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Lombard Medical Technologies - A New Dawn (LMT)     

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.

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

FDA Approves Aorflex Delivery System

skinny - 21 Jun 2013 12:43 - 67 of 106

Invesco > 39%

Abingworth LLP -> 17.85%

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

Chart.aspx?Provider=EODIntra&Code=LMT&SiExpansion 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-

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