Introduction

Epilepsy is a neurological disorder characterized by abnormal brain activity resulting in seizures. Epileptic seizures occur when the neurons in the brain miscommunicate. This miscommunication typically results in involuntary muscle seizure activities and/or periods of perceptual disconnect where the individual appears frozen.

Normal Brain Activity
Partial Seizure
Generalized Seizure

The majority of epilepsy is genetic or has no known cause while secondary causes of epilepsy, such as stroke, brain tumor, traumatic brain injury and central nervous system infections account for the remaining cases. According to the Centers for Disease Control and Prevention4 (CDC) and Citizens United for Research in Epilepsy5 (CURE), there are over three million patients currently suffering with epilepsy in the U.S., with an additional 200,000 diagnosed every year. They also estimate that epilepsy costs the U.S. $15.5 billion per year.

In addition to poor quality of life, epilepsy is associated with increased mortality rates, especially in children. CURE reported that Sudden Unexpected Death in Epilepsy (SUDEP) accounts for 34% of all deaths in children5. Such deaths have increased by close to 100% from 2005 to 2015 according to the CDC4.

Surgical Intervention

Up to one third of epilepsy patients are not well controlled with pharmaceutical treatment and may be appropriate for surgical treatment of this disorder. Surgical treatment typically requires a craniotomy, a highly invasive surgical procedure where a portion of the skull is removed to facilitate diagnosis, surgical planning, and correction through resection. This procedure:

  • Carries high-risk
  • May result in infection (the skull remains off for a period of 1 to 4 weeks)
  • Is costly
  • Is highly intimidating and painful to patients
  • Suboptimal outcomes which many clinicians believe are due to low resolution diagnostics

Despite the large market opportunity, it is estimated that few than 10,000 patients undergo surgery for epilepsy each year. This represents a significantly underpenetrated market, likely due to the invasiveness of the procedure and uncertain treatment outcomes which rely on accuracy and specificity of recorded brain activity. For most patients who could benefit from surgical treatment of epilepsy, the perceived risk often outweighs the reward.

Cancer Research UK

Opportunity to Improve Outcomes

We believe our technology will offer a number of significant advantages over the current technologies:

  • Our proprietary thin-film cortical electrode technology is significantly thinner than competitive technology and accommodates many more electrodes per square centimeter for greater recording specificity and accuracy.
  • Limited testing to date by Mayo Clinic suggests that our proprietary thin-film technology can detect single neuron brain activity; this could allow for more rapid detection of irregular brain activity versus the average of two and a half weeks with the currently available technology, during which time the patient remains hospitalized.
  • In the future, we expect our thin-film technology to enable a minimally invasive procedure utilizing a small burr hole, versus a full craniotomy, to insert the electrode grid or strip. All-in-one devices offering recording, stimulation, and ablation are also in development. These all-in-one devices will allow for diagnosis and treatment in a single minimally invasive procedure rather than requirement multiple surgeries.