Compumedics Ltd (ASX:CMP) has received US Food and Drug Administration (FDA) 510(k) clearance for its Okti® high-density EEG amplifier range – the world’s first-of-its-kind high-density ambulatory EEG amplifier.
FDA clearance gives CMP the green light to start selling this next-generation neurological monitoring device in the US, where the estimated EEG (Electroencephalogram) market is US$400 million with a CAGR of 9%.
The company’s newly expanded US sales team will now actively pursue sales of Okti® across the US and is targeting a 1% to 2% share of this market in the medium term. The company focused on expanding its market share in neurology in the USA.
Okti®is already CE marked and TGA approved with regulatory submissions for other territories to be completed in due course.
“Compumedics is pleased to have achieved this important milestone for the Okti® EEG amplifier range,” chairman and CEO of Compumedics Dr David Burton said.
“Receiving 510(K) clearance from the FDA, whilst expected, is nevertheless satisfying, and validating. In addition to the technical accomplishments achieved by the company, it represents a key milestone in relation to a major objective to expand our EEG market share in the USA.”
What is Okti®
Combining decades of experience in EEG monitoring with a deep understanding of patient care, Compumedics has created a high-density ambulatory EEG amplifier that is the first of its kind in the world.
EEG, a measurement of electrical activity in the brain, is critical for monitoring and diagnosing disorders of the brain such as epilepsy.
A tool like Okti® can be used for not just basic EEG monitoring but also things like Routine and Long-Term EEG epilepsy monitoring (LTM).
Okti® systems typically sell for around US$50,000 to US$250,000 depending on the number of devices and the final configuration, with large LTM sites in the US$1 million plus range.
These large LTM sites have previously not been accessible to Compumedics with its past product offering.
Okti® combines several different channel interfaces into a compact hand-held format and enables patients to undergo high-resolution studies with the flexibility to be mobile within the Hospital or Clinic.
A further benefit is the improvement of wireless and high-definition capabilities in clinical workflows and the patient experience.
How it works
Okti® is a modular, multi-functional design with interchangeable 32, 64 and 128 channel interfaces and is approved for both paediatric and adult applications. The tool has up to 72 hours of 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 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. CMP feel that this device will help it double the market size opportunity in the USA.