Diabetic

Neuropathy

FDA-Cleared In-Office Neuromodulation for Painful Diabetic Neuropathy (PDN)

Partner with Fields Consulting Group and NeuroDynamics Global to offer the NS100—a 30-minute in-office procedure engineered to deliver non-pharmacological chronic pain relief, reduce blood glucose levels, and create a significant new revenue stream for your practice.

Key Clinical Metrics Bar

  • 87% Reduction in NRS Pain Scores over 90 Days (Published Study)

  • it actively helps lower blood glucose and A1c levels, although individual results vary.

  • up to 20 Days Temporary Wear Period with Results Lasting up to 6 Months

  • 100% Managed Prior Authorization & Managed Pre-Determination Support

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Clinical Efficacy & Mechanism of Action

Advanced Neuromodulation Designed for Long-Term Relief

The NS100 by NeuroDynamics Global is an FDA-cleared Class II trial Peripheral Electrical Neurostimulator (PENS/PNS/CNS) specifically designed as a non-pharmacological treatment for chronic pain associated with diabetic neuropathy.

How It Works:

Using four independent, pre-programmed titanium electrode arrays, the NS100 is precisely applied in a 30-minute office/outpatient procedure to stimulate key neural targets:

  • TrigeminoCervical Nucleus & C1–C3 Cervical Spinal Roots

  • Trigeminal Nerve (ATN) & Auricular Branch of the Vagus Nerve (ABVN)

  • Activates central opioid, nicotinic, and cannabinoid receptors, modulating the cholinergic anti-inflammatory pathway and vagal control of metabolic states.

Peer-Reviewed Clinical Proof (Frontiers in Neuroscience, 2025):

  • Sustained Pain Relief: Baseline pain scores drop from an average of 7.92 to 1.04 on the NRS scale over 90 days (an 87% reduction), with over 70% of patients experiencing pain relief for up to 6 months.

  • Metabolic & Glycemic Improvement: Clinical trial data demonstrated a reduction in mean blood glucose levels, over 90 days. Individual results vary.

  • Reduced Opioid Reliance: Helps physicians mitigate chronic pain without relying on prescription opioids, NSAIDs, tricyclics, or anti-epileptic medications.

Key Advantages for Medical Practices & Facilities

Turnkey Operational Implementation

NeuroDynamics Global provides comprehensive, one-on-one clinical training for your providers and clinical staff to ensure seamless adoption into your workflow.

Broad Insurance Coverage

The NS100 program is covered by Traditional Medicare and most major commercial insurance carriers.

Fully Managed Prior Authorization

Eliminate administrative overhead. NeuroDynamics Global manages the predetermination and prior authorization workflow on your practice’s behalf to streamline approvals and mitigate claim denials.

Rapid In-Office Procedure

The placement takes roughly 30 minutes in an outpatient setting. Precision positioning is guided by a proprietary Programming Technical Unit (PTU) utilizing real-time neural impedance feedback.

Medical Necessity & Practice Qualification

Ideal Provider Profiles:

  • Endocrinology & Diabetes Care

  • Neurology & Pain Management

  • Primary Care & Internal Medicine

  • Podiatry, Rheumatology, & Vascular Surgery

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Medical Necessity Criteria for Patients:

To establish coverage and medical necessity, patients typically require:

  1. Diagnosis: Confirmed diabetic neuropathy (e.g., E11.41, E11.42, E10.41, E10.42) paired with chronic pain codes (G89.29 or G89.4).

  2. Pain History: 3 to 6 months of documented chronic pain (NRS score $\ge$ 5).

  3. Failed Conservative Care: At least one failed prior conservative modality (e.g., prescription medications, OTC options, physical therapy, compression socks, or injections).

  4. No Contraindications: Free of active pacemakers, deep brain/spinal cord stimulators, hemophilia, or pregnancy.

How the Program Works: Step-by-Step

Patient Identification: Identify eligible patients presenting with painful diabetic neuropathy who have failed standard conservative management.

1

Authorization & Verification: Submit patient demographics and clinical history; NeuroDynamics Global secures the prior authorization or Medicare scheduling confirmation.

2

30-Minute Procedure: Provider uses the Programming Technical Unit (PTU) to place the 4 titanium electrode arrays.

3

20-Day Wear & Removal: Patient wears the discrete device for up to 20 days and returns to your office for a rapid, non-invasive removal, enjoying up to 6 months of relief.

4

Frequently Asked Questions (FAQ)

Is the NS100 covered by insurance?

1

Yes. The NS100 device and procedure are covered by Traditional Medicare as well as most commercial insurance plans. Once medical necessity is documented, Medicare patients can be scheduled immediately, while commercial plans go through pre-determination.


Does our billing team have to handle complex pre-authorizations?

2

No. NeuroDynamics Global manages the prior authorization and predetermination process for your practice to minimize administrative fatigue and help ensure clean claim submissions.


What equipment or technical training is required?

3

Zero heavy capital investment is required. The NeuroDynamics Global team provides complete, hands-on, one-on-one training for your clinical staff, as well as the proprietary Programming Technical Unit (PTU) required for placement.


What are the patient contraindications?

4

Contraindications include patients with implantable cardiac devices (pacemakers), indwelling/implantable stimulators (SCS, deep brain stimulators), hemophilia, pregnancy, or severe cognitive impairment.

Bring Advanced Neuromodulation to Your Practice

Expand your clinical treatment options for diabetic neuropathy while growing your practice's operational revenue. Schedule a brief advisory call to evaluate bringing the NS100 program to your clinic.

Request a Practice Assessment

Complete the form below, and our advisory team will connect with you within one business day.