Introduction

NeuroOne is a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, initially targeting epilepsy. We have a robust and growing intellectual property portfolio for a pipeline of products in various stages of development.

Today, our attention is on the development and commercialization of the following product categories:

Diagnostic Recording

Cortical electrodes are used in electrocorticography (ECoG), more commonly referred to as intracranial electroencephalography (iEEG), to record the electrical activity of the brain and identify the location of irregular brain activity for surgical planning and treatment. iEEG recording with cortical electrodes involves an invasive surgical procedure, referred to as a craniotomy.

Depth electrodes are another less invasive method of intracranial recording that uses electrodes placed stereotactically in targeted brain areas via small holes drilled through the skull. This method, known as stereoelectroencephalography (sEEG), is also used to record electrical activity in the brain and identify the location of irregular brain activity for surgical planning and treatment.

Therapeutic Modalities

Deep brain stimulation (DBS) therapies involve activating or inhibiting the brain with electricity that can be given directly by electrodes on the surface or implanted deeper in the brain via depth electrodes. This procedure involves sending electrical impulses through implanted depth electrodes to specific targets in the brain.

RF ablation is a procedure that directs radiofrequency energy to the site of the brain tissue that is targeted for removal. The ablation does not remove the tissue, rather, it is left in place and typically scar tissue forms in the place where the ablation occurs. This procedure is also known as brain lesioning as it causes irreversible lesions.

Planned Technology Attributes

Existing technology in these categories have significant shortcomings that limit their widespread use. Products in the NeuroOne pipeline are intended to address many of these limitations.

NeuroOne aims to offer the following features and benefits in our future Cortical Electrodes:
  • Significantly thinner substrate for better conformability to recording surface
  • Advanced materials reduce brain inflammation2
  • Detection of microseizures for faster diagnosis and reduced hospital stays3,6
  • High-resolution recording increases accuracy and specificity of diagnostics, improving resection planning and, therefore, outcomes2,3
  • Single tail to minimize risk of infection2
  • Includes disposable, sterile cable saving EEG technician time and costs related to cable management
  • Allows for minimally invasive placement2
NeuroOne aims to offer the following features and benefits in our future Depth Electrodes:
  • Detection of microseizures for faster diagnosis and reduced hospital stays3,6
  • High-resolution recording increases accuracy and specificity of diagnostics, improving resection planning and, therefore, outcomes2
  • Includes disposable, sterile cable saving EEG tech time and costs related to cable management
  • Second generation technology may offer diagnoses and treatment using a single device

Preclinical Testing

Our cortical technology for the diagnosis of epilepsy has been used by doctors at Mayo Clinic in multiple preclinical tests conducted from 2012 to 2017. In preclinical models, doctors examined the biological impact on mammalian brains.

Porcine Histological Analysis2

Polyimide substrate electrodes (NeuroOne technology) were implanted into porcine subdural space for one week alongside standard competitive electrodes. The tissue underneath the two types of electrodes was removed, fixed, stained, and examined for immunological responses. The results of a histological analysis showed reduced immunological reaction to prolonged polyimide substrate implants (NeuroOne technology) compared to standard silicone substrate competitive clinical electrodes.

Recording Resolution Analysis2,3

Electrophysiological (brain neuron activity) properties were examined through intraoperative recordings obtained and evaluated in a porcine seizure model and on areas of the cortex planned for resection five human subjects undergoing surgery for drug resistant epilepsy. Doctors examined the changes in local field potential activity of the brain with thin film electrodes (NeuroOne technology) and then compared it to competitive electrodes. Electrophysiological recordings showed data obtained from polyimide electrodes showed feasibility of high fidelity multi-scale electrophysiology while also displaying easier deployment of polyimide electrodes (NeuroOne technology) through burr holes utilizing a minimally invasive approach. In addition, the flexibility and reduced thickness of polyimide electrodes should reduce pain and swelling associated with implantation of the device, and the single tail exiting the skull should reduce infection risk.

Combined, these properties suggest that the replacement of current competitive silicone electrodes with polyimide substrate electrodes (NeuroOne technology) for recording brain activity for epilepsy could provide enhanced clinical value with reduced cost, reduced infection risk, and improved patient comfort.

University of Wisconsin Research6

In addition, our cortical implant technology has been tested by researchers at the University of Wisconsin-Madison in multiple preclinical studies conducted from 2006 to 2016. These studies, illustrated in a variety of preclinical animal models that included mice, rats and primates, that thin film cortical implant technology can reliably record brain activity from different areas of the brain, can be implanted successfully in a minimally invasive fashion, can be safely implanted over long-time periods of up to five years, can electrically provide brain stimulation and tissue ablation, and has increased flexibility versus existing commercially available technology that allows the grids to conform to the brain surface.