Compumedics Limited announced that it has recently received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for its Okti high-density EEG amplifier range. This news will allow the newly expanded sales team in the USA to actively pursue sales of Okti across the USA EEG market, which is estimated at $400 million with a CAGR of 9%. Compumedics targets taking a 1% to 2% share of this market in the medium term.

Okti is the culmination of decades of experience in EEG monitoring and a deep understanding of patient care. Okti is the world's first of its kind high-density ambulatory EEG amplifier. Electroencephalogram (EEG) is the measurement of electrical activity in the brain, critical for monitoring and diagnosing disorders of the brain such as epilepsy.

As such, Okti can also be used for Routine and Long-Term EEG epilepsy monitoring (LTM). By combining several different channel interfaces into a compact hand-held format, Okti enables patients to undergo high resolution studies with the flexibility to be mobile within the Hospital or Clinic. Okti's wireless and high-definition capabilities will improve clinical workflows and the patient experience.

Okti allows for high-density EEG recordings, for LTM and Clinical Routine EEG studies in the USA. Okti is a modular, multi-functional design with interchangeable 32, 64 and 128 channel interfaces. Okti is approved for both pediatric and adult applications and has up to 72 hours battery life, with hot swappable batteries, to ensure continuous recording.

Typically, Okti will be used in a clinical or hospital setting, where neurological departments are based. When a patient goes into one of these facilities they would be wired to the device and monitored over a period of time. Okti's wireless capability enables the patient to freely move around with the device whilst the data is continuously captured.

Neurological or EEG monitoring and measurement is typically a subset of the data captured in sleep diagnostic studies. As such, the Company has focused on building its capability in the market so as to double the market size opportunity in the USA. This device will enable the Company to focus and expand its market share in neurology in the USA.

With the FDA approval in place, the Company may now enter the lucrative US clinical EEG market, with its expanded sales team. Okti systems will typically sell for around USD 50k to USD 250k depending on the number of devices and the final Okti configuration, with large LTM sites in the USD 1m plus range. These large LTM sites have previously not been accessible to Compumedics with its past product offering.

Okti is already CE marked and TGA approved with regulatory submissions for other territories to be completed in due course.