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.

Analyst comments

Julie Simmonds, Analyst at Canaccord Genuity writes that 2012 approval is still possible, although likely late in the fourth quarter or early in the first quarter of 2013. “The timing of the final FDA decision is particularly critical to Lombard as it triggers a second tranche of funding (£13.6m) from existing investors if it occurs prior to the year end. After this date the funding falls away, but discusssons with investors lead us to believe that they would remain supportive."

She maintains her “Buy” rating and 332p price target.

Currently up 14% but on pitiful volume.

Skinny, I note your rider re volume, the same was on the way down when a sell of 500 was reason for a drop. MM are only priced for 1000 shares. There was a buy of 15000 recently which only pushed the share up 5p.
Where next, those that have stayed in for the past 12 months and resisted selling will hold, todays rise must have been fueled by something that we are not privy to but I will stay and watch

Stable - its just a 'thing' of mine :-)

5 straight days of rises, some coverage - broker or otherwise over the weekend wouldn't go amiss.

Analysis: Lombard Medical Technologies rise continues
By Chris Menon

Thu 18 Oct 2012

LMT - Lombard Medical Technologies

Latest Prices
Name Price %
Lombard Medical Technologies 164.00p +13.89%

FTSE AIM All-Share 712 -0.34%
Health Care Equipment & Services 3,667 -0.98%

LONDON (SHARECAST) - This week has seen a 40% rise in the share price of Lombard Medical Technology, following an update on October 15th that had well respected healthcare analyst Julie Simmonds pushing out a Buy note, maintaining her price target of 332p.

Admittedly, she works for the house broker Canaccord Genuity, but anyone who has followed her recommendations over the course of a few years will take note of her views on a company.

In a 14-year career she’s been Head of Lifesciences Research at Evolution Beeson Gregory, an Equity Analyst at Nomura, Senior Research Analyst at Piper Jaffray and is now Healthcare Analyst at Canaccord Genuity. With a a Phd in Microbiology she can also assess the science as well as crunch numbers.


Announcement

For those who missed the announcement: the Aim-listed company has received written feedback from the FDA asking a couple of questions, which the company says are “relatively straightforward”. Lombard Medical intends to answer them within two weeks.

In addition, the FDA has scheduled a Good Manufacturing Process audit of the company’s UK facility in late October. The company states that such audits are “typically part of the final stage of the FDA’s review process.”


Analyst assessment

So what does Simmonds have to say about the latest development for Lombard? She believes it “marks the closing stages of the FDA process.”

She continues: “We are encouraged that a date has been set for the manufacturing audit as we believe this signals that the remainder of the submission is in order. With this due to be completed in late October, 2012 approval is certainly still possible, though likely late Q4/ early Q1-13. The timing of the final FDA decision is particularly critical to Lombard as it triggers a second tranche of funding (£13.6m) from existing investors if it occurs prior to the year end. After this date the funding falls away, but discussions with investors lead us to believe that they would remain supportive.”

Make no mistake, it has been a tortuous process that has taken years. Without the support of long term investors, such as Invesco Perpetual, which holds 39.28% of Lombard, this story would not be likely to have a happy ending.

“Our investment case is based on Lombard receiving FDA approval for Aorfix at the end of the fourth quarter. We expect a positive FDA outcome to result in a rerating; the current price only assumes a 20-40% chance of a positive result,” she adds.

Clearly, it still isn’t in the bag until the FDA sings but it is close. Very close.

Writing on October 15th when the price was 101p, she commented: “Our investment case is based on Lombard receiving FDA approval for Aorfix at the end of the fourth quarter. We expect a positive FDA outcome to result in a rerating; the current price only assumes a 20-40% chance of a positive result.”

That re-rating higher appears to be happening. Nevertheless, the recent spike in Lombard’s share price has occurred on very low volumes given the tightly held nature of the company's stock.

Moreover, US approval when it comes (and it must surely be ‘when’, not ‘if’, in my humble opinion) would open up a huge market for Lombard Medical’s aorfix stent.

This is Julie Simmonds view: “The opportunity for Lombard is substantial. Aorfix is designed to treat patients with high angle abdominal aortic aneurysms, no other device is approved in the US for this indication. An approval with labelling for this patient group would make Aorfix the only FDA approved product for these complex patients, circa 30% of the $1.1bn AAA repair market, 54% of which is in the US. We believe this would result in a rapid adoption the US (the device already has an 8%+ market share in the UK), and ultimately bring Lombard to the attention of the medical device majors.”

Ultimately this is the end game, to be taken out by one of the majors. US approval when it comes should bring this one step closer.

I'm in danger on making a profit here at this rate.

Extension of Long Stop Date for Second Tranche

London, UK, 20 December 2012 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focused on innovative vascular products, today announces a six month extension, from 31 December 2012 to 30 June 2013, of the existing Long Stop Date for the c. £14.1m Second Tranche of the two tranche placing and subscription announced by the Company on 20 April 2011 (the "May 2011 Fundraising"). Lombard Medical also announces that, in addition to certain existing shareholders, the Second Tranche will be supported by LSP Life Sciences Fund N.V. ("LSP"). LSP will replace MVM Life Science Partners LLP ("MVM"), who have decided to assign their rights to subscribe for new ordinary shares in the Second Tranche, pursuant to the terms of the original subscription agreement dated 20 April 2011.

US FDA Approval of Aorfix

U.S. FDA Approval of Aorfix™

London, UK, 15 February 2013 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focused on innovative vascular products, today announces that Aorfix™ has been approved for commercial sale in the U.S. by the U.S. Food and Drug Administration ("FDA"). Aorfix™ is the Company's flexible stent graft for the endovascular repair of abdominal aortic aneurysms ("AAAs"). Data from the U.S. PYTHAGORAS trial of Aorfix™, has demonstrated that Aorfix™ can successfully treat a larger patient population than competing devices, including both standard and difficult to treat cases of AAAs.

The U.S. approval for Aorfix™ includes a label indication for the treatment of patients with angulations at the neck of the aneurysm from 0 to 90 degrees. Aorfix™ is now the only endovascular stent graft licensed in the U.S. for use in more challenging cases with neck angulations greater than 60 degrees. Independent market research suggests that the U.S. market for the repair of AAAs is worth over $600 million per annum1, is forecast to grow at approximately 8%1 per annum, and that up to 30% of all patients have some tortuosity either at the neck of the aneurysm or in the iliac arteries2. It is to this segment of patients that Aorfix™ is targeted with its uniquely flexible design. In Europe Aorfix™ is already licensed to treat neck angulations of up to 90 degrees.

Just the +25% at open :-)

Canaccord Genuity Buy 229.50 178.50 332.00 332.00 Reiterates

Well done Skinny & Deamcatcher.
Wow, and that is the start I think.

Thanks Ahoj.

Excellent volume and near the day's high.

Satisfaction of FDA Milestone Requirements

Satisfaction of FDA Milestone Requirements
for the Second Tranche of the May 2011 Fundraising


London, UK, 13 March 2013 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focused on innovative vascular products, announces the determination of satisfaction of the FDA Milestone requirements for the Second Tranche of the two tranche placing and subscription announced by the Company on 20 April 2011 (the "May 2011 Fundraising").

This determination is the trigger for the transfer of the £14.1m Second Tranche subscription monies and the application for admission of shares on the London Stock Exchange both of which are anticipated by the middle of April 2013.

Admission of Second Tranche Shares

Admission of shares issued in relation to the Second Tranche of the May 2011 Fundraising

London, UK, 22 March 2013 - Lombard Medical Technologies PLC (AIM: LMT) is pleased to announce that, further to the announcement made by Lombard Medical on 19 March 2013, admission of 10,040,000 ordinary shares of 20 pence each, being the total number of ordinary shares being issued under the Second Placing and the Second Subscription, has today taken place.

Following allotment and admission of the new ordinary shares, the Company's largest shareholder, Invesco Asset Management Limited managed funds now holds 39.5% of the issued share capital of Lombard Medical.

Definitions used in this announcement will have the same meaning as those used in the circular of Lombard Medical dated 20 April 2011, unless the context requires otherwise.


- Ends -

Canaccord Genuity Buy 186.00 186.00 332.00 332.00 Reiterates

Final Results

Operational highlights
· Demand, as measured by patients treated, for Aorfix™ increased 13% in main EU markets (UK, Germany, Italy and Spain) with 382 patients treated (2011: 338 patients)
o Demand was not fully reflected in revenue as it was partly supplied from distributor stock
· Aorfix™ revenue of £2.3m in main EU markets (2011: £2.2m)
o 32% growth in Germany reflecting expansion of direct sales team
· High angle clinical data from US PYTHAGORAS trial presented in June 2012
o Strong data despite extremely challenging patient group with high neck angles
· Launch of Aorflex™ delivery system in April 2012
o Encouraging clinician feedback
· Key hire - appointment of Ian Ardill to the Board asChief Financial Officer in January 2012

Financial highlights
· Total commercial revenue (total revenue less revenue from the clinical trial) flat at £3.9m (2011: £3.9m) despite procedure growth of 13% in main EU markets
· Total revenue declined to £3.9m (2011: £4.0m) due to completion of US trial enrolment and loss of related revenues
· Operating loss decreased by 28% to £8.2m (2011: £11.4m)
· Cash and cash equivalents of £2.7m as at 31 December 2012 (31 December 2011: £7.5m)
· £3.0m raised from issue of convertible loan notes to Invesco Asset Management Limited ("Invesco") in March 2012
· Share consolidation of 1 new ordinary share of 20p for every 200 existing ordinary shares of 0.1p in March 2012
· Six month extension of Long Stop Date of Second Tranche of the May 2011 Fundraising
· Participation of £2.8m by LSP Life Sciences Fund N.V., a specialist healthcare fund, in the Second Tranche of the May 2011 Fundraising

Post period events
· 14 February 2013 - US FDA approval of Aorfix™ for the endovascular repair of AAAs
o Label indication for the treatment of patients with angulations at the neck of the aneurysm from 0 to 90 degrees
o Aorfix™ the only endovascular stent graft licensed in the US for use in cases with neck angulations greater than 60 degrees (consistent with high-angle, 90 degree, label claim in Europe)
· US approval of Aorfix™ has triggered receipt of £14.1m gross funds from the Second Tranche of the May 2011 Fundraising
· Aorfix™ approval in Japan anticipated in 2014
o US approval has triggered receipt of $2.5m from the $5.0m convertible loan facility granted by Medico's Hirata Inc., the Company's distribution partner in Japan

Listen to the interview with Lombard Medical Technologies CEO Simon Hubbert on their final results, which have come out today.Interview link

Files Petition for Inter Partes Review of Patent

London, UK, 7 May 2013 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focused on innovative vascular products, today announces that it has filed a petition with the US Patent and Trademark Office (USPTO) for Inter Partes Review of the validity of the broadest claims of US patent No. 6,306,141 ('141 patent), entitled "Medical devices incorporating stress-induced martensite (SIM) alloy elements", which is assigned to Medtronic Inc.

The Company believes that claims of the '141 patent directed to the use of a shape memory alloy exhibiting SIM in a medical device, are invalid because the use of self-expanding shape memory alloys utilizing stress induced martensite (an inherent property of all Nitinol based devices that exhibit thermally induced martensite (TIM)) for medical devices was well known before the patent was filed. As such the claims in the '141 patent are invalid and not entitled to protection under the US patent laws. A final determination by The Patent and Trademark Appeals Board (PTAB) of the validity of the '141 patent will be issued within 18 months after institution of the Review. No counterpart patents to the '141 patent are in force in other territories outside of the US.

Lombard Medical does not believe it infringes the '141 patent and will launch Aorfix™, its lead product for the treatment of abdominal aortic aneurysms (AAAs), in H2 2013 as planned.

Canaccord Genuity Buy 202.00 203.50 321.00 321.00 Reiterates