19.09.2014 08:00:00 CET

Nexstim Plans an Initial Public Offering on NASDAQ OMX First North

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Nexstim Plans an Initial Public Offering on NASDAQ OMX First North

Helsinki, 19 September 2014

Nexstim Oy ("Nexstim" or "Company"), a medical technology company aiming to improve rehabilitation for stroke patients through the use of non-invasive brain stimulation, announces its intention to proceed with an Initial Public Offering of Nexstim on NASDAQ OMX First North Finland and NASDAQ OMX First North Sweden ("Admission"). It is expected that the Admission will occur in the 4^th Quarter of 2014.

Nexstim has developed a technology which allows a non-invasive targeting of a specific area of the brain with high accuracy. Nexstim has pioneered the technology as a diagnostic tool for brain surgery planning with its Navigated Brain Stimulation (NBS) System. The NBS System is the first and only FDA cleared and CE marked device utilizing so-called navigated transcranial magnetic stimulation (nTMS) for mapping of the motor and speech cortices. 

Based on the same technology platform the Company has developed a device for stroke therapy called Navigated Brain Therapy (NBT®), which focuses stimulation on targeted locations in the brain to enhance and accelerate stroke rehabilitation by removing natural barriers for recovery. The NBT® System was tested in a Phase II proof of concept study in 29 post-acute stroke patients to study the effect on hand and arm function in connection with rehabilitation. The patients were randomized into two groups of which a group of 19 patients received NBT® therapy and a group of 10 patients received sham (placebo) treatment. Out of the group receiving NBT® treatment, 84% of the patients showed a clinically important improvement in motor function of the upper extremity six months after treatment compared to 50% in the sham group.  The difference was statistically significant (p<0.05).

Nexstim has earlier this year initiated a two-year clinical Phase III study at 12 prominent rehabilitation sites in the US, aiming to demonstrate the effectiveness of the NBT® System and to obtain an FDA clearance for marketing the device for post-acute stroke treatment in the US.

Each year, more than two million patients have a stroke in the US and Europe and the annual cost to the society are estimated to be USD36bn and EUR42bn respectively. Of these patients, Nexstim intends to target the 0.7 million patients in need of an effective rehabilitation method for motor function disability, the most common disorder following a stroke. The Company estimates that this potential market is worth approximately USD 1.8bn in annual sales. In the future, the Company intends to investigate the applicability of its technology platform also in other indications within stroke and, for example, in pain and tinnitus.

The Company's major shareholders are HealthCap, the Finnish Innovation Fund Sitra, Capricorn Health-Tech Fund, Life Science Partners (LSP) and Lundbeckfond Ventures.

Pareto Securities has been appointed Lead Financial Adviser and Joint Arranger and UB Securities has been appointed Financial Co-Adviser and Joint Arranger in connection with the contemplated IPO.

Commenting on today's announcement, Janne Huhtala, CEO of Nexstim, said: "Nexstim's board of directors has decided that now could be an appropriate time to broaden the shareholder base and to apply for the listing of the Company's shares on First North Finland and First North Sweden. The initial public offering is expected to support Nexstim in the next development stage through to the end of the ongoing Phase III study and the potential FDA clearance for the use of its NBT® System in stroke therapy, expected to take place at the end of 2016. We thank our shareholders and staff for their continued support as we strive to create a novel therapy for stroke sufferers in this significant international market."  

For more information about Nexstim, please contact:

Please Note: Nexstim's NBS System is cleared by the FDA for assessment of the motor and speech cortices for pre-procedural planning. The NBT® System is not cleared for commercial distribution in the United States.

Information about Nexstim
Nexstim is a medical technology company aiming to improve rehabilitation for stroke patients. Nexstim has pioneered its technology in brain diagnostics with the Navigated Brain Stimulation (NBS) system as the first and only FDA-cleared and CE-marked navigated Transcranial Magnetic Stimulation (nTMS) device for pre-surgical mapping of the motor and speech cortices. Based on the same technology platform the company has developed a device for stroke therapy, called Navigated Brain Therapy (NBT®). Nexstim has initiated a two-year pivotal Phase III study at 12 sites in the US aiming to demonstrate the effectiveness of NBT® and gain FDA clearance for commercialisation in post-acute stroke therapy in the US.

The Board of Directors

Timothy Irish, Chairman
Currently holds non-executive directorships in three medtech firms. Previously Senior VP at Philips Healthcare as well as VP and GM at Medical Diagnostics division at GE

Juha Vapaavuori
Chairman of the board of directors of Galilaeus and KC-Holding 3 and member of the board of FIT Biotech and Vivoxid. He is also a Senior Lead at Sitra, the Finnish innovation fund

Dr Johan Christenson
Partner at HealthCap and positions on several private company boards. Previously supervised health care portfolio at SEB Företagsinvest

Dr René Kuijten
Co-owner and GP of Life Sciences Partners. Previously at McKinsey & Company as co-leader of European Health Care and Pharmaceuticals Practice

Olli Riikkala
Currently  board member of several Finnish medical industry firms. Previously board member of Tieto, chairman of the boards of of Comptel Oriola-KD

Casper Breum
Partner of Lundbeckfond Ventures. Previously worked in business development and as project manager at H. Lundbeck A/S

Ken Charhut
Chairman of the board at two medical industry firms. CEO at Compellon. Previously CEO at other medtech firms

Harri-Pekka Puolakka
Chairman of M.A.S.I Company Oy, Action Learning Oy, Interdomer Oy, and a board member of Novagent Oy

Dr Ekaterina Smirnyagina
Partner of Health-Tech Fund Venture Fund at Capricorn Venture Partners. Previously partner at Alta Partners, a healthcare focused VC firm

Management

Janne Huhtala
Chief Executive Officer since 2013. Chief Financial Officer from 2008 to 2012. Previously manager at financial consultant firm Gutta Oy. Masters in Economics at Turku School of Economics (2001)

Mikko Karvinen
Chief Financial Officer since 2014. Previously held CFO and deputy CEO positions at two tech firms. MSc in economics at Helsinki School of Economics (2001)

Henri Hannula
VP Sales Europe since 2013. Various roles at Nexstim starting 2001 from a previous position as director of sales. MSc in technology from Helsinki U. of Technology (2001)

John Hardin
VP Global PSM Commercialisation since 2014. Previously served as VP global sales and marketing of Mindframe before joining Nexstim. MBA at William Woods U. (1996)

Rainer Harjunpää
VP Quality Assurance and Regulatory Affairs, since 2013. Previously director and manager of quality and regulatory affairs since 2010. MSc in biomedical engineering from Tampere U. of Technology (1993)

Gustav Järnefelt
VP R&D since 2013, previously Director of R&D since 2008. Previously held managerial positions at GE Healthcare Finland. MSc at Helsinki U. of Technology (1988)

Jarmo Laine
VP Medical Affairs since 2013, previously Director of Clinical Affairs since 2008. Previously held several directorial positions at Finnish Red Cross Blood Service. MBA at Helsinki U of Technology (2007) and PhD at U.Helsinki (1995)

Petriina Puolakka
VP Legal Affairs since 2013. Various roles at Nexstim starting 2001 from a previous position as director of legal affairs and HR. Master of Laws at U.Lapland (2001)

IMPORTANT NOTICE

This announcement is not a prospectus. The information contained herein does not constitute an offer to sell or the solicitation of an offer to buy, 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 jurisdiction. Any such offer will be made solely on the basis of a prospectus for the purposes of Directive 2003/71/EC (together with any applicable implementing measures in any Member State, the "Prospectus Directive") to be duly approved by the Finnish Financial Supervisory Authority and passported by way of notification to the Swedish Financial Supervisory Authority.

This communication is not addressed to the public in any Member State of the European Economic Area other than Finland and Sweden. With respect to each Member State of the European Economic Area other than Finland and Sweden (each, a "Relevant Member State"), no action has been undertaken to date to make an offer to the public of the securities requiring a publication of a prospectus in any Relevant Member State. As a result, this communication is only addressed to and directed at qualified investor in the Relevant Member States in circumstances not requiring the company to publish a prospectus as provided under the Prospectus Directive.

This announcement is not an offer for sale nor a solicitation of an offer to buy any securities in the United States or outside the European Economic Area. The securities referred to in this announcement may not be offered or sold in or into the United States of America absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. Nexstim has not registered and will not register any part of its contemplated offering in the United States nor will it offer any securities to the public in the United States. 

This communication is only being distributed to and is directed only at (i) persons who are outside the United Kingdom, or (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") and (iii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2) of the Order, and (iv) other persons to whom it may otherwise lawfully be communicated (all such persons together being referred to as "relevant persons"). Any investment or investment activity to which this communication relates will only be available to and will only be engaged in with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.

Securities in the company have not been, and will not be, registered under the applicable securities laws of Australia, Canada, Hong Kong, Japan or South Africa and may not be offered or sold within Australia, Canada, Japan or South Africa or to, or for the account or benefit of, citizens or residents of Australia, Canada, Hong Kong, Japan or South Africa except under circumstances which will result in full compliance with the applicable laws and regulations promulgated by the relevant regulatory authorities in effect at the relevant time.

This announcement contains forward looking statements. These forward looking statements include statements that are not historical facts and statements concerning inter alia Nexstim's future revenues, financial position, financial standing, prospects, growth, strategies and its plans, beliefs and current expectations in relation to its field of business. By their very nature, forward looking statements involve inherent risks and uncertainties, since they relate to events or result from circumstances that may or may not occur in the future, and therefore they only describe the circumstances prevailing when the statement is given. Nexstim cautions that forward looking statements or historical facts do not guarantee future performance and that its true revenues, financial position and financial standing and the development of the industry may significantly differ from the forward looking statements presented in this release.  The company does not intend and does not assume any obligation to update any forward looking statement contained herein.

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