The electroceutical market continues growth around the world, providing new opportunities to tech companies, but Korean innovators cannot make headway due to the industry’s low awareness of the burgeoning field and the government’s regulatory barrier, experts say.

Electroceuticals or bioelectronic medical applications refer to medical devices that stimulate the brain or nerve function with energy such as electric current or magnetic field to produce a therapeutic effect.

The electronic approach to disease treatment is now expanding its area to include depression and dementia, rheumatoid arthritis, and more recently cancer. Electroceuticals are in the spotlight for many reasons such as low side effects, affordability and the patient’s better tolerance.

In 2013, GlaxoSmithKline jumped into the market after first naming its electrical signal-based therapeutic device as electroceutical. The company agreed with Google to establish a joint venture and invest $715 million by 2023 to develop an electroceutical to treat rheumatoid arthritis.

The U.S. Food and Drug Administration (FDA) has so far granted marketing approval to more than 10 electroceuticals. In May of last year, Novocure, a U.S. electroceutical developer, scored an FDA nod for its brain tumor electroceutical used in combination with an existing chemotherapy.

Another U.S. company Inspire Medical Systems received FDA approval for its electronic application to treat patients with obstructive sleep apnea (OSA). Some doctors try to use an electric signal controller to suppress nerve transmission signals to treat obesity patients or those with attention deficit hyperactivity disorder (ADHD).

According to a Market & Market report, the global electroceutical market is expected to grow from $17.2 billion in 2016 to $25.2 billion in 2021, an 8 percent annual growth on average. The 2018 World Economic Forum picked electroceuticals as one of the top 10 promising technologies.

Still, electroceutical remains foreign to Korea, without any legal provision in the Medical Affairs Act.

Some therapies based on electrical stimulation have been approved by the Ministry of Food and Drug Safety, but the term electroceutical is not used. Key products include low-frequency and high-frequency stimulators for muscle pain relief, and a body implant to control urination. In particular, electroceutical products with excellent performance must pass the ministry’s new medical technology evaluation for verification of their safety and efficacy as new technology even after marketing approval by the Ministry of Food and Drug Safety.

Korean medical device maker Ybrain developed MINDD STIM to treat depression and received approval from the MFDS in early 2017 but has yet to pass the new medical technology review. None naturally has been sold. Ybrain is developing seven electroceuticals to treat other brain diseases such as migraine, dementia and insomnia with a goal of marketing approval in Korea by the end of next year.

Another Korean company NuEyne is developing an electrical stimulation therapy to treat dry eye and help recover nerve damage after glaucoma surgery. The treatment for dry eye is being studied in a clinical trial of patients undergoing LASIK surgery.

The government started to develop a strategy to foster the electroceutical industry with Korea Health Industry Development Institute (KHIDI). A KHIDI official said the government will prepare a mid- to long-term roadmap that spans the definition of electroceuticals, and industry revitalization, and come up with a result by the end of June.

By Kim Byung-ho and Minu Kim

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