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Nexstim Oyj. (12/1/17). "Press Release: Nexstim Plc Appoints Steve Beller as Vice President and General Manager, North America". Helsinki.

Region Region North America
Organisations Organisation Nexstim Oyj
  Group Nexstim (Group)
  Organisation 2 Abbott (Group)
Product Product brain stimulation device
     


Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company"), a medical technology company developing and marketing pioneering navigated non-invasive brain stimulation systems for both therapeutic and diagnostic applications, announces the appointment of Steve Beller as Vice President and General Manager, North America effective from 1 January 2018. Mr. Beller will join the Nexstim Management Team and report to CEO Martin Jamieson.

Steve Beller has extensive experience in the US neuro-stimulation market where he was most recently Area Vice-President at Abbott Neuromodulation, managing a team of over 170 people in the Western half of the US. Prior to this, Mr. Beller held Senior Director and Regional Sales Director roles at St Jude Medical Neuromodulation, before it was acquired by Abbott.

Steve Beller will lead commercialisation efforts for Nexstim’s NBT® system in the US across indications, starting with depression, following the recently announced FDA clearance for use of the NBT® system in the treatment of Major Depressive Disorder (MDD).

The NBT® system is currently in a supplementary Phase III E-FIT trial for its use in stroke rehabilitation, which is expected to complete in mid-2018, allowing Nexstim to file for FDA clearance, following which Mr. Beller would also lead commercialisation efforts for this indication.

The NBT® system is based on Nexstim’s unique navigated Transcranial Magnetic Stimulation (nTMS) which allows for accurate, reproducible brain stimulation in therapy.

Commenting on the appointment, Martin Jamieson, Chairman and CEO, Nexstim Plc stated: “I am very pleased to welcome Steve Beller to the team. His experience in managing and directing sales in the neuromodulation field in the US will be invaluable as we develop our commercialisation capacity for the NBT® system in the US ahead of its introduction to the market for the treatment of depression during H1 2018.”


NEXSTIM PLC

Martin Jamieson, Chairman and CEO

Further information is available on the website www.nexstim.com or by contacting:

Nexstim +447715163942
Martin Jamieson, Chairman and CEO martin.jamieson@nexstim.com

UB Securities Oy (Certified Adviser) +358 (0)9 2538 0246

Citigate Dewe Rogerson +44 (0)207 2822949
David Dible/Isabelle Andrews/Shabnam Bashir david.dible@citigatedewerogerson.com


About Nexstim Plc

Nexstim is a medical technology company developing and marketing pioneering navigated non-invasive brain stimulation systems for both therapeutic (NBT® system) and diagnostic (NBS system) applications. Nexstim's NBS system is the only FDA cleared and CE marked system based on navigated Transcranial Magnetic Stimulation (nTMS) for the pre-surgical mapping of the speech and motor cortices of the brain. Based on the same technology platform, the Company has developed the Navigated Brain Therapy (NBT®) which is CE marked in Europe for the treatment of stroke, major depression and chronic neuropathic pain.

Nexstim has received clearance from the FDA for marketing and commercial distribution of its NBT® system for the treatment of Major Depressive Disorder (MDD) and looks forward to introducing the NBT® system for this important indication during H1 2018.

The NBT® system is currently in a 60 patient, supplemental Phase III study, E-FIT trial, for its use in stroke rehabilitation. The trial is expected to complete in mid-2018, allowing Nexstim to file for FDA clearance. FDA clearance would allow Nexstim to start marketing and selling its NBT® system for stroke rehabilitation in the USA.

Nexstim shares are listed on the Nasdaq First North Finland and Nasdaq First North Sweden. For more information please visit www.nexstim.com


[ als ZUSATZINFO geholt via http://www.nexstim.com/about-us/contact/ ; ML ]


http://www.nexstim.com/about-us/contact/



Headquarters:
Nexstim Plc

Elimäenkatu 9 B
FI-00510 Helsinki
Finland
Tel. +358 9 2727 170
Fax +358 9 2727 1717
info@nexstim.com

VAT # FI16288811
Nexstim Inc.

The John Hancock Building
875 N. Michigan Ave. Suite #3100
Chicago, IL 60611
USA
Tel. +1 312 373 3704
Fax +1 312 794 7801
info@nexstim.com
Nexstim Germany GmbH

Lyoner Straße 14
60528 Frankfurt
Germany
Tel. +49 69 6655 4149
Fax +49 69 6655 4100
info@nexstim.com

VAT # DE2616623567

Rainer Corn
Director, Sales D/A/CH
M. +49 151 6732 2965
rainer.corn@nexstim.com
Distributors:
Austria

Rainer Corn
Director, Sales D/A/CH
M. +49 151 6732 2965
Fax +49 69 6655 4100
rainer.corn@nexstim.com

Henri Hannula
Vice President, Sales Europe
M. +49 170 330 4215
M. +358 50 548 57 69
Fax +358 9 2727 1717
henri.hannula@nexstim.com
Denmark

PO Medica AB
Sparsörsvägen 1,
51350 Sparsör, Sweden
Pierre Kullander
Nordic Sales Manager
M. +46 0 705 26 68 89
pierre.kullander@po-medica.se
Estonia

Henri Hannula
Vice President, Sales Europe
Office +358 9 2727 1712
M. +358 50 548 57 69
Fax +358 9 2727 1717
henri.hannula@nexstim.com
Finland

PO Medica AB
Sparsörsvägen 1,
51350 Sparsör, Sweden
Kaija Hämäläinen
Product Manager
M. +358400653608
Kaija.hamalainen@po-medica.se
France

CMT Wenger
19 Rue des Freres Lumiere
67201 Eckbolsheim
France
Tel. +33 0 3 88 76 99 76
Fax +33 0 3 88 78 10 63
Iceland

PO Medica AB
Sparsörsvägen 1,
51350 Sparsör, Sweden
Pierre Kullander
Nordic Sales Manager
M. +46 0 705 26 68 89
pierre.kullander@po-medica.se
Italy

Integra LifeSciences Italy
Centro Direzionale Milanofiori Strada 6 Palazzo N 3
20089 Rozzano (MI) - Italy
Fax +39 02 57511371
custsvcitaly@integralife.com


Latvia

Henri Hannula
Vice President, Sales Europe
Tel. +358 9 2727 1712
M. +358 50 548 57 69
Fax +358 9 2727 1717
henri.hannula@nexstim.com
Lithuania

Henri Hannula
Vice President, Sales Europe
Tel. +358 9 2727 1712
M. +358 50 548 57 69
Fax +358 9 2727 1717
henri.hannula@nexstim.com
Norway

PO Medica AB
Sparsörsvägen 1,
51350 Sparsör, Sweden
Pierre Kullander
Nordic Sales Manager
M. +46 0 705 26 68 89
pierre.kullander@po-medica.se
Russian Federation

Medical Systems Joint Stock Company
V.O., 10 Linia, 17 korp 2, lit.A office 1H
191915 Saint-Petersburg
Russia
Business identity code (INN) 7825700581
Tel. + 7 812 448 5775
belyaev@nicolet.ru


Saudi Arabia

Amico Group
Jeddah Head Office
PO Box 3871
Jeddah 21481
Kingdom of Saudi Arabia
Tel. +966 2 660 1149
ksa@amicogroup.com
Spain

Synmed
R. M. Barcelona, Tomo 20.198, Folio 124, Hoja B-2.902, Inscripción 3ª,
Avd. Príncipe de Asturias, 43-45, 08012 Barcelona
Tel. +34 934 159 497
Fax +34 934 161 970
www.synmed.es
Sweden

PO Medica AB
Sparsörsvägen 1,
51350 Sparsör, Sweden
Pierre Kullander
Nordic Sales Manager
M. +46 0 705 26 68 89
pierre.kullander@po-medica.se
Switzerland

Rainer Corn
Director, Sales D/A/CH
M. +49 151 6732 2965
Fax +49 69 6655 4100
rainer.corn@nexstim.com

Henri Hannula
Vice President, Sales Europe
M. +49 170 330 4215
M. +358 50 548 57 69
Tel. +358 9 2727 1712
Fax +358 9 2727 1717
henri.hannula@nexstim.com


Taiwan

Jings Instrument Co. Ltd
9F-2, No. 84, Sec 1 Zhong -Shan North Road, Taipei City, Taiwan, ROC.
www.jings.url.tw
Tel. +886 2 2564 3536 (Ext.602)
M. +886 9 1951 0327
Fax +886 2 2564 3576
info@ww.jings.url.tw
Turkey

Deltamed Medical Instruments Industry & Trade Co. Ltd
Karanfil Sokak 12/1-2 Kizilay,
06650 Ankara, Turkey
Tel. +0312 418 40 90
Tel. +0212 635 69 95
www.deltamed.com.tr
United Kingdom

Optima Medical Ltd
1 Archway Mews,
241 Putney Bridge Rd,
London SW15 2PJ, UK
Tel. +44 0 20 8874 4770
Fax +44 0 20 8874 5770
www.neurophys.co.uk


Greece

Neuraxon Ltd.
Kyprou 1
P.O.Box 15451, Neo Psychiko
Athens
Tel. +30 210 77 57 320
Fax +30 210 77 57 322
pantelis.stanitsas@neuraxon.gr



http://www.nexstim.com/about-us/


A Leader in Navigated Transcranial Magnetic Simulation (TMS)
About Nexstim

Nexstim is a medical technology company focusing on improving rehabilitation for stroke patients through the use of noninvasive brain stimulation. Nexstim has pioneered the technology for brain diagnostics with its Navigated Brain Stimulation (NBS System) as the first and only FDA cleared and CE marked navigated transcranial magnetic stimulation (nTMS) device for presurgical mapping (PSM) of the motor and speech cortices. Based on the same technology platform Nexstim has developed a device for stroke therapy called Navigated Brain Therapy (NBT® System).

In 2014, Nexstim initiated a pivotal Phase III clinical trial in 12 of the leading US rehabilitation centres (see above) on the therapeutic effects of Nexstim’s NBT® following highly encouraging Phase II results. Nexstim stopped the trial after 138 patients at end of March 2016 following the recommendation of the Data Safety Monitoring Board (DSMB), an independent committee of experts monitoring the trial, after significant and clinically meaningful responses from both active and sham patient groups. No safety concerns were observed with any of the 199 patients enrolled in the trial.

Nexstim is now preparing a FDA 510(k) De Novo submission based on the clinical data, and aims to obtain FDA marketing clearance for the NBT® device for post-acute stroke treatment.

With its NBT® System, Nexstim is initially focusing on the rehabilitation of hand and arm movement (upper limb motor disability) which is the most common symptom following a stroke. Nexstim has developed a navigational technology which allows for the accuracy to target the correct area of the brain repeatedly, maximising the dose control of stimulation for improvement of hand and arm control. Nexstim has been able to achieve promising levels of improvement in motor functions (twofold improvement compared to conventional rehabilitation) that last throughout a 6-month observation period due to the effectiveness of its navigation algorithms. Nexstim is preparing to seek for an FDA clearance in the US to begin the commercialization of its NBT® System for use in stroke rehabilitation.
Our History of Innovation

Nexstim was established in 2000 as the result of a spin off from research into low temperature physics at the Helsinki University of Technology (currently part of Aalto University) following various research projects that were carried out at the BioMag laboratory of the Helsinki University Central Hospital in 1994-1999.

The purpose of Nexstim was to commercialize the opportunities discovered through the addition of navigation to existing transcranial magnetic stimulation (TMS) technology. Nexstim believed navigation to be the crucial aspect for the emerging TMS technology to become a clinical tool for patient treatment.

To materialize the full potential of navigated TMS, Nexstim first set out to develop the navigation aspect of the technology by developing and launching a diagnostics tool. By proving the safety, accuracy and reliability of the NBS System through diagnostics established a regulatory base and market foundation for the use of the same device in other more commercially profitable markets, such as the stroke therapy market. Nexstim's NBS System has been successful in receiving positive research attention and utilization by key opinion leaders (KOLs) in addition to being fully CE marked and FDA cleared, paving the way for use in stroke therapy.

With safety and reliability proven through the diagnostic utilization of the NBS System, application of Nexstim's NBT® System in stroke rehabilitation now requires proof of efficacy through Phase III studies, which aims to prove the repeatability of earlier Phase II results on a larger patient base in order to receive FDA clearance.
Our Strategy

Nexstim’s strategy is to validate the navigated transcranial magnetic stimulation (nTMS) technology's therapeutic utility in post-acute stroke motor rehab demonstrating the high value clinical impact of the navigated technology platform in noninvasive neuromodulation.

Nexstim’s strategy is also to further validate the commercial potential with the clinical utility of the same technology in presurgical mapping. For presurgical mapping, Nexstim has developed the NBS System, which is FDA cleared, CE marked and sold to approximately 120 universities and teaching hospitals. Nexstim now plans to utilize the validation of its navigation technology in the PSM market to launch its stroke rehabilitation device the NBT® System on the basis of the promising Phase II results achieved in the rehabilitation of upper extremity motor disability.

After the first interim analysis of the Phase III results, Nexstim received a recommendation from the Data Safety Monitoring Board (DSMB), an independent committee of experts monitoring the trial, to continue the Phase III stroke therapy NICHE trial, without any modifications towards the goal of achieving its primary endpoint. The first interim analysis on the NICHE (Navigated Inhibitory rTMS to Contralesional Hemisphere) trial using Nexstim’s Navigated Brain Therapy (NBT®) was performed after 81 patients reached their primary safety outcome assessment, on track, at six months post-treatment.

The second interim analysis is expected to occur in Q1 2016 and the study is scheduled to complete in Q3 2016 when full data will be disclosed.

In the future, Nexstim plans to expand to other indications within stroke and, for example, in pain and tinnitus.
Our Commitment to High Quality Technology

The Navigated Brain Stimulation and Navigated Brain Therapy Systems are manufactured using internationally-accepted standards of performance. Nexstim is ISO 13485 (medical device standard) certified. Nexstim has also achieved ISO9001 Quality Certification. Nexstim’s products are CE-marked as medical devices in the EU, Medical Device Directive 93/42/EEC. The Navigated Brain Stimulation System and NexSpeech® are cleared by the FDA for use in presurgical planning for patients undergoing brain surgery.

Nexstim’s noninvasive Navigated Brain Therapy (NBT) System is not approved for Stroke Therapy by the Food and Drug Administration in commercial distribution or use in the United States and is available to select physician for investigational use only.

   
Record changed: 2017-12-07

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