Spinal cord stimulation: which startup is ahead?

Why is spinal cord stimulation attracting so much attention now?

Spinal cord stimulation is becoming a much bigger field because companies such as Saluda Medical and ONWARD Medical are bringing new treatments to market, including devices that can respond to nerve activity or help people regain movement after spinal cord injuries.

The technology has been used for decades to treat chronic pain. Traditional systems deliver electrical pulses through electrodes placed near the spinal cord, helping reduce pain signals. Newer devices can measure neural responses and adjust stimulation automatically.

Meanwhile, ONWARD Medical is pushing spinal stimulation into neurological rehabilitation. Its ARC-EX system received FDA authorization in December 2024 to improve hand strength and sensation in people with chronic cervical spinal cord injuries. The company subsequently secured clearance for home use and European CE certification.

The commercial progress is becoming measurable. Saluda reported $90.2 million in fiscal 2026 revenue, while ONWARD sold or supplied 159 ARC-EX systems through paid evaluations during the first half of 2026, up 430% in unit volume from the previous year.

These companies are pursuing different patients and medical needs. Saluda wants to improve an established pain-treatment procedure, while ONWARD is developing technologies that could restore neurological functions lost after spinal cord injury.

Which spinal cord stimulation startup is actually ahead today?

Saluda Medical is currently the strongest commercial spinal cord stimulation challenger, while ONWARD Medical is leading the newer field of spinal cord injury rehabilitation.

Saluda's Evoke system has been FDA-approved since 2022. Its annual revenue reached $90.2 million in fiscal 2026, compared with $70.4 million the previous year, and 2,676 US patients received implants during that period.

ONWARD is growing from a much smaller base. Its ARC-EX product revenue reached €3.4 million during the first half of 2026, up from €1 million a year earlier. The company now has devices available in more than 130 US clinics and over 150 clinics worldwide.

The difference becomes clearer when we consider what each company has achieved. Saluda has persuaded thousands of patients and hundreds of physicians to use its implants. ONWARD has established an early commercial market for treating lost function after spinal cord injury, a field where many technologies remain experimental.

Saluda wins on commercial scale and established clinical evidence. ONWARD has the more ambitious neurological rehabilitation program, including implantable stimulation and brain-controlled movement.

Company	Main technology	What sets it apart today
Saluda Medical	Evoke closed-loop SCS	Strong commercial growth and long-term randomized evidence
ONWARD Medical	ARC-EX, ARC-IM, ARC-BCI	Leading commercial platform for spinal cord injury rehabilitation
Medtronic	Inceptiv closed-loop SCS	Established competitor with closed-loop technology
Abbott	Proclaim and Eterna	Established pain-treatment systems and distribution
Boston Scientific	WaveWriter	Broad commercial SCS portfolio
Nalu Medical	Miniaturized neurostimulation	Smaller implanted components
SpineX	Non-invasive spinal stimulation	Emerging neurological rehabilitation technology

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

Is Saluda Medical's spinal stimulation business really taking off?

Saluda Medical's business is growing convincingly, with more doctors using Evoke and existing physicians implanting it more often.

Its fiscal 2026 results show revenue rising 28% to $90.2 million. US implantations increased 34%, from 1,998 to 2,676 patients, while the average number of active US implanting physicians rose 21%, from 236 to 286.

We can also see an acceleration toward the end of the fiscal year. Fourth-quarter revenue reached $27 million, growing 43% year over year, compared with 28% growth for the full year. US implantation volume jumped 50% in that quarter, from 511 to 769 patients.

Saluda's growth also extends beyond the US. International revenue increased 32% to $26.9 million, while US revenue rose 27% to $63.2 million.

One particularly interesting finding is that implantation growth has outpaced physician growth. Based on average quarterly active physicians, US implantations per active physician rose by approximately 11% when comparing the two fiscal years. The metric is an approximate activity indicator because the physician count represents quarterly averages.

Saluda is gaining additional physicians while increasing the number of procedures performed by doctors already using its technology. That's a healthier growth pattern than relying entirely on new physician recruitment.

Does Saluda Medical have better clinical results than traditional spinal cord stimulators?

Saluda Medical has produced some of the strongest long-term evidence supporting closed-loop spinal cord stimulation over conventional fixed-output treatment.

The EVOKE trial randomized 134 patients with chronic back and leg pain to closed-loop or open-loop stimulation. At 36 months, 77.6% of patients in the closed-loop group achieved at least 50% pain reduction, compared with 49.3% in the open-loop group.

That represents a 28.3-percentage-point advantage, with the closed-loop group achieving approximately 1.6 times the responder rate.

For more substantial pain relief, 49.3% of closed-loop patients reported at least 80% improvement, compared with 31.3% of patients receiving open-loop stimulation. The study also found better outcomes across measures of physical function, sleep, and quality of life.

The findings were published in Regional Anesthesia & Pain Medicine following a randomized, blinded trial with three-year follow-up. Researchers found no significant difference in adverse-event rates between the groups.

There is one important limitation: the trial compared two stimulation modes using the Evoke platform. It did not directly test Evoke against every modern competitor.

Even so, the EVOKE trial gives Saluda a major advantage. Few spinal stimulation challengers can point to similarly detailed randomized evidence extending three years after treatment.

Can Medtronic copy Saluda Medical's closed-loop technology?

Medtronic has already brought closed-loop spinal cord stimulation into its portfolio. Saluda Medical can no longer count on automatic neural feedback being a rare feature.

Medtronic received FDA approval for its Inceptiv closed-loop spinal cord stimulator in April 2024. Like Saluda's Evoke, the system measures physiological responses and adjusts stimulation according to neural activity.

Saluda's original advantage was the ability to measure evoked compound action potentials, or ECAPs, and use that information to regulate stimulation. These measurements help keep the electrical dose closer to a desired level as patients change posture or move.

The competition is now shifting toward clinical outcomes and ease of use. Saluda's EVA automated programming technology, cleared in the US in late 2024, reduces some of the manual work involved in measuring neural responses and configuring therapy.

Medtronic has the advantage of an extensive global medical-device business, established relationships with hospitals, and a large installed base across multiple treatment categories.

We still lack independent head-to-head trials demonstrating that one company's latest closed-loop system consistently outperforms the other. Saluda's three-year EVOKE results remain valuable, but its next challenge is defending that clinical advantage as competitors improve their own devices.

Is ONWARD Medical making a bigger breakthrough than Saluda?

ONWARD Medical is pursuing a more ambitious neurological goal than Saluda: helping people recover physical abilities after spinal cord injury rather than primarily relieving chronic pain.

Its ARC-EX system delivers electrical stimulation through electrodes placed on the skin over the spinal cord. Patients receive stimulation while performing rehabilitation exercises aimed at improving arm and hand function.

In the Up-LIFT study published in Nature Medicine in 2024, 60 participants completed the treatment protocol. Of those, 72% achieved meaningful improvements in both strength and functional performance, while 90% improved in at least one of those areas.

For patients living with cervical spinal cord injuries, improvements in grip strength, hand control, and sensation can affect everyday activities such as holding objects, eating, or dressing.

Saluda's Evoke addresses a different and very serious medical problem: persistent pain that has not responded adequately to other treatments.

ONWARD's work could eventually change how neurological rehabilitation is delivered. The company is also developing implanted systems to address movement and blood-pressure problems, widening its ambitions beyond hand rehabilitation.

But a more ambitious treatment objective doesn't automatically translate into a larger business. ONWARD still needs to demonstrate how widely its therapies can be used and reimbursed.

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

Is ONWARD Medical's ARC-EX actually selling, or is it still experimental?

ONWARD Medical's ARC-EX is already a commercial product, and its recent adoption numbers show that rehabilitation clinics are buying into the technology.

The FDA granted De Novo authorization in December 2024. By November 2025, more than 60 US clinics had purchased ARC-EX systems.

The company's September 2026 financial update showed a much larger commercial footprint: ARC-EX was available in more than 130 US clinics and over 150 clinics globally.

During the first half of 2026, ONWARD sold or supplied 159 systems through paid evaluations, representing 430% year-over-year unit growth. That means the reported volume was approximately 5.3 times higher than the comparable period a year earlier.

The company disclosed that 89 systems were supplied in the second quarter alone, compared with approximately 70 in the first quarter. Sequential volume therefore grew around 27%.

One distinction is worth keeping in mind: the 159 total includes paid evaluation placements alongside completed sales, so we cannot treat every unit as a permanent purchase.

Still, ARC-EX has crossed an important commercial threshold. Its adoption now spans rehabilitation clinics in the US and several European countries, and the company has begun supplying devices for home use.

Could ONWARD Medical's home-use devices make spinal stimulation much bigger?

ONWARD Medical's home-use authorization could significantly expand ARC-EX adoption by allowing selected patients to receive treatment outside rehabilitation centers.

In November 2025, the FDA cleared an expanded ARC-EX indication covering home use. Previously, the system was authorized for use in clinical settings.

The company reported its first home-use system sales during the first half of 2026, including purchases connected to the US Veterans Affairs healthcare system.

ONWARD also said its systems had reached approximately half of the VA's specialized spinal cord injury hub facilities following two quarters of focused selling. That's a promising early result because these facilities treat patients who could be candidates for the technology.

In July 2026, the VA National Program Office issued guidelines covering transcutaneous spinal cord stimulation. The guidance does not require facilities to adopt ARC-EX, but it shows that the treatment has attracted enough clinical attention to warrant a more standardized approach.

The commercial opportunity extends beyond selling devices to hospitals. Home use could create additional demand from individual patients, rehabilitation programs, and insurers.

However, widespread home adoption will depend on practical questions that are still being tested: who pays for the device, how long patients use it, and whether meaningful improvements continue outside structured rehabilitation.

Which spinal cord stimulation company is growing faster right now?

ONWARD Medical is currently growing much faster in percentage terms, but Saluda Medical generates substantially more revenue and has a longer commercial track record.

ONWARD's ARC-EX revenue increased 240%, from €1 million to €3.4 million, between the first halves of 2025 and 2026. Its reported unit volume grew even faster, at 430%.

Saluda's revenue increased 28% to $90.2 million for fiscal 2026, while its most recent quarter grew 43% year over year.

The growth rates reflect two very different stages. ONWARD is scaling a product launched commercially in 2025. Saluda has already established a larger business selling implanted devices.

There is also a difference between product volume and revenue. ONWARD's 430% unit increase exceeded its 240% product revenue increase. Given that some systems were provided through paid evaluations, we should avoid interpreting the two growth rates as evidence of a simple change in device prices.

Saluda's results are more established, while ONWARD is showing the faster early commercial ramp. Neither company has yet demonstrated that its current growth rate can continue indefinitely.

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

Which startup is in better financial shape, Saluda or ONWARD?

Saluda Medical has the much stronger revenue base, while ONWARD Medical has recently raised substantial funding to support its expansion. Both companies are still spending heavily.

Saluda reported a $113.7 million adjusted EBITDA loss in fiscal 2026, alongside $90.2 million in revenue. Operating cash use reached approximately $116 million, compared with $118.2 million the previous year.

Its gross margin improved to 48.9%, up 2.3 percentage points. Manufacturing and selling the devices is becoming more profitable at the gross-margin level, although operating expenses remain high.

ONWARD reported a €23.3 million operating loss during the first half of 2026 against €4.2 million in total revenue and other income. It ended June with €81.5 million in cash.

The company raised more than €40.6 million in equity in April, including €25 million from EQT Life Sciences. It also secured a financing agreement of up to €50 million with funds managed by BlackRock, with €20 million initially drawn and further access subject to conditions.

The difference between the two businesses is considerable. Saluda is spending aggressively to build a larger commercial implant operation. ONWARD must fund both its ARC-EX rollout and clinical trials for future implanted therapies.

Financial measure	Saluda Medical	ONWARD Medical
Reporting period	Fiscal year ending June 2026	First half of 2026
Revenue	$90.2M	€4.2M total revenue and other income
Comparable revenue growth	28%	250% in total revenue and other income
Operating profitability	Adjusted EBITDA loss of $113.7M	Operating loss of €23.3M
Gross profitability	48.9% gross margin	€2.9M gross profit
Cash position	Not directly comparable from figures presented	€81.5M at June 30
Recent financing	Listed-company financing and cash resources	€40.6M equity raise and up to €50M debt facility
Main financial challenge	Reducing heavy commercial spending	Funding commercialization and clinical development

Could ONWARD Medical's implantable ARC-IM system become its biggest product?

ONWARD Medical's ARC-IM could eventually become more important than ARC-EX because it targets several serious consequences of spinal cord injury, including unstable blood pressure and difficulty moving.

ARC-IM is an implantable spinal stimulation platform currently being tested in clinical studies.

The company's Empower BP pivotal trial is investigating whether ARC-IM can help manage blood-pressure instability after spinal cord injury. These patients can experience dangerous drops in blood pressure, particularly when changing posture.

According to ONWARD's September 2026 update, the trial had enrolled 22 participants, with 14 clinical sites actively recruiting across the US and Canada. The study uses a randomized, double-blind, sham-controlled design.

ONWARD has also launched the EIGER feasibility study, which is investigating ARC-IM for restoring standing and walking in people with subacute or chronic spinal cord injuries.

The company's development pipeline extends to bladder control and spasticity, with several FDA Breakthrough Device Designations covering different applications.

These designations provide regulatory advantages but do not establish that the treatments work or authorize commercial sales.

The next decisive evidence will come from controlled clinical outcomes, particularly Empower BP. ONWARD has indicated that an interim analysis is targeted for 2027 and a potential commercial launch for blood-pressure treatment in 2028, subject to successful trials and regulatory approval.

Can ONWARD Medical really connect the brain to a spinal cord stimulator?

ONWARD Medical has already tested brain-controlled spinal stimulation in human participants, although ARC-BCI remains an early experimental technology.

The company's ARC-BCI platform combines a brain-computer interface with an implanted spinal stimulation system. Brain signals are interpreted and used to activate stimulation patterns intended to help people control movements of their paralyzed limbs.

In its September 2026 update, ONWARD reported that seven participants had received investigational ARC-BCI therapy, including two additional implants announced during the first half of the year.

This progress builds on research demonstrating that brain signals can be linked to spinal stimulation to support voluntary movement after spinal cord injury.

The number of participants remains small, and the treatment involves technology that is substantially more complex than external stimulation through the skin.

Long-term safety, reliability, surgical requirements, and reproducibility across patients remain open questions.

ARC-BCI is among ONWARD's most ambitious projects, but seven research participants are nowhere near enough to establish that a widely available brain-controlled rehabilitation product is close to market.

Are smaller spinal stimulation startups like Nalu Medical and SpineX falling behind?

Nalu Medical and SpineX remain interesting spinal stimulation challengers, but neither currently matches Saluda's documented commercial scale or ONWARD's published progress in spinal cord injury rehabilitation.

Nalu Medical is working on miniaturized neurostimulation. Its approach reduces the size of implanted components by using an external system for power and control, which could offer advantages for selected patients who need long-term stimulation therapy.

SpineX is developing non-invasive spinal stimulation technologies aimed at improving neurological function. Its work is closer to ONWARD's rehabilitation ambitions than to Saluda's chronic-pain implant business.

Mainstay Medical provides another useful comparison. Its ReActiv8 system stimulates the medial branch of the dorsal ramus to activate lumbar multifidus muscles in selected patients with chronic mechanical low-back pain. The system targets muscle function rather than delivering conventional spinal cord stimulation.

These companies show how diverse neurostimulation has become. Smaller implants, external stimulation, muscle activation, and neural feedback are all being developed to address different clinical limitations.

For now, Saluda has the stronger commercial evidence among the specialized pain-stimulation challengers considered here, while ONWARD has advanced further in regulated non-invasive therapy for spinal cord injury.

Are Medtronic, Abbott, and Boston Scientific still ahead of the startups?

Medtronic, Abbott, and Boston Scientific remain major established spinal cord stimulation manufacturers, and none of the newer challengers has demonstrated that it has displaced them across the overall pain-treatment market.

Medtronic has already introduced Inceptiv, its FDA-approved closed-loop system. Boston Scientific expanded the FDA indication for its WaveWriter technology in February 2024 to cover selected patients with chronic back and leg pain who had not previously undergone back surgery.

Abbott continues selling established spinal stimulation systems, including its Proclaim and Eterna platforms.

The larger companies benefit from extensive physician relationships, hospital distribution channels, manufacturing capacity, and years of experience obtaining regulatory authorization for implantable devices.

Saluda's progress is still impressive in that context. Its fiscal 2026 results showed US revenue increasing to $63.2 million and international revenue reaching $26.9 million, while its closed-loop technology continued gaining adoption.

Saluda also has room to enter surgical procedures that were previously harder for it to serve. The FDA approved its CAP24 paddle lead in June 2026, allowing the Evoke platform to address more patients treated through surgical paddle-lead implantation.

According to Saluda's July 2026 investor update, paddle-lead procedures account for approximately 30% of the US spinal cord stimulation market, representing an estimated $670 million in 2024 revenue.

That gives Saluda access to a meaningful new part of the market, although the approval alone does not guarantee it will win those procedures.

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

Which spinal cord stimulation startup has the strongest clinical proof?

Saluda Medical currently has the stronger long-term randomized evidence for its approved spinal stimulation product, while ONWARD Medical has produced meaningful clinical results in a newer treatment area.

Saluda's EVOKE trial compared closed-loop and open-loop stimulation through a randomized, blinded study that followed patients for three years.

ONWARD's Up-LIFT trial investigated whether adding ARC-EX stimulation to rehabilitation improved hand and arm function in people with chronic cervical spinal cord injuries.

The studies used different designs. Up-LIFT was a prospective, open-label study in which participants moved from rehabilitation alone to rehabilitation with stimulation. EVOKE used a parallel randomized comparison.

That difference affects how confidently we can attribute improvements to the treatment itself. A randomized comparison generally provides better protection against bias than a sequential study without a parallel sham-control group.

However, ONWARD's results concern functional abilities after spinal cord injury, while Saluda's results concern chronic pain reduction. Their reported responder rates cannot be ranked against each other as though they measure the same outcome.

Evidence measure	Saluda Evoke	ONWARD ARC-EX
Primary condition	Chronic back and leg pain	Chronic cervical spinal cord injury
Main study	EVOKE	Up-LIFT
Study design	Randomized, blinded comparison	Prospective, open-label sequential study
Participants	134 randomized	60 completed
Headline outcome	77.6% achieved ≥50% pain reduction at 36 months	72% achieved meaningful improvements in strength and function
Comparator	Open-loop stimulation	Rehabilitation-alone phase
Follow-up supporting headline	36 months	Two-month stimulation phase
FDA commercial authorization	2022	2024
Main limitation	No comparison with every latest competing system	No parallel randomized sham-controlled group
Overall assessment	Stronger long-term comparative evidence	Strong early evidence for a different clinical application

Can spinal cord stimulation become a much bigger treatment market?

Spinal cord stimulation has room to grow in both chronic pain and neurological rehabilitation, but the two markets face different obstacles.

For Saluda, the opportunity comes partly from persuading more physicians to adopt its Evoke system and expanding into additional procedures.

The company's CAP24 paddle lead is particularly relevant. Saluda estimates that its approval opens access to approximately 2,100 US neurosurgeons and orthopedic spine surgeons who mainly use paddle leads.

That represents a sizable expansion of the physician base it can target. According to management, the US paddle-lead segment generated approximately $670 million in 2024.

For ONWARD, the opportunity depends more heavily on creating new treatment pathways. ARC-EX now has a presence in over 150 clinics worldwide, but many potential patients will need access through specialized rehabilitation services, home programs, or reimbursement arrangements.

ONWARD's clinical ambitions also include standing, walking, blood-pressure regulation, and other neurological functions that currently lack widely available spinal stimulation treatments.

We expect commercial expansion to be easier to measure for Saluda because the relevant implant procedures and hospital purchasing processes already exist. ONWARD could eventually address a broader range of neurological problems, but several of those applications still require pivotal evidence and regulatory approval.

What could stop Saluda Medical from staying ahead?

Saluda Medical's biggest risks are competition from larger manufacturers and the high cost of maintaining its commercial growth.

Medtronic already sells a closed-loop spinal stimulation system. Other established medical-device companies have the resources to develop competing technologies, run clinical trials, and sell through existing physician networks.

Saluda's recent financial results show the cost of competing in this environment. Despite 28% annual revenue growth, its adjusted EBITDA loss remained above $113 million in fiscal 2026.

The company expects revenue of $113 million to $122 million for fiscal 2027, representing projected growth of approximately 25% to 35%.

Management also expects its adjusted EBITDA loss to narrow to between $95 million and $101 million. These are forecasts, so the actual improvement remains to be demonstrated.

The CAP24 launch adds another test. Saluda is entering a surgical segment that accounted for around 30% of US spinal stimulation revenue in 2024, but it will need to train physicians, build inventory, and win procedures from established competitors.

Saluda has proved that physicians will implant Evoke and that patients can achieve lasting pain relief. The harder question now is whether it can keep growing while moving toward profitability.

What would make ONWARD Medical the clear spinal stimulation leader?

ONWARD Medical could become the leading company in restorative spinal cord stimulation if ARC-EX continues gaining customers and its implantable ARC-IM system succeeds in pivotal clinical trials.

Its recent commercial expansion gives us a useful starting point. ONWARD reported 159 ARC-EX systems sold or supplied through paid evaluations in the first half of 2026, more than five times the comparable volume a year earlier.

Those early placements need to translate into continuing use, permanent purchases, and stronger revenue. Broader home adoption could help, especially through specialized rehabilitation programs and the Veterans Affairs system.

The bigger potential change concerns ARC-IM. The Empower BP trial had enrolled 22 participants by September 2026, while the EIGER study had begun investigating mobility restoration.

Successful randomized results in blood-pressure regulation would give ONWARD evidence supporting a possible new approved indication. Positive mobility results would expand its clinical ambitions further.

ARC-BCI could eventually add brain-controlled movement to that product portfolio, although its clinical development remains much earlier.

ONWARD has made enough progress to be taken seriously as a medical-device business. Becoming the overall leader would require substantially larger sales and successful regulatory approvals for its investigational systems.

So which spinal cord stimulation startup is ahead?

Saluda Medical is ahead in commercial spinal cord stimulation today, while ONWARD Medical is leading the newer race to restore function after spinal cord injuries.

Saluda has the stronger established business. Its Evoke system is FDA-approved, its clinical evidence extends to three years, and its annual revenue has reached $90.2 million. The company is also gaining implanting physicians and expanding into additional surgical procedures.

ONWARD has made the bigger move into neurological rehabilitation. ARC-EX is now available in more than 150 clinics worldwide, and the company's first-half 2026 unit volume was more than five times higher than the previous year. Its ARC-IM and ARC-BCI programs could eventually extend treatment into movement, blood-pressure control, and brain-directed spinal stimulation.

The financial gap remains large, and ONWARD's most ambitious technologies still require further clinical validation.

We would rank Saluda first among these challengers for commercial execution and established clinical evidence. ONWARD deserves the lead for spinal cord injury restoration, where it has already turned a promising research approach into an authorized commercial treatment.

The overall spinal stimulation industry remains heavily influenced by Medtronic, Abbott, and Boston Scientific. Saluda and ONWARD are the two challengers worth watching most closely for different reasons: Saluda is building a substantial business around better pain treatment, while ONWARD is opening up new possibilities for patients with spinal cord injuries.

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