Fundraising of £7.6 million
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN THE UNITED STATES, CANADA, AUSTRALIA, SOUTH AFRICA OR JAPAN
Lombard Medical Technologies PLC
(“Lombard” or “Company”)
Fundraising of £7.6 million
London, UK, 20 December 2007- Lombard Medical Technologies PLC (AIM: LMT), the specialist medical device company, is pleased to announce a fundraising by Nomura Code Securities Limited of approximately £7.1 million (net). The Placing, representing approximately £6.4 million of the total fundraising, has been underwritten by Nomura Code Securities Limited; an additional subscription of £1.2 million has been committed by Camden Partners. The Directors have subscribed for a total of approximately £0.1m as part of the Placing.
Highlights
• Fundraising by way of a Placing and a Subscription of new Ordinary Shares to raise gross proceeds of approximately £7.6 million at 14p per share
• The Directors have agreed to take up a total of 784,282 Placing Shares at the Issue Price and will, at Admission, be interested in 0.7% of the Company’s issued share capital as enlarged by the Placing and the Subscription
Reasons for the Placing and Subscription and use of net proceeds
The Directors currently expect that the £7.1 million net proceeds of the fundraising, together with the Company’s existing cash and cash equivalents, will be utilized to:
• Complete recruitment of the Aorfix™ trials
• Fund the Company’s operations through 2008 during which time the Company will pursue a number of strategies which will include:
o disposal of non-core assets,
o further financing from strategic investors
o discussions with potential partners or acquirers of the business
Simon Neathercoat, Lombard Medical’s Non-Executive Chairman, said:
“It is very pleasing that the investment community has continued to show its support for the Company, particularly at a time when the capital markets are under such pressure. These funds, along with existing cash balances, will be sufficient to fund the Company through 2008 and complete recruitment of the Aorfix™ trials. During this time we will pursue a number of strategies which will include the disposal of non-core assets, further financing from strategic investors and discussions with potential partners or acquirers of the business.”
Enquiries:
Lombard Medical Technologies PLC Tel: +44 (0) 1235 750 800
Simon Neathercoat, Executive Chairman
Brian Howlett, Chief Executive Officer
Tim Hall, Finance Director
Financial Dynamics Tel: +44 (0) 20 7831 3113
David Yates / Sanjeev Pandya / Susan Quigley
Nomura Code Securities Limited Tel: +44 (0) 20 7776 1200
Juliet Thompson / Richard Potts
Notes to editors
About Lombard Medical
Lombard Medical is a medical devices company developing stent grafts and other medical products for use in the treatment of vascular disease. The Company’s lead product, Aorfix™, is a stent graft for the treatment of aortic aneurysms, a balloon-like enlargement of the aorta, which, if untreated, may rupture, and cause death. Abdominal and thoracic aortic aneurysms are the 13th largest cause of death in the US and the market is estimated to be worth approximately US$2 billion by 2010. Aorfix™ is currently being commercialised in the EU and US clinical trials are ongoing. The Company’s Polymer Coatings Division primarily develops polymer coatings for use in drug-eluting stents and has a number of research collaborations developing novel products for this US$5 to 6 billion market.
The Company, headquartered in Oxfordshire, with operations in Yorkshire, Ayrshire and Boston, USA, employs over 100 people.
Further background on the Company can be found at www.lombardmedical.com.
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NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN THE UNITED STATES, CANADA, AUSTRALIA, SOUTH AFRICA OR JAPAN
Lombard Medical Technologies PLC
(“Lombard” or “Company”)
Fundraising of £7.6 million
Introduction:
The Board was pleased to announce today that we are proposing to raise £7.6 million before expenses by means of a placing and subscription of a total of 54,191,425 new Ordinary Shares at 14 pence per Ordinary Share. This fundraising is subject to the approval of Shareholders at the EGM. I am writing to set out further details of this fundraising and of the progress made by the Company since my appointment.
I became a Director and Chairman of the Company on 1 October 2007 and saw it as my first task to undertake a review of strategy, operations, people, finances and, most importantly of all, the opportunity that we offer to Shareholders.
I spent the first month meeting the key people in the Company and many others outside the Company who are important to its current and future development, both here in the UK and in the US.
What became clear to me very quickly was the high degree of enthusiasm, within the Company and outside, for the Company's flagship product, the Aorfix™ stent graft. The product is currently approved in Europe and certain other countries for the treatment of abdominal aortic aneurysms with neck angles up to 65 degrees. Once approved in high-angle aneurysms (up to 90 degrees), through its current trials both in Europe (ARBITER II) and in the US (PYTHAGORAS), Aorfix™ will provide a more complete treatment solution than any other AAA stent graft currently available thus creating a very significant opportunity in the market for treatments for this serious disease, sometimes known as the “Silent Killer”.
Since its IPO in December 2005, the Company has encountered a number of set backs which have had an impact on its development. Throughout this period, the Chief Executive, Brian Howlett, who was appointed at the time of the IPO, has successfully put together a high calibre group of senior executives. Furthermore, the Board has been strengthened by the appointment of additional Non-executive Directors on 1 October 2007. Consequently, I believe that the Company has now moved from a research and development company to a business capable of meeting the demands of the commercial environment.
The strategy is now clear. As a small company competing with large corporations with much greater resources than us, we must focus as much of our efforts and resources as we can on our core and most commercially promising products, our family of Aorfix™ stent grafts.
Like most small companies moving into a commercial environment, the Company has encountered growing pains, not least of all in the areas of manufacturing, production and quality control. The difficulties in these areas have been at the heart of the Company's past problems in delivering to predicted time lines. Until the middle of this year, we had insufficient stock levels of our Aorfix™ products to be able to supply our customers when they called for product. I am pleased to say that this is a problem of the past and that we can now supply the majority of requests for product from stock. This has increased the confidence of our customers and has generated a marked uplift in the demand for Aorfix™.
We have recently designed and introduced a new system to load Aorfix™ into its delivery sheath, which should further improve efficient and timely production of our Aorfix™ products. We have also instigated an initiative to improve the efficiency of our quality control processes.
The funds raised, along with existing cash balances, will be sufficient to fund the Company through 2008 and complete the recruitment of the Aorfix™ trials. During this time we will pursue a number of strategies which will include the disposal of non-core assets, further financing from strategic investors and discussions with potential partners or potential acquirors of the Company or the business. I would draw your attention to the section headed “The City Code” below.
Chief Executive's review
For further and more detailed information on the Company's business, I refer you to Brian Howlett's review set out below.Placing and Subscription
It was announced today that the Company has conditionally placed 45,977,140 new Ordinary Shares with institutional investors at 14 pence per Ordinary Share to raise approximately £6.4 million before expenses. This Placing has been underwritten by Nomura Code. In addition, Camden Partners have entered into a subscription agreement whereby they will subscribe in aggregate for 8,214,285 new Ordinary Shares at 14 pence per Ordinary Share, raising a further £1.2 million before expenses. Together, the Placing and Subscription are expected to raise a total of £7.6 million before expenses. The Subscription has not been underwritten by Nomura Code.
Placing participation by Directors
As part of the Placing, the following Directors have agreed to subscribe the indicated numbers of Ordinary Shares at the Issue Price:
| Simon Neathercoat | 178,571 |
| Brian Howlett | 71,427 |
| Tim Hall | 70,000 |
| Tim Cook | 71,428 |
| Craig Rennie | 178,571 |
| Martin Rothman | 71,428 |
| Mike Stevens | 142,857 |
| Total | 784,282 |
Subscription by Camden Partners
Camden Partners currently hold 13,055,006 Ordinary Shares representing 16.4% of the Company's Existing Ordinary Shares. As part of the Subscription, Camden Partners have agreed to subscribe for a further 8,214,285 Ordinary Shares at the Issue Price. As Camden Partners is a substantial shareholder of the Company, this subscription constitutes a related party transaction under the AIM Rules. The Directors, with the exception of Mr Richard Johnston, who is a director of Camden Partners, consider, having consulted the Company's nominated adviser, Nomura Code, that the terms on which Camden Partners are subscribing Ordinary Shares are fair and reasonable insofar as the Company's Shareholders are concerned.
Extraordinary General Meeting
The Placing and Subscription are subject to the approval of Shareholders at the EGM of the Company to be held on 14 January 2008.
Yours sincerely,
Simon Neathercoat
Non-Executive Chairman
Chief Executive's Review
Aorfix™ commercialisation outside the US:
The market for endovascular stent grafts for the repair of abdominal aortic aneurysms continues to increase strongly with the number of implants in Western Europe increasing by 17.6% to 17,178 in 2006. This increase is driven by rising levels of diagnosis and a growing preference among patients and clinicians for endovascular repair over the alternative of open surgery. Reasons for the increase in diagnosis include an ageing population, a rising incidence of causal factors such as obesity and high blood pressure and greater screening for the disease. Reasons for the increasing preference for EVAR among patients and healthcare professionals include quality of life benefits and a faster recovery time that leads to a better utilisation of healthcare resources and a lower overall cost.
The uptake of EVAR varies from country to country with EVAR representing just 12% of AAA procedures in 2006 in France but 43% in Italy, which is the world's second largest market for EVAR behind the US. On average, in Western Europe, EVAR is undertaken in 26% of AAA procedures.
The Company sells Aorfix™ directly in the UK and through a series of national distributors in the rest of Europe and Brazil. In the second half of 2007, the number of implants of Aorfix™ has started to increase again, after a series of flat quarters, rising from 26 implants in Q2 2007 to 32 in Q3 2007 with an expectation of 52 for Q4 2007 and 135 for the whole of 2007.
The principal reason for this improvement in sales performance is the Company's increasing ability to supply the required size of stent graft directly from stocks rather than having to make the graft to order, a process that can take up to four weeks. Further, the growing body of good clinical data on the product is attracting the interest of clinicians. A summary of the outcomes of 101 cases for which follow-up data are available in the Retrospective Aorfix™ Data Retrieval (“RADAR”) clinical registry was presented in early September at the Cardiology and Interventional Radiology Society of Europe (CIRSE) congress in Athens by Professor M. Trojanowska, Lublin, Poland. These data illustrate the competitive profile of Aorfix™, with the product comparing favourably to National Institute for Clinical Excellence (NICE) guidance, especially in terms of frequency of endoleaks and stent migration (see the table below) and producing aneurysm diameter reductions in the majority of patients followed up after 12 months or longer.
NICE Guidance (including EUROSTAR references) March 2006 | Aorfix bifurcated device September 2007 | |
30-day all-cause mortality of those fit for surgery | 2% | 2% * |
Stent migration at 12 months | 1% | 0% |
Wire fracture at 12 months | 3% | 0% |
Aneurysm rupture at 36 months | 0.9% | 0% |
13.8% total 3.4% type Ia | ||
Endoleaks at 12 months | 19% (mainly type II) | 10.4% type IIa |
*Not device-related
Professor Trojanowska concluded from the data that the:
“Aorfix™ stent graft is a feasible option for endovascular repair of AAA with an excellent technical success rate”.
The product has received endorsement from a number of international opinion leaders, including the Principal Investigator of the PYTHAGORAS trial, Dr. Mark Fillinger, MD, Dartmouth Hitchcock Medical Centre, Lebanon, New Hampshire, USA. Dr Fillinger commented recently at an international symposium in New York that:
“The performance of Aorfix™ in the first 21 patients is excellent. The cases followed up to six months, have levels of aneurysm regression on par with the best competitors. I, and fellow investigators, have started using Aorfix™ in very challenging anatomy and it has been successfully implanted in several cases where no other implant would have been appropriate.”
The Directors believe that Aorfix™ has the potential to obtain at least a 20% volume market share in Europe and certain other key markets outside the US, such as Brazil, by the end of 2011 through the continued marketing of the product's core differentiating features: greater flexibility and ability to conform to the anatomy. These characteristics are summarised in the following positioning statement:
Aorfix™ is the only stent graft that has the potential to treat both complex and routine EVAR cases, as it moves to the body's shape due to its flexible coiled design distinct from all other grafts.
A clinical trial (ARBITER II) is currently ongoing in Europe in patients with aneurysms with neck angulations between 65 and 90 degrees. Data from this trial will be used to support a change in the European labelling of Aorfix™ which is currently for use in aneurysms with neck-angulations of up to 65 degrees. No other stent graft currently has a label indicating its use in patients with aneurysms with neck-angulations greater than 60 degrees and I am optimistic that Aorfix™ will be the first to gain this indication. Thirty patients will be recruited into the trial and followed up for a period of 6 months following which data will be submitted on 25 patients. Currently four centres are actively recruiting for patients with another four in the pipeline and six cases have been performed.
In May 2007, Aorfix™ was launched in Brazil, the world's fourth largest market for EVAR with between 1,800 and 2,000 EVAR procedures performed each year. Uptake of Aorfix™ in Brazil has been promising with 20 procedures performed to date.
Aorfix™ manufacture
The number and range of sizes of Aorfix™ held in stock at the Company's manufacturing facility in Didcot has progressively increased during 2007 with 145 units in stock at 30 November 2007. The recent implementation of a new delivery device loading process is expected to improve yields significantly and will help to ensure that the Company's target of holding 200 units of stock is achieved by the end of the year.
The acquisition of Culzean Medical Devices Limited (“Culzean”) in June 2007 provided the Company with an expertise in medical fabrics together with extra manufacturing capacity at its leased facility in Prestwick, Ayrshire.
Employees at Culzean are currently in the process of being trained on the production of Aorfix™ with the intention that devices for use in development will be produced at Prestwick in 2008, thus freeing up capacity in Didcot.
Major changes to the production systems and processes have been introduced over the last eighteen months as the Company has moved from an R&D organisation, producing small quantities of product, to one capable of producing commercial quantities in accordance with strict regulatory standards. The Board was pleased that the Company's regulatory body (TÜV) recognised the improvements made to the systems and processes during their visit in September 2007 and reported no major issues.
US Clinical Trial
During 2007, the Company received FDA approval for a number of favourable changes to the protocol for the pivotal US trial of Aorfix™ in the treatment of AAA disease. Permission to use the second generation (“Gen II”) version of Aorfix™ with an improved delivery system preferred by clinicians was received in April. Approval to extend the patient entry criteria to include patients with aneurysm neck angulations of up to 90 degrees for whom there is no other licensed endovascular treatment was received in July along with permission to reduce the number of patients in the trial to the numbers shown in the table below.
Patients to be recruited | Study (total including loss to follow up | Control (total including loss to follow up) | ||
High angles | Original
110 (110) | Revised
120 (up to 150) | Original
110 (110) | Revised Primary: Lifeline Registry of 323 patients plus |
Normal angles |
275 (275) |
40 (up to 50) | Secondary: 60 patients (up to 75) | |
Further, in November 2007, following a positive review of the first 21 cases by the FDA, the Company received authorisation to increase the number of centres participating in the trial to 30. Prior to this review, although the Company had permission to contract with up to 20 centres and had contracts in place with 19 centres, it could only recruit patients in a maximum of ten centres.
These protocol changes along with the availability of stock, the recent appointment of three clinical site specialists to support patient recruitment and a focus of resources on the higher performing centres has significantly increased the number of patients being recruited into the trial in the fourth quarter of 2007. We anticipate that a total of 15 cases will have been performed during the last quarter of 2007. This forecast total compares favourably with the average of 5 in each of the previous four quarters. The patient recruitment rate is expected to increase further as more centres become involved in the trial and the body of good clinical data from the trial increases. The Company expects to complete recruitment into the trial during the second half of 2008 and to complete its PMA submission in the second half of 2009.
Organisation
Since the Company's IPO, the Company has assembled an experienced management team capable of successfully commercialising Aorfix™. The key members of the executive team are:
Brian Howlet, CEO, ex-Boston Scientific
Tim Hall, Finance Director, ex Celltech
Peter Phillips, President US Operations, ex-MD Cardiovascular Devices
Jan Champion, International Director of Regulatory Affairs, ex Medtronic
Mike Karim, Director, Sales and Marketing, ex Boston Scientific
David Clennell, International Director of Quality, ex J & J
Duncan Keeble, Director of Product Development, Internal
Nick Allen, Operations Director, ex Amba Medical & Renishaw
David Richmond, MD, Culzean Medical Devices, ex CEO & majority shareholder of Culzean
Karen Holdway, Human Resources Business Partner, ex RBS
Kadem Al-Lamee, MD, Polymer Coatings
Thoracic Aorfix™
Development of the Company's stent graft for thoracic aortic aneurysms has been on hold for most of 2007 as development resources have been focussed on Aorfix™. Development of this product may recommence in 2008 should additional funding become available. It is estimated that it will take 18 months of further development before the product is ready to enter clinical trials.
The market for thoracic stent grafts is expected to grow rapidly over the next few years for many of the same reasons as that for AAA stent grafts.
EndoRefix™
CE Mark approval was received in October 2007 for a reconfiguration of EndoRefix™, the Company's patented endovascular stapling device initially to be used to provide extra fixation for endovascular stent grafts. The first eight cases of a small, ten-patient clinical study to evaluate the clinical utility of EndoRefix™ in this indication have been successfully completed. Upon the successful completion of the first ten cases, Medtronic will undertake a limited launch of the product in Europe under the trade name Securant™. Medtronic currently plan to expand the European distribution during 2008 as further clinical experience of the product becomes available.
The FDA investigational device exemption has been approved for the commencement of the recruitment of centres and the enrolment of patients (subject to receiving centre ethics approval). Recruitment is expected to commence in the early part of 2008. The product will be filed with the FDA under a 510k application, approval of which is expected in Q3 2008. Lombard will then receive a one-off fee of $3 million from Medtronic.
Polymer Coatings Divisioon
The Polymer Coatings Division continues to negotiate with a number of parties for licenses to its durable GlideMax™ surface treatment for catheters to reduce friction. Progress is also being made in the various research collaborations it has in the field of drug-eluting stents. However, as this division, which will require funding for a number of years, is not core to the Company's main business the Board has decided to seek alternative funding for this business by mid 2008.
Key Operating Objectives
Current key operating objectives for the business over the next year are:
1. Aorfix™ US trial recruitment – to continue to increase recruitment rates in order to complete the process during the second half of 2008;
2. Aorfix™ US PMA submission – to commence a modular approach to the Aorfix™ PMA submission;
3. Aorfix™ European trial recruitment – to complete recruitment of the ARBITER II trial;
4. Aorfix™ commercialisation outside the US – to continue to increase volume market share in Europe and other key markets outside the US, such as Brazil, in line with a long-term objective of achieving a 20% volume market share by the end of 2011;
5. EndoRefix™ regulatory – to complete the 10-patient study to Medtronic's satisfaction in early 2008 and secure FDA approval in the second half of 2008; and
6. Polymer Coatings Division – to consider strategic options for this division that maximise near-term Shareholder value and ensure that alternative funding for this division is obtained by mid 2008.
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EXPECTED TIMETABLE OF PRINCIPAL EVENTS
Extraordinary General Meeting 10.00 a.m. on 14 January 2008
Admission of and commencement of dealings in the First Placing Shares 15 January 2008
CREST accounts expected to be credited for the First Placing Shares 15 January 2008
Admission of and commencement of dealings in the Second Placing Shares and Subscription Shares 16 January 2008
CREST accounts expected to be credited for the Second Placing Shares and Subscription Shares 16 January 2008
Where applicable, despatch of definitive share certificates for the Placing Shares and Subscription Shares expected by 23 January 2008
Each of the times and dates in the above timetable is subject to change. If any of the above times and/or dates change, the revised times and/or dates will be notified to Shareholders by announcement on a Regulatory Information Service. References to time are to Greenwich Mean Time.
The Company’s SEDOL code is B0Q5QPS and ISIN code is GB00B0Q5QP56.
PLACING AND SUBSCRIPTION STATISTICS
Number of Ordinary Shares in issue at the date of this announcement 79,788,506 shares
Number of Placing Shares 45,977,140 shares
Number of Subscription Shares 8,214,285 shares
Total number of Ordinary Shares in issue immediately following the Placing and Subscription 133,979,931 shares
Issue Price 14p
Percentage of Enlarged Issued Share Capital represented by the Placing Shares and Subscription Shares 40.4%
Gross proceeds of the Placing and Subscription £7,586,799.50
Estimated net proceeds of the Placing and Subscription* £7,086,799.50
THE CITY CODE
Dealing Disclosure Requirements
Due to the Panel on Takeovers and Mergers regarding the statements in the Chairman’s letter concerning the Company’s strategy for 2008 as constituting a strategic review announcement, the Company is until further notice regarded by the Panel on Takeovers and Mergers as being in an “offer period” under the Takeover Code (the “Code”) and therefore the following information is included:
Under the provisions of Rule 8.3 of the Code, if any person is, or becomes, “interested” (directly or indirectly) in 1% or more of any class of “relevant securities” of Lombard Medical, all “dealings” in any “relevant securities” of that company (including by means of an option in respect of, or a derivative referenced to, any such “relevant securities”) must be publicly disclosed by no later than 3.30 pm (London time) on the London business day following the date of the relevant transaction. This requirement will continue until the date on which the offer becomes, or is declared, unconditional as to acceptances, lapses or is otherwise withdrawn or on which the “offer period” otherwise ends. If two or more persons act together pursuant to an agreement or understanding, whether formal or informal, to acquire an “interest” in “relevant securities” of Lombard Medical, they will be deemed to be a single person for the purpose of Rule 8.3.
Under the provisions of Rule 8.1 of the Code, all “dealings” in “relevant securities” of Lombard Medical by Lombard Medical, or by any of their respective “associates”, must be disclosed by no later than 12.00 noon (London time) on the London business day following the date of the relevant transaction.
A disclosure table, giving details of the companies in whose “relevant securities” “dealings” should be disclosed, and the number of such securities in issue, can be found on the Panel on Takeovers and Mergers’ website at www.thetakeoverpanel.org.uk.
“Interests in securities” arise, in summary, when a person has long economic exposure, whether conditional or absolute, to changes in the price of securities. In particular, a person will be treated as having an “interest” by virtue of the ownership or control of securities, or by virtue of any option in respect of, or derivative referenced to, securities.
Terms in quotation marks are defined in the Code, which can also be found on the Panel on Takeovers and Mergers’ website. If you are in any doubt as to whether or not you are required to disclose a “dealing” under Rule 8, you should consult the Panel on Takeovers and Mergers.
The new Ordinary Shares that are the subject of the Placing and the Subscription are not being offered or sold to any person in the United Kingdom, other than to qualified investors as defined in Section 86(7) of the Financial Services and Markets Act 2000 (“FSMA”), being persons falling within Article 2.1(E)(I), (II) or (III) of Directive 2003/71/EC (the “Prospectus Directive”), which includes legal entities which are regulated by the Financial Services Authority (the “FSA”) or entities which are not so regulated whose corporate purpose is solely to invest in securities.
The information contained herein is not for publication or distribution into the United States. The material set forth herein is for informational purposes only and is not intended, and should not be construed, as an offer of securities for sale into the United States or any other jurisdiction. The securities of the Company described herein have not been and will not be registered under the US Securities Act of 1933, as amended (the “Securities Act”), or the laws of any state of the United States, and may not be offered or sold within the United States, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state laws. There is no intention to conduct a public offering of securities in the United States.
This announcement does not constitute an offer to sell or issue or a solicitation of an offer to buy or subscribe for new Ordinary Shares in any jurisdiction including, without limitation, Canada, Australia, South Africa Japan or any other jurisdiction in which such offer or solicitation is or may be unlawful. This announcement and the information contained herein are not for publication or distribution, directly or indirectly, to persons in Canada, Australia, South Africa or Japan unless permitted pursuant to an exemption under the relevant local law or in any jurisdiction in which such publication or distribution is unlawful.
The distribution of this announcement, the Placing and/or Subscription and/or issue of the new Ordinary Shares in certain jurisdictions may be restricted by law. No action has been taken by the Company or Nomura Code that would permit an offer of the new Ordinary Shares or possession or distribution of this announcement or any other publicity material relating to such new Ordinary Shares in any jurisdiction where action for that purpose is required. Persons to whose attention this announcement has been drawn are required by the Company and Nomura Code to inform themselves about and to observe any such restrictions.
Past performance cannot be relied upon as a guide to future performance.
Nomura Code is authorised and regulated by the Financial Services Authority, is acting for the Company and for no one else in connection with the Placing and Subscription and will not be responsible to anyone other than the Company for providing the protections afforded to the clients of Nomura Code or for affording advice in relation to the Placing, the Subscription or any other matters referred to herein.
Appendix 1
Definitions
The following definitions apply throughout this announcement, unless the context requires otherwise:
“Act” the Companies Act 1985 (as amended)
“2006 Act” the Companies Act 2006
“Admission” First Admission and Second Admission
“AIM” a market operated by the London Stock Exchange
“AIM Rules” the rules governing the admission to, and operation of, AIM as published by the London Stock Exchange from time to time
“Camden Partners” Camden Partners Strategic Fund 11-A, LP and Camden Partners Strategic Fund 11-B, LP
“Capita Registrars” Capita Registrars Limited, registrars to the Company
“City Code” the City Code on Takeovers and Mergers as modified, varied or amended from time to time
“Companies Act” the company law provisions of the 2006 Act, the Act, Part 2 of the Companies (Audit, Investigations and Community Enterprise) Act 2004, the Companies Consolidation (Consequential Provisions) Act 1985 and the Companies Act 1989 that remain in place
“Company”, “Lombard” or “LMT” Lombard Medical Technologies PLC
“CREST” the computerised settlement system operated by Euroclear which facilitates the transfer of title to shares in uncertificated form
“CREST Regulations” the Uncertificated Securities Regulations 2001 (as amended) (SI 2001/3755)
“Directors” or “Board” the board of directors of Lombard
“DTRs” the Disclosure Rules and Transparency Rules published by the FSA
“Enlarged Issued Share Capital” the issued ordinary share capital of the Company as enlarged by the issue of the Placing Shares and the Subscription Shares
“Euroclear” Euroclear UK and Ireland Limited, the operator of CREST
“Existing Ordinary Shares” the Ordinary Shares in issue and fully paid immediately prior to Admission
“Extraordinary General Meeting”or “EGM” the extraordinary general meeting of Lombard convened for 10.00 a.m. on Monday, 14 January 2008 (or any adjournment thereof)
“Financial Promotion Order” the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005
“First Admission” the admission of the First Placing Shares to trading on AIM becoming effective pursuant to paragraph 6 of the AIM Rules
“First Placees” subscribers for First Placing Shares pursuant to the Placing Agreement
“First Placing” the conditional placing of the First Placing Shares pursuant to the Placing Agreement
“First Placing Shares” the 5,892,856 new Ordinary Shares to be issued to the First Placees pursuant to the Placing Agreement
“FSA” the Financial Services Authority
“Group” the Company and its Subsidiaries
“IPO” the admission to trading on AIM of the Company's then entire issued share capital on 13 December 2005
“Issue Price” 14 pence per new Ordinary Share
“London Stock Exchange” London Stock Exchange plc
“Medtronic” Medtronic, Inc.
“Nomura Code” Nomura Code Securities Limited
“Option Schemes” the Lombard Medical Technologies PLC Share Option Plan and the Lombard Medical Technologies PLC Share Option Plan (2005)
“Ordinary Shares” ordinary shares of 2 pence each in the capital of Lombard
“Placees” the First Placees and the Second Placees
“Placing” the placing of the Placing Shares pursuant to the Placing Agreement
“Placing Agreement” the conditional agreement dated 20 December 2007 and made between Nomura Code and the Company in relation to the Placing
“Placing Shares” the First Placing Shares and the Second Placing Shares
“£” and “p” respectively pounds and pence sterling, the lawful currency of the United Kingdom
“Prospectus Rules” the Prospectus Rules published by the FSA
“Resolutions” the resolutions set out in the notice of the EGM and “Resolution” shall mean any of them
“Second Admission” the admission of the Second Placing Shares and the Subscription shares to trading on AIM becoming effective pursuant to paragraph 6 of the AIM Rules
“Second Placees” subscribers for Second Placing Shares pursuant to the Placing Agreement
“Second Placing” the conditional Placing of the Second Placing Shares pursuant to the Placing Agreement
“Second Placing Shares” the 40,084,284 new Ordinary Shares to be issued to the Second Placees pursuant to the Placing Agreement
“Shareholders” holders of Ordinary Shares
“Subscribers” subscribers for the Subscription Shares pursuant to the Subscription Agreement, being Camden Partners
“Subscription” the subscription for the Subscription Shares pursuant to the Subscription Agreement
“Subscription Agreement” the agreement dated 20 December 2007 and made between the Company and the Subscribers
“Subscription Shares” the 8,214,285 new Ordinary Shares to be issued to the Subscribers pursuant to the Subscription Agreement
“Subsidiaries” the subsidiaries of the Company
“US” or “USA” or “United States of America” the United States of America, each state thereof, its territories and possessions, and all areas subject to its jurisdiction
Appendix 2
Glossary
510(K) application an application to the FDA for approval to market a device that is `substantially equivalent' to a device that is already on the market
abdominal aortic aneurysm or AAA balloon-like enlargement of the aorta in the region of the abdomen (occurring in the length of the aorta between the diaphragm and the iliac bifurcation)
drug-eluting controlled release of one or more drugs by a chemical complex, such as a polymer coating
endoleak or endovascular leakage leakage of blood beyond the stent graft into the space between the outer stent wall and the wall of the blood vessel
endostapler a stapling instrument used endoscopically for the purposes of fixing tissues to other tissues or devices
EVAR endovascular aneurysm repair
FDA the US Food and Drug Administration
Investigational Device Exemption or IDE an approval by the FDA for a device that permits its use in a clinical study to collect the safety and effectiveness data required for an application to market the device
PMA Pre-Market Approval
stent graft a tubular device made of fabric attached to an expandable metal structure. Once the metal structure is expanded, the device forms a tube
thoracic aortic aneurysm or TAA balloon-like enlargement of the aorta in the region of the thorax (occurring in the length of the aorta between the heart and the diaphragm)
TÜV Technischer Überwachungsverein, a third party organisation appointed to be a notified body by a member state of the European Union to undertake prescribed activities relating to quality standards including, inter alia, providing conformity assessment in support of CE markings