Scientific Resources

Study Highlight

Implantation Accuracy of Novel Polyimide Stereotactic Electroencephalographic Depth Electrodes

Implantation accuracy of sEEG electrodes is critical for safety and efficacy of the procedure. The goal of this study was to evaluate the implantation accuracy and user interface of NeuroOne's EVO® sEEG electrodes under conditions stimulating clinical practice.

NeuroOne Publications

  1. Implantation accuracy of novel polyimide stereotactic electroencephalographic depth electrodes—a human cadaveric study
    Ref: Aura Kullmann1* Farida Akberali2 Jaime J. Van Gompel3 Robert A. McGovern4 W. Richard Marsh3 Debra Kridner1 Camilo A. Diaz-Botia1 Michael C. Park4,5
    Frontiers Feb 2024

  2. First Food and Drug Administration Cleared Thin-Film Electrode for Intracranial Stimulation, Recording, and Monitoring of Brain Activity-Part 1: Biocompatibility Testing
    Ref: Aura Kullmann et al.
    Frontiers in Neuroscience. 2022

  3. Electrochemical Testing of a New Polyimide Thin Film Electrode for Stimulation, Recording, and Monitoring of Brain Activity
    Ref: Samuel Ong et al.
    Micromachines 2022, 13(10), 1798

  4. Flexible and conformable thin film subdural electrodes for neural recordings – a new era in clinical practice
    Ref: Aura Kullmann et al.
    White Paper

  5. Commercial Scale Production of Thin-Film Electrode Arrays for Clinical Intracranial EEG*
    Ref: Gregory A. Worrell et al.
    American Epilepsy Society. 2019

  6. Development of polyimide electrodes for high-resolution intracranial EEG recordings*
    Ref: Regina Bower et al.
    American Epilepsy Society. 2017

  7. Multi-resolution Intracranial EEG Rodent Recording System*
    Ref: Inyong Kim et al.
    American Epilepsy Society. 2017

  8. 2019 Frontiers in Medical Devices Abstracts, Biomedical Engineering Society Bipolar Radiofrequency Ablation of the Brain Using a Virtual Patient Population*
    Ref: Erica E. Neumann et al.
    Biomedical Engineering Society

NeuroOne Conferences and Scientific Participation

    Past


  1. Society of Neuroscience – SFN
    Title: Evaluation of a new stereoelectroencephalography-guided radiofrequency ablation system in an in vivo swine model
    Presentation Number: PSTR575.03
    Abstract Control Number: 7332
    Presentation Date/Location: 11/15/2023 1:00:00 PM - 5:00:00 PM, Washington DC

  2. American Epilepsy Society - AES
    Title: In Vivo Evaluation of a New Stereoelectroencephalography-guided Radiofrequency Ablation System
    Poster Session Number: 3.079
    Presentation Date/Location: Monday December 4, 2023, 12:00 PM - 1:45 PM, Orlando FL

  3. Congress of Neurosurgical Surgeons – CNS
    Title: Evaluation of a new stereoelectroencephalography - guided radiofrequency ablation system: an in vivo swine study
    Presentation Date/Location: Tuesday September 12, 2023, 6:00-7:30 pm, Washington DC

  4. 8th Neurological Disorders Summit - NDS-2023
    Title: Innovative Stereoelectroencephalography - guided radiofrequency ablation system - in vivo swine evaluation
    Presentation Date/Location: June 13, 2023, Rome, Italy

  5. NANS Annual Meeting
    Presentation Type: Poster
    Title: Electrochemical Characterization of the First FDA-Cleared Thin-Film Electrodes for Recording and Stimulation of Brain Activity
    Presentation Date/Location: January 12-15, 2023, Las Vegas, NV
    Session: tbd

  6. Gordon Research Conferences: Neuroelectronic Interfaces
    Presentation Type: Poster
    Title: First FDA cleared thin film electrode for intracranial recording and monitoring of brain activity – device testing and initial clinical use
    Presentation Date/Location: March 13-18, 2022, Ventura CA
    Session: Posters

  7. World Society for Stereotactic and Functional Neurosurgery - WSSFN
    Presentation Type: Oral Presentation
    Title: Implantation accuracy of novel polyimide stereotactic electroencephalographic depth electrodes - a human cadaveric study
    Presentation Date/Location: September 5 2022, South Korea
    Session: AI & Technological Innovation
    Presenter: Michael C. Park, United States
    Co-Authors: Michael C. Park, Jamie J. Van Gompel, Robert A. McGovern, Richard Marsh, Farida Akberali, Camilo A. Diaz-Botia, Aura Kullmann
    Link: https://www.wssfn2022.org/program/page2.php

  8. Congress of Neurosurgical Surgeons – CNS
    Presentation Type: Digital Poster
    Title: A Novel Polyimide Stereo-electroencephalographic (sEEG) Electrode: Safety and Performance Testing
    Presentation Date/Location: October 10-12, 2022, San Francisco CA

  9. Society of Neuroscience - SFN
    Presentation Type: Poster
    Title: A Novel Polyimide-Based Electroencephalographic Depth Electrode Array: Safety and Performance Testing
    Session Number: I.04.f. Electrophysiology – Electrode arrays
    Presentation Number: Nov. 13, 2022 3:00 PM - 4:00 PM, San Diego, CA

  10. American Epilepsy Society - AES
    Presentation Type: Poster
    Title: Novel Polyimide Stereoelectroencephalographic Depth Electrodes: Safety and Performance Testing
    Presentation Date/Location: Monday, December 5, 2022 12:00 PM - 1:45 PM, Nashville TN
    Poster Session Number: 3.100

  11. Congress of Neurosurgical Surgeons - CNS
    Presentation Type: Oral Presentation
    Title: First FDA Cleared Thin Film Electrode for Intracranial Recording and Monitoring of Brain Activity – Device Testing and Initial Clinical Use
    Presentation Date: October 19, 2021 - (07:00 AM - 08:30 AM)
    Session: Sunrise Science and Late Breaking Abstract Session IV

  12. Society of Neuroscience - SFN
    Presentation Type: Virtual Poster, Abstract #952
    Title: Device testing and initial clinical use of thin film electrodes for intracranial recording and monitoring of brain activity
    Session Number: P545
    Presentation Number: P545.09
    Session Title: Neurophysiology: Implanted Electrodes and Other Direct Interactions with Neurons I
    Virtual Poster Session Time: 11/10/2021 2:15:00 PM - 11/10/2021 3:15:00 PM CT

  13. American Epilepsy Society - AES
    Presentation Type: Poster Presentation: In-Person/Virtual
    Title: First FDA Cleared Thin Film Electrode for Intracranial Recording and Monitoring of Brain Activity – Device Testing and Initial Clinical Use
    Poster Session #: 2.094
    Learn More
  14. American Epilepsy Society - AES
    Presentation Type: Poster
    Title: Development of polyimide electrodes for high-resolution intracranial EEG recordings
    Presentation Date: December 2, 2017
    Abstract Number: 1.060

  15. American Epilepsy Society - AES
    Presentation Type: Poster
    Title: Multi-resolution Intracranial EEG Rodent Recording System
    Presentation Date: December 3, 2017
    Abstract Number: 2.062

Other Relevant Scientific Articles and Abstracts

  1. Stereoelectroencephalography-Guided Radiofrequency Thermocoagulation: Diagnostic and Therapeutic Implications
    Ref: James F. Castellano 1,*,Shobhit Singla 1,Niravkumar Barot 2 and Joshua P. Aronson 3
    Brain Sciences Jan 2024
  2. Human Intracranial EEG: Promises and Limitations*
    Ref: Joseph Parvizi and Sabine Kastner
    Nature Neuroscience. 2018 Apr; 21(4): 474–483.

  3. Intracranial EEG in the 21st Century*
    Ref: Barbara C. Jobst et al.
    Epilepsy Current. 2020, Vol. 20(4) 180-188

  4. Diagnostic utility of invasive EEG for epilepsy surgery: Indications, modalities, and techniques*
    Ref: Prasanna Jayakar et al.
    Epilepsia. 57(11):1735-1747, 2016

  5. Stereoelectroencephalography in epilepsy, cognitive neurophysiology, and psychiatric disease: safety, efficacy, and place in therapy*
    Ref: Youngerman BE et al.
    Dove Press journal: Neuropsychiatric Disease and Treatment

Links to Foundations and Societies

Links to foundations:

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Footnotes

*The links provided through this page are not under the control of NeuroOne and are provided strictly for your convenience. NeuroOne does not represent, warrant, or endorse such web sites, and is not responsible or liable for the accuracy, currency, completeness, availability or reliability of such web sites or the content, products or services obtained from such web sites. NeuroOne shall have no liability for any damages or injuries of any kind arising from the content of or products or services obtained from such web sites.

1. Frederico A C Azevedo , Ludmila R B Carvalho, Lea T Grinberg, José Marcelo Farfel, Renata E L Ferretti, Renata E P Leite, Wilson Jacob Filho, Roberto Lent, Suzana Herculano-Houzel, J Comp Neurol. 2009 Apr 10;513(5):532-41. doi: 10.1002/cne.21974. Equal numbers of neuronal and nonneuronal cells make the human brain an isometrically scaled-up primate brain https://pubmed.ncbi.nlm.nih.gov/19226510/

2. Josef Parvizi, Sabine Kastner, Nat Neurosci. 2018 Apr; 21(4): 474–483. doi: 10.1038/s41593-018-0108-2 Human Intracranial EEG: Promises and Limitations, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6476542/

3. Vossler et al, 2018 Epilepsy Curr. 2018 Jul-Aug; 18(4 Suppl 1): 1–26. doi: 10.5698/1535-7597.18.4s1.1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6130739/

4. https://www.aesnet.org/clinical_resources/treatments/drug_alerts_fda_news

5. Baumgartner et al., F1000Res 2019 Oct 29;8:F1000 Faculty Rev-1818. doi: 10.12688/f1000research.17714.1. Presurgical epilepsy evaluation and epilepsy surgery https://pubmed.ncbi.nlm.nih.gov/31700611/

6. Jayakar et al., Epilepsia. 2016 Nov;57(11):1735-1747. doi: 10.1111/epi.13515. Diagnostic utility of invasive EEG for epilepsy surgery: Indications, modalities, and techniques PMID: 27677490 https://pubmed.ncbi.nlm.nih.gov/27677490/

7. George et al, Front Neurol. 2020 May 12;11:320. doi: 10.3389/fneur.2020.00320 Stimulation Mapping Using Stereoelectroencephalography: Current and Future Directions https://pubmed.ncbi.nlm.nih.gov/32477236/

DAVE ROSA
President & Chief Executive Officer

Mr. Rosa is an entrepreneur with three decades of experience in the medical device industry spanning a variety of technologies and products. In addition to CEO roles with early-stage medical device companies, Mr. Rosa’s background also includes senior roles with C.R. Bard Inc., Boston Scientific Inc., and St. Jude Medical, where his responsibilities included marketing, product development and business development. He has been named as an inventor on multiple medical device patents, serves on seven corporate boards, and has raised $200M in the capital markets. Mr. Rosa holds an MBA from Duquesne University and a BS in Commerce and Engineering from Drexel University.

RON McCLURG
Chief Financial Officer

Mr. McClurg has over 30 years of financial leadership experience with private and public companies. Prior to joining NeuroOne, Mr. McClurg was VP - Finance & Administration and Chief Financial Officer of Incisive Surgical, Inc., a privately-held medical device manufacturer, and Chief Financial Officer and Treasurer of Wavecrest Corporation, a privately-held manufacturer of electronic test instruments for the semiconductor industry. Mr. McClurg also served as Chief Financial Officer for several publicly-held companies, including Video Sentry Corporation, Insignia Systems, Inc., and Orthomet, Inc. Currently, he serves as a director for a privately held company. He began his career in public accounting with Ernst & Young, where he earned his CPA certificate. He holds a Bachelor of Business Administration degree in accounting from the University of Wisconsin – Eau Claire.

MARK CHRISTIANSON
Co-Founder, Business Development Director, Medical Sales Liaison

In excess of 15 years of executive sales, sales management, marketing, and project management experience with development stage companies. Prior to NeuroOne, Mr. Christianson held the positions of North American Sales Manager for Cortec Corporation, a manufacturer of specialty chemical products, and Regional Sales Manager for PMT Corporation, a leading manufacturer of products for neurosurgery, orthopedics and plastic surgery. He holds an accounting degree from Augsburg College.

STEVE MERTENS
Chief Technology Officer

Prior to joining NeuroOne, Mertens was Sr. Vice President of R&D and Operations at Nuvaira, a privately held lung denervation company developing minimally invasive products for obstructive lung diseases. Before that, Mertens was a Senior Vice President of Research and Development for Boston Scientific, where he guided a wide range of technologies through product development for the cardiology, electrophysiology, and peripheral vascular markets.

Mertens began his medical device career working in engineering, quality control, and manufacturing roles at SciMed Life Sciences. Mertens holds a Bachelor of Science degree in Chemical Engineering from the University of Minnesota and a master’s degree in Business Administration from the University of St. Thomas.

Chris Volker
Chief Operating Officer

Mr. Volker has over 20 years of experience in the medtech industry including at Abbott, Cardiovascular Systems, Inc. (CSI), St. Jude Medical and in investment banking. At CSI, Mr. Volker held the role of Vice President & General Manager of International and had direct responsibility for international commercial expansion, including Sales, Training & Education, Marketing, Business Development and Program Management. Prior to CSI, Mr. Volker held executive leadership roles at St. Jude Medical where he led Corporate Development, Health Economics & Reimbursement and Strategic Market Research across all of St. Jude Medical's business units as well as held executive responsibilities for Human Resources for the Cardiovascular Division. He began his career in healthcare and technology investment banking where he gained expertise in M&A, strategic planning, growth equity investments and financings. Mr. Volker earned a Bachelor of Arts degree from St. John’s University and a Masters of Business Administration degree from the Wharton School at the University of Pennsylvania.

Hijaz Haris
Vice President of Marketing

Mr. Haris has more than 20 years of experience with Medtronic, the world’s largest Medical Device company. Most recently he led Global Marketing for Medtronic’s Brain Modulation business, where he helped refresh the Deep Brain Stimulation product pipeline and led the business through a period of new competitive entries, new product launches, brand refresh, and various distribution partnerships. Prior to that Hijaz held various roles of increasing responsibility across multiple business segments (Cardiac Rhythm Management, Neuroscience, Neuromodulation) and business functions (Product and Strategic Marketing, Corporate Sales, Sales Strategy, and Corporate Finance). In his career with Medtronic, he has been part of new category launches and led significant commercial initiatives across multiple areas.

CAMILO DIAZ-BOTIA
Director of Electrode Development

Dr. Camilo Diaz-Botia is a highly experienced neural engineer whose work has focused on the development of technologies for bidirectional communication with the nervous system. He has authored and co-authored multiple peer reviewed scientific articles published in journals including Journal of Neural Engineering, Neuron, and Lab-on-a-Chip.

Most recently, Dr. Diaz-Botia worked for Neuralink where he led and mentored the process engineering team to deliver projects with unique microfabrication processes. Under his direction, the team built and designed novel processes for integration of thin film neural probes with brain machine interface systems.

Dr. Diaz-Botia earned a B.S. in Electrical Engineering from Universidad Nacional de Colombia and a Ph.D. in Bioengineering from the joint program at the University of California Berkeley and the University of California San Francisco. During his graduate studies, he conducted research on microfabricated thin film neural interfaces for chronic implants developing electrocorticography arrays with silicon carbide, a material suitable for long-term performance in harsh environments, and electrode arrays for minimally invasive subcortical recordings.

Chad Wilhelmy
Vice President of Quality Control and Regulatory Affairs

Chad Wilhelmy joined NeuroOne with 20 years of medical device experience developing, implementing, and leading quality management systems. Prior to joining NeuroOne, he held top leadership roles at HLT Medical as the Vice President of Quality and at Sunshine Heart as the Senior Director of Quality. He has driven quality strategies from early-stage development to commercial distribution with both the FDA and Notified Body. Chad earned a Bachelor of Science degree from the University of Wisconsin - Stout in Engineering Technology with an emphasis in Quality.

Paul Buckman
Chairman
Jeff Mathiesen
Director
Ed Andrle
Director
Dave Rosa
President and CEO
Greg Worrell MD, PhD
Chairman
Jamie Van Gompel, MD
Board Member
Gregory J Esper, MD, MBA
Board Member
Justin Williams, PhD
Board Member
Bob Gross, MD, PhD
Board Member
Kip Ludwig, PhD
Board Member
Kip Ludwig PhD
Chairman
Parag Patil MD, PhD
Board Member
R Jacob Vogelstein Phd
Board Member
Ayem M Salem MD
Board Member
Cristin Welle PhD
Board Member
Douglas J Weber PhD
Board Member
Joost Wageenar PhD
Board Member