Neuralace Medical Announces FDA Clearance of Axon Therapy for Chronic Painful Diabetic Neuropathy
Published on MedED: 18 January 2024
Originally published: 11 January 2024
Source: Neuralace Medical, Inc
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN001
Category: Diabetes
Crossreference: Gerontology, Microvascular complications
Category tags: Diabetes, microvascular complications, peripheral neuropathy, painful peripheral neuropathy, pDPN, electromagnetic devices
Originally published: 11 January 2024
Source: Neuralace Medical, Inc
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN001
Category: Diabetes
Crossreference: Gerontology, Microvascular complications
Category tags: Diabetes, microvascular complications, peripheral neuropathy, painful peripheral neuropathy, pDPN, electromagnetic devices
| Product Category | Product Name | Company | Status |
|---|---|---|---|
|
Medical Device |
AXON |
FDA Approved |
SAN DIEGO, Jan.11, 2024 /PRNewswire/ -- Neuralace Medical, Inc.
The FDA has approved AXON, the first non-invasive, magnetic peripheral nerve stimulation (PNS) device for treating Diabetic Neuropathy (DN) pain.
Globally, 537 million adults live with diabetes.1 Diabetic neuropathy (DN) is the most common microvascular complication associated with the condition, affecting about 50% of all diabetic patients. Painful DPN (pDPN) occurs in 30–50% of those patients. The pathogenesis of the pDPN is unclear, which makes treating the condition challenging, and treatment outcomes are often poor.2
The approval of this innovative treatment by the FDA is a significant advancement in pain management for these patients and offers hope to millions around the globe.
According to the treatment's developer, Neuralace Medical Inc., the device delivers high-intensity, time-varying magnetic fields directly to the affected nerves using it's proprietary magnetic Peripheral Nerve Stimulation (mPNS) technology.
The AXON treatment is non-invasive, easy to administer, and has few side effects. It can be administered in a physician's practice by mid-level practitioners. The treatment regimen involves an initial series of treatments in the first month, followed by a monthly maintenance regimen. Each treatment lasts approximately 13 minutes.
Clinical trials supporting its approval included:
- The Safety and Efficacy of Axon Therapy Study (SEAT) which recorded a 65.2% responder rate and a 55% average reduction in pain at the 180-day follow-up.
- A retrospective review of the real-world use of Axon Therapy and mPNS evaluated the longer-term performance of Axon Therapy (>180 days) for treatment efficacy. Initial treatment data from 81 patients at the 180-day milestone revealed a remarkable 78% responder rate (>50% pain relief).
- The Axon Therapy and Conventional Medical Management for Painful Diabetic Neuropathy Compared to Sham and Conventional Medical Management study was a double-blind Multi-Center Randomized Controlled Trial (RCT)
- 71 patients were enrolled in the study: 21 participants in a sham group and 50 in the mPNS active group, with the sham group allowed to cross over (CX group) at 30 days.
- At Day 30, there was a 72.3% responder rate in the treatment group, with a reported average reduction of 58 57.6% VAS Pain Score. Individuals in this group also reported an average decrease of 35% in numbness at Day 30 and a 20% average reduction in QoL-DN total score. At Day 90, the treatment group exhibited an 81.4% responder rate, with the CX group showing an 88.9% responder rate.
Dr. Lora Brown, principal investigator on the Axon Therapy in Painful Diabetic Neuropathy Study (AT-PDN)I trial, commented in the recent press release: "In my opinion, Axon Therapy will offer physicians treating diabetic patients a new non-invasive tool which can bring relief to millions of patients suffering from PDN".
Clinical Trials & Supporting Information
| Clinical Study | ClinicalTrial.gov Registration | LInks to Clinical Trial Information |
|---|---|---|
|
NCT05620225 |
The Axon Therapy and Conventional Medical Management for Painful Diabetic Neuropathy Compared to Sham and Conventional Medical Management |
|
|
Magnetic Peripheral Nerve Stimulation (mPNS) for Chronic Pain |
References
2. Abd-Elsayed AA, Marcondes LP, Loris ZB, Reilly D. Painful Diabetic Peripheral Neuropathy – A Survey of Patient Experiences. J Pain Res. 2023;16:2269-2285 https://doi.org/10.2147/JPR.S409876
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This article is compiled from a variety of resources. Every effort has been made to correctly attribute quotes and content. Where possible all information has been independently verified. The Medical Education Network bears no responsibility for any inaccuracies which may occur from the use of third-party sources. If you have any queries regarding this article contact us
Fact-checking Policy
The Medical Education Network makes every effort to review and fact-check the articles used as source material in our summaries and original material. We have strict guidelines in relation to the publications we use as our source data, favouring peer-reviewed research wherever possible. Every effort is made to ensure that the information contained here is an accurate reflection of the original material. Should you find inaccuracies, out of date content or have any additional issues with our articles, please make use of the contact us form to notify us.
