On 19 April, NeuroSigma was granted permission to market its Monarch external Trigeminal Nerve Stimulation (eTNS) System – the first medical device given this type of approval for the treatment of attention deficit hyperactivity disorder (ADHD) – by the US Food and Drug Administration (FDA).
ADHD non-drug treatment
ADHD is a common disorder, with symptoms beginning in childhood. Seven years is the average age of diagnosis. Children affected by ADHD often have difficulty controlling their behaviour, paying attention and staying focused. The US Census Bureau estimates that roughly 129 million children between the ages of 5 and 19 had ADHD in 2013. The current standard treatment is behavioural therapy and medication, with 6.1% of US children currently being treated for ADHD with medication. While the causes for ADHD are not precisely known, a combination of genetics, environment and improper neurological system development are thought to play a role.
Medical devices have been used as treatments for neurological disorders for a long time. In particular, neurostimulation (also known as neuromodulation) is one of the fastest-growing medical device markets.
The concept of modern neuromodulation began in the 1960s when deep-brain and spinal cord stimulators were developed and used to treat chronic, intractable pain. Since then, neurostimulation devices have been used to treat a wide array of diseases/disorders, including but not limited to Parkinson’s disease, epilepsy, major depression disorder, and even urinary and faecal incontinence. In general, neuro-stimulation devices work by delivering electrical signals directly to nerves.
GlobalData estimated the global market value for neurostimulation devices to be over $4.5 billion in 2017 and projects exponential growth into the future. Medtronic commands this market, with Boston Scientific and Abbott Healthcare being other big players.
NeuroSigma is a Los Angeles-based life sciences company that focuses on manufacturing TNS devices for neurological disorders. Its Monarch eTNS system is a small, mobile phone-sized device with a small patch attached via a wire. The patch can adhere to the patient’s forehead while the patient is asleep and, under the supervision of a caregiver, delivers low-level electrical stimulation to branches of the trigeminal nerve, which then signals to the parts of the brain thought to be involved in ADHD. This device is intended for ADHD patients aged 7 to 12 who are not currently taking any prescription ADHD medication. A placebo-controlled clinical trial showed significant improvement in moderate to severe ADHD symptoms in patients who used the Monarch eTNS system compared to those who used the placebo device.
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The Monarch eTNS System is the first neurostimulation device indicated for ADHD, and thus clears the path for future devices in treatments of other related neurological disorders. Factors that threaten this market are the lack of knowledge of the mechanisms that cause many neurological disorders and the high cost of these devices.