Reviewed by Sarim Mir, MD — Board-Certified Neurologist, Mir Neurology (Hagerstown & Cumberland, MD)
Key takeaways
- The FDA cleared Neuralace Medical’s Axon Therapy, a noninvasive device that uses magnetic peripheral nerve stimulation (mPNS) to treat painful diabetic neuropathy (PDN).
- It is a drug-free, non-addictive option — appealing for people limited by medication side effects or who want to avoid opioids.
- Each treatment is a short session (about 13.5 minutes) in which magnetic pulses pass through the skin, with no surgery or needles.
- This is an FDA-cleared device, not a cure. A proper diagnosis — often including an EMG/nerve conduction study — should come first.
What changed
For people living with burning, aching nerve pain from diabetes, the treatment menu has long been dominated by medications — and those drugs don’t work for everyone. That picture is now shifting. The FDA has cleared Axon Therapy, a noninvasive device made by Neuralace Medical, for painful diabetic neuropathy. Instead of a pill, it uses magnetic peripheral nerve stimulation to calm the overactive pain-signaling nerves in the legs and feet.
The clearance was supported by a double-blind, randomized controlled trial of 71 patients. At day 30, the active-treatment group showed a 72.3% responder rate, an average 57.6% reduction in pain on a standard pain scale, and about a 35% reduction in numbness. By day 90, the responder rate reached 81.4%. Importantly, the FDA granted clearance — meaning the device met safety and performance standards for its intended use — rather than the “approval” pathway used for new drugs.
A plain-English explainer of painful diabetic neuropathy
Diabetic neuropathy is nerve damage caused by high blood sugar over time. The longest nerves are hit first, which is why symptoms usually start in the feet and lower legs and can move upward. When those nerves misfire, the result is painful diabetic neuropathy (PDN) — a deep burning, tingling, stabbing, or electric-shock feeling, often worse at night. Some people also feel numbness or a “walking on cotton” sensation at the same time.
PDN is more than uncomfortable. Pain disrupts sleep, mood, and the ability to stay active, and the underlying numbness raises the risk of unnoticed foot injuries. That’s why getting the diagnosis right — and finding a treatment a patient can actually tolerate — matters so much.
How Axon Therapy works, and why a non-drug option matters
Axon Therapy delivers magnetic pulses through the skin during a short in-office session. Those pulses stimulate the peripheral nerve cells involved in pain signaling, helping to quiet the abnormal activity that diabetes-damaged nerves produce. Because the magnetic field works through intact skin, there is no incision, no implant, and no needle — making it a noninvasive procedure.
The appeal of a drug-free option is practical. The standard medications for nerve pain — certain antidepressants, anti-seizure drugs, and topical agents — can cause drowsiness, dizziness, weight changes, or brain fog, and not every patient tolerates them or gets enough relief. Opioids carry their own well-known risks of dependence and are a poor long-term fit for chronic nerve pain. A non-addictive, noninvasive device gives clinicians another tool for patients who are limited by medication side effects, who haven’t responded well to drugs, or who simply want to reduce how many pills they take.
It’s worth being clear about expectations. Axon Therapy is not a cure for neuropathy and does not reverse nerve damage or treat the underlying diabetes. It is one part of a broader plan that still includes blood-sugar control, foot care, and management of other risk factors.
What this means for you in Hagerstown & Cumberland
At Mir Neurology, the first priority is making sure your symptoms are truly diabetic neuropathy and not another treatable cause of foot pain or numbness — such as nerve compression or a different type of neuropathy. We often confirm this with an in-office EMG and nerve conduction study, which measures how well your nerves are actually working. Learn more about our EMG / electromyography testing and neuropathy treatment.
Once we understand what’s driving your pain, we can build a plan that fits you — which may include newer non-drug options like magnetic nerve stimulation alongside the proven fundamentals of neuropathy care. If you have burning, tingling, or aching feet, you don’t have to just live with it.
Call (301) 797-7600 to request an appointment, or request an appointment online.
Frequently asked questions
Is Axon Therapy a cure for diabetic neuropathy? No. It is an FDA-cleared, noninvasive treatment shown to reduce pain and numbness for many patients, but it does not cure neuropathy or reverse nerve damage. It works best as part of a complete plan that includes blood-sugar control.
Does the treatment hurt or require surgery? No. It is noninvasive — magnetic pulses pass through the skin during a short session of roughly 13.5 minutes, with no needles, incisions, or implants.
Should I get an EMG before trying a device like this? Often, yes. An EMG and nerve conduction study helps confirm that your symptoms are diabetic neuropathy and not another condition, which makes any treatment choice — including Axon Therapy — more accurate.
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This article is for general education and is not a substitute for personalized medical advice from your own physician.
Need to talk to a neurologist about this?
Mir Neurology offers same-week appointments in Hagerstown & Cumberland, MD. No referral needed for most plans.
