⚡ How bioelectronic medicine is rewiring chronic disease care

Welcome back to Healthy Innovations! 👋

This week brings groundbreaking news that validates an entire field: the FDA just approved the first bioelectronic device for treating rheumatoid arthritis (RA). But this milestone represents far more than a single product - it signals the emergence of bioelectronic medicine as a legitimate therapeutic approach that could transform how we treat dozens of conditions.

So, let's dive into this breakthrough and explore the broader world of bioelectronic medicine!

Breaking: A new era begins

Last Wednesday, the FDA approved the SetPoint System from SetPoint Medical - an inch-long device surgically implanted in the neck that stimulates the vagus nerve for just one minute each day, as highlighted in this New York Times article.

The SetPoint System represents a radical departure from standard care - instead of suppressing the immune system with drugs, it uses targeted electrical stimulation to "reset" inflammation naturally.

The approval came with breakthrough designation, expediting development due to the device's potential to transform treatment for a condition that has relied almost entirely on pharmaceutical interventions.

In a yearlong randomized controlled trial of 242 RA patients that included a sham-treatment arm, over half of the participants using the SetPoint implant alone achieved remission or saw their disease recede. Measures of joint pain and swelling fell by 60% and 63%, respectively. Trials for patients with multiple sclerosis and Crohn’s disease are also planned.

For Dawn Steiner, a 58-year-old speech pathologist from New York who participated in the trial, the results have been life-changing. She was diagnosed with rheumatoid arthritis 15 years ago and has tried eight different biologic agents since then. Some worked temporarily, but their efficacy eventually waned and they carried serious side effects.

Ms. Steiner received the implant in July 2023. "Before the implant, the doctor would ask where I was in terms of pain on a scale of one to 10, and I would say I was living a six or seven," Ms. Steiner said in the NYT article. "Now I'm about a two."

Best of all, she added, she can go to rock concerts and ball games, which she often had to miss in the past because it was so hard to get in and out of large arenas and stadiums. "I literally feel like I got my life back," Ms. Steiner said.

The science behind the signals

The SetPoint device is the product of decades of research spearheaded by neurosurgeon Dr. Kevin J. Tracey. He describes the vagus nerve, which originates in the brain and travels to virtually all the organs of the body, as an "on-off switch" for an overactive immune system.

"The brain can turn off inflammation as long as the vagus nerve is intact," he said. "It's like a brake system in your car."

Dr. David Chernoff, chief medical officer of SetPoint Medical, explains the fundamental difference: "Drugs find a pathway that contributes to damaging joints in RA patients and try to block it. What we're doing is completely different - we're re-educating the immune system through the brain to behave differently." As a result, he said, "we're not blocking the ability to fight off infection."

This is crucial because most current rheumatoid arthritis drugs suppress the immune system, leaving patients vulnerable to serious infections.

The bioelectronic revolution across medicine

The SetPoint approval validates bioelectronic medicine - a field that uses precisely targeted electrical stimulation to treat disease by programming the body's electrical system rather than introducing foreign chemicals. What makes this approach so promising is its precision: unlike drugs that affect the entire body, electrical stimulation can target specific nerve circuits with millimeter accuracy.

This versatile field already spans multiple medical specialties, with established applications and exciting emerging uses:

Cardiac Rhythm Management represents the most established bioelectronic field, with pacemakers and defibrillators saving millions of lives. Next-generation systems incorporate AI to predict and prevent dangerous arrhythmias.

Deep Brain Stimulation (DBS) has been treating Parkinson's disease for decades, with over 160,000 patients implanted worldwide. Beyond Parkinson's, researchers are exploring DBS for epilepsy, essential tremor, dystonia, severe depression, Alzheimer's disease, and traumatic brain injury. Modern systems are advancing toward closed-loop technology that adapts stimulation based on real-time brain activity.

Spinal Cord and Peripheral Nerve Stimulation helps manage chronic pain by interrupting pain signals before they reach the brain. Companies like Nevro have revolutionized the field with high-frequency therapy that doesn't cause tingling sensations. These approaches offer alternatives to opioids for complex regional pain syndrome, post-surgical pain, and neuropathy.

Transcranial Stimulation uses external magnetic fields or electrical currents to treat depression, ADHD, anxiety, PTSD, and addiction without surgery. The FDA has cleared several devices, including systems for treatment-resistant depression, offering new hope for difficult-to-treat mental health conditions.

Vagus Nerve Stimulation extends far beyond the new rheumatoid arthritis application. LivaNova offers FDA-cleared devices for epilepsy and depression, while electroCore provides non-invasive stimulation through their gammaCore device for migraines and cluster headaches. Clinical trials are already underway testing vagus nerve stimulation for inflammatory bowel disease in children, lupus, obesity, diabetes, and other conditions. Trials for multiple sclerosis and Crohn's disease are also planned.

The expanding competitive landscape

Multiple companies are pioneering different approaches across this growing field:

Medtronic dominates several categories, from DBS systems for neurological disorders to spinal cord stimulators for chronic pain, with their latest innovations including MRI-compatible devices and smartphone-controlled programming.

LivaNova specializes in vagus nerve stimulation with automatic stimulation adjustments based on heart rate patterns, while electroCore focuses on non-invasive approaches.

Boston Scientific advances neuromodulation for pain management and neurological conditions, while Galvani Bioelectronics, a collaboration between GSK and Alphabet's Verily, develops bioelectronic medicines for metabolic disorders.

SetPoint Medical represents the newest breakthrough, focusing specifically on inflammatory diseases through their novel immune system modulation approach.

Challenges and the road ahead

Despite its promise, bioelectronic medicine faces significant challenges:

Safety and surgical risks: The most common serious complication with the SetPoint device was hoarseness associated with implantation surgery, affecting just under 2% of participants. Most advanced bioelectronic systems require implantation, carrying risks of infection, device failure, and surgical complications.

Cost and access: Advanced bioelectronic devices can cost tens of thousands of dollars. While the SetPoint device is designed to last 10 years and may cost less than a year's worth of some RA drugs (which can cost thousands of dollars monthly), insurance coverage varies widely across applications.

Long-term unknowns: The device's long-term effectiveness and safety outside clinical trials are not yet known. The FDA required post-marketing monitoring of patients and adverse events as part of the approval.

Technical complexity: Unlike pills with standard dosing, electrical stimulation requires precise parameter adjustment and ongoing medical supervision, with optimal settings varying significantly between patients.

The future is power-ful!

The SetPoint approval represents an early test of bioelectronic medicine's promise to modulate inflammation, which plays a key role in diseases including diabetes, heart disease, and cancer. It validates decades of research into the body's electrical systems and opens the door for similar approaches across medicine.

Looking ahead, we can expect closed-loop systems that automatically adjust stimulation based on real-time biological feedback, continued miniaturization requiring only outpatient procedures, and AI integration enabling personalized stimulation patterns that adapt to individual patient responses.

Bioelectronic medicine represents a fundamental shift from traditional pharmaceutical approaches. Rather than introducing foreign chemicals, it harnesses the body's existing electrical systems to restore health. For patients like Dawn Steiner, this technology offers hope for managing chronic conditions without the side effects and limitations of traditional drugs.

As Dr. Tracey noted, the body needs some level of inflammation to help with healing wounds, fighting infections, and promoting tissue repair. The goal isn't to eliminate inflammation entirely, but to restore the proper balance - something the body's own electrical systems are uniquely positioned to achieve.

The next breakthrough therapy might not come from a chemistry lab - it might come from better understanding the electrical language our bodies already speak.

Innovation highlights

🌊 Seas the day, live longer. US researchers analyzed 66,000+ census tracts and found coastal residents live about a year longer than the 79-year average. Surprisingly, urban dwellers near inland waters had slightly shorter lifespans. The ocean advantage likely comes from milder temperatures, cleaner air, better recreation opportunities, and higher incomes. This groundbreaking study is the first to systematically examine "blue space" and longevity across America.

🔮 Crystal ball for calories. Scientists created a genetic test using data from 5+ million people that predicts childhood obesity risk before age 5 - twice as accurate as previous methods! The polygenic risk score could enable early interventions to prevent obesity rather than just treat it. Interestingly, high-risk individuals respond better to lifestyle changes but also regain weight faster when interventions stop. The breakthrough works best for European ancestry populations.

🫀 Shots for healthy hearts. A massive study of 46 million English adults found COVID-19 vaccines actually reduce heart attack and stroke risk by up to 27%! Researchers analyzed health records and discovered cardiovascular events were consistently lower after vaccination compared to before or without vaccination. This adds to mounting evidence that vaccine benefits far outweigh rare risks, providing reassurance about cardiovascular safety across first, second, and booster doses.

Weird and wonderful

🐠 Meet "Reef," a delightfully backwards digital aquarium that only thrives when you abandon your screens. This concept design flips addiction on its head - your virtual fish grow happier the longer you stay offline, while neglecting them for three days makes the tank go murky (requiring actual physical scraping). The irony is beautiful: using technology to escape technology.

Complete with a tiny spoon for feeding digital fish and housed in a minimalist clear frame with pastel bases, this desktop aquarium rewards absence instead of presence. Ignore your finned friends too long and they'll literally faint from neglect. The mobile app tracks your "digital detox progress" with calming blue interfaces that somehow make screen time feel zen-like. It's gamification turned inside out - collect new species by touching grass instead of doom-scrolling. Finally, pets that actually want you to ignore them.

Thank you for reading the Healthy Innovations newsletter!

Keep an eye out for next week’s issue, where I will highlight the healthcare innovations you need to know about.

Have a great week!

Alison ✨

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