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Neuropathy & Relief

Person grasping pain points on foot

SECTION 7

NEUROPATHY TREATMENT

PENS Device  ·  NS-100 Clinical Data  ·  Photo-Energized PRP  ·  IV Therapy

Comprehensive, Multi-Modal Neuropathy Care — Including Medicare-Covered Options for Diabetic Patients

Neuropathy — nerve pain, numbness, tingling, and burning — affects over 20 million Americans and is profoundly under-treated. Standard care relies on medications like gabapentin that mask symptoms without addressing nerve health. KIM’s four-pillar protocol is designed to reduce pain, support nerve regeneration, and improve function.

MEDICARE BENEFIT: Diabetic patients with diagnosed neuropathy may qualify for PENS Device (NS-100) coverage under Traditional Medicare. Call (812) 282-1575 to verify eligibility.

PILLAR 1:                                                                                              

The NS-100 PENS Device – FDA-Cleared for Diabetic Peripheral Neuropathy

The NS-100 (NeuroSolutions 100) is an FDA-cleared Class II medical device for chronic intractable pain due to diabetic peripheral neuropathy, approved for use up to 56 days. It uses Percutaneous Electrical Nerve Stimulation (PENS) — tiny electrode arrays precisely placed at auricular nerve endings (in and around the ear) during a 20–30 minute in-office procedure under topical anesthetic. The device is worn continuously for up to 20 days, delivering low-level neurostimulation targeting the trigeminocervical (TCN) and vagus nerve (VNS) pathways that modulate pain signals throughout the body.

Unlike home TENS units, the NS-100 works at a neuroanatomical level — activating the brainstem pathways that regulate pain perception and, emerging evidence suggests, metabolic function including blood glucose regulation.

 NS-100 Clinical Evidence: Observational Study — Staats & Staats (2024)

A clinical observational study (Staats & Staats) followed 93 diabetic patients who received the NS-100 device (average wear time: 19 days) for an average follow-up of 227 days. The results were statistically extraordinary:

78% Average pain reduction at 30 days (pain scores: 7.95 to 1.87 / 10, p<0.0001)
83% Average pain reduction at 60 days (pain scores: 7.95 to 1.36 / 10, p<0.0001)
87% Average pain reduction at 90 days (pain scores: 7.95 to 1.04 / 10, p<0.0001)
80% Of tracked patients who discontinued ALL pain medications after treatment
37% Improvement in blood glucose levels at 90 days — suggesting metabolic benefit beyond pain
19 days Average device wear time — yet benefits persisted up to 227 days average

These results achieved p-values below 0.0001 at every time point — statistically ruling out chance. A Cleveland Clinic-registered clinical trial is ongoing to validate these findings in a controlled setting. The NS-100 is FDA-cleared (not just cleared — it has received Class II FDA approval specifically for diabetic peripheral neuropathy pain).

Who May Qualify for NS-100 — Traditional Medicare Coverage

  • Diagnosis of Type 1 or Type 2 Diabetes
  • Diagnosed diabetic mono- or polyneuropathy (documented)
  • Neuropathy pain rated 5/10 or greater
  • Prior medications have provided inadequate pain control
  • Enrolled in Traditional Medicare (not Medicare Advantage)
Our billing team will verify your Traditional Medicare eligibility for the NS-100 PENS device BEFORE your appointment. Call (812) 282-1575.

PILLAR 2: Photo-Energized PRP & Regenerative Injections

For neuropathy affecting specific peripheral nerve territories — particularly feet, ankles, and lower legs — our Photo-Energized PRP injections may reduce local neuroinflammation and support nerve health when administered adjacent to affected nerve pathways. Prolozone injections improve local oxygenation. Off-label, investigational.

PILLAR 3: FDA-Cleared Laser Therapy & Advanced Electrostimulation

Our FDA-cleared therapeutic laser delivers photo-biomodulation — light energy at specific wavelengths that may reduce neuroinflammation, stimulate mitochondrial function in nerve cells, and improve microcirculation. Combined with in-office electrostimulation, this pillar supports the environment needed for nerve recovery.

PILLAR 4: Advanced IV Nutritional & Metabolic Therapy

Diabetic neuropathy has a strong nutritional and metabolic component. We offer IV Alpha Lipoic Acid (published evidence in diabetic neuropathy), IV Glutathione, IV B-vitamin complexes, IV Methylcobalamin (B12), and targeted nutrient infusions supporting nerve cell health at the cellular level.

SERVICE INVESTMENT
NS-100 PENS Device (Traditional Medicare — may be covered) Call to verify
Comprehensive Neuropathy Program (all pillars) $7,000 – $20,000
Photo-Energized PRP — Neuropathy Application $1,600 / session
IV Alpha Lipoic Acid $130 / session
IV Glutathione $110 / session
Advanced Microcurrent Neuropathy Program $4,400

REGULATORY NOTICE

The NS-100 PENS device is FDA-cleared as a Class II medical device for chronic pain due to diabetic peripheral neuropathy. Medicare coverage is not guaranteed and requires eligibility verification and medical necessity documentation. NS-100 clinical data (Staats & Staats) is from an observational retrospective study, not a randomized controlled trial; results cannot be guaranteed for individual patients. Photo-Energized PRP, Prolozone, LLLT, and IV nutritional therapies for neuropathy are off-label and investigational. These therapies do not cure neuropathy or diabetes. Results vary significantly among individuals.

SECTION 6

CRPS — COMPLEX REGIONAL PAIN SYNDROME

Neridronate IV  ·  Ketamine  ·  Laser  ·  Cellular Biologics ·  PRP 

CRPS Treatment That Rivals European Protocols — Without the Overseas Travel

Complex Regional Pain Syndrome is considered one of the most painful conditions in medicine — rated above childbirth and amputation in some studies. At KIM, we offer a multi-modal CRPS protocol that combines the most evidence-supported approaches available, including an IV bisphosphonate protocol equivalent to Neridronate (the gold-standard European treatment) combined with IV ketamine, FDA-cleared laser therapy, Photo-energized PRP and cellular biologic injections.

70%+ CRPS patients in published research achieving 50%+ pain reduction with bisphosphonate protocols
32% Complete remission rate when treated within 1 year of CRPS onset (published research)
Landmark Italian RCT by Varenna et al. — PAIN (2013) — showing neridronate’s superiority over placebo

Our CRPS Protocol

IV Bisphosphonate Protocol (Neridronate-Equivalent)

Neridronate is approved for CRPS in Italy and Europe but not yet FDA-approved in the U.S. for this indication. We administer an equivalent IV bisphosphonate protocol modeled after the landmark Italian RCT (Varenna et al., PAIN, 2013). This is an off-label use of FDA-approved bisphosphonate medications.

IV Ketamine Infusion Intensive

High-dose IV ketamine over multiple monitored days provides dramatic pain relief in CRPS by modulating NMDA receptor pathways involved in central sensitization. Administered personally by Dr. Cruz with anesthesia-level monitoring.

FDA-Cleared Low-Level Laser Therapy & Cellular Biologics

FDA-cleared therapeutic laser reduces inflammation and supports microcirculation. Photo-Energized PRP or adipose cellular biologic injections to affected areas provide additional regenerative support.

High-volume, Hyper-concentrated SGB – Stellate Ganglion Block guided with Ultrasound

SERVICE INVESTMENT
IV Bisphosphonate Protocol (4-day intensive) $15,000
IV Ketamine Intensive (4-day) $5,000
Cellular Biologic Regenerative Injection $10,000
Stellate Ganglion Block (upper extremity CRPS) $3,500
IV High-volume, Hyper-concentrated, Photo-energized PRP – Platelet Rich Plasma $3,500

REGULATORY NOTICE

IV bisphosphonate therapy for CRPS is off-label use of FDA-approved medications. Neridronate is not FDA-approved in the U.S. Results from Varenna et al. (PAIN, 2013) cannot be universally generalized. Early treatment (within 12 months of onset) is associated with better outcomes. Not covered by insurance. Individual results vary and cannot be guaranteed.

CRPS & Neuropathy Pain Relief

Complex Regional Pain Syndrome (CRPS) [formerly RSD Reflex Sympathetic Dystrophy] and neuropathic pain can be among the most devastating conditions – yet many patients often see life-changing improvement through multi-therapy protocols combining:

*Neridronate Equivalent IV (for Bone/Inflammatory Pain)

*IV Ketamine

*Regenerative Medicine Injections

*Prolozone & PRP Injections
*Messenger Signaling Cell Therapy

 Therapies Not FDA-approved and not intended to diagnose, treat, cure, or prevent disease.

Patient CRPS Video Journeys

Dr. Cruz explains CRPS – RSD 2 minutes

Sarah Shingle – CRPS Journey

James – CRPS Journey

Call 812-913-4416 for CRPS or Pain Consultation

Take the First Step

 Call: 812-913-4416
Visit: www.RegenMedKY.com
Questions & Heart Screening Requests: kimregenmed@gmail.com

“Even when traditional medicine says there’s nothing more to do — there may still be hope.”
— Dr. Rafael F. Cruz, MD

Important Medical Disclosure:

All information is provided for educational purposes only and is not medical advice. Many services are off-label, not FDA-approved, and not covered by insurance, unless labelled Medicare approved. Individual responses vary. A medical evaluation is required prior to initiating care.

What is Peripheral Neuropathy?

Chronic nerve pain or constant nerve discomfort, also known as Peripheral Neuropathy, results from damage to the nerves. Sufferers often experience chronic pain that can be described as burning, stabbing, or numbing in the affected area. Loss of sensation or even a weird feeling of sensation causing much discomfort.

Some sufferers experience symptoms such as:

  • Weakness
  • Burning pain
  • Numbness
  • Tingling
  • Impairing balance issues

What Patients Say

What Causes Chronic Nerve Pain & Discomfort?

The cause of nerve damage is unique to each patient and often must be identified before treatment is administered. Some of the most common causes of nerve damage are:

  • Poor blood flow to nerves
  • Abnormal blood sugar levels (diabetes)
  • Chronic Infections
  • Pesticide exposure
  • Genetic variants
  • Autoimmune disease – When the body inadvertently begins to attack itself, killing nerves.

Are There Effective Treatments for Neuropathy?

Indeed! Our neuropathy treatment focuses on four essential areas that produce optimal results. These can be broken down into Fuel and Activation. The goal is to eliminate the cause of nerve damage, and properly support and stimulate nerve regeneration.

This combination optimizes the natural ability of nerves to heal by focussing on the four essential areas of neuropathy treatment. According to Blueprint Healthcare Network, “this technology has 21 peer-reviewed studies with a 97% success rate with peripheral neuropathy”.

Four Essential Areas of Neuropathy Treatment

  1. Low-Level Light Therapy LLLT (Fuel)
    Low-level light therapy is essential to increase blood flow and repair nerve damage. The goal of light therapy is to signal the creation of new blood vessels.. These new blood vessels supply the nutrients needed to heal and repair peripheral nerves.
  2. Electrostimulation (Activation)
    Electrostimulation aids the growth of nerves known as Nerve Re-education and can be carried out daily in the privacy of your own home. Cancer Centers of America use this technique for patients who have suffered nerve damage as a result of chemotherapy. Immediate results have been felt in pain relief and restoration of normal feeling in the affected areas.
  3. Nutrition Therapy (Fuel)
    Nutrition is essential for maximum tissue and nerve restoration. Advanced Nutrition Therapy speeds healing and promotes blood flow and other components necessary for nerve repair.
  4. In-Person Consults and Virtual Education (Fuel/Activation)
    Weekly office consults for electromagnetic and electrostimulation therapy paired with at-home education and treatments.

A combination of fuel and activation therapies creates the perfect cocktail for nerve regeneration. We perform a comprehensive neurological and vascular evaluation in order to determine the level of treatment that is right for you. Complete the form below to schedule a consultation and learn how you can find relief for chronic nerve pain and discomfort.

Get Back to Feeling Good!

Safe and effective treatment for nerve pain.

Increase blood flow to nerves in the legs, feet, and hands. No more sensations.

Schedule a consultation and learn all about neuropathy treatment.

Frequently Asked Questions About
Treatment for Nerve Damage

1

How much treatment Is needed to heal nerve damage?

Each person is unique, and the causes of nerve damage vary. Therefore, the level of damage, severity, and types of fibers damaged will determine the amount of treatment necessary for each patient.

2

Can I get rid of neuropathy without surgery?

We offer non-invasive and non-surgical therapy to heal nerve damage resulting in pain relief and chronic nerve-related discomforts. Our goal is to treat chronic pain of the nervous system without surgery and without addictive pain medicine.

3

Can all types of nerve damage be reversed?

There are sensory and motor nerves. Sensory nerves include small fiber nerves and diameter nerves. Motor nerves control the movement of muscles. If there is muscle weakness due to neuropathy for more than two years, this may result in permanent muscle damage. A complete and personalized evaluation will determine if you will have success.

4

How does peripheral neuropathy therapy improve nerve function?

  1. Optimizes the body’s environment to promote nerve regeneration.
  2. Increases the flow of blood to nerves
  3. Stimulates damaged nerves resulting in improved balance and decreased pain.
  4. Reduces brain-based pain.

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