomura/Code Securities are first rate, and the media advisors Financial Dynamics are first division as are the new legal team at Berwins. Of course as jpon points out the website still lacks, but that was said to be under very active development.

In essence it is a new start building on the foundations already laid so it does not make much sense to sell just when the dawn is breaking. It makes more sense to be buying.

Two notable share purchases
a) Because I like FD's to own stock
b) The Chairman has bought more stock when he already has loads and has lost a lot of value in the dilution of LMT.

#################################

21 December 2005

Lombard Medical Technologies PLC

Directors share purchase

Didcot, UK, 21 December 2005: Timothy Hall, Financial Director of Lombard
Medical Technologies PLC, yesterday purchased 5,000 ordinary shares at 1.60 in
Lombard Medical Technologies PLC for a total consideration of 8,000. Following
this acquisition Mr. Hall holds a total of 5,000 Lombard Medical Technologies
PLC ordinary shares, representing 0.01% of the issued share capital.


22 December 2005

Lombard Medical Technologies PLC

Directors share purchase

Didcot, UK, 22 December 2005: Alistair Taylor, Executive Chairman of Lombard
Medical Technologies PLC, has today purchased 25,000 ordinary shares at 1.60 in
Lombard Medical Technologies PLC for a total consideration of 40,000.
Following this acquisition Mr. Taylor holds a total of 1,224,257 Lombard Medical
Technologies PLC ordinary shares, representing 2.50% of the issued share
capital.

Good news off the presses. UK wide screening means more patients, means more graft sales means more cash for LMT.

Pulse magazine article

Government to bring in aneurysm screening
By Emma Wilkinson
Issue: 05 January 2006

The Government plans to introduce a national screening programme for abdominal aortic aneurysm, Pulse has learned.

The National Screening Committee has agreed routine screening should be introduced for patients over the age of 65 but only for men. Surgery will be recommended for aneury-sms over 5.5cm in diameter.

GPs welcomed the move, but questioned the committee's decision not to screen women justified by the much higher death rate in men.

Abdominal aortic aneurysms account for 1.36 per cent of deaths in men and 0.45 per cent in women among over-65s, according to British Heart Foundation figures for England and Wales.

Dr Surendra Kumar, a GP in Widnes and member of the committee, told Pulse: 'It is going to happen in men over the age of 65 and be based on the size of the aneurysm.

'From a GP point of view, if we have information about small or medium aneurysms we can use the opportunity to give health promotion advice. It's not going to have any real workload implications.'

Sir Muir Gray, director of the National Screening Programmes, said the focus would now be on improving services for aneurysm treatment. He said: 'We are recommending screening for aortic aneurysm, but there is an issue over lack of treatment services. It looks good but there's a lot of work needed.'

A UK study previously reported by Pulse (6 August, 2005) found general practice-based ultrasound screening for abdominal aortic aneurysm was feasible. But committee members signalled the national screening programme was likely to take place in secondary care.

Dr Terry McCormack, chair of the Primary Care Cardiovascular Society, welcomed the move, but said it could increase workload.

'If you can put an evidence-based argument forward, it's a worthwhile thing to do. It probably will increase work because we'll find more aneurysms and have to explain to patients what is going on. And patients with small or medium aneurysms will still need following up.'

Dr McCormack, a GP in Whitby, added: 'We have to be careful about excluding women from the cardiovascular picture.'

Screening committee decisions
Abdominal aortic aneurysm
Routine screening for all men over 65
Surgery for aneurysms over 5.5cm classified as large
Health promotion advice for small/medium aneurysms (3.0-4.4cm and 4.5-5.4 respectively)

A quick search on Google news shows that many have picked up on the story including the BBC:

BBC article


Experts 'urging artery screening'

Experts have recommended a national screening programme for a blood vessel condition which kills thousands each year in the UK, a magazine reports.

Abdominal aortic aneurysm - a swelling in the main blood vessel from the heart which can kill if it bursts - accounts for 1.36% of deaths in men over 65.

The National Screening Committee (NSC) has backed routine screening for men in that age group, Pulse magazine says.

The Department of Health says ministers will consider the NSC's proposals.

The risk to women is thought to be lower than for men - statistics suggest abdominal aortic aneurysm accounts for 0.45% of deaths among women aged over 65 - but some groups say women should not be excluded from any screening programme.

The NSC's decision follows a number of recent studies finding ultrasound screening for abdominal aortic aneurysms could be effective.

Surgery will be recommended for aneurysms over 5cm in diameter.

Sir Muir Gray, director of the National Screening Programmes, told Pulse magazine: "We are recommending screening for aortic aneurysm, but there is an issue over lack of treatment services.

"It looks good but there's a lot of work needed."

Dr Terry McCormack, chair of the Primary Care Cardiovascular Society, told Pulse: "If you can put an evidence-based argument forward, it's a worthwhile thing to do.

"Although the incidence will be lower in women there will still be a significant number and we have to be very careful about excluding women from the cardiovascular picture."

Cathy Ross, of the British Heart Foundation, agreed that women should also be considered for screening.

She said: "Although the risk to women from this potentially life threatening condition is lower than to men, gender should not be a factor on which to base treatment or care."

A Department of Health spokesperson said: "Ministers will be considering the UK National Screening Committee's detailed proposals shortly and will take all its detailed recommendations into account."

Bought a small bunch of these today on the back of a speculative buy report ...worth a punt, anyone still in this one?

Charts added so we can appreciate the sp increases when they happen!

Nice news released today and a nice little tick-up to go along with it...

onwards and upwards me thinks!


Lombard Medical signs Distribution Agreement for Aorfix in Japan



London, UK, 6 October 2010 - Lombard Medical Technologies PLC (AIM: LMT), a medical device company focused on solutions for the $1 billion abdominal aortic aneurysm (AAA) repair market, today announces that it has signed an agreement for the distribution of Aorfix in Japan, a new geographic market for Lombard Medical.



Japan is a major market for AAA stent grafts, estimated to be worth $100 million a year. Lombard Medical's commercial partner has the sales infrastructure to maximise the potential of Aorfix in Japan. The identity of the commercial partner has not been disclosed at this stage for reasons of commercial confidentiality.



Lombard Medical's Japanese partner will apply for marketing approval of Aorfix in Japan and once this is obtained, the commercial partner and Lombard Medical have agreed to a mutually exclusive contract to sell Aorfix in Japan.



In order to assist Lombard Medical's funding of its various development projects, including its thoracic stent graft whose development is currently on hold, the Japanese partner has agreed to provide the Company with a loan facility of up to $5 million. The first part of the loan, for a total of $2.5 million, will be available to Lombard Medical at its option once FDA approval of Aorfix has been received. This loan may be increased to up to a total of $5 million subject to certain conditions requiring the approval of both parties. The loans are repayable at the end of the term of the agreement, but may be forgiven if the parties agree to a second distribution term.



Commenting on this agreement, Lombard Medical Chief Executive John Rush said:



"Japan represents the third largest market worldwide for endovascular AAA procedures and is one of the fastest growing. We are pleased to have an opportunity to launch Aorfix into this important market with such an excellent partner. "

This should start a nice climb as we approach the final hurdles.

3p broker price target,so somewhere between here and there must be fair value.I suspect closer to 3p than 1p.

Nice climb has started, with a little stumble this afternoon as rise ran out of steam

Will be interesting where it goes from here but I would like to see a much steadier movement.

SP consolidating at this level...now 86% up on my layout from a few months ago...and it could well double from here very soon. (imho)

SP continuing to climb ...nice...now 124% up on my outlay...wished I'd bought alot more...seems there's tons of potential here! (imho, dyor)

RNS Number : 2986J

Lombard Medical Technologies PLC

29 June 2011

Lombard Medical Technologies PLC

("Lombard Medical" or "the Company")

Regulatory Update

London, UK, 29 June 2011 - Lombard Medical Technologies PLC, a medical devices company focused on device solutions for the $1.1 billion dollar abdominal aortic aneurysm repair market, today provides an update on the U.S. regulatory process for its lead product, the Aorfix(TM) stent graft.

The Company has filed five of the six PMA (Pre-Market Approval) modular filings required for its FDA (Food and Drug Administration) submission and three of these have been accepted by the FDA. As announced in April 2011, the FDA responded with questions related to modules four (engineering, bench testing and shelf-life) and five (manufacturing). The Company has submitted comprehensive responses to all questions and continues to perform confirmatory bench testing, which will be available later this year.

Module six, the final clinical module, has been prepared for submission and on 2 June 2011, the Company completed and submitted its Statistical Analysis Plan (Sap) to the FDA. The SAP is the first part of the module six submission with a review period of up to 30 days. The full module will be filed once review of the SAP has been completed. Following submission, the FDA will have up to 180 days in which to review the final module and respond to the Company. The Company continues to anticipate FDA approval of Aorfix(TM) between the first and third quarters of 2012.

- Ends -

RNS Number : 1723N

Lombard Medical Technologies PLC

30 August 2011

Interim results for the six months ended 30 June 2011

U.S. trial data submitted to FDA

London, UK, 30 August 2011 - Lombard Medical Technologies PLC ("Lombard Medical", "LMT" or "the Company"), a medical device company focused on device solutions for the $1.1 billion per annum abdominal aortic aneurysm ("AAA") repair market, today announces its unaudited interim results for the six months ended 30 June 2011.

Operational highlights

-- Aorfix(TM) sales up 51% in 4 main EU markets (UK, Germany, Italy, Spain) to GBP936,000 (H1 2010: GBP622,000)

-- Total revenues increased 26% to GBP1.8 million (H1 2010: GBP1.4 million)

-- U.S. clinical trial complete and final pre-market approval ("PMA") submission made on 5 August 2011

-- Four of six Aorfix(TM) PMA modules now approved

-- European sales organisation strengthened:

o Highly experienced Director of Central Europe appointed

o Business Managers recruited for Italy and Spain

o Third German sales executive appointed

-- Experienced U.S. medical device executive appointed Chief Operating Officer to:

o Oversee operations and product development

o Deliver manufacturing cost efficiencies

-- Manufacture of stent grafts for commercial use commenced at Prestwick facility

-- Aorfix(TM) development projects for a new generation delivery system and expanded size range progressing in line with Company expectations

Financial highlights

-- GBP27.2 million raised from two-tranche placing, subscription and offer:

o First tranche of GBP13.0 million (GBP12.2 million net of expenses) received May 2011

o Second tranche of GBP14.2 million (GBP13.6 million net of expenses) to be received following FDA approval of Aorfix(TM)

-- Commercial revenues increased 27% to GBP1.7 million (H1 2010: GBP1.3 million)

-- Gross margin increased to 53% (H1 2010: 46%)

-- Operating loss up GBP0.8 million to GBP5.0 million (H1 2010: GBP4.2 million)

-- Loss after taxation for the period up 18% to GBP4.4 million (H1 2010: GBP3.7 million)

-- Net cash of GBP12.1 million as at 30 June 2011

Commenting on the results, Simon Hubbert, Chief Executive of Lombard Medical, commented:

"Lombard Medical has made important progress towards bringing our lead product to market in the U.S. and to putting the Company on the path to long-term revenue growth and profitability. We secured funding which is enabling us to deliver our strategy for Aorfix(TM), including building up a specialist sales team, ensuring sufficient manufacturing capacity and moving ahead with product innovation. We have seen the benefits of targeting major markets through our own dedicated sales force in Germany and the UK and will build on this momentum there and in other markets. The final submission to the FDA was made earlier this month and we look forward to bringing the substantial clinical benefits of Aorfix(TM) to patients with hard-to-treat aneurysms in the U.S. and around the world."

About Lombard Medical

Lombard Medical Technologies PLC (AIM: LMT), is a medical device company focused on device solutions for the $1.1 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 U.S.

skinny
another one we are both interested in. I am sure that we will have to wait another 6 months for THE news. In the meantime some selling and buying will go on, I have turned the light out, shut the door and will wait to be woken up with the us approval.
I wish we heard news re Japanese approval (is it linked to USA?)
T
last weeks half year told us nothing of note.

Aorfix: greater choice and flexibility

Pythagoras study shows Aorfix successfully treats both
standard and tortuous AAAs

Aorfix provides clinicians with greater choice and flexibility


London, UK, 21 November 2011 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focussed on innovative vascular products, today announces that data presented at the VEITH symposium in New York (16th - 20th November), a major international conference for vascular surgeons, has shown that its endovascular stent graft Aorfix has the potential to treat a larger patient population than competing devices, including both standard and difficult to treat cases of Abdominal Aortic Aneurysms (AAAs).

Dr Mark Fillinger of Dartmouth Hitchcock Medical Centre, New Hampshire, presented an update on the US Pythagoras trial of Aorfix, the largest trial in the world having patients with highly tortuous aortic and iliac anatomy. The trial consists of two groups of patients. The study group of 150 cases with aortic neck angles > 60 and a 'roll-in' group of 62 patients with aortic neck angles < 60.

In his paper, Dr Fillinger presented data from the roll-in group and reported excellent results including:
No cases where graft failed to seal against the artery wall and no cases where the graft leaked at either 30 days or 1 year postoperatively
The absence of any reported graft migration or fracture at either 30 days or 1 year
Sac shrinkage of more than 5 mm or no change in sac growth was shown in 100% of cases

Dr Fillinger commented:
"The Aorfix device has given excellent results in patients with typical anatomy, based on prospective independent monitoring. Although neck angles were less than 60 degrees in all 'roll-in' patients, 65% were greater than 45 degrees which is already at a challenging level."

CEO Simon Hubbert commented:
"Data from the Pythagoras trial demonstrates that Aorfix can be used to treat patients across the board, with results at least as good as competing products treating neck angles < 60 degrees. We believe that this, combined with the product's superior performance in more tortuous anatomies, creates an even more compelling case for Aorfix in the AAA market."

Nothing exciting, big buy 13 mill yesterday no following today

stable - a bit of a damp squib of late to say the least!

skinny
still holding for 1st quarter next year

Me too! ,,,, what's happening in 1st quarter next year ?

in the first quarter 2012 we will be close to US authorisation or not

Cool! thanks for the reply..let's hope it's positive.