We want our CEFALY family to know that we’re committed to serving you during this unpredictable time. Here are some important updates on how we’re dealing with COVID-19.

  • Shipping may be delayed for new orders. We’re experiencing high demand and following local COVID-19 related regulations. As a result some orders are taking longer to process and ship. If you expect to need new electrodes soon, we recommend ordering them now so you can maintain your CEFALY regimen.

    If you have any questions regarding the delivery of a recent order that you have placed, please call (203) 309-5670 or email info@cefaly.us and a team member will help you.
  • If you need to obtain a prescription for a CEFALY device, ask your doctor about telehealth/digital consultations. Your doctor can send the prescription by email to info@cefaly.us, or fax it to (203) 309-6045.

    If you or your doctor have recently sent in a prescription and you have questions, please call (203) 309-5670 or email info@cefaly.us and a team member will help you.
  • Have concerns about making a product return within our 60-day return policy timeframe?

    Please call (203) 309-5670 or email info@cefaly.us and a team member will be happy to work with you to find a solution.

During this challenging time, we’re working hard to continue providing you with the migraine relief you trust. If you have any questions or concerns, we encourage you to contact us so we may help.

Wishing you well,

The CEFALY Team

Botox and CEFALY DUAL are two FDA-cleared preventive treatments for migraine. Botox treatment is applied every three months in a doctor’s office, while CEFALY DUAL is used at home for 20 minutes daily. This comparison examines the proven benefits of each treatment, with respect to efficacy, side effects and cost. 

Botox For Migraine

An injectable drug best known as a cosmetic treatment to reduce wrinkles, OnabotulinumtoxinA, or Botox, was approved in 2010 as a treatment for chronic migraine headaches in adults. (“Chronic” means 15 or more migraine days per month.) Botox is not recommended for less frequent migraines. Doctors don’t know exactly how Botox prevents migraines, but they believe that it deactivates pain receptors in nerves, thus blocking pain signals transmitted to the brain.[1]

CEFALY DUAL For Migraine

Introduced in 2008, the CEFALY medical device is FDA-cleared to treat migraine pain by modifying pain transmission and processing in the trigeminal nerve, the largest and most complex cranial nerve. Drug-free and non-invasive, CEFALY DUAL magnetically secures to an electrode positioned on the forehead between the eyebrows. Then, it begins sending tiny electrical impulses to the trigeminal nerve, reducing or eliminating migraine pain. Migraineurs use the 60-minute ACUTE program for immediate treatment of migraine pain. Compliant daily use of the 20-minute PREVENT program can reduce the frequency and intensity of migraine days. In the United States, a prescription is required for CEFALY. 

Treatment Regimen — Botox vs. CEFALY DUAL

Botox treatment for migraine must be given in a doctor’s office. In each 15-minute session, the doctor uses a small needle to inject 30 to 40 small doses of Botox around the head and neck, concentrating on areas where pain is greatest. Botox does not provide immediate pain relief. It can take several weeks or even months to take effect. The treatment session must be repeated every 12 weeks. The effect usually lasts about two-and-a-half months, according to the Mayo Clinic, and “because injections are repeated no sooner than every three months, some people need other headache treatment for the last two weeks of a Botox cycle.”[2]

CEFALY DUAL can be used at home or in any other setting for immediate and/or long-term treatment of migraine pain. It’s easy to use; the user simply has to wash their forehead, apply the electrode, and attach the CEFALY device. The intensity can be adjusted during the session, and regular users report that CEFALY produces a relaxing or sedative effect.

The ACUTE program provides rapid relief of migraine pain and should be used as soon as one feels the signs of an oncoming migraine. It can be used multiple times per day, if needed, for up to two hours per session. A break of at least 60 minutes is recommended between sessions, regardless of session length.

Some users report that CEFALY DUAL has allowed them to discontinue or significantly reduce use of migraine medication.[3] Other users include both CEFALY and medication in their treatment routine. 

Treatment Efficacy — Botox vs. CEFALY DUAL

The most comprehensive clinical trials of Botoxfor patients with chronic migraine both showed a significant decrease in the number of headache days (per 28 days) with eight to nine fewer headache days at 24 weeks, as well as a significant improvement in quality of life in the Botox group.[4,5]

CEFALY DUAL preventive treatment is also effective in reducing migraine days. In the pivotal study used to obtain FDA clearance for CEFALY, total headache days were reduced by 32% between baseline and a 3-month endpoint.[6]  In a follow-up study, researchers found a 75% reduction in migraine days in individuals new to the treatment who responded to treatment.[7] 

Not only that, but in clinical studies, the ACUTE program effectively reduced migraine pain. Users recorded 57% reduction in intensity of pain after one hour and 52% at two hours when scored on a visual analog scale (VAS).[8]

Side Effects — Botox vs. CEFALY DUAL

In clinical trials of Botox for migraine, Allergan reports the most common side effect was neck pain, experienced by 9% of people. Other side effects include: dry mouth, discomfort or pain at the injection site, tiredness, headache, eye problems (such as double vision, blurred vision, decreased eyesight, drooping eyelids [ptosis], swelling of eyelids, or dry eyes) and drooping eyebrows.[9] In another study of 254 patients, adverse events included:

  • Injection site pain (15%)
  • Neck stiffness (15%)
  • Drooping eyelid (11%)
  • Inability to frown (6%)
  • Exacerbation of headache for 5 days (4%)[10]

Serious and/or immediate allergic reactions have been reported with Botox for migraine, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. If Botox spreads away from the injection site, it can cause serious side effects that can be life threatening, such as loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing. There has not been a confirmed serious case of spread of toxin effect away from the injection site when Botox has been used at the recommended dose to treat chronic migraine.[11]

In clinical trials of CEFALY DUAL for migraine, side effects have been shown to be minor and fully reversible. The most common side effects are a mild sedative effect, allergic contact dermatitis on the skin under the electrode, and intolerance of the sensation produced by CEFALY. Uncommon side effects (less than 5%) are headache, neck muscle tightness and persistent sensation after a session has ended. Rare side effects are nausea, tooth pain, tinnitus (perception of noise or ringing in the ears), and hyperlacrimation (overproduction of tears).

Cost — Botox vs. CEFALY DUAL

The average retail price for one vial of Botox is $1,563, according to GoodRx. With a discount or coupon, the average price drops to $1,153.[12] For four treatments per year, the annual cost of Botox adds up to $4,612 to $6,252. The procedure itself (injection fee) is an additional cost as well. 

Botox for migraine is at least partially covered by most insurance plans, including Medicare and Medicaid. Allergan offers a savings program to reimburse commercially insured patients for their out-of-pocket costs, up to a certain limit. Many insurance providers require a patient to have tried and failed at least two other preventive treatments for migraine before they will approve and pay for Botox. The insurer may also require that a patient prove Botox has reduced their migraine days before the insurance company will re-approve treatments.[13] 

CEFALY is not typically covered by insurance. However, by comparison, it costs much less over time. The CEFALY DUAL kit, which includes one reusable electrode, costs $499 in the U.S. A set of 3 CEFALY reusable electrodes costs $25. An electrode typically lasts 20 days. The average patient buys 6 packs of 3 electrodes (18 electrodes) per year.* 

Year 1: $ 499 + (6 x $25) = $649.00
Year 2: 6 x $25 = $ 150.00 
Total After Year 2: $799.00
(*Frequent use of CEFALY ACUTE modality could increase the electrode usage and needed supply.)

Generally, one out of five patients treated with any migraine preventive pharmaceutical agent will discontinue treatment because of tolerability and safety reasons.[14] CEFALY DUAL includes a 60-day money-back warranty, so if the treatment is not effective for an individual’s symptoms, they can return it. No such money-back policy exists with Botox for migraine.

Botox vs. CEFALY DUAL: Which Should Consumers Choose? 

Each person living with migraine has unique triggers and experiences, and so there’s no single migraine treatment that works for everyone. Both Botox and CEFALY DUAL are FDA-cleared treatments with manageable side effects. Only CEFALY DUAL puts control in the user’s hands, with preventive and acute relief of migraine pain delivered via cost-effective treatments that can be received outside of a doctor’s office.

Article Footnotes

[1] https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-q-and-a-botox-a-treatment-for-chronic-migraine-headaches-but-not-a-cure/

[2] https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-q-and-a-botox-a-treatment-for-chronic-migraine-headaches-but-not-a-cure/

[3] Schoenen, Vandermissen, et al. Prevention of migraine by supraorbital transcutaneous neurostimulation using the Cefaly® device (PREMICE). Journal of Headache Pain, 2013; 14(Suppl 1): P184

[4] Diener HC, Dodick DW, et al. OnobotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia, 2010; 30(7): 793-804.

[5] Diener HC, Dodick DW, et al. OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia, 2010; 30(7): 804-814.

[6] Schoenen J, Vandermissen B, et al. Migraine prevention with a supraorbital transcutaneous stimulator: A randomized, controlled trial. Neurology. 2013.  

[7] Russo, A, Tessitore, A, et al. Transcutaneous supraorbital neurostimulation in “de novo” patients with migraine without aura: the first Italian experience. J. of Headache and Pain. 2015; 16:69

[8]  Chou DE, Gross, GJ, et al. External Trigeminal Nerve Stimulation for the Acute Treatment of Migraine: Open-label Trial on Safety and Efficacy. Neuromodulation Journal. 2017.

[9] https://www.botoxchronicmigraine.com/botox-faq

[10] Khalil M, Zafar HW, Quarshie V & Ahmed F 2014. Prospective analysis of the use of OnabotulinumtoxinA (BOTOX) in the treatment of chronic migraine; real-life data in 254 patients from Hull, U.K. The Journal of Headache and Pain, vol. 15, no. 54, doi:10.1186/1129- 2377-15-54.

[11] https://www.botoxchronicmigraine.com/botox-faq

[12] https://www.goodrx.com/botox

[13] https://www.theverge.com/2018/6/22/17474902/botox-migraine-insurance-step-therapy-health-care-allergan

[14] Gracia-Naya M, Santos-Lasaosa S, Ríos-Gómez C, Sánchez-Valiente S, García-Gomara MJ, Latorre-Jiménez AM, et al. Predisposing factors affecting drop-out rates in preventive treatment in a series of patients with migraine. Rev Neurol. 2011;53:201–8.

Katie was a guest on Good Morning America, where she discussed how CEFALY helps her migraines. Click here to learn more about her news segment!

First Name: Katie
Location: New York, NY
Years with Migraines: 20+
Occupation:  Real Estate Agent 
 
How long have you had migraines?
I’ve had migraines since I was around 7 and they’d occur almost weekly. I would get extremely nauseous and had severe head and neck pain. They were debilitating. We went to a neurologist who determined they were migraines. 
 
When do you usually get migraines?
Most frequently when the seasons or weather changes. They’re also sometimes triggered by florescent lights or strong perfumes and colognes (eek!). My migraines are associated with barometric pressure but I scuba dive and it doesn’t happen then, which is very strange.
 
What have you tried pre-Cefaly?
I’ve done neurotoxin injections, nerve blockers, CGRP-inhibitors, and muscle relaxers. I find that muscle relaxers combined with Cefaly is the best solution for me.
 
What does your migraine feel like?
It’s behind my left eye usually – really, really intense pain that spreads down the left side of my head, down my neck to my shoulder. It almost always starts on left side and sometimes will go to the right side. My neck and jaw muscles get extremely tight, I’ll get extremely nauseous, and vomit if I don’t catch it in time. They can last anywhere from 6 hours to 2 days. 

How did you hear about Cefaly?
A neurologist mentioned it to me 3 or 4 years ago as a solution to my migraines.
 
What’s your Cefaly experience like?
It’s been life changing. Cefaly is the only solution I’ve found that offers two settings (acute and preventative) and I use them both. When I get a migraine (which I sometimes wake up in the middle of the night with them), I put on the Cefaly device, take a hot bath and a muscle relaxer, and it’s amazing how much this tiny machine reduces my symptoms. In fact, just the other day I woke up at 4 am with a terrible migraine (nausea, extreme pain, muscle tightness)  I was able to put it on the acute setting (60 minutes), rest, and in a few hours was able to get up and have a productive day. Before Cefaly, I’d have lost the entire day to my symptoms. It’s that remarkable. Cefaly allows me to live my life.  

Want to share your story too? We’d love to hear from you! Please send an email to m DOT coder AT cefaly DOT us. Please include your name, contact information, and let us know where you’re located so we can set up a good time to talk.

Tagged with: , , , , , ,

On March 23 CEFALY Technology will join the mission to reduce the global burden of migraine through education and fundraising

Photo credit: Migraine World Summit

NEW YORK, March 18, 2020_ CEFALY, the first device of its kind to receive FDA medical clearance for migraine headaches announced that on March 23rd it will sponsor a full day of the Migraine World Summit, the largest online event of its kind founded by migraine patients for migraine patients. 

“We’re excited to once again be involved with this event and relieved that patients anywhere can log on for relevant discussions about their condition from the comfort and safety of home, especially amid the COVID-19 pandemic,” said Jennifer Trainor-McDermott, CEO with CEFALY Technology. CEFALY Technology was among the speakers at the inaugural summit. The event is now in its fifth year and has ballooned to more than 150,000 attendees.

This 2020, patients will hear from renowned experts at organizations such as Stanford, Georgetown and Harvard Universities covering topics including the benefits of mediation on brain elasticity, pediatric indicators of migraine and the potential for genetic testing on migraine. Proceeds help benefit migraine research and support through organizations like American Migraine Foundation, Migraine Research Foundation, Headache Australia and the National Headache Foundation.

“We want people living with migraine to know we are a clinically-proven migraine device that can help prevent a migraine and also help to stop a migraine already in progress.”  Since the CEFALY DUAL is a device and not a drug, it may be used as a standalone treatment or as part of an existing regimen. The device is placed on the forehead atop of self-adhesive electrode, where it stimulates and desensitizes the area research identifies as a center for migraine pain, the Trigeminal nerve. In studies, people who used the CEFALY device every day saw a reduction in migraine days and reduced use of migraine medication. 

Participation in Migraine World Summit is free and online from March 18-26, 2020, and available to order thereafter. To register, go to MigraineWorldSummit.com.

About CEFALY Technology

CEFALY Technology is a global company that has been transforming migraine treatment since 2008, when the CEFALY device was introduced. CEFALY Technology’s mission is to solve the persistent problem of migraine through advanced therapeutic innovations.

For more information about CEFALY Technology visit: https://www.cefaly.com/.

About Migraine

Migraine is a debilitating and painful neurological disease that is under-recognized, undertreated and frequently misunderstood as “just a headache.” Despite one in seven people living with this incapacitating condition worldwide,[i] finding access to qualified healthcare professionals can be difficult.

About Migraine World Summit

The mission of the Migraine World Summit is to reduce the global burden of migraine through education and fundraising. Each year, patient advocates Carl Cincinnato and Paula K. Dumas interview over 30 leading migraine experts, doctors and specialists from around the world to provide free, unprecedented access to the latest science in migraine and answer the most difficult questions for patients in desperate need of relief. To date, more than 150,000 people have participated in the Migraine World Summit to discover how to better manage the disease.

Sources

[i] Steiner TJ et al. Migraine: the seventh disabler. The Journal of Headache and Pain 2013, 14:1.

Tagged with: , , , , , , , ,

The Buy Back allows CEFALY users in the U.S. and Canada to trade up their device and receive a discount for a smaller, sleeker, device with two migraine treatment programs, rechargeable battery, and a renewed 60-day money back guarantee.

The Buy Back allows CEFALY users to trade up their device for a smaller, sleeker, device with two migraine treatment programs, rechargeable battery, and a renewed 60-day money back guarantee.

Click here to view the full press release on PRNewswire.

NEW YORK, March 17, 2020 _ CEFALY, the first device of its kind to receive FDA medical clearance for migraine headaches announced a Buy Back program today where customers in the United States and Canada may return their original CEFALY 1 device (C1) and receive a discount off the purchase of a CEFALY DUAL device.

The new CEFALY DUAL device is small and sleek in comparison to its older model, which uses bands along the sides to create room for batteries. The newest device is palm-sized, more portable, and uses a battery that is rechargeable via USB.

The CEFALY DUAL offers two distinct treatment options — a 60-minute ACUTE setting that serves as an abortive treatment for pain relief at the onset of a migraine, which is clinically proven to stop or reduce migraine pain during an attack; and a 20-minute PREVENT setting for daily use to help prevent future episodes. The Buy Back program offers users already accustomed to the CEFALY treatment an opportunity to swap their device and pay the difference to upgrade to a the CEFALY DUAL. The new device will again come with a renewed 60-day money back guarantee.

“We are excited to provide a program where customers already familiar with the many benefits of CEFALY can upgrade their existing device and benefit from the latest in migraine treatment technology and a new compact device with two program options,” said Jennifer Trainor-McDermott, CEO with CEFALY Technology.

CEFALY has rapidly become a global brand, widely recognized among the migraine community, which is estimated to be around 1 billion worldwide1. The non-invasive device is placed on the forehead to stimulate and desensitize the area research identifies as a center for migraine pain, the Trigeminal nerve. Since CEFALY is not a drug, it can be used as a standalone option or with an existing treatment. Customers who use the device consistently show a decrease in migraine days and a reduced use of migraine medication.

To participate in the Buy Back program eligible users in the United States will receive a $150 USD discount code to purchase a CEFALY DUAL device. For more information visit: https://www.cefaly.us/en/cefaly1-trade-in-program. In Canada, eligible users will receive a CA$50 discount code to purchase a CEFALY DUAL device. For more information visit: https://www.cefaly.com/en-ca/cefaly-c1-device-trade-in-program

About CEFALY Technology

CEFALY Technology is a global company that has been transforming migraine treatment since 2008, when the CEFALY device was introduced. CEFALY Technology’s mission is to solve the persistent problem of migraine through advanced therapeutic innovations.

For more information about CEFALY Technology visit: https://www.cefaly.us.

For more information on purchasing CEFALY in Canada visit: https://www.cefaly.com/en-ca.

Sources

1 Migraine facts. American Migraine Foundation website. Accessed March 16, 2020.


Tagged with: , , , , , , ,