Vagus nerve stimulation: which startup is ahead?

Why are vagus nerve stimulation startups getting so much attention now?

Vagus nerve stimulation is entering a new phase, with startups bringing FDA-approved treatments for stroke recovery and rheumatoid arthritis to market while consumer devices are making nerve stimulation accessible without surgery.

Three companies explain much of the current interest. Mobia Medical, formerly MicroTransponder, is growing quickly with Vivistim, an implanted device that helps stroke survivors recover arm function. SetPoint Medical received FDA approval in July 2025 for a vagus nerve stimulation system that treats rheumatoid arthritis. Meanwhile, electroCore is expanding its prescription and consumer businesses with devices that stimulate the nerve through the skin.

The commercial figures are becoming difficult to ignore. Mobia more than doubled its annual revenue in 2025 and completed a $150 million IPO in May 2026. electroCore generated $32 million in sales during 2025, while SetPoint raised $140 million to bring its newly approved treatment to hospitals.

These businesses are taking quite different approaches. Mobia pairs stimulation with rehabilitation exercises, SetPoint targets inflammation, and electroCore focuses mainly on headache disorders. Consumer brands such as Parasym and Pulsetto are exploring stress, sleep, and general wellness.

That leaves an interesting question: which company has actually turned vagus nerve stimulation into a successful medical technology business, and which is still relying on its future potential?

Which vagus nerve stimulation startup is winning right now?

Mobia Medical is currently ahead among younger medical VNS companies when we look at revenue growth, commercial adoption, and financial resources. SetPoint Medical is its strongest challenger in terms of clinical innovation.

Mobia's Vivistim system has been FDA-approved since 2021 for improving upper-limb function after chronic ischemic stroke. Revenue increased from $15.6 million in 2024 to $32 million in 2025, and the company generated another $25.6 million during the first six months of 2026.

SetPoint has made a different kind of breakthrough. Its FDA-approved rheumatoid arthritis implant opens a treatment category that previously had no approved neuroimmune stimulation device. The company also raised $140 million in August 2025, although it has not disclosed comparable commercial revenue.

electroCore is further along than most non-invasive competitors. Its gammaCore system is an established prescription treatment for specific headache disorders, and the company reported $19 million in consolidated sales during the first half of 2026.

Then there is LivaNova, which sits in a completely different league commercially. The established epilepsy-device manufacturer generated almost $593 million in neuromodulation revenue in 2025.

Mobia leads on demonstrated business performance, while SetPoint has opened a major new medical application. That's the real competition among the younger companies.

Company	Main VNS application	Key evidence	Current position
LivaNova	Drug-resistant epilepsy	$592.8M neuromodulation revenue in 2025	Established market leader
Mobia Medical	Stroke rehabilitation	$32M revenue in 2025; FDA-approved	Leading younger commercial contender
SetPoint Medical	Rheumatoid arthritis	FDA approval in 2025; $140M financing	Autoimmune-treatment leader
electroCore	Migraine and cluster headache	$32M consolidated revenue in 2025	Established non-invasive competitor
Parasym	Auricular stimulation	Commercial Nurosym/NuroPod products	Consumer and research contender
Pulsetto	Stress and wellness	Commercial neck-worn stimulation device	Consumer-market contender
Neuvana	Wellness and relaxation	Commercial Xen ear-based device	Consumer-market contender
Skaaltec	Stroke rehabilitation	SmartVNS wearable under development	Early-stage technology challenger

If you want more recent data on this point, see the latest figures in our Neurotech report ↓.

Is Mobia Medical really growing faster than other VNS companies?

Mobia Medical has the strongest publicly documented revenue growth among the younger medical VNS specialists, and the latest results show that its expansion is continuing.

According to the company's SEC filings, revenue climbed 105% in 2025, reaching $32 million. That pace continued in 2026: first-quarter revenue rose 113% to $12.1 million, followed by 102% growth to $13.5 million in the second quarter.

Two consecutive quarters of revenue more than doubling make the annual increase harder to dismiss as an isolated spike. Both quarters benefited primarily from higher sales of Vivistim implantable pulse generators.

The comparison with electroCore is revealing. electroCore generated $19 million during the first half of 2026, growing approximately 35% year over year. Mobia brought in about 35% more revenue over the same period despite being newer to full-scale commercialization.

Mobia also maintained an 82.8% gross margin during those six months, compared with 82.2% a year earlier. Rapidly increasing sales have therefore come without obvious pressure on product-level profitability.

There is one limitation to the ranking: SetPoint, Parasym, and Pulsetto do not publish similarly detailed financial statements. Mobia leads the disclosed growth comparison, but we cannot rank every private VNS company by revenue.

Has SetPoint Medical made the biggest VNS breakthrough so far?

SetPoint Medical has achieved one of the most important recent advances in vagus nerve stimulation by securing FDA approval for treating rheumatoid arthritis through an implanted device.

Its pivotal RESET-RA study enrolled 242 patients who had responded inadequately to, or could not tolerate, advanced rheumatoid arthritis medicines. The randomized, double-blind, sham-controlled trial tested whether stimulating the vagus nerve could improve disease activity.

After three months, 35.2% of patients receiving active stimulation achieved at least a 20% improvement under the American College of Rheumatology response criteria. The control group reached 24.2%, giving SetPoint an 11-percentage-point advantage. The difference was statistically significant, with a reported P value of 0.0209.

That translates to approximately one additional responder for every nine patients treated, compared with sham stimulation during the initial study period. The result is meaningful, although it also shows that most patients did not meet the primary response threshold after three months.

Longer-term findings were more encouraging. Among patients completing the relevant assessments, response rates reached 50% after six months and 52.8% after twelve months. Those later results came from open-label treatment, so they do not provide the same comparison against a sham group.

The FDA approved the SetPoint System in July 2025 for adults with moderately to severely active rheumatoid arthritis who had not responded adequately to, lost response to, or could not tolerate advanced drug treatments.

SetPoint now has something very few neuroimmune startups possess: an approved treatment for a major autoimmune disease, backed by a large randomized trial.

Does Mobia Medical's stroke treatment work better than SetPoint's arthritis implant?

Mobia Medical's Vivistim produced a larger improvement over its control group on a key stroke-rehabilitation outcome, although the results cannot establish that Mobia's therapy is better than SetPoint's rheumatoid arthritis treatment.

The pivotal VNS-REHAB trial, published in The Lancet in 2021, enrolled 108 stroke survivors. Patients received rehabilitation paired with either active vagus nerve stimulation or sham stimulation.

Ninety days after completing in-clinic therapy, 47% of patients receiving active stimulation achieved a clinically meaningful improvement in upper-limb impairment. Only 24% of the control group reached the same threshold.

That 23-percentage-point difference is more than twice the absolute improvement reported for SetPoint's primary three-month endpoint.

But the two trials measured different things. Vivistim was tested on recovery of arm movement after stroke, while SetPoint was evaluated on rheumatoid arthritis disease activity. Patient populations, treatment schedules, and response criteria were also different.

Mobia has since reported two-year follow-up results in Neurology showing sustained improvements in motor function, daily activities, and quality of life among followed patients.

Both companies have convincing evidence for their approved indications. Mobia's trial demonstrated a particularly strong treatment effect on a functional recovery measure, while SetPoint proved that electrical stimulation can work as an approved therapy for an autoimmune disease.

If you want more recent data on this point, see the latest figures in our Neurotech report ↓.

Why is LivaNova still much bigger than every VNS startup?

LivaNova remains the clear commercial leader in vagus nerve stimulation because its epilepsy-device business has decades of clinical experience and a sales base that younger companies are nowhere near matching.

In 2025, LivaNova generated $592.8 million in neuromodulation revenue, up approximately 7% from $554.2 million in 2024. Its neuromodulation segment then grew another 9.7% during the first half of 2026, reaching $318.7 million.

To put the gap into perspective, LivaNova's 2025 neuromodulation revenue was roughly 18.5 times the annual revenue of either Mobia or electroCore.

The company's second-quarter 2026 neuromodulation sales alone reached $166.9 million, up 10.1% from the previous year. Most of that revenue came from the United States, although international sales also increased.

LivaNova benefits from a long-established epilepsy treatment network, experienced implanting physicians, existing hospital relationships, and years of clinical evidence supporting its devices.

Mobia and SetPoint are not trying to take LivaNova's epilepsy customers directly. They are building businesses around different conditions where VNS adoption is still much less developed.

For now, LivaNova dominates the established market while the younger companies are competing to create the next major one.

Are non-invasive VNS devices better than implanted stimulators?

Non-invasive vagus nerve stimulators are much easier to use, but implanted systems currently have stronger evidence for several serious medical conditions.

electroCore's gammaCore stimulates the cervical vagus nerve through the skin and has FDA clearance for specific migraine and cluster headache indications. Parasym's Nurosym uses electrodes placed on the ear, while Pulsetto uses a neck-worn device aimed mainly at stress, sleep, and wellness.

These products avoid surgical implantation, making treatment more convenient and reducing procedure-related risks.

Implanted devices have their own advantages. Mobia's Vivistim delivers precisely timed stimulation during rehabilitation exercises, while SetPoint's device is placed directly on the vagus nerve and automatically provides a prescribed daily treatment.

Transcutaneous stimulation is also more sensitive to factors such as electrode positioning, skin contact, anatomy, and the electrical parameters used. Its effects cannot simply be assumed to match those of an implanted system.

The strongest products therefore serve different patients. Someone buying a wearable device to help with relaxation has very different clinical needs from a stroke survivor undergoing rehabilitation or a patient with severe rheumatoid arthritis considering surgery.

Is electroCore the biggest non-invasive vagus nerve stimulation company?

electroCore is currently the strongest established non-invasive VNS specialist among companies publishing detailed financial results, with a business driven mainly by prescription headache treatments.

Its 2025 revenue increased 27% to $32 million. U.S. prescription sales reached $24.1 million, while general wellness revenue nearly doubled to $5.5 million.

Those figures reveal an important pattern: prescription treatments represented approximately 75% of electroCore's annual sales, compared with 17% from wellness products. Most customers are therefore being reached through medical channels rather than direct consumer marketing.

The same pattern continued during the first half of 2026. U.S. prescription sales increased approximately 39% to $14.9 million, while general wellness revenue rose around 37% to $2.9 million.

One important detail in electroCore's filings is its dependence on the U.S. Department of Veterans Affairs. The company expected the VA channel to account for the majority of its 2026 revenue.

That gives electroCore access to an established medical customer base, although it also creates considerable exposure to one purchasing channel.

electroCore has already demonstrated that non-invasive VNS can support a real prescription-device business. Its consumer division has yet to prove it can become equally important.

If you want more recent data on this point, see the latest figures in our Neurotech report ↓.

Can Parasym and Pulsetto compete with FDA-approved VNS treatments?

Parasym and Pulsetto are credible competitors in consumer vagus nerve stimulation, but neither has established the same level of regulatory and clinical proof as the leading prescription-device companies.

Parasym markets ear-based stimulation products, including Nurosym and NuroPod. Its approach draws on research into the auricular branch of the vagus nerve, which can be stimulated without reaching the cervical nerve directly.

Pulsetto has chosen a more consumer-oriented approach. Its neck-worn device is controlled through a smartphone application and marketed primarily around stress management, sleep, and relaxation.

Neither business requires patients to visit a specialized hospital simply to access its consumer products. That gives them an obvious convenience advantage.

However, Pulsetto describes its device as a general wellness product rather than an FDA-cleared medical treatment. The company has announced studies investigating areas such as migraine, sleep, inflammation, and autonomic function, but announced research does not establish successful clinical outcomes.

Scientific interest in transcutaneous VNS is genuine. Researchers have investigated potential effects on heart-rate variability, inflammation, mood, and other physiological measurements.

The problem is that evidence from one device or stimulation protocol does not automatically apply to another. A measurable physiological change also does not prove that a consumer product treats a disease.

We would need reliable device-level sales figures, customer retention data, and stronger controlled clinical studies to establish whether Parasym or Pulsetto is genuinely leading the consumer category.

Is SetPoint Medical's rheumatoid arthritis implant already reaching patients?

SetPoint Medical has started treating patients across multiple U.S. regions, although its commercial rollout is still too young to demonstrate large-scale adoption.

After receiving FDA approval, the company announced its first rheumatoid arthritis procedures at institutions including Rush University Medical Center in Chicago in February 2026 and Ascension Dell Seton Medical Center in Texas in March.

Further procedures followed at Oregon Health & Science University in September and AtlantiCare Regional Medical Center in New Jersey later that month.

SetPoint has now moved beyond its initial launch locations into the Midwest, South, Pacific Northwest, and Northeast.

The treatment itself requires a relatively short surgical procedure. According to SetPoint's patient information, the implant is typically placed during a 60-to-90-minute outpatient operation, with stimulation activated at a subsequent appointment. The device then delivers 60 seconds of therapy each day.

That daily treatment schedule is relatively simple once the implant is in place. Getting patients through referrals, surgery, and insurance authorization is more complicated.

SetPoint has not yet disclosed national implantation totals, commercial revenue, or average treatment volumes by hospital. Announcing first procedures establishes that a center has started offering treatment, but tells us little about the number of patients it can treat over a year.

The company is making progress. We still need commercial data before calling its rollout a success at scale.

Could insurance coverage decide whether Mobia or SetPoint wins?

Insurance coverage could determine how quickly both Mobia Medical and SetPoint Medical grow, because their treatments depend on hospitals being able to obtain payment for surgical procedures.

SetPoint received approval for transitional pass-through payment status from the Centers for Medicare & Medicaid Services in November 2025. Effective from January 2026, the arrangement can provide additional reimbursement for qualifying procedures in hospital outpatient departments and ambulatory surgery centers for up to three years.

CMS also established device category C1607 for the SetPoint System, creating a specific payment classification for the technology.

Mobia has made progress through a different route. Vivistim benefits from an established implantation procedure code, and Medicare increased the relevant hospital outpatient payment classification beginning in 2026.

However, Mobia's SEC disclosures also point to an important obstacle. There is no national or local Medicare coverage determination specifically governing Vivistim therapy, meaning many coverage decisions are assessed individually. Commercial insurers may also classify the treatment as investigational or experimental.

Payment rates and insurance coverage are closely connected, but they are not identical. Hospitals can have a defined payment rate for a procedure while individual patients still face coverage restrictions.

SetPoint's new reimbursement arrangements could help hospitals begin offering its treatment more widely. Mobia has the advantage of a longer commercial track record but continues to face insurance-related obstacles.

Neither company has completely solved the access problem, and that could become a bigger constraint than demand itself.

Does Mobia Medical have enough money to keep growing?

Mobia Medical currently has a much larger disclosed financial cushion than electroCore, putting it in a stronger position to fund expansion despite substantial operating losses.

Mobia completed its IPO in May 2026, raising approximately $134 million after underwriting discounts, commissions, and offering costs. Its cash balance reached $177.1 million at the end of June.

The company is spending heavily to build its business. First-half 2026 operating expenses increased as Mobia hired more commercial staff, paid higher commissions, and expanded development activities. Its net loss reached $38.8 million, compared with $21.1 million a year earlier.

electroCore reported approximately $10 million in cash and marketable securities at the same midyear point. Its first-half net loss was $8.3 million, while operating cash consumption came to approximately $6.5 million.

Mobia therefore held more than seventeen times electroCore's reported liquid resources, although its current spending was also considerably higher.

SetPoint's recent $140 million financing puts it in a potentially strong position, but as a private company it has not disclosed a directly comparable current cash balance or operating cash burn.

The financial statements give Mobia plenty of room to keep investing in growth. They also make clear that the company is still far from funding its expansion entirely through operating profits.

Financial measure	Mobia Medical	electroCore
2024 revenue	$15.6M	$25.2M
2025 revenue	$32.0M	$32.0M
2025 revenue growth	~105%	~27%
H1 2025 revenue	$12.3M	$14.1M
H1 2026 revenue	$25.6M	$19.0M
H1 2026 revenue growth	~107%	~35%
H1 2026 gross margin	82.8%	~86.9%
H1 2026 net loss	$38.8M	$8.3M
Midyear 2026 cash and equivalents	$177.1M	$8.5M
Midyear 2026 cash plus marketable securities	$177.1M	~$10.0M
Recent major financing	~$134M net IPO proceeds	No comparable IPO financing

Are hospitals actually using Mobia Medical's Vivistim more often?

Mobia Medical's Vivistim is seeing a sharp increase in real-world adoption, with implantation figures supporting the growth reported in its financial statements.

According to the company's IPO disclosures, more than 1,000 Vivistim implants had been performed by the end of 2025, including approximately 700 during that year alone.

That means roughly 70% of all cumulative implants reported through the end of 2025 took place within a single year.

The pace changed substantially following Vivistim's full commercial launch in 2023. A product that had previously been used by a relatively small group of patients was reaching several hundred new recipients annually by 2025.

Product sales tell a similar story. Mobia reported that implantable pulse-generator units sold increased 108.1% in 2025. During the first quarter of 2026, unit sales rose another 108.9% compared with the previous year.

Those figures are useful because they show that sales growth is coming primarily from volume rather than rising product prices.

There is a distinction between implant sales and completed procedures, since a hospital can purchase equipment before using it. Nevertheless, the combination of implantation history and increasing unit sales is strong evidence that Vivistim adoption is accelerating.

The next challenge will be expanding beyond early-adopting stroke rehabilitation centers into a much wider hospital network.

Could VNS eventually treat diseases beyond epilepsy, stroke, and arthritis?

Vagus nerve stimulation could eventually address several additional neurological and inflammatory conditions, but most of those opportunities still require dedicated clinical trials.

LivaNova's epilepsy systems influence neurological activity associated with seizures. Mobia's Vivistim uses stimulation to support brain plasticity during rehabilitation. SetPoint's implant targets pathways involved in regulating inflammation.

These established applications help explain why scientists are investigating VNS for other conditions.

SetPoint is exploring additional autoimmune diseases, while Mobia has discussed studying other types of functional impairment and stroke-related recovery. Researchers working with non-invasive stimulation are investigating autonomic disorders, mood, sleep, and inflammatory responses.

However, each application needs its own clinical evidence. Success in rheumatoid arthritis does not establish that SetPoint's device will work for multiple sclerosis or inflammatory bowel disease. Similarly, Vivistim's benefits for upper-limb recovery do not automatically extend to walking or other impairments.

A newer startup worth watching is Switzerland's Skaaltec, founded in 2026. Its SmartVNS project uses a wrist sensor to detect arm movements and trigger non-invasive stimulation through the ear during rehabilitation.

The concept could eventually offer some advantages of movement-paired stimulation without surgery. Skaaltec remains at an early stage, although its research and engineering work has attracted attention through the Swiss Technology Award and James Dyson Award programs.

There are several promising directions for VNS development. The next major market will belong to whichever application produces convincing clinical results and can actually reach patients.

What can Mobia and SetPoint do that other VNS startups cannot easily copy?

Mobia Medical and SetPoint Medical have stronger competitive protection because reproducing their products commercially requires far more than building a device capable of stimulating the vagus nerve.

Mobia has an FDA-approved treatment supported by a randomized clinical trial, rehabilitation protocols, physician training, and growing hospital adoption. Its Vivistim system is designed to coordinate short electrical pulses with specific rehabilitation exercises.

A competitor could create a similar stimulation device, but proving equivalent improvements in stroke recovery would require substantial clinical work.

SetPoint has a comparable advantage in rheumatoid arthritis. The company developed a purpose-built implant, demonstrated effectiveness in a controlled study, obtained regulatory approval, and began building a network of treatment centers.

electroCore benefits from its own clinical approvals and distribution relationships, particularly within headache medicine and the Veterans Affairs healthcare system.

Consumer companies compete under different conditions. Parasym, Pulsetto, and Neuvana can attract customers through hardware design, convenience, pricing, and brand recognition, but similar-looking wellness devices can also enter the market with fewer regulatory barriers.

Skaaltec illustrates how new technology could eventually challenge the established products. Its proposed movement-triggered wearable system could simplify stroke rehabilitation if future trials demonstrate the necessary clinical benefits.

For now, Mobia and SetPoint have a substantial head start over startups that still need to prove their therapies work in patients.

If you want more recent data on this point, see the latest figures in our Neurotech report ↓.

What could prevent Mobia Medical or SetPoint Medical from becoming major companies?

Mobia Medical and SetPoint Medical both face a difficult commercial challenge: their treatments work for specific patients, but making them available to thousands of people requires substantial changes in clinical practice.

For Mobia, one of the biggest obstacles is the rehabilitation process. Vivistim involves surgical implantation followed by structured therapy. A patient needs access to both an implanting specialist and a rehabilitation team trained to use the system.

That makes Vivistim harder to distribute than an ordinary medical device that requires little ongoing clinical support.

SetPoint faces a different problem. Rheumatoid arthritis specialists already have well-established treatment options, including biologic medicines and targeted synthetic drugs. SetPoint needs to persuade physicians and insurers that an implanted device deserves a place in those treatment pathways.

There is also the question of which patients benefit most. SetPoint's pivotal trial showed a statistically significant advantage, but the initial response was far from universal.

Financial pressure adds another challenge. Mobia is growing quickly while generating substantial losses, and SetPoint will need to finance its hospital rollout before it has a long commercial track record.

Neither company has an easy path. Mobia must make a specialized rehabilitation treatment widely available, while SetPoint must convince a pharmaceutical-centered specialty to adopt a surgical alternative.

Which VNS startup could become the biggest competitor to LivaNova?

Mobia Medical currently has the clearest route to becoming a much larger VNS business, while SetPoint Medical may have more room to surprise the market if its rheumatoid arthritis treatment gains widespread acceptance.

Mobia already sells an FDA-approved product, has demonstrated rapid growth in device volumes, and recently strengthened its balance sheet through an IPO. Its immediate opportunity is to reach more patients within an existing approved indication.

SetPoint's opportunity is more difficult to measure. Rheumatoid arthritis is a major chronic disease, and the company has introduced an entirely new treatment approach. If physicians adopt its device and long-term outcomes remain favorable, SetPoint could build a substantial specialty-medical business.

electroCore is an established non-invasive competitor, but its slower growth and more limited financial resources currently place it behind Mobia in the commercial race.

The next decisive developments will be measurable. We want to see whether Mobia can keep increasing implantation volumes while reducing its dependence on external financing, whether SetPoint can turn new hospital launches into substantial procedure numbers, and whether non-invasive competitors can obtain approvals for additional medical conditions.

Those results will tell us which businesses have a realistic chance of approaching the scale LivaNova has built in epilepsy.

Final verdict: which vagus nerve stimulation startup is ahead?

Mobia Medical is currently the strongest overall contender among younger commercial-stage vagus nerve stimulation companies, while SetPoint Medical is the leader in VNS-based autoimmune treatment.

Mobia has the strongest combination of documented sales growth, increasing device adoption, FDA-approved clinical evidence, and available financing. Its business is already generating tens of millions of dollars annually, with demand for Vivistim continuing to rise.

SetPoint has accomplished something equally important from a medical perspective by establishing the first FDA-approved neuroimmune stimulation treatment for rheumatoid arthritis. However, its commercial launch remains young, and we cannot yet judge its sales performance against Mobia's.

electroCore has built an established non-invasive prescription business, while Parasym, Pulsetto, and other consumer brands are competing in a different market with lower barriers to entry and less extensive disease-treatment evidence.

LivaNova remains far ahead in total commercial scale, thanks to its mature epilepsy business.

Our ranking therefore favors Mobia on present execution and SetPoint on the potential to open a major new medical market. SetPoint could eventually overtake Mobia, but that outcome will depend on treatment adoption and reimbursement rather than clinical promise alone.

If you want more recent data on this point, see the latest figures in our Neurotech report ↓.