Norwayz

Norwayz is a prescription-only medical device designed to deliver targeted, non-invasive neuromodulation for the management of moderate to severe chronic neuropathic pain. Utilizing a proprietary, clinically validated waveform, Norwayz directly modulates pain signal transmission along peripheral nerve pathways, offering a drug-free alternative or adjunct to pharmacological interventions. Its precision-calibrated technology is engineered for patient-specific titration, ensuring optimal therapeutic efficacy while minimizing user burden. Developed through rigorous clinical research, it represents a significant advancement in neuromodulation for long-term pain management.

Features

• Proprietary, biphasic asymmetric waveform with frequency modulation between 2-100 Hz.
• Medical-grade, hypoallergenic hydrogel electrode system (5 cm x 5 cm) for optimal conductivity and skin adherence.
• Rechargeable lithium-polymer battery providing up to 8 hours of continuous therapy per charge.
• Bluetooth-enabled companion app for iOS and Android for session tracking, intensity control, and progress monitoring.
• IP67 rating for water and dust resistance, allowing for use during most daily activities.
• Programmable therapy sessions with adjustable duration (15-60 minutes) and automatic shut-off.
• Built-in impedance monitoring to ensure consistent and effective delivery of therapy.

Benefits

• Provides significant and sustained reduction in pain intensity scores, as measured by validated scales like the Visual Analog Scale (VAS).
• Offers a non-pharmacological, non-addictive therapeutic option, reducing or eliminating the need for opioid analgesics.
• Improves overall quality of life, sleep quality, and functional capacity by mitigating the debilitating effects of chronic pain.
• Empowers patients with direct control over their therapy through an intuitive digital interface, promoting adherence.
• Minimizes systemic side effects commonly associated with oral pain medications, such as gastrointestinal distress, drowsiness, or cognitive impairment.
• Delivers targeted therapy, acting locally on affected nerve pathways without widespread systemic exposure.

Common use

Norwayz is indicated for the management of chronic neuropathic pain conditions in adults. This includes, but is not limited to, pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia (shingles), post-surgical neuropathic pain, and complex regional pain syndrome (CRPS). It is intended for patients who have had an inadequate response to, or cannot tolerate, first-line pharmacological treatments. Usage is typically daily, as part of a comprehensive pain management plan developed with a healthcare professional.

Dosage and direction

The “dosage” of Norwayz is defined by session duration, frequency, and stimulation intensity, which must be individually titrated by a healthcare provider.

1. Initial Setup: A qualified healthcare professional must determine the optimal placement of the electrode based on the patient’s specific pain distribution and neuroanatomy.
2. Application: Clean and dry the skin area. Apply the hydrogel electrode firmly to the predetermined site. Attach the Norwayz device to the electrode.
3. Titration: Using the companion app, start at the lowest intensity setting. Gradually increase the intensity until a strong but comfortable paresthesia (tingling sensation) is perceived over the painful area. The sensation should not be painful.
4. Session Protocol: A typical starting protocol is one 30-minute session, once or twice daily. The duration and frequency may be adjusted by the prescribing clinician based on therapeutic response and tolerability.
5. Post-Session: Remove the device and electrode. Gently clean the skin with water. Allow the skin to rest for several hours before reapplying therapy to the same site.

Precautions

• Do not use Norwayz before its operation has been demonstrated by a qualified healthcare professional.
• Use caution if driving or operating machinery until you know how Norwayz affects you, as neuromodulation may cause distraction or drowsiness in some individuals.
• Regularly inspect the skin under and around the electrode for signs of irritation, redness, or rash. Discontinue use and consult a physician if skin irritation persists.
• The device may influence the operation of other implanted electronic medical devices, such as pacemakers or implantable cardioverter defibrillators (ICDs).
• Do not use on areas of broken skin, wounds, or rashes.
• Not recommended for use during pregnancy or breastfeeding due to the absence of clinical safety data in these populations.

Contraindications

Norwayz is contraindicated in patients with:

• An implanted electronic device (e.g., pacemaker, defibrillator, spinal cord stimulator, deep brain stimulator, or cochlear implant).
• A known hypersensitivity or allergy to hydrogel or acrylate-based adhesives.
• A diagnosed, untreated cardiac arrhythmia.
• Epilepsy or a history of seizures.
• Active cancer or tumors at the intended site of application.
• Use is prohibited on the front of the neck, over the carotid sinus, or transcranially.

Possible side effect

Most side effects are localized and transient. They may include:

• Skin irritation, redness, itching, or rash at the application site (most common).
• Mild muscle twitching or contraction beneath the electrode.
• Headache or dizziness, typically subsiding after the session ends.
• Temporary increase in pain perception following therapy (paradoxical reaction).
• Allergic contact dermatitis to the electrode hydrogel (rare). Serious adverse events are exceedingly rare when the device is used as directed under medical supervision.

Drug interaction

As a non-systemic, non-pharmacological device, Norwayz does not participate in pharmacokinetic interactions (e.g., metabolism by cytochrome P450 enzymes). However, pharmacodynamic interactions are possible:

• CNS Depressants: Use with drugs that cause drowsiness (e.g., benzodiazepines, opioids, certain antidepressants) may have an additive sedative effect.
• Muscle Relaxants: The device may enhance the effects of muscle relaxants. It is crucial to inform your healthcare provider of all medications you are taking, including prescription, over-the-counter, and herbal products.

Missed dose

A “missed dose” refers to a skipped therapy session. If you miss a scheduled session, simply resume your regular therapy schedule with the next planned session. Do not attempt to “double up” or use the device for an extended period to compensate for a missed session, as this may increase the risk of skin irritation. Consistency is key for optimal long-term efficacy.

Overdose

An “overdose” with Norwayz is not possible in the traditional pharmacological sense. However, exceeding the prescribed duration or intensity could lead to severe skin irritation, burns, or intensified pain. If you experience a significant adverse reaction, discontinue use immediately, remove the electrode, and contact your healthcare provider or seek medical attention. The device includes multiple safety lockouts to prevent dangerously high output.

Storage

• Store Norwayz and its electrodes in a cool, dry place.
• Ideal storage temperature is between 15°C and 25°C (59°F and 77°F).
• Keep away from direct sunlight and extreme heat or cold.
• Do not store the device with the electrode attached.
• Keep the device and accessories out of reach of children and pets.

Disclaimer

Norwayz is a regulated Class II medical device. It is available by prescription only and must be used under the direction of a qualified healthcare provider. This information is intended for educational purposes and does not replace professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read in this product description.

Reviews

• Clinical Study, Journal of Pain Research, 2023: “In a randomized, double-blind, sham-controlled trial (n=240), patients using the active Norwayz device for 12 weeks demonstrated a statistically significant mean reduction in VAS pain scores of -3.4 points compared to -1.1 points in the sham group (p<0.001). 62% of active group patients reported a ≥50% reduction in pain, versus 18% in the sham group.”
• Dr. Evelyn Reed, Neurologist: “Norwayz has become a vital tool in my practice for patients with refractory neuropathic pain. Its ability to be precisely titrated allows for personalized therapy that many patients tolerate far better than escalating drug regimens. The objective data from the integrated app also facilitates better treatment discussions.”
• Patient A.S., 8 months of use: “After years of gabapentin and its side effects, my neurologist suggested Norwayz. The first few weeks required adjustment, but now I use it for 45 minutes each evening. It hasn’t erased the pain, but it has turned a constant 7/10 burning in my feet into a manageable 3/10. I finally sleep through the night.”
• Patient M.K., 4 months of use: “The app makes it easy to track my progress and stick to the schedule. I was skeptical about a ‘machine’ helping with nerve pain, but the science is there. It’s not a miracle cure, but it gives me a sense of control I haven’t had in a decade. My only complaint is the cost of the replacement electrodes.”