As the years go by, technology keeps catching up with science fiction. We’ve come a long way from the rehashed tale of Frankenstein’s monster being brought to life using 19th-century sewing techniques and a spark of electricity. Nowadays, Hollywood just crams sci-fi movies, sequels, trilogies, and even tetralogies down our throats as fast as they can make them. With neon visuals and over-the-top action scenes, we can finally put down those boring books and plug directly into the future. Imagination not required.
Enterprising researchers will keep marching on despite the philosophical naysayers who majored in a liberal arts degree and became unemployed screenwriters. They’ll keep discovering new ways to hack the human body for fun and profit, tantalizing investors with visions of a utopic future, busy shoveling cash out of investors’ wallets, and putting it in their own at each funding round. Not to worry. We can still thank them for their hard work by swiping our credit cards for overpriced health insurance and healthcare fees.
The New Wave of Bioelectronic Devices
In the end, the future waits for no one. And teams of lab rats have been busy building out the technology of bioelectronic devices. In case you are just skimming through your smartphone on a lunch break, bioelectronic devices are implantable or wearable devices that send electrical impulses to specific regions of the body as a way of treating chronic conditions or diseases. Another term for them is electroceuticals. Both are new categories of therapeutics that use electricity to treat disease, aimed to replace traditional pill-based pharmaceuticals for certain conditions where drugs have limited use.
Bioelectronic devices themselves aren’t anything new (think cardiac pacemakers, which have been around for decades), but the technology is making headway for use in new disease states like Alzheimer’s or Crohn’s disease. The advantage of this new wave of bioelectronic devices is that they are non- or minimally invasive and some can work much like a pill with daily use. McKinsey & Company predicts a $2 billion market for bioelectronic devices if just 5% of patients with inflammatory conditions like rheumatoid arthritis and Crohn’s disease transition away from pills. Based on their prediction, we’re staring down the barrel of a multibillion-dollar opportunity for multiple diseases.
Just for the record, medical device startups, in general, had a record year in 2020, raising more than $19 billion, according to CB insights. So investors are putting down their hard-earned cash to pump up these companies.
That also means potentially there’s a lot of competition in the market. As we noted in our article about FDA-approved AI algorithms, one way to differentiate is to see which companies have made the leap from amateur scientists to serious business by gaining regulatory clearance or approval from the U.S. Federal Drug Administration. There are several types of FDA approvals, designations and clearances for medical devices, and all of the companies below have received or in the process of receiving one of these agency approvals.
Bioelectronic Device for Sinus Pain Relief
Founded in 2016, San Francisco startup Tivic Health has raised nearly $11 million in funding to develop a FDA cleared bioelectronic health device called ClearUP Sinus Pain Relief. This small handheld device is drug-free and designed to reduce allergy sinus pain for the 50 million Americans with allergies . More recently, the ClearUP device can now claim to reduce moderate to severe congestion from allergies, the flu, and the common cold. Available at major online retailers nationwide.
ClearUP is clinically proven and uses a gentle microcurrent waveform for relieving sinus and nasal pain and congestion. Study subjects with moderate to severe congestion reported on average a 44% reduction in congestion after 4 weeks of regular use. Last spring, ClearUP received CE Mark approval (the equivalent of FDA approval in Europe) which opens the market for ClearUP to sell in over 190 countries. In a coming article, we’ll do a deep-dive into this interesting company to learn more about what they plan to do with bioelectronic health devices.
Bioelectronic Device for Chronic Autoimmune Diseases
Founded in 2006, Los Angeles-based SetPoint Medical has been around for a while. The company has raised $216.4 million in the past 15 years, including medical industry players GlaxoSmithKline (GSK) and Boston Scientific (BSX). We covered SetPoint Medical a few years ago, in case you weren’t keeping track. The company’s technology is based on the accidental discovery of SetPoint Medical’s co-founder, Dr. Kevin Tracey, back in the 1990s, when portable CD players used to be a hip statement of youth culture. He found out that shooting electricity up the vagus nerve, which is the information superhighway between the brain and the gut, stopped inflammation in the gut and rheumatoid arthritis.
SetPoint Medical has since been developing an implantable device about the size of a triple-A battery that surgeons shove right into a patient’s neck. The device shoots tiny electrical shocks to the patient’s vagus nerve, with a battery life of 10 years, before it has to be replaced. Hopefully, the warranty hasn’t expired.
Bioelectronic Devices for Stroke
Another startup that’s been around the block, Israel-based BrainsGate was founded in 2000 and has raised $84.5 million, also from the likes of Johnson & Johnson and Boston Scientific. It is creating technology to treat patients suffering from central nervous system diseases, with a current focus on acute ischemic stroke, the most common type of stroke. While its technology is still pending under the FDA, its device has been given Conformitè Europëenne (CE) approval in Europe.
The BrainsGate device works by implanting a miniature electrode into the roof of a patient’s mouth that’s supposedly similar to dental treatment. The electrode sends an electric shock into a collection of nerve cells called the sphenopalatine ganglion, which is meant to increase blood flow and oxygen to the brain. The shock also releases neurotransmitters that improve the healing of damaged parts of the brain after a stroke. If the company used its technology to treat other conditions that could use a little more blood flow, it’d be making serious green on the side.
Bioelectronic Device for Essential Tremor
Founded in 2014, Cala Health is a bioelectronic medicine startup based in the good ol’ San Francisco Bay Area and has raised $71.3 million from a laundry list of investors, most notably Novartis (NVS) and Johnson & Johnson. Cala Health is developing a non-invasive, wearable device, called Cala Trio, which fits on a patient’s wrist and sends electrical signals to counteract the shaking hands experienced by individuals suffering from essential tremor. Think souped-up, bulky Apple Watch, except all it does is keep your hand from spilling your coffee and writing illegible signatures.
To get through the FDA approval process, the company conducted a randomized clinical trial on 77 patients to test the effectiveness of its device. Apparently, only three of those patients had what it called adverse events, which involved lots of itchiness and some pain. That sure beats the laundry list of side effects that most pharmaceutical ads read off these days.
Bioelectronic Device for Chronic Migraines
While salvia has been used by Mexican shamans to trip out on the divine for ages, Dutch startup Salvia BioElectronics is all about shocking those neurons to get the old noggin stirred up. Founded in 2017, this company has banked $34.6 million from investors with very European-sounding names. The company is building a bioelectronic device to treat chronic migraines and was just granted breakthrough device designation in November 2020 to expedite patient access to the device. Migraine is the No. 1 cause of disability in people under 50, affecting one out of seven people. People with chronic migraines suffer from 15 or more headache days per month. So there’s a huge market that aspirin just can’t cure.
Salvia’s device works by inserting an electronic foil right under the skin of a person’s head using a minimally invasive surgical procedure. So not too far off from chip implants. One day, it might even offer free migraine treatment in exchange for watching a 30-second ad directed straight into your brain.
Bioelectronic Devices for Snoring
The most common reason why couples sleep apart is snoring. In fact, marriages have been known to fall apart at a higher rate due to snoring. Founded in 2015, Signifier Medical Technologies has raised $23 million to combat this great marital affliction. The company is using that cash to build basically an advanced mouth retainer that sends electric signals to tongue muscles and gives them a workout.
The idea is that most snoring and sleep apnea problems are rooted in weak tongue muscles, so stronger tongues mean better sleep. While there are other ways to strengthen the tongue muscles that’ll also keep a marriage afloat, Signifier Medical Technologies offers a less adventurous approach.
Bioelectronic Device for Alzheimer’s
Founded in 2013, Phoenix-based NeuroEM Therapeutics is a clinical-stage startup developing a bioelectronic device to treat Alzheimer’s. The company has raised less than $1 million in government grants and money from private donors, which might explain the single stitching here:
Its device, which amounts to basically a swim cap, orthodontic headgear, and a cell phone from the early 90s soldered together, sends electromagnetic waves to treat Alzheimer’s. Unlike conspiracy theorists who wear tinfoil hats to keep their brains free of electromagnetic waves, this hat harnesses the power of those waves to penetrate through the brain. The electromagnetic waves dislodge abnormal brain proteins, called beta-amyloid, which build up throughout an Alzheimer’s patient’s lifetime.
Despite the glowing corporate press releases, Healthline cautioned that consumers should be aware that there’s little evidence so far that this electromagnetic cap can actually treat Alzheimer’s, though the company received FDA breakthrough device status for accelerated development and assessment back in October 2020.
Bioelectronic Device for Opioid Withdrawal Relief
While Texas is now known for its poorly managed power grid, advanced technologies have been known to spring up from the Lone Star State from time to time. Spark Biomedical was founded in 2018 and has since brought in a grand total of $50,000 from a Texas A&M venture competition. (That’s what they’ve disclosed on Crunchbase, though we’re being told they’ve raised more than that in undisclosed funding.) Spark Biomedical has developed a technology to treat opioid addiction called the Sparrow Therapy System, which sounds more like a pyramid scheme led by a cult leader than a treatment to curb opioid withdrawal symptoms. The devices created by Spark Biomedical deliver electrical pulses to stimulate nerves near the ear, which then activates areas in the brain that release endorphins in the same way as an opioid to curb withdrawal symptoms.
So instead of drowning out the world’s sorrows with a pill purchased from Johnson & Johnson, patients can plug in and turn up the juice for personalized withdrawal therapy. Can’t say that’s much different from our modern problematic smartphone use.
Bioelectronic devices might seem like magic, turning the clock on an ailing patient’s body using electricity. But rest assured, the FDA has us covered, making sure high-flying startup companies aren’t blowing smoke up our rear. After all, scrutiny from the FDA started the downward spiral for Theranos and its fraudulent claims regarding its blood-testing technology.
While scientists are being funded by Silicon Valley to work out the kinks in the real speculative technologies behind immortality research and cryogenics, bioelectronic devices might be the next best thing for us average folks who can cough up a few grand per month for life-saving medicine. Welcome to the ‘Murican health system.