March 2019 Nanalyze
Cochlear implants spark interest in an emerging healthcare technology called electroceuticals.
Our cells are specialized to carry electrical currents, which are essential for the nervous system to send signals to and fro throughout the body and the brain. There is a growing body of evidence that devices that deliver a targeted electrical impulse could help treat chronic pain and disease. These electroceuticals, also known as bioelectronics or even neuromodulators, aren’t exactly new. Anyone with a pacemaker or cochlear implant is using an electroceutical device. Or those who have played with one of those at-home Transcutaneous Electrical Nerve Stimulator (TENS) instruments for pain treatment have also experienced a type of electroceutical therapy.
These devices can be either external, such as a wearable, or implanted into the body.
Many are designed to stimulate the vagus nerve, the longest cranial nerve in the human body that helps keep your heart beating and your lungs breathing. It’s also a key link between the gut and brain, with some research suggesting the of electroceuticals a couple of years ago, but in this article we’ll look at some of the specific conditions that bioelectronic therapies can treat and some of the companies behind the treatments.
Electroceuticals for Treating Headaches
One of the most active areas is chronic headaches. A company out of New Jersey called electroCore (ECOR) had raised about $127 million in funding before going public last year on the NASDAQ. It had a value of about $426 million at the time of the IPO, but has dropped to a current market value around $245 million in just nine months, despite receiving FDA clearance last November for gammaCore, its non-invasive vagus nerve stimulator therapy to help prevent cluster headaches in adults. Cluster headaches are a series of short but intensely painful headaches that can occur daily for weeks or months at a time. At least 325,000 people in the United States get them.
In one clinical trial, about 40% of patients who used the handheld instrument, which delivers a mild electrical pulse at the neck, experienced a 50% or greater reduction in weekly cluster attacks versus about 8% for those who only used standard therapy.
Neuromodulation for Treating Epilepsy
While cannabis has emerged as an effective treatment for some types of epilepsy, the disorder affects about 65 million people worldwide, requiring different kinds of therapies. London-based LivaNova (LIVN) is known for its implantable SenTiva VNS (Vagus Nerve Stimulation) Therapy. The FDA has approved VNS Therapy as an add-on therapy for those 4 years and older to treat focal or partial seizures that do not respond to seizure medications. A device is implanted under the skin in the left chest area. An attached wire is wound around the vagus nerve in the neck. The whole package is then programmed to deliver pulses at regular intervals. Studies have shown that the therapy improves over time, from reducing seizures by 36% after six months to about 75% after 10 years.
The company also has FDA approval of using VNS Therapy for treating depression and is currently investigating its application for heart disease. In addition, thanks to a $225 million acquisition of a California company called ImThera Medical, LivaNova also offers an electroceutical for treating sleep apnoea that stimulates the hypoglossal nerve to the tongue. It also carries a line of cardiovascular medical devices, which accounts for about 60% of its business, with electroceuticals making up the other 40%.
Electroceuticals for Treating Chronic Back Pain
Back pain is the single leading cause of disability around the world, with estimates that it costs the U.S. economy alone more than $100 billion in healthcare bills, lost wages, and productivity. Not surprisingly, then, we found quite a few companies offering nutraceutical solutions for back pain.
For instance Nevro out of Silicon Valley went public less than five years ago and sits on a market cap of about $1.8 billion after an initial IPO valuation of nearly $425 million. It offers an FDA-approved spinal cord stimulation technology it calls HF10, which involves inserting thin, insulated wires in the back near the spinal cord that are connected to a small battery-powered pulse generator, which is implanted just under the skin. The mild electrical pulses help calm the nerves.
The company says its system helps eight out of 10 people achieve a significant reduction in severe back and leg pain, which is probably a better option than getting hooked on opioids. Nevro has pretty steadily increased revenue every year since it went public in 2014, but has also steadily lost money as well.
Sacral Neuromodulation for Urinary and Faecal Dysfunction
This next topic isn’t for the squeamish: Urinary and faecal dysfunction. At least 33 million Americans suffer from an overactive bladder, while it’s estimated that one in three people deal with poo problems. One possible treatment is through sacral neuromodulation, which involves sending mild electrical pulses to stimulate the sacral nerves located in the pelvis area to modify the messages between the muscles there and the brain. Axonics Modulation Technologies (AXNX) out of the Los Angeles area already has approval for its sacral neuromodulation system in Europe. A lead with four electrodes is inserted in the sacrum and connected to an implantable pulse generator that sits under the skin in the upper buttock area.
Axonics just went public in October, and its stock saw a surge last month after news over a successful clinical trial and submission of the data to the FDA for approval of the electroceutical therapy in the United States.
Electroceutical for Treatment of ADHD
While exact numbers are hard to come by, as much as 11% of children and even 4.5% of adults have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Most treat the condition with medication. But a Los Angeles company called NeuroSigma, which has raised $13.4 million in financing since it was founded in 2008, has an alternative to drug stimulants for millions of kids and adults. Its Monarch eTNS System is a noninvasive electroceutical device for stimulating the trigeminal nerve, the largest of the cranial nerves that is responsible for sensations in the face and motor functions such as biting and chewing. It also projects directly or indirectly to areas of the brain involved in ADHD, epilepsy, and depression, among other conditions.
NeuroSigma has approval for the Monarch eTNS System in Europe for ADHD, as well as epilepsy and depression. The results of a double-blind showed that the system is as effective as FDA-approved nonstimulant ADHD medications. Composed of a cell-phone sized pulse generator and a single-use electric patch that is applied to the forehead, the device is still under investigation in the United States.
Bioelectronic Treatment for Sinus Pain
To prove there’s no chronic condition too niche for bioelectronics, Tivic Health out of Silicon Valley has raised $1.8 million for a handheld device to treat sinus pain due to allergic rhinitis or hay fever. There’s certainly a huge market potential: About 8% of U.S. adults were diagnosed with hay fever in 2016 alone. In January, Tivic received FDA clearance to sell ClearUP as an over-the-counter device for sinus pain. It works by gliding along the outside of the nasal passages to deliver low-current electrical waveforms that stimulate the nerves under the skin to help relieve sinus pain. No drugs or sprays required.
A 2018 double-blind, randomized control trial found that three out of four users found relief from sinus pain, while more than 80% reportedly said they preferred ClearUp to their current treatment.
The electroceuticals industry is rapidly ramping up amid big investments, new IPOs, mergers, acquisitions, and partnerships among some of the biggest names in healthcare. GlaxoSmithKline (GSK), for example, teamed up with Verily Life Sciences company, a subsidiary of Alphabet (GOOGL) in a $700-million joint venture called Galvani Bioelectronics to take on the electroceuticals industry. One key to the long-term health of the industry is sound scientific data that will convince the FDA to greenlight more of this technology, which seems to be happening, though not at the pace that it is in Europe.