American corporations SetPoint Medical announced on 31st (local time) that its electroceutical for treating rheumatoid arthritis has received Food and Drug Administration (FDA) approval. Electroceuticals, a portmanteau of electronic and pharmaceutical, refers to treating diseases through electrical stimulation instead of medication.
An era is approaching in which intractable diseases are treated with electricity instead of medication. Electroceuticals can be used by patients who cannot swallow pills. There is no need to remember to take medicine on time, and patients are free from side effects caused when medications go to unwanted places. The National Research Foundation of Korea (NRF) projected in a report last year that the global electroceutical market size will grow from 25 trillion won in 2020 to 51 trillion won by 2030.
◇Reconfiguring the immune system to prevent overreactions
Rheumatoid arthritis is an autoimmune disease in which the immune system attacks itself. Immune cells attack the joints, causing inflammation that results in pain and swelling. SetPoint Medical reported that, in a clinical trial involving 242 patients over one year, joint pain and swelling were reduced by 60% and 63%, respectively. Side effects were less than 2%.
SetPoint's electroceutical is a 2.5 cm device implanted in the neck. It stimulates the vagus nerve, which transmits signals between the brain and organs, for one minute each day. According to SetPoint's research, electrical stimulation suppresses inflammation.
The company stated that the electroceutical reconfigures the immune system to produce therapeutic effects. This means it fundamentally treats arthritis by managing the overreaction of the immune system. Currently, most rheumatoid arthritis treatments suppress the immune system, leading to side effects that make patients susceptible to infections.
There are 1.5 million rheumatoid arthritis patients in the U.S. Each patient spends thousands of dollars a month on medication. SetPoint Medical said, 'The electroceutical can be used for up to 10 years once implanted,' adding, 'The cost will be lower than a year's worth of medication.'
◇Treating everything from depression to ADHD and COVID-19
Overseas, electroceuticals have been approved for a variety of diseases ranging from Parkinson's disease and epilepsy to obesity, sleep apnea, and intestinal disorders.
American corporations Enteromeedics received FDA approval for an electroceutical for obesity treatment in 2015. The electroceutical is implanted between the stomach and esophagus to stimulate nerves and induce a feeling of fullness. The FDA approved ElectroCore's vagus nerve stimulator for use in patients with acute COVID-19 who are experiencing breathing difficulties in 2020.
Electroceuticals have even awakened patients in a vegetative state. A research team led by Dr. Angela Sirigu at the French National Institute of Health and Medical Research awakened a person in a vegetative state with electroceuticals in 2017. The patient had been unresponsive for 15 years due to a traffic accident. After electro-stimulation of the vagus nerve for three months, the patient regained consciousness, with increased activity in brain areas associated with movement, sensation, and awareness.
In Korea, an electroceutical has been developed to treat depression and attention deficit hyperactivity disorder (ADHD). Ybrain developed a depression electroceutical named 'Mindstimulation,' which received approval from the Ministry of Food and Drug Safety in 2021. The cumulative prescriptions have exceeded 180,000.
The electroceutical developed by New-Ain called 'Smile' treats attention deficit hyperactivity disorder by electrically stimulating the trigeminal nerve, which is a facial nerve connected to the brain.
Electroceuticals treat intractable diseases that medications do not affect, but they are not a cure-all. This electroceutical for arthritis could not be used by patients whose vagus nerve is damaged. There are also side effects different from those of medications. The National Research Foundation of Korea (NRF) noted, 'Patients sensitive to electrical stimulation may experience inflammation in the skin or nerves,' adding, 'As this is a new treatment method, research on its safety is insufficient.'