Every clinician who manages diabetes has the same patients in mind. The ones who describe burning feet that keep them awake at night. The ones who have stopped walking the dog, stopped standing long enough to cook, stopped sleeping through the night. The ones who have tried two or three medications, each trading a little relief for grogginess, dizziness or nausea, and who eventually stop asking because they have concluded nothing more can be done.
Painful diabetic peripheral neuropathy (DPN) is one of the most common and most undertreated complications of diabetes. Roughly half of the 40 million American adults with diabetes will develop neuropathy, and of those, an estimated 30 to 50 percent live with the pain it causes.¹⁰ For many, that pain becomes a permanent companion. It is not just a clinical problem; it is a quality-of-life problem that touches sleep, mood, mobility and independence.
Why current options leave a gap
The standard pharmacologic approach — antidepressants, antiepileptics, opioids — helps some patients, but the honest data are sobering. Across guideline agents, roughly five patients must be treated for one to achieve a meaningful response, and responders typically experience only around a 30% reduction in pain.⁶ Only a minority respond at all, and side effects frequently drive patients to stop. For those who exhaust medications, the next option has traditionally been a surgically implanted device — effective for selected patients, but carrying the real risks of any implant.
In other words, many patients with painful DPN find themselves caught between long-term medication management and invasive surgical intervention, with few practical treatment options available in between. It is within this treatment gap that countless patients continue to struggle.
A different kind of option
STIMPOD® NMS460 is now FDA-cleared for the relief of mild to moderate neuropathic pain associated with diabetic peripheral neuropathy of the lower extremities.¹
What makes it different is not only how it works, but how little it requires from the patient:
- It is non-invasive and drug-free. No implant, no incision, no new pill.
- It is fast. Treatment sessions last 10 minutes and only need to be repeated a few times.
- It is comfortable. No anesthesia, no recovery, no downtime. Patients walk in and walk out.
- It is portable. The device fits in the palm of your hand, so treatment can come to the patient. They can be in the clinic they already visit, no need for a distant specialist center.
Why it fits clinical practice
STIMPOD is not a conventional TENS device. It delivers a patented hybrid radiofrequency waveform (a monophasic square wave with a superimposed high-frequency RF burst), and is, to our knowledge, the only FDA-cleared device delivering this patented waveform non-invasively, without an implant, with a specific DPN-pain indication.³
- Non-invasive and drug-free. No implant, no surgical risk, no systemic drug exposure, no additive side-effect burden in patients already managing complex comorbidities.
- Minimal treatment burden. Three 10-minute sessions versus daily medication or the multi-month, multi-session schedules of other device-based approaches.
- Fits your workflow. A handheld unit that fits in your palm, with no anesthesia, recovery or downtime. Treatment can be delivered chairside in pain, podiatry, diabetes, rehabilitation, wound-care and primary-care settings.
- Well tolerated. No device-related adverse events were reported in the pivotal study, supporting use in patients for whom medication tolerability is a limiting factor.
For the right patient, STIMPOD offers something the current pathway rarely does: meaningful, rapidly-onset relief without asking the patient to trade one burden for another.
Proven Results
In a randomized, placebo-controlled trial, a single course of three sessions produced relief that was measured immediately and remained significant at three months.² Nearly half of treated patients were responders on the Brief Pain Inventory at one month, more than double the placebo rate, and the effect held even after accounting for age, baseline pain and the medications patients were already taking.² No procedure- or device-related adverse events were reported.
For a clinician, that combination — rapid onset, durable benefit, and a clean safety profile — is rare. It means you can offer a patient relief without asking them to accept new risks or a heavier daily burden of treatment.
Why it matters beyond the exam room
There is a larger story here, too. Severe painful DPN is associated with total annual all-cause healthcare costs of approximately $27,000 to $31,000 per patient, driven largely by hospitalizations and disease-related complications rather than by the medications themselves.⁹ When pain is poorly controlled, patients move less, heal slower, and progress toward the costly complications that drive those numbers up. A low-burden, well-tolerated treatment option that helps patients engage with earlier, more effective pain control speaks directly to that trajectory.
At Algiamed, we think of this as more than symptom management. Our work focuses on the body’s internal communication network and the control systems that govern it — an approach we call neuro-remodelling — and how carefully applied, non-harmful stimuli can help a maladapted system return toward its natural state of function. For the patient sitting across from you, who will be unable to sleep tonight because of their pain, that vision starts with something simple: thirty minutes, no needles, no downtime, and a real chance at relief.
Footnotes & substantiation
¹ Cleared Indication for Use (FDA 510(k) K252712): “The STIMPOD NMS460 Nerve Stimulator is a Transcutaneous Electrical Nerve Stimulation (TENS) device used for symptomatic relief and management of chronic intractable pain conditions. The device is also used as an adjunctive treatment in the management of post-surgical pain, post traumatic acute pain problems, as well as adjunct for pain control due to rehabilitation. The device provides temporary relief of mild to moderate neuropathic pain associated with diabetic peripheral neuropathy of the lower extremities.” Promotional statements herein are limited to this cleared indication.
² Single-blind, randomized, prospective, placebo-controlled study supporting K252712. Responder definitions: DN4, crossing the diagnostic threshold; BPI worst pain, ≥3-point reduction (established MCID). Endpoints assessed post-treatment and at 1, 3 and 6 months. Figures are study results and do not represent or extend the cleared Indication for Use.
³ Distinctiveness statement qualified to Algiamed’s knowledge and based on the combination of attributes, not any single one. STIMPOD is non-invasive (surface electrode; no skin penetration or implant), electrical, and delivers a patented hybrid RF waveform (monophasic square wave with superimposed 130 kHz RF burst). Named DPN-pain comparators each differ on at least one attribute: Neuralace Axon Therapy is non-invasive but magnetic (mPNS), not electrical and not this waveform; DyAnsys First Relief (K212859) is electrical but percutaneous (microneedle electrodes through the skin), not non-invasive; Abbott Proclaim XR is implanted spinal cord stimulation. The statement claims uniqueness of this attribute combination, not comparative clinical superiority. Verify against the FDA 510(k) database and confirm with regulatory and patent counsel prior to publication.
⁴ Treatment course and durability are stated as study findings, not as the cleared Indication for Use. In the pivotal study, treatment was delivered in three 10-minute sessions and the DN4 responder benefit was statistically significant at the 3-month follow-up. The cleared indication is “temporary relief”; this footnote and the related text describe study results and do not extend the cleared labeling.
⁵ Neuralace Axon Therapy treatment schedule per the AT-PDN trial registration (ClinicalTrials.gov NCT05620225): Days 1–30, six treatments (Week 1, three treatments; Weeks 2–4, weekly), followed by bi-weekly treatment in Month 2 and treatments every 2–4 weeks in Month 3, plus additional treatments for pain flare-ups; Neuralace patient information describes monthly maintenance thereafter. The first-month figure (6 treatments) is taken directly from the registered protocol. The first-year total (≈18 treatments × 13.5 min ≈ 243 minutes) is an Algiamed estimate derived from that schedule plus monthly maintenance, not a figure published by Neuralace. STIMPOD comparison: three 10-minute sessions = 30 minutes. Figures describe treatment time only, not comparative clinical effectiveness. Confirm against the current Neuralace IFU prior to publication.
⁶ Pharmacotherapy efficacy: across guideline agents, number needed to treat (NNT) for a clinically meaningful response in DPN pain is generally ~5–6 (e.g., duloxetine NNT ~5 for ≥30% pain reduction, Cochrane 2014; gabapentin NNT ~6, Cochrane/TheNNT), and responders typically achieve roughly a 30–50% reduction in pain (AAFP, 2010). Reviews note only a minority of patients respond and that adverse effects commonly drive discontinuation. Sources: Cochrane reviews (Lunn et al., 2009/2014); AAFP DPN treatment review (2010); systematic review of duloxetine in PDN (Moore et al.).
⁷ SCS complication data: lead migration commonly reported (literature ranges ~13–23%), device-related infection (~2–10%), and aggregate complication incidence of ~30–40% in some reviews; revision/hardware failure also reported. Sources: ASRA review (2019); Pain Medicine review (2016); Diabetes Care RCT (2014); StatPearls (2025).
⁸ Neuralace Medical Axon Therapy (mPNS), FDA-cleared for painful diabetic neuropathy; 13.5-minute sessions per company materials (Neuralace press release, Jan 11, 2024). See note 5 regarding the multi-month schedule. Comparison is limited to publicly documented, nonefficacy treatment characteristics.
⁹ Cost-of-illness figure refers to total annual all-cause healthcare costs for patients with severe painful DPN, not the cost of any specific therapy. Reported at ~$27,931 (painful DPN) to ~$30,755 (severe painful DPN) versus ~$6,632 for diabetes alone, with outpatient and inpatient care (not medication) the primary cost drivers. Source: retrospective US claims analysis (Sadosky et al., reported in healthcare-utilization studies of the DPN clinical spectrum); corroborated by Optum Clinformatics analysis (2024) showing ~$20,887 incremental annual all-cause cost for severe PDPN. Figures describe disease burden, not a comparative cost claim for any product.
¹⁰ Prevalence: approximately 40 million US adults live with diabetes (2021); DPN affects nearly 50% of people with diabetes, and an estimated 30–50% of those with DPN experience associated pain. Sources: US diabetes prevalence data (2021); peer-reviewed DPN epidemiology reviews (Pain Medicine, 2026; American Diabetes Association compendium, 2022).
General: This content is promotional and intended for healthcare professionals. It is not a substitute for the full Instructions for Use. Claims are limited to the FDA-cleared indication; clinical-study figures describe trial results and do not extend the cleared labeling. All comparative and substantiation footnotes should be confirmed by regulatory review prior to publication.
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