2Bob
- 05 Jan 2006 23:30
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.
2Bob
- 05 Jan 2006 23:30
- 2 of 106
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.
2Bob
- 06 Jan 2006 12:29
- 3 of 106
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)
2Bob
- 06 Jan 2006 12:30
- 4 of 106
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."
skyhigh
- 22 Sep 2010 18:42
- 5 of 106
Bought a small bunch of these today on the back of a speculative buy report ...worth a punt, anyone still in this one?
skyhigh
- 23 Sep 2010 22:38
- 6 of 106

Charts added so we can appreciate the sp increases when they happen!
skyhigh
- 06 Oct 2010 19:58
- 7 of 106
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. "
skyhigh
- 20 Dec 2010 14:07
- 8 of 106
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.
stable
- 22 Dec 2010 17:06
- 9 of 106
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.
skyhigh
- 30 Dec 2010 09:57
- 10 of 106
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)
skyhigh
- 12 Jan 2011 20:17
- 11 of 106
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)
skinny
- 29 Jun 2011 08:54
- 12 of 106
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 -
skinny
- 30 Aug 2011 07:26
- 13 of 106
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.
stable
- 04 Sep 2011 10:35
- 14 of 106
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.
skinny
- 21 Nov 2011 07:40
- 15 of 106
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."
stable
- 29 Nov 2011 19:27
- 16 of 106
Nothing exciting, big buy 13 mill yesterday no following today
skinny
- 29 Nov 2011 20:32
- 17 of 106
stable - a bit of a damp squib of late to say the least!
stable
- 02 Dec 2011 08:16
- 18 of 106
skinny
still holding for 1st quarter next year
skyhigh
- 03 Dec 2011 20:37
- 19 of 106
Me too! ,,,, what's happening in 1st quarter next year ?
stable
- 06 Dec 2011 17:46
- 20 of 106
in the first quarter 2012 we will be close to US authorisation or not
skyhigh
- 06 Dec 2011 20:17
- 21 of 106
Cool! thanks for the reply..let's hope it's positive.
skinny
- 17 Jan 2012 07:26
- 22 of 106
17 January 2012
Lombard Medical Technologies PLC
("Lombard Medical" or "the Company")
Change of Nominated Adviser and Broker
London, UK, 17 January 2012 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focussed on innovative vascular products, is pleased to announce the appointment of Collins Stewart Europe Limited as Nominated Adviser and Broker to the Company with immediate effect.
- Ends -
skinny
- 17 Jan 2012 07:26
- 23 of 106
RNS Number : 6563V
Lombard Medical Technologies PLC
17 January 2012
Lombard Medical Technologies PLC
("Lombard Medical" or "the Company")
Appointment of New CFO
London, UK, 17 January 2012 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focussed on innovative vascular products, is pleased to announce the appointment of Ian Ardill to the Board as Chief Financial Officer, with effect from January 23(rd) 2012.
Ian joins Lombard Medical after leaving Biocompatibles International plc, a listed medical technology company, where he was Finance Director for over six years after joining in 2003 as Financial Controller and Company Secretary. Ian played a leading role in transforming the business from a loss making company to a profitable enterprise with sales of GBP33 million and latterly overseeing the successful sale of the business for GBP177 million to BTG plc in 2011.
Before joining Biocompatibles, Ian worked at Novartis Pharmaceuticals UK Limited, in a variety of senior roles that encompassed accounting, systems implementation and treasury (1997-2002). Ian has also held the positions of: Finance Director of Letheby & Christopher Ltd (a subsidiary of Compass Group PLC, 1994-1997), Finance and Planning Manager at NHA International plc (1993-1994) and worked within the corporate finance team at Grant Thornton (1988-1992).
Ian Leslie Ardill (aged 44), qualified as a Chartered Accountant in 1990 and holds an Accounting and Financial Analysis degree from Warwick University.
stable
- 17 Jan 2012 09:38
- 24 of 106
skinny
the two notices in themselves do not justify the 16pc rise today alone. Is there some thing else around the corner?
skinny
- 17 Jan 2012 09:42
- 25 of 106
Hardly earth shattering is it? £16k in 2 trades!
skinny
- 18 Jan 2012 12:14
- 27 of 106
Up again today +0.05 +6.5%. Which coincidentally is the spread!
skinny
- 19 Jan 2012 10:05
- 28 of 106
Up again today +12% albeit on paltry volume.
stable
- 19 Jan 2012 10:12
- 29 of 106
Skinny
up because of rns repeating how good the product is.
Us doctors seem to be imprssed
skinny
- 19 Jan 2012 10:17
- 30 of 106
Stable - I thought I had posted it! I must be cracking up!
Anyway - here it is.
Lombard Medical Technologies PLC
("Lombard Medical" or "the Company")
Pythagoras study data on Aorfix™ presented at ISET symposium in Miami
London, UK, 19 January 2012 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focussed on innovative vascular products, today announces that data from the US Pythagoras trial of its endovascular stent graft Aorfix™ was presented at the 24th annual International Symposium on Endovascular Therapy (ISET) on 15-19 January in Miami. The Pythagoras trial, data from which was also presented at the VEITH symposium in New York in November 2011, was designed to show the potential that Aorfix™ has to treat a larger patient population than competing devices, including both standard and difficult to treat cases of Abdominal Aortic Aneurysms (AAAs).
Dr William Gray, Director of Endovascular Services at Columbia University Medical Center, New York, who presented results from patients with standard anatomy in the Pythagoras trial, commented:
"Aorfix™ has produced promising results in this patient group and in my experience, the results in tortuous anatomies are also very encouraging. It is significant that the majority of patients even in this group with normal anatomy had neck angles greater than 45°. Aorfix™ should provide clinicians with a new treatment option which is both safe and versatile. Clinical practice is increasingly moving towards endovascular aneurysm repair and away from surgery, and devices that both perform well and are flexible such as Aorfix™ will play an important role as a highly effective option for patients with more complex anatomy and increase the number of patients for whom a non-operative AAA repair is possible."
Pythagoras is the largest prospective controlled study in the world involving patients with highly tortuous aortic and iliac anatomy, consisted of two groups of patients. The study group consisted of 150 caseswith aortic neck angles ≥ 60° and a 'roll-in' group of 62 patients with aortic neck angles < 60°.
Dr Gray presented data from the roll-in group and reported excellent results including:
· No cases of graft failing to seal against the artery wall and no cases where the graft leaked at either 30 days or 1 year post-operatively
· The absence of any reported graft migration or fracture at either 30 days or 1 year
· In all cases the aneurysm sac decreased in diameter or remained stable after implantation of Aorfix™
The International Symposium on Endovascular Therapy (ISET) brings together practitioners in the fields of interventional radiology, vascular surgery, interventional cardiology and cardiothoracic surgery and others who specialize in treating cardiovascular disease. The meeting pioneered the use of live case demonstrations as an educational tool and promotes the multidisciplinary treatment of cardiac and vascular disease by endovascular means.
- Ends -
skyhigh
- 19 Jan 2012 19:14
- 31 of 106
SP just resting... for the next leg up?...looking good!
stable
- 21 Feb 2012 08:30
- 32 of 106
Nice movement recently, does someone think they know something not yet in public domain, oris this just Investor chronicle/broker tips?
skinny
- 21 Feb 2012 09:42
- 33 of 106
Yes - just over 30% in the last four days, so who knows!
skyhigh
- 22 Feb 2012 19:22
- 34 of 106
drooping back abit now ... mms just playing games or is this recent spike sustainable ?
skyhigh
- 24 Feb 2012 09:24
- 35 of 106
MMs obviously playying games...so predictable so going back down to 1p!...but at least something is happening and imho this will be much higher at the end of the year! (or next year! maybe)
skinny
- 27 Mar 2012 18:52
- 36 of 106
Results Of General Meeting.
London, UK, 27 March 2012 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focussed on innovative vascular products, is pleased to announce that at the General Meeting held earlier today, all of the Resolutions set out in the Notice of General Meeting included in the circular of the Company sent to Shareholders on 9 March 2012 were duly passed. The issue of Convertible Loan Notes to raise £3 million and 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 have, therefore, both been approved by Shareholders.
skinny
- 28 Mar 2012 09:19
- 37 of 106
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.
skinny
- 29 Mar 2012 07:12
- 38 of 106
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
skinny
- 02 May 2012 07:09
- 39 of 106
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 -
skinny
- 12 Jun 2012 07:07
- 40 of 106
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.
skinny
- 30 Aug 2012 07:09
- 41 of 106
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)
skinny
- 15 Oct 2012 10:56
- 42 of 106
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.
dreamcatcher
- 16 Oct 2012 21:18
- 43 of 106
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.
stable
- 18 Oct 2012 08:43
- 45 of 106
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
skinny
- 19 Oct 2012 17:22
- 46 of 106
Stable - its just a 'thing' of mine :-)
5 straight days of rises, some coverage - broker or otherwise over the weekend wouldn't go amiss.
dreamcatcher
- 19 Oct 2012 17:38
- 47 of 106
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.
skinny
- 22 Oct 2012 10:54
- 48 of 106
I'm in danger on making a profit here at this rate.
skinny
- 20 Dec 2012 07:16
- 49 of 106
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.
skinny
- 15 Feb 2013 07:16
- 50 of 106
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.
skinny
- 15 Feb 2013 08:00
- 51 of 106
Just the +25% at open :-)
skinny
- 15 Feb 2013 11:38
- 52 of 106
Canaccord Genuity Buy 229.50 178.50 332.00 332.00 Reiterates
ahoj
- 15 Feb 2013 14:14
- 53 of 106
Well done Skinny & Deamcatcher.
Wow, and that is the start I think.
skinny
- 15 Feb 2013 15:13
- 54 of 106
Thanks Ahoj.
skinny
- 13 Mar 2013 10:36
- 56 of 106
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.
skinny
- 22 Mar 2013 11:14
- 57 of 106
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 -
skinny
- 22 Mar 2013 11:14
- 58 of 106
Canaccord Genuity Buy 186.00 186.00 332.00 332.00 Reiterates
skinny
- 09 Apr 2013 07:03
- 59 of 106
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
Morigam
- 09 Apr 2013 09:11
- 60 of 106
Listen to the interview with Lombard Medical Technologies CEO Simon Hubbert on their final results, which have come out today.
Interview link
skinny
- 07 May 2013 07:05
- 61 of 106
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.
skinny
- 07 May 2013 14:03
- 62 of 106
Canaccord Genuity Buy 202.00 203.50 321.00 321.00 Reiterates
skinny
- 24 May 2013 13:25
- 63 of 106
Proposed Placing and Subscription of Shares
London, UK, 24 May 2013 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focussed on innovative vascular products, today announces that it proposes to raise £21.0 million (before expenses) through a Placing and Subscription, arranged on the Company's behalf by Canaccord Genuity Limited and WG Partners, a trading name of Charles Stanley & Co. Ltd. The Issue Price of 175 pence per Ordinary Share represents a discount of 5 per cent. to the closing middle market price of 184.5 pence per existing Ordinary Share on 23 May 2013 (being the last practicable date prior to the date of this announcement). In conjunction with the Placing and Subscription, Qualifying Participants are being invited to participate in the Fundraising pursuant to an Offer that may raise up to an additional £2.0 million (before expenses).
The Company expects to use the net proceeds of the Placing and Subscription of £20 million, together with Lombard Medical's existing cash resources of £15.2 million, approximately as follows:
• Build sales and marketing infrastructure ahead of U.S. commercial launch in the second half of 2013 (10%)
• Post U.S. launch continue to grow AorfixTM market share in the U.S. (35%)
• Expand AorfixTMproduction capacity (17%)
• Develop next generation products, line extensions and delivery devices (17%)
• Clinical trials (10%)
• Grow rest of world sales of AorfixTM and launch in select new territories (including Japan in 2014) (11%)
The Directors currently anticipate that the proceeds of this proposed Placing and Subscription will enable the Company to achieve its longer-term goals in the U.S. market and to support Lombard Medical's strategy through to cash generation.
skinny
- 13 Jun 2013 08:29
- 64 of 106
Result of Offer
London, UK, 13 June 2013 - On 24 May 2013, Lombard Medical Technologies PLC (AIM:LMT) announced an issue of equity to raise GBP21.0 million (before expenses) by way of a Placing and Subscription. In conjunction with the Placing and Subscription, the Board also announced details of an Offer to Qualifying Participants to raise up to an additional GBP2.0 million (before expenses). The Board also announced that the Convertible Loan Notes issued to Invesco Asset Management Limited would be converted into ordinary shares.
The Company is pleased to announce that, at the close of the Offer at 11.00 a.m. on 12 June 2013, Qualifying Participants had conditionally applied for 398,518 New Ordinary Shares at a price of 175 pence per New Ordinary Share, raising an additional GBP0.7 million (before expenses).
Application has been made for 14,541,375 New Ordinary Shares, being the total number of New Ordinary Shares being issued under the Placing and Subscription, the Offer and the conversion of the Convertible Loan Notes, to be admitted to trading on AIM. Subject to and conditional upon the passing of the Resolutions at the forthcoming General Meeting, admission is expected to become effective on 17 June 2013.
skinny
- 14 Jun 2013 07:05
- 65 of 106
Share Option Grant
London, UK, 14 June 2013 - Lombard Medical Technologies PLC (AIM:LMT), the specialist medical technology company focussed on innovative vascular products, announces that it has yesterday, under the Company's Share Option Plan (2005), granted 3,209,394 new share options over ordinary shares of 20p each in the Company, at an exercise price of 177.5 pence per share, to its Directors and employees. Following this grant, there will be 5,342,607 share options in issue, representing 11.9% of the Company's issued shares, calculated including the shares to be issued following the Placing, Subscription and Offer and conversion of Convertible Loan Notes announced on 24 May 2013; the share options in issue to the Directors will represent 7.4% of this issued shares figure.
skinny
- 21 Jun 2013 08:04
- 66 of 106
skinny
- 21 Jun 2013 12:43
- 67 of 106
skinny
- 15 Jul 2013 07:04
- 68 of 106
Trading Update
London, UK, 15 July 2013 - Lombard Medical Technologies PLC (AIM:LMT), the specialist medical technology company focussed on innovative vascular products, providesthe following update for the six months ended 30 June 2013, ahead of the planned announcement of its Interim Results on 29 August 2013.
Trading in the first six months has been in line with expectations, delivering total revenue of £2.0m. AorfixTM commercial revenue grew 8% with revenue from the main EU markets growing 6% and revenue from the Rest of World markets growing 9%. In Europe, revenue and demand were strong in Germany and Spain, countering the effect of continued EVAR centre consolidation in the UK.
The Company's US launch plans are progressing according to plan. Fifteen new sales representatives and two regional sales managers have been recruited as planned and, in June, the new team attended and successfully completed the in-depth training programme about the use of AorfixTM and the EVAR procedure. The sales team is now focussed on increasing US physician knowledge of AorfixTM and organising their participation in physician training programmes, which will commence at various US venues in August.
As previously announced on 21 June 2013, FDA approval of the next generation AorflexTM delivery system was received. The Company expects to launch AorfixTM commercially in the US in late Q3 2013 and to hold a coordinated launch event at the VEITH symposium in New York City in November 2013.
The Company closed the period with cash of £34.3m following the successful placing, subscription and offer of shares, completed in June 2013 that raised £20.9m net of expenses.
Simon Hubbert, CEO of Lombard Medical Technologies said:
"This trading update highlights the strong position of the Company, both operationally and financially, ahead of the US launch of AorfixTM, our uniquely differentiated stent graft for the endovascular repair of abdominal aortic aneurysms. We are looking forward to building relationships with US physicians and providing them with a product approved to address a high unmet clinical need. In our main EU markets and also in the Rest of the World we have made good progress to date and anticipate additional growth in AorfixTM sales in future periods."
-Ends-
skinny
- 15 Jul 2013 11:24
- 69 of 106
Canaccord Genuity Buy 168.50 167.50 243.00 243.00 Reiterates
skinny
- 22 Jul 2013 07:02
- 70 of 106
London, UK, 22 July 2013 - Lombard Medical Technologies PLC (AIM:LMT), the specialist medical technology company focussed on innovative vascular products, will announce its interim results for the six months ended 30 June 2013 on Thursday 29 August 2013.
skinny
- 27 Aug 2013 07:14
- 71 of 106
First U.S. patients treated with Aorfix
London, UK and Irvine, CA, August 27 2013 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focused on innovative vascular products, today announces that the first U.S. patients have been successfully treated with Aorfix™, the Group's flexible stent graft for the endovascular repair of abdominal aortic aneurysms (AAAs).
Aorfix was approved by the FDA for commercial sale in the U.S. in February 2013. The approval included a label indication for the treatment of patients with angulations at the neck of the aneurysm from 0 to 90 degrees. Moreover, Aorfix is the only endovascular stent graft with approved labeling for use in more challenging cases with neck angulations greater than 60 degrees.
The first U.S. cases using Aorfix included patients with aortic neck angles significantly greater than 60 degrees that would have previously required more invasive open surgical AAA repair or "off label" use of an alternative device not designed to treat patients with this level of tortuosity in the aorta. The patients were treated by Victor J. Weiss, M.D., a vascular surgeon at Meriter Hospital in Madison, WI and Sachinder Hans, M.D. of Henry Ford Hospital in Detroit, respectively. Kim Hodgson, M.D. of Southern Illinois University School of Medicine, Division of Vascular Surgery, Springfield, Illinois, also reported a further case where the patient was successfully treated using Aorfix. All patients are doing well following the procedures.
skinny
- 29 Aug 2013 07:07
- 72 of 106
Half Yearly Report
Operational highlights
· US FDA approval of Aorfix™ for the endovascular repair of AAAs (Abdominal Aortic Aneurysms)
o Only endovascular stent graft approved in US for use in cases with neck angulations up to 90 degrees
o Unique 0-90 degree label indication enabling treatment of broadest range of AAA anatomies
o Compelling case for use over competing products supported by extensive body of clinical evidence
o One of only nine PMAs (pre-market approvals) granted by the FDA in H1 2013
· Aorflex™ next generation delivery system approved by the FDA in June for commercial use in the US
· Aorfix US commercial launch underway, formal launch event at VEITH Symposium, November 2013
o Initial commercial cases successfully completed
o Direct sales team of 20 people recruited and product training completed
o Physician training programme commenced
· Approval for Aorfix in Japan on track, approval anticipated in H1 2014
Financial highlights
· Total revenue increased 2%, in line with expectations, to £2.0m (H1 2012: £2.0m)
· Aorfix commercial revenue increased 8% to £1.7m (H1 2012: £1.6m)
o Revenue increased 6% in the four main EU markets (UK, Germany, Italy and Spain) to £1.1m (H1 2012: £1.0m)
o Revenue in Germany increased by 47% offsetting the effect of continued EVAR centre consolidation in the UK
o Revenue outside the main EU markets increased 9% to £0.6m (H1 2012: £0.5m)
· Significant increase in demand for Aorfix in Germany and Spain offsetting decline in demand for Aorfix in UK which is expected to stabilise in H2 2013
o Combined demand for Aorfix over the four main EU markets steady with 194 patients treated (H1 2012: 195)
· Operating loss increased by 11% to £4.8m (H1 2012: £4.4m)
· Loss after taxation increased by 14% to £4.9m (H1 2012: £4.4m)
· Financing
o Aorfix US approval triggered receipt £13.5m (net of expenses) of the c.£14.1m Second Tranche of the two tranche April 2011 fundraising as well as the Company's ability to draw down $2.5m from the $5.0m loan facility granted by its exclusive Japanese distribution partner, Medico's Hirata Inc.
o £20.9m (net of expenses) raised from a placing, subscription and offer of shares in June
o £3.0m Convertible Loan Notes issued to Invesco in 2012 were converted into new Ordinary Shares
· Strong cash position - £34.3m as at 30 June 2013 (30 June 2012: £5.2m)
Post period events
· Appointment of Raymond W. Cohen as Non-executive Chairman in July
skinny
- 04 Sep 2013 10:52
- 73 of 106
Canaccord Genuity Buy 163.50 161.50 243.00 256.00 Reiterates
skinny
- 02 Oct 2013 10:30
- 74 of 106
Expansion of UK facilities
London, UK and Irvine, CA, 2 October 2013 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focused on innovative vascular products, today announces that due to increasing demand for its lead product, Aorfix, the Company is expanding its facility in Didcot, Oxfordshire and has taken a strategic decision to divest its non-core OEM business based in Prestwick, Scotland. The R&D and process development activities for Aorfix currently undertaken at the Prestwick facility will be transferred to the expanded R&D and manufacturing facilities in Didcot. The Company will continue to run the OEM business until 20 December 2013, the completion date of the transaction.
The Company is seeing growing demand for Aorfix in the US following receipt of US FDA approval earlier this year; is experiencing growing sales in Europe; and anticipates regulatory approval for Aorfix in Japan in H1 2014. Aorfix is the Company's uniquely labeled stent graft device for the treatment of AAAs ("Abdominal Aortic Aneurysms") with neck angulations up to 90 degrees. To meet the increasing demand for Aorfix, the Company is expanding its facilities in Didcot by around 10,000 sqft., involving the construction of a new cleanroom and materials handling space, at a cost of around £0.3m. The expansion is expected to be completed in the first quarter of 2014 and new jobs will be created at the site once the new facility is operational.
The OEM business, which manufactures a range of medical products for third parties, and certain assets, will be divested to Culzean Medical Devices Limited for £0.6m in cash. The consideration is receivable in four annual instalments from the end of 2014 and will be used for general working capital purposes. The book value of the assets to be disposed of was less than £0.1m as at 31 December 2012; and in the year ended 31 December 2012, the OEM business generated a profit before tax of £0.1m (after the recharge of central costs) on revenue of £0.7m. OEM revenue in the first half of 2013 was £0.3m and is expected to show a decline in the full year.
Under the terms of the divestment agreement, some employees in Scotland will transfer to support the new owner's business activities; other employees will be given the opportunity to relocate to Didcot.
-Ends-
skinny
- 17 Oct 2013 07:05
- 75 of 106
Intellectual Property Update
London, UK and Irvine, CA, 17 October 2013 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical device company focused on the treatment of abdominal aortic aneurysms (AAAs), today announces it has entered into a mutually beneficial licensing agreement with Medtronic Inc.
Under the terms of the agreement, Lombard Medical has been granted a non-exclusive license by Medtronic to the US patent No. 6,306,141 ('141 or "Jervis" patent). Consequently, the Company will formally request a withdrawal of its petition to review the validity of the patent with the US Patent and Trademark Office (USPTO) regarding the '141 patent, (see 7 May 2013 Press Release). Other terms of the licensing agreement have not been disclosed.
Commenting on the licensing agreement, Simon Hubbert, Chief Executive of Lombard Medical, said: "The signing of this licensing agreement, the terms of which are advantageous to both parties, will allow Lombard Medical to focus our resources on the US launch of Aorfix™. While we do not believe that the Company infringes the '141 patent or any other Medtronic patent, we are keen to avoid potentially protracted and distracting IP discussions with a large and well-resourced company such as Medtronic."
Following receipt of US FDA approval earlier this year demand for our unique AAA stent graph continues to grow. The Aorfix physician training program has resulted in well over a hundred clinicians being trained and a number of Aorfix procedures have already been successfully completed in the US. The Company is also experiencing growing sales in Europe and anticipates regulatory approval for Aorfix in Japan in H1 2014. To meet this increasing demand the Company recently announced plans to expand its facilities in Didcot, Oxfordshire.
-Ends-
skinny
- 17 Oct 2013 12:05
- 76 of 106
Canaccord Genuity Buy 208.00 204.50 256.00 256.00 Reiterates
skinny
- 18 Nov 2013 07:17
- 77 of 106
Formal US Launch of Aorfix at VEITH Symposium
The Only FDA Approved Endovascular Stent Graft for Use in Challenging Abdominal Aortic Aneurysm Cases
London, UK and Irvine, CA, November 18, 2013 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical device company focused on the treatment of abdominal aortic aneurysms (AAAs), today announces a stand-alone symposium and program of presentations to mark the formal US launch of Aorfix™, the Company's flexible stent graft, at the 40th Annual VEITH Symposium, November 19-23, New York Hilton Midtown Hotel, Manhattan, New York City.
CEO of Lombard Medical Technologies, Simon Hubbert, commented:
"Published clinical data suggest that up to 30% of patients present with tortuous AAA anatomy. US physicians now have access to Aorfix, a highly effective, FDA approved treatment option for such cases. VEITH Symposium is one of the most important annual gatherings of vascular surgeons from around the world and the ideal venue to formally launch Aorfix in the US."
Aorfix was approved by the US FDA in February this year and includes a unique label indication for the treatment of patients with neck angulations up to and including 90 degrees. Lombard Medical will be hosting a launch stand-alone symposium, where leading physicians will present clinical data and provide their first-hand experience of Aorfix, on Thursday November 21, 12:00 noon to 1:00 PM.
Clinical discussions at the launch stand-alone symposium will be led by key investigators from the Pythagoras US clinical trial of Aorfix, including:
· Overall 1-year results of the Aorfix Pythagoras PMA Study - Mark F. Fillinger, M.D. Director, Vascular Surgery Training Programs, Professor of Surgery, Geisel School of Medicine, Dartmouth and Principal Investigator for Lombard's PMA Trial
· Anatomical angles and effect on Aorfix PMA Study results - Mahmoud B. Malas, M.D. Chief of Endovascular Surgery and Director of Vascular and Endovascular Clinical Research, Johns Hopkins Bayview Medical Center
· Gender and its impact on Aorfix PMA Study outcomes - William D. Jordan Jr., M.D. Professor of Vascular Surgery, University of Alabama School of Medicine
· Access techniques for tortuous anatomy - Jeffrey P. Carpenter, M.D. Chairman and Chief, Department of Surgery, Cooper University Health Care
· Clinical insights from the Aorfix PMA Study - Kim J. Hodgson, M.D. Professor and Chair, Division of Vascular Surgery, SIU School of Medicine
In addition, Lombard Medical will host a meeting and product demonstration for investors and analysts on November 20, 2:30 PM to 4:30 PM at the Hilton hotel, no new material financial or other information will be disclosed.
The following presentations highlighting Aorfix will also take place at this year's VEITH Symposium on Friday November 22:
· Advantages and Limitations of the Lombard Aorfix Endograft. Now FDA Approved in the US - Mark F. Fillinger, M.D. Director, Vascular Surgery Training Programs, Professor of Surgery, Geisel School of Medicine, Dartmouth and Principal Investigator for Lombard's PMA Trial
· Challenging Anatomy: Can Freedom from Adjunctive Fixation mean Freedom from Migration and Endoleak? - Prof. Brian R. Hopkinson, M.D., Emeritus Professor of Vascular Surgery, University of Nottingham; Consultant Vascular Surgeon, Queen's Medical Centre, Nottingham, United Kingdom
-Ends-
skinny
- 18 Nov 2013 10:40
- 78 of 106
Canaccord Genuity Buy 198.00 198.00 256.00 256.00 Reiterates
skinny
- 08 Jan 2014 11:25
- 79 of 106
Pre-Close Trading and Strategic Update
Trading Update
Aorfix™ commercial revenue grew 25% to £3.9m with revenue from the main EU markets growing 9%. Revenue from the Rest of World ("ROW") markets grew 28% and the US contributed to fourth quarter Aorfix commercial revenue growth of 38% following formal launch in November. In Europe, the Company experienced strong demand and revenue growth in Germany and Spain. Following consolidation of EVAR centers in the UK, which negatively impacted UK revenue in the first half of 2013, second half 2013 Aorfix revenue in the UK recovered and was flat compared to the same period the previous year. Total Company revenue grew by 14% to £4.5m, reflecting a decline in revenue of the recently divested OEM business in Scotland which fell by 27% compared to last year. As previously announced, this business was divested on 20 December 2013.
Aorfix was approved by the United States Food and Drug Administration ("US FDA") in February 2013 with a unique label indication for the treatment of patients with angulations at the neck of the aneurysm up to and including 90 degrees. The product was formally launched in the US, the largest EVAR market, at the 40th Annual VEITH Symposium, in New York in November. While Aorfix is still in the initial phase of the US launch, the product rollout is progressing well, with the number of US physicians trained to use the device standing at 244 at the year end. As previously disclosed, the Company's 20-person sales team is targeting around 300 high volume EVAR centers that perform more than half of the EVAR procedures in the US.
In Japan, the Company now anticipates regulatory approval for Aorfix during 2014. Our exclusive Japanese marketing partner, Medico's Hirata, remains in dialogue with the Pharmaceuticals and Medical Devices Agency (PMDA) to achieve this. Medico's Hirata is a leading supplier of medical device products in Japan, with the sales infrastructure to realize the potential of Aorfix in this growing market, which in 2013 was estimated to account for approximately $140m or 10% of the global EVAR market.
As previously announced, the Company is expanding its manufacturing facility in Didcot, Oxfordshire, to support increasing global demand for Aorfix. The expansion, which involves the construction of a new cleanroom and materials handling space, will add around 10,000 sq. ft. to the existing facility. The expansion project is expected to be completed by the end of the first quarter of 2014.
The global AAA market for EVAR devices is estimated to be approximately $1.4bn. The US market is estimated to be worth around half of the global market and is expected to grow at a compound annual growth rate in excess of 7% over the next 5 years, driven largely by the growth of the ageing population and patient screening programs. In addition, introduction of new technologies such as Aorfix, which allow more patients to received endovascular treatment of AAA disease, could potentially further expand the market.
The Company closed 2013 with cash of £24.8m and debt of £1.5m on its balance sheet.
NASDAQ IPO
As announced today in a separate press release, the Company intends to submit a registration statement to the US Securities and Exchange Commission ("SEC") relating to a proposed US initial public offering of ordinary shares and a listing on NASDAQ ("NASDAQ IPO").
To facilitate the NASDAQ IPO, a new Cayman Islands holding company will be created and existing shares in Lombard Medical will be exchanged for new shares in that holding company ("Share Exchange")
Commencement of the initial public offering is conditional upon completion of the SEC review process with respect to the registration statement and is subject to market conditions and other considerations. In connection with the NASDAQ IPO, Lombard Medical will also delist its ordinary shares from AIM, a market of the London Stock Exchange.
In the Share Exchange, existing shareholders will receive shares in the new Cayman Islands holding company in exchange for the shares they hold in Lombard Medical. These new shares will not be admitted to trading on AIM. Shareholders will need to consider their ability to hold and trade NASDAQ listed shares following the Share Exchange and the AIM delisting. Full details of the proposals will be set out in a circular to shareholders in due course.
Lombard Medical intends to use proceeds from the NASDAQ IPO to accelerate its commercialization strategy for Aorfix in the US with a particular focus on continuing to expand its direct sales force to accelerate penetration of the US AAA market. The Company will also continue to invest in developing new products to treat complex vascular disease, including a stent graft to treat aneurysms in the thoracic aorta.
This press release does not constitute an offer of any securities for sale.
-Ends-
skinny
- 08 Jan 2014 11:25
- 80 of 106
Intention to pursue a US IPO and NASDAQ listing
London, UK, 8 January, 2014 - Lombard Medical Technologies PLC (AIM: LMT), the specialist medical device company focused on Endovascular Aortic Repair ("EVAR") of abdominal aortic aneurysms ("AAAs"), today announces that it intends to submit a registration statement to the US Securities and Exchange Commission ("SEC") relating to a proposed initial public offering of ordinary shares and a listing on NASDAQ ("NASDAQ IPO").
Lombard Medical has appointed Jefferies LLC ("Jefferies") and Barclays Capital Inc. ("Barclays") as financial advisors in relation to the overall transaction, including the Share Exchange, and as joint bookrunners in connection with the proposed NASDAQ IPO.
To facilitate the NASDAQ IPO, a new Cayman Islands holding company will be created and existing shares in Lombard Medical will be exchanged for new shares in the holding company ("Share Exchange").
more...
skinny
- 09 Jan 2014 13:14
- 81 of 106
Up another 11% on £80k shares traded.
skinny
- 11 Mar 2014 07:11
- 82 of 106
Results for the year ended 31 December 2013
Operational highlights
· US FDA approval of Aorfix™ for the endovascular repair of AAAs in February 2013
o Only endovascular stent graft approved by the US for use in cases with neck angulation up to 90 degrees
· US FDA approval of Aorflex™, the next generation delivery system for Aorfix in June 2013
· Official US launch of Aorfix together with Aorflex at the VEITH Symposium in New York in November 2013
· Following US Aorfix approval, recruited and trained a US direct sales force of 20 individuals, including two regional managers
· Trained 244 physicians in the US to use Aorfix between July and December 2013
· Appointment of Raymond W. Cohen as Non-Executive Chairman in July 2013
Financial highlights
· Total revenue increased by 13% to $7.0m (2012: $6.2m)
· Aorfix commercial revenue increased 23% to $6.1m (2012: $5.0m)
o Aorfix revenue in main EU markets increased 8% to $3.9m (2012: $3.6m)
o Aorfix revenue in the US was $0.5m following launch in H2 2013
· Operating loss increased to $20.0m (2012: $13.1m) due to increases in sales and marketing headcount and activity in the US
· Cash and cash equivalents of $40.9m as at December 31, 2013 (December 31, 2012: $4.5m), increased primarily through the receipt of $53.2m (£34.4m) from equity fundraisings
· Financing:
o US approval of Aorfix in February 2013, which triggered receipt of the $20.4m (net of expenses) second tranche of the two tranche April 2011 fundraising
o US approval of Aorfix triggered Company's ability to draw down $2.5m from the $5.0m loan facility granted by our exclusive Japanese distribution partner, Medico's Hirata Inc.
o Raised an additional $32.8m (net of expenses) in June 2013 through a placing, subscription and offer for new shares
Post period events
· Live case demonstration using Aorfix at
o 2014 Leipzig Interventional Course (LINC) in Germany
o iCON 2014, a meeting of the International Society of Endovascular Specialists in Phoenix, Arizona
· Approval for Aorfix in Japan continues to be anticipated in 2014
This press release does not constitute an offer of any securities for sale. As a result of regulations applying to the Company after the filing of a Form F-1 Registration Statement with the US Securities and Exchange Commission on 10 March 2014, this press release does not include comments on Outlook or by our Chief Executive Officer.
-Ends-
skinny
- 11 Mar 2014 07:12
- 83 of 106
skinny
- 01 Apr 2014 12:16
- 84 of 106
Posted elsewhere :-
Stent developer Lombard Medical sets terms for $60 million US IPO
Lombard Medical, which develops stent-grafts for endovascular aorta repair, announced terms for its IPO on Monday. The Oxfordshire, United Kingdom-based company plans to raise $60 million by offering 3.6 million shares at a price range of $15 to $18. At the midpoint of the proposed range, Lombard Medical would command a fully diluted market value of $252 million. The company currently trades on the LSE AIM under the ticker LMT but intends to delist in conjunction with its US offering.
skinny
- 11 Apr 2014 07:17
- 85 of 106
skinny
- 25 Apr 2014 08:42
- 86 of 106
Suspension of trading on AIM
London, UK, 25 April, 2014- On 26 February 2014, Lombard Medical (AIM: LMT), the specialist medical device company focused on Endovascular Aortic Repair of abdominal aortic aneurysms, announced that it had published a circular which set out the Board of Directors' recommendations to, inter alia, reorganise the Lombard Medical Technologies Group pursuant to a Court approved scheme of arrangement (the "Scheme") so that Lombard Medical becomes a directly-owned subsidiary of Lombard Medical, Inc ("LM, Inc").
Earlier today, LM, Inc. announced the pricing of the initial public offering on the NASDAQ Global Market of 5,000,000 ordinary shares at a price to the public of $11 per share, raising $55 million. In addition, LM, Inc. has granted the underwriters a 30-day option to purchase up to an additional 750,000 ordinary shares from LM, Inc.
Ahead of the Court Hearing to approve the Scheme, scheduled to take place on Tuesday 29 April 2014, shares in the Company will be suspended from trading on AIM from 7.30 a.m. BST today.
Following Court approval, the Scheme is expected to become effective on 30 April 2014 and trading in shares in the Company will be cancelled on AIM at 7.00 a.m. BST (2.00 a.m. ET).
Shares in LM, Inc. are expected to commence trading on the NASDAQ Global Market at 2.30 p.m. BST (9.30 a.m. ET) on 30 April 2014.
This press release and the information it contains is not for publication or distribution, directly or indirectly, in or into the United States. This press release is not intended to, and does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities referred to herein in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration, exemption from registration or qualification under the securities laws of any such jurisdiction.
-Ends-
skinny
- 30 Apr 2014 07:03
- 87 of 106
Result of Court Hearing
London, UK, 29 April, 2014 - On 26 February 2014, Lombard Medical (AIM: LMT), the specialist medical device company focused on Endovascular Aortic Repair of abdominal aortic aneurysms, announced that it had published a circular which set out the Board of Directors' recommendations to, inter alia, reorganise the Lombard Medical Group pursuant to a Court approved scheme of arrangement (the "Scheme") so that Lombard Medical becomes a directly-owned subsidiary of Lombard Medical, Inc ("LM, Inc"). The Court Hearing, adjourned from 14 April 2014, was held today and the Scheme has been approved.
On 25 April 2014 the Company announced the suspension of the Company's shares from trading on AIM. In addition, on the 25 April, LM, Inc. announced the pricing of the IPO of LM, Inc shares on the NASDAQ Global Market. LM, Inc shares commenced trading on the NASDAQ Global Market on 25 April.
The Scheme is expected to become effective tomorrow morning, 30 April 2014, following delivery of the Court Order to the Registrar of Companies for registration.
At 7.00 a.m. BST (2.00 a.m. ET) tomorrow shares in Lombard Medical, will be cancelled on AIM.
This press release and the information it contains is not for publication or distribution, directly or indirectly, in or into the United States. This press release is not intended to, and does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities referred to herein in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration, exemption from registration or qualification under the securities laws of any such jurisdiction.
-Ends-
stable
- 13 Aug 2014 10:04
- 88 of 106
1st half figures on company website , open media
still cause for hope
skinny
- 13 Aug 2014 10:09
- 89 of 106
stable
- 25 Aug 2014 12:40
- 90 of 106
Directors buying announced today, not great numbers still interesting
skinny
- 02 Sep 2014 14:22
- 91 of 106
skinny
- 24 Sep 2014 14:40
- 92 of 106
stable
- 08 Jan 2015 11:46
- 93 of 106
Lombard announce 4th quarter and end year results
Looks promising for long term holders
skinny
- 08 Jan 2015 11:55
- 94 of 106
stable
- 27 Feb 2015 08:12
- 95 of 106
results yesterday, no chance of profits for a year or two but good future predictions, all available on company web pages
stable
- 26 Mar 2015 19:32
- 96 of 106
report today with analyst views. long term hold
skinny
- 27 Mar 2015 06:45
- 97 of 106
It certainly is!
stable
- 09 May 2015 17:21
- 98 of 106
Monday 16.30 should see first quarter results.
let us see how they have done against last year
stable
- 11 May 2015 22:07
- 99 of 106
1st quarter results after close today show continued expansion, with forecast for year expecting same to continue.
Still expanding product range, expenses up, as is profit margins.
still holding, although expect it to be a long hold
stable
- 11 May 2015 22:07
- 100 of 106
1st quarter results after close today show continued expansion, with forecast for year expecting same to continue.
Still expanding product range, expenses up, as is profit margins.
still holding, although expect it to be a long hold
stable
- 20 Jul 2015 21:53
- 101 of 106
6 monthly figures to be announced after close next Monday.
stable
- 20 Jul 2015 21:54
- 102 of 106
after close next Monday , 1/2 year results to be announced
stable
- 27 Jul 2015 21:20
- 103 of 106
Q2 and Recent Operational Highlights
• Total 2015 second quarter Aorfix™ revenue grew 107 percent1 to $4.5 million compared to revenue of $2.2 million in the second quarter of 2014.
• U.S. Aorfix revenue grew to $1.3 million in the second quarter of 2015, up 123 percent from $0.6 million in the second quarter of 2014.
• Gross margin for the 2015 second quarter was 52 percent compared to 46 percent for the prior year period.
• Opened new Innovation Center in Irvine, California.
• In June, the first clinical cases using the new 34mm Aorfix Plus™ endovascular stent graft were successfully completed in the U.S. Up to 10 percent more AAA patients have the potential to be treated with Aorfix as a result of this expanded size range.
Operational and Financial Results
With U.S. procedures that more than doubled, global Aorfix revenue increased 107 percent1 to $4.5 million in the second quarter of 2015 compared to $2.2 million in the second quarter of 2014. For the first six months of 2015, global Aorfix revenue grew 87 percent1 to $7.9 million compared to $4.3 million in the year-earlier period.
In the U.S., where Aorfix was formally launched in November 2013, and is sold exclusively through the Company’s own sales force, revenue in the 2015 second quarter and first six months was $1.3 million and $2.4 million, respectively. Comparative U.S. revenue in the 2014 second quarter and first six months was $0.6 million and $1.1 million, respectively.
"We had another solid quarter of rapidly growing procedures and revenues across key markets while making significant progress on our key commercial, regulatory and strategic initiatives,” said CEO Simon Hubbert. “In the U.S., we added new physicians and new centers to our growing list of customers. We also launched Aorfix Plus, a new addition to our portfolio that allows us to treat patients with larger aortic neck diameters that we believe expands our addressable market by about 10 percent. In Japan, as a result of continued strong procedural growth, we estimate that we have captured approximately 5 percent market share within nine months of launching Aorfix.”
In Japan, where Aorfix is sold through the Company’s exclusive distributor, Medico’s Hirata, and where regulatory approval was received in August 2014, revenue in the 2015 second quarter and first six months was $1.8 million and $2.7 million, respectively. There was no comparative revenue in the second quarter and first six months of 2014.
Gross margin for the 2015 second quarter and first six months was 52 percent and 49 percent, respectively, compared to 46 percent and 40 percent for the prior year periods. The improvement was primarily due to the effect of higher average U.S. selling prices and the spreading of fixed manufacturing costs over increased production volumes.
Total operating expenses for the 2015 second quarter and first six months were $10.6 million and $21.9 million, respectively, compared to $12.4 million and $20.2 million in the prior year periods. The net loss for the second quarter of 2015 was $8.2 million, or $0.51 loss per share, compared to a net loss of $11.1 million, or $0.76 loss per share, for the second quarter of 2014. The net loss for the first half of 2015 was $17.7 million, or $1.10 loss per share, compared to $18.0 million, or $1.49 loss per share, for the first half of 2014.
stable
- 30 Jul 2015 21:22
- 104 of 106
Report of Foreign Issuer (6-k)
Share On Facebook Print
Alert
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________
FORM 6-K
____________________
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
July 30, 2015
____________________
Lombard Medical, Inc.
(Exact Name of Registrant as Specified in Its Charter)
____________________
N/A
(Translation of Registrant’s Name into English)
____________________
Cayman Islands 3841 Not applicable
(State or other
jurisdiction of
incorporation or
organization) (Primary Standard
Industrial
Classification Code
Number) (IRS
Employer
Identification
Number)
4 Trident Park
Didcot
Oxfordshire OX11 7HJ
United Kingdom
+44 (0)1235 750800
(Address, Including ZIP Code, and Telephone Number, Including Area Code, of Registrant’s Principal
Executive Offices)
____________________
Lombard Medical, Inc.
15420 Laguna Canyon Road
Suite 260
Irvine, CA 92618
(Name, Address, Including Area Code, of Agent for Service)
____________________
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ x] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Furnished as Exhibit 99.1 to this Report on Form 6-K is a press release of Lombard Medical, Inc. dated July 30, 2015, announcing the acquisition of Silicon Valley-based Altura Medical, a privately-held, venture-backed company that has developed an innovative ultra-low profile endovascular stent graft technology that offers a simple and predictable solution for the treatment of standard AAA anatomies.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Lombard Medical, Inc.
(Registrant)
Date: July 30, 2015 /s/ WILLIAM J. KULLBACK
William J. Kullback
Chief Financial Officer
EXHIBIT 99.1
Lombard Medical Acquires Endovascular Stent Graft Developer Altura Medical
Acquisition Expands Lombard Product Portfolio with Simple, Safe and Efficient Ultra-Low Profile Endovascular Stent Graft
CE Mark in Place – European Launch Scheduled for January
IRVINE, Calif., July 30, 2015 (GLOBE NEWSWIRE) -- Lombard Medical, Inc. (NASDAQ:EVAR), a medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), today announced the acquisition of Silicon Valley-based Altura Medical, a privately-held, venture-backed company that has developed an innovative ultra-low profile endovascular stent graft technology that offers a simple and predictable solution for the treatment of standard AAA anatomies.
The terms of the transaction include the issuance of $15 million of Lombard common stock at $4 per share (3,750,000 shares of Lombard common stock subject to certain lock up conditions), the assumption of $5.5 million in bank debt and $2.5 million in certain liabilities and transaction-related costs.
In addition, up to $27.5 million may be paid based on the achievement of certain commercial and regulatory milestones anticipated over the next five years. Under the terms of the agreement, Lombard has the option to pay the additional consideration in either cash or stock.
The Altura endograft system received CE Mark in 2015 and Lombard plans to launch the device in Europe in January 2016 with a broader international roll out later the same year. In the U.S., Lombard intends to file for an IDE (Investigational Device Exemption) from the U.S. FDA in early 2016 with the intent to begin recruitment for a U.S. clinical study later in 2016.
Lombard CEO Simon Hubbert said, "The acquisition of Altura and the launch of its new AAA stent graft will provide a near-term and substantial increase in revenues. In fact, we believe this innovative technology could account for up to 20 percent of our 2016 total revenue. The combination of Altura's technology with our flagship Aorfix™ platform creates a truly patient driven platform that we believe will allow us to capture share from our competitors. The Altura device offers a simple, safe and efficient treatment option for standard AAA anatomy, while Aorfix offers the only on-label solution for patients with Aortic neck angulation up to 90 degrees."
"The Altura device offers a new ultra-low profile stent graft system without compromising the robustness and durability of the wire and graft fabric," said Professor Dierk Scheinert, M.D., Chairman of the Division of Interventional Angiology, University Hospital Leipzig, Germany. Noting that, "The added benefits of this smart system are the ability to reposition during deployment and place each graft accurately to each renal artery enabling physicians to utilize all the available aortic neck. It also removes the need for cannulation and therefore provides a simple, intuitive, safe and consistent deployment system with predictable and shorter procedure times."
"Many patients who present for AAA repair can be treated quickly and efficiently with minimal hospital stay and recovery times," said Stuart A. Harlin, M.D., board certified vascular surgeon, Coastal Vascular & Interventional, Pensacola, FL. "The introduction of an easy-to-deploy AAA stent graft that offers enhanced safety and accuracy on an ultra-low profile delivery system will allow physicians to treat a large percentage of AAA patients more efficiently in the future."
Conference Call
Lombard's management will discuss the acquisition and answer questions during a conference call, which will include a slide presentation, beginning at 5:00 p.m. Eastern Time today, Thursday, July 30, 2015. To join the call, participants may dial 1-855-327-6837 (domestic), 0808-101-2791 (UK toll-free) or 1-631-982-4565 (international). To access the slide presentation and/or listen to a live webcast of the conference call, visit the Events and Presentations page under the Investors tab at www.lombardmedical.com. Phone participants who are accessing the slides from the webcast link should, after completing the registration, click the "Listen by Phone" black box under the smaller screen on the left hand side to turn off the webcast audio and sync the slides to the phone audio.
An archived replay of the webcast will be available shortly following the completion of the call on the Events and Presentations page under the Investors tab at www.lombardmedical.com.
About Altura Medical, Inc.
Founded in 2008 and based in Menlo Park, CA, Altura Medical has developed a next generation endograft technology to treat AAA and other related conditions. The development of Altura's highly differentiated technology was led by experienced technologists and supported by a prestigious syndicate of venture capital investors, including SV Life Sciences, New Leaf Ventures and Advanced Technology Ventures. Andrew Cragg, MD, a prolific physician inventor, entrepreneur and a principal at Intersect Partners, initially conceived the Altura AAA endograft technology.
stable
- 05 Aug 2015 11:34
- 105 of 106
CEO (500shares) and Chairman (1000) purchased 4th August
stable
- 05 Nov 2015 10:16
- 106 of 106
third quarter results out yesterday, no surprises and as always hi hopes for the future