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.

RNS Number : 2422A

Lombard Medical Technologies PLC

28 March 2012

Lombard Medical Technologies PLC

Share Consolidation

London, UK, 28 March 2012 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focussed on innovative vascular products, is pleased to announce that the consolidation of the Company's ordinary share capital on the basis of 1 New Ordinary Share of 20 pence for every 200 Existing Ordinary Shares of 0.1 pence each has become effective following admission of the New Ordinary Shares to trading on AIM at 8.00 a.m. this morning.

As a result, the Company now has in issue 20,161,812 New Ordinary Shares of 20 pence each. The Company's new SEDOL code is B7FT8W8 and its new ISIN code is GB00B7FT8W85.

Capitalised terms used (but not defined) in this announcement have the same meanings as in the circular of the Company sent to shareholders on 9 March 2012 unless the context requires otherwise.

Final Results.

Operational Highlights

· Total revenue increased by 33% to £4.0m (2010; £3.0m)
· Total AorfixTM revenue increased by 31% to £3.4m (2010: £2.6m)
o Revenue in main European markets increased 50% to £2.2m (2010: £1.5m)
o Revenue in the UK increased 26% to £1.3m (2010: £1.0m)
· US clinical trial complete and final pre-market approval ("PMA") submission made
o Four of six Aorfix™ PMA modules approved
· Completion of recruitment into the clinical study to support French reimbursement submission for Aorfix™
· Italy distribution model re-structured
· Two new product development projects commenced
· Submission for regulatory approval in Japan filed
· Aorfix™ launched into new international markets through distribution partners
· Appointment of Brian Ranft as Chief Operating Officer
o Extensive industry and medical device experience

Financial Highlights

· Gross margin increased to 49% (2010: 46%)
· Operating loss increased by 31% to £11.4m (2010: £8.7m)
· Cash and cash equivalents of £7.5m (2010: £5.8m)
· £27.2m raised from two-tranche placing, subscription and offer:
o First tranche of £13.0m (£12.2m net of expenses) received May 2011
o Second tranche of £14.2m (£13.6m net of expenses) to be received following FDA approval of Aorfix™

Post Period Highlights

· FDA accepted the Company's PMA for review
· FDA approved 50 more patients to be treated under the continued access programme
· £3m raised from Invesco through the issue of convertible loan note to provide additional working capital ahead of AorfixTM US approval anticipated by Q3 2012
· Appointment of Ian Ardill as Chief Financial Officer
o Significant financial, business development and international experience

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 AorfixTM, 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 9th 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 £3m 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™ 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™. 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 -

Research Update

US Pythagoras data suggests that Aorfix™ has the potential to provide a less invasive treatment option for AAA patients with highly angulated neck anatomy.

The PYTHAGORAS trial's results were achieved despite the inclusion of patients with predictors of worse short and long-term outcomes such as:

· age (75.4 +/-8 years vs. 69.2 +/-7 years, p=0.001);

· proportion of female patients (35% vs. 20%, p=0.015);

· congestive heart failure (14% vs. 4%, p=0.029); and

· high neck angles (83 +/- 15 degrees, compared to SVS control group: 48 +/-22 degrees, p<0.05)

Aorfix™ is currently commercially available in Europe and the Company expects to launch the stent graft in the USA later this year, subject to FDA approval.

Half Yearly Report

Operational highlights

· Demand for Aorfix™ increased 23% in the four main EU markets (UK, Germany, Italy and Spain) with 195 patients treated (H1 2011: 158 patients)

· Total revenues increased 9% to £2.0m (H1 2011: £1.8m)

· Aorfix™ sales increased 11% in the four main EU markets to £1.0m (H1 2011: £0.9m)

o 53% growth in Germany reflecting expansion of direct sales team

· US regulatory approval submission on track; response to FDA including additional data analyses submitted in July 2012

· 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 AorflexTM delivery system in April

o Encouraging clinician feedback from initial procedures

· Key hire - appointment of Ian Ardill to the Board as Chief Financial Officer in January 2012

o Significant financial, medical device, business development and international experience

Financial highlights

· Total commercial revenues increased 15% to £2.0m (H1 2011: £1.7m)

· £3.0m raised from issue of convertible loan notes to Invesco in March 2012

· Operating loss reduced by £0.6m to £4.4m (H1 2011: £5.0m)

· Loss after taxation for the period steady at £4.4m (H1 2011: £4.4m)

· Cash of £5.2m as at 30 June 2012 (30 June 2011: £12.1m)

Regulatory Update

London, UK, 15 October 2012 - Lombard Medical Technologies PLC (AIM:LMT), the specialist medical technology company focussed on innovative vascular products, today announces that it has received written feedback from the U.S. Food and Drug Administration ("FDA") on the pre-market approval ("PMA") application for AorfixTM, the Company's flexible stent graft for the endovascular repair of abdominal aortic aneurysms ("AAAs"). The FDA has provided the Company with a short list of questions. The Company believes these questions to be relatively straightforward and intends to submit answers to the Agency within 2 weeks. In addition the FDA has also scheduled a Good Manufacturing Process (GMP) audit of the Company's UK facility in late October. Such audits are typically part of the final stage of the FDA's review process.

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.