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. Challenges and opportunities of acquiring cortical recordings for chronic adaptive deep brain stimulation
    Ref: Jeffrey Herron, Aura Kullmann, Timothy Denison, Wayne K. Goodman, Aysegul Gunduz, Wolf-Julian Neumann, Nicole R. Provenza, Maryam M. Shanechi, Sameer A. Sheth, Philip A. Starr, Alik S. Widge
    Nature Biomedical Engineering, Dec 2024
  2. 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

  3. 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

  4. 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

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

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

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

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

  9. 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. North American Neuromodulation Society (NANS)
    Title: Percutaneous Implantation and Stimulation Versatility of Thin-Film Paddles – Cadaveric and in vivo Sheep Study
    Presentation Date/Time: Friday, January 31, 2025, 5:00 PM – 6:30 PM
  2. Materials Research Society (MRS), Boston
    Title: Advancing Thin Film Implants for Spinal Cord Stimulation—Innovations in Electrode Design and Methodology from Industry Perspectives
    Presenter: Maria Vomero
    Presentation Date/Location: 12/01/2024, Boston, MA
  3. American Epilepsy Society (AES), Los Angeles
    Title: sEEG-based drug delivery system - feasibility bench and in vivo studies
    Presenter: Aura Kullmann et al.
    Presentation Date/Location: 12/01/2024, Los Angeles, CA
  4. American Epilepsy Society (AES), Los Angeles
    Title: Initial Clinical Experience with the First FDA-Cleared sEEG-Guided Radiofrequency Ablation System
    Presenter: Efstathios Kondylis, MD and Cleveland Clinic Team
    Presentation Date/Location: 12/01/2024, Los Angeles, CA
  5. American Epilepsy Society (AES), Los Angeles
    Title: First-in-Human Experience with FDA Cleared sEEG-Guided RFA System
    Presenter: Michael D. Staudt, MD, University Hospitals Cleveland and Sanjeet S. Grewal, MD, Mayo Clinic Jacksonville
    Presentation Date/Location: 12/01/2024, Los Angeles, CA
  6. American Epilepsy Society (AES), Los Angeles
    Title: Real-time temperature monitoring sEEG - guided radiofrequency ablation (RFA) system: in vivo and ex vivo lesion characterization
    Presenter: Aura Kullmann et al.
    Presentation Date/Location: 12/01/2024, Los Angeles, CA
  7. International Conference on Neurology and Brain Disorders (INBC)
    Title: Innovative sEEG-based device for neural recordings, ablation, and drug delivery into the brain
    Presentation Date/Location: 10/21/2024, Baltimore, MD
  8. Society for Neuroscience (SFN)
    Title: Innovative sEEG-based device for neural recordings, ablation and drug delivery into the brain
    Presenter: Aura Kullmann et al.
    Presentation Date/Location: 10/10/2024, Chicago, IL
  9. CNS
    Title: Real-time temperature monitoring sEEG-guided RFA system – lesion characterization
    Presentation Date/Location: 10/01/2024, Houston, TX
  10. Congress of Neurological Surgeons (CNS)
    Title: sEEG-based device for concomitant neural recordings and drug delivery into the brain
    Presentation Date/Location: 09/30/2024, Houston, TX
  11. Business of Pain – ePoster
    Title: Application of Thin-Film Technology in Percutaneous Paddle Leads for Spinal Cord Stimulation
    Presentation Date/Location: 09/26/2024, Nashville, TN
  12. Business of Pain – Gator Pit
    Title: The Perc-Paddle, a Percutaneously Implantable Paddle Lead
    Presenter: Dr. Sean Li
    Presentation Date/Location: 09/26/2024, Nashville, TN
  13. ASSFN Biennial Meeting
    Title: Preclinical evaluation of a new sEEG-guided RFA system
    Presenter: Robert Gross
    Presentation Date/Location: 06/01/2024, Nashville, TN
  14. ASSFN
    Title: Ex vivo lesion characterization of new sEEG-guided RFA system
    Presenter: Mary McNeil
    Presentation Date/Location: 06/01/2024, Nashville, TN
  15. INS World Congress
    Title: Feasibility of Implantation of Epidural Thin-Film Paddle Leads
    Presenter: Aura Kullmann
    Presentation Date/Location: 05/15/2024, Vancouver, Canada
  16. ASGCT Annual Meeting
    Title: Device for Concomitant Therapeutic Delivery and Neural Recordings
    Presentation Date/Location: 05/10/2024, Baltimore, MD
  17. AAPS-NBC
    Title: Innovative device for neural recordings and drug delivery
    Presenter: Guadalupe Zepeda
    Presentation Date: 05/05/2024
  18. Gordon Research Conference – Neuroelectronic Interfaces
    Title: Feasibility of Thin-Film Paddle Lead Implantation
    Presenter: Maria Vomero
    Presentation Date/Location: 03/12/2024, Galveston, TX
  19. North American Neuromodulation Society (NANS)
    Title: Feasibility of Thin-Film Paddle Leads – in vivo Sheep Study
    Presenter: Aura Kullmann
    Presentation Date/Location: 01/15/2024, Las Vegas, NV
  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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
  33. 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

  34. 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:

Links to societies:

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.

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.

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.

Parag G. Patil, M.D., Ph.D.
Chief Medical Advisor

Dr. Parag G. Patil is a neurosurgeon-engineer with 20 years’ experience serving patients and advancing innovative therapies to alleviate neurological disorders. After joining the faculty at the University of Michigan in 2005, he has served as an Associate Professor of Neurosurgery, Neurology, Anesthesiology, and Biomedical Engineering. He additionally serves as Associate Chair for Clinical and Translational Research and in leadership roles in diverse multi-disciplinary, multi-investigator research efforts and national societies. His academic goal is to utilize engineering and mathematical techniques, along with interdisciplinary collaboration, to improve neuroprosthetics and perform translational neuroscience research. His NIH and NSF-funded research focuses on electrophysiology, imaging, mathematical modeling, and the development of improved therapies for the treatment of paralysis, pain, and movement disorders using neural-interface devices.
Dr. Patil received a B.S. in electrical engineering from the Massachusetts Institute of Technology. After graduation, he was awarded a Marshall Scholarship to study Philosophy and Economics at Magdalen College, Oxford University in the UK. On returning to the U.S., Dr. Patil pursued combined medical and doctoral studies in biomedical engineering at Johns Hopkins University, followed by a neurosurgery residency at Duke University and a fellowship at the University of Toronto.

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.

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.

Emily Johns
General Counsel and Corporate Secretary

Ms. Johns is an experienced public company lawyer who most recently served as a partner at Honigman LLP, where she represented many biotechnology companies in securities and corporate governance matters, including representing NeuroOne on all transactional work since 2017. Previously, she began her career at Sullivan & Cromwell LLP, where she represented public companies in securities offerings and merger transactions. She received her J.D. from UCLA School of Law and her bachelor's degree from the University of Michigan.

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.

Evan Goulet, Ph.D.
Senior Director of Quality Assurance and Regulatory Affairs

Evan brings 20 years of experience in medical device quality assurance and regulatory affairs, with a multi-faceted background in the industry. He earned his Ph.D. in Materials Science and Engineering from the University of Pennsylvania and a bachelor’s degree in Materials Engineering from Auburn University.

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