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FDA Cleared | Class II Medical Device

NeuroSolutions 100 (NS100)

A breakthrough, non-pharmacologic therapy for painful diabetic neuropathy — FDA-cleared, insurance-covered, and designed for in-office use.

The Challenge Your Patients Face

Painful Diabetic Neuropathy (PDN) is one of the most difficult conditions to manage. Traditional pharmacologic options — Gabapentin, Lyrica, Cymbalta, opioids — deliver limited relief and carry significant risks including tolerance, dependency, and reduced quality of life. Many patients remain at a pain scale of 5 or greater despite maximal medical therapy.

The NS100 gives your practice a covered, non-pharmacologic alternative backed by a Level 1 Randomized Controlled Trial and published peer-reviewed research.

How It Works

The NS100 is a programmable, software and voltage-controlled Class II peripheral nerve stimulator. Four titanium electrode arrays are precisely implanted in a 45–60 minute in-office procedure, targeting the TrigeminoCervical Complex (TCC), cervical spinal roots (C2–C3), and the trigeminal and vagus nerves. The device is worn continuously for 20 days, delivering low-level electrical pulses that activate multiple neuroreceptors.

Results can last up to 6 months. The procedure is performed by or under the direction of a physician or qualifying mid-level provider.

1
Patient Identification — PDN with pain scale ≥5, failed pharmacologic therapy
2
Device Programming — NS100 programmed via PTU; titanium arrays connected
3
In-Office Implant — 45–60 minute procedure; electrode arrays placed on wrist, ear, and neck
4
20-Day Wear Period — Continuous wear; patient follows up as needed
5
Removal & Follow-Up — Device removed in-office; outcomes evaluated; repeat as clinically indicated

Clinical Evidence

  • Level 1 Randomized Controlled Trial demonstrating significant PDN pain reduction
  • Published in Frontiers in Neuroscience (August 2025) — 83-patient observational trial in Native Americans demonstrating pain reduction and blood sugar improvement
  • Cleveland Clinic Foundation serving as Principal Investigator for a 2,000-subject prospective multi-center study
  • Off-label benefit: significant blood sugar reduction observed in a meaningful subset of Type 2 diabetes patients
  • 70%+ of patients report meaningful pain relief

Reimbursement & Practice Revenue

  • Covered by Medicare, UHC, BCBS, Aetna, and major commercial payers
  • On-label indication: Painful Diabetic Neuropathy with pain scale ≥5
  • Full RCM services included — billing, prior authorization, claims submission, and collections
  • NeuroSolutions 100 handles clearinghouse enrollment under your NPI
  • All remittances remain with your practice
  • Consistent, favorable cash-on-cash returns documented across multiple provider sample reports

What's Included with Summit

  • Full practice onboarding and staff training
  • Medical necessity review and documentation support
  • Prior authorization and predetermination management
  • Post-procedure adjudication and payment tracking
  • Dedicated account support from Summit Medical

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