Alon Ironi is the CEO and co-founder of Theranica, a medical technology company that recently introduced a product that offers a revolutionary new way to treat migraines and other severe headache disorders without the use of pharmaceuticals.
The FDA approved this new treatment and so did the Department of Veterans Affairs (VA) because of the prevalence of migraines and severe headaches among those who serve and have served in the military.
Ironi recently spoke with Military Matters about this new treatment, what it can do for military members suffering from migraines and severe headaches, and what new treatments Theranica may be sending down the medical innovation pipeline.
Military Matters (MM): Thank you for speaking with us. Let’s get right to it. Your company Theranica is making waves – or is it more accurate to say Theranica is generating pulses – in the medical industry with a new treatment for migraines and severe headaches?
Alon Ironi (AI): Therania develops and markets neuromodulator devices for idiopathic pain diseases. This is a group of diseases where pain is the most prevalent symptom.
NOTE: Idiopathic pain refers to pain that occurs despite there being no observable physical condition causing it. Migraines and related severe headaches fall into this category.
Our product is Nerivio® Remote Electrical Neuromodulation. It is a drug-free and non-invasive treatment.
Nerivio is worn on the arm, and when activated, it sends electrical pulses up the arm to the brain. These impulses stimulate the brain to release certain neurotransmitters which can reduce or end pain.
What you need to know about the Nerivio® Remote Electrical Neuromodulation (REN) wearable:
The Device
FDA-cleared, drug-free, non-invasive wearable device developed by Theranica, a prescribed digital therapeutics company with U.S. headquarters in Bridgewater.
Indicated for acute and preventive treatment of migraines; available in all U.S. states with a prescription.
Cost
For veterans enrolled in the VA health system, the cost for Nerivio is covered. Nerivio is also covered by New Jersey Medicaid.
Additionally, some commercial health insurance plans cover Nerivio.
- Those without insurance coverage may qualify for the Nerivio Savings Program which provides eligible patients with the first device for $49 and refills at $89 each or a bundle of three for $199.
Prescriptions
Download a prescription form and other information here and talk to your healthcare provider to have Nerivio prescribed for you.
Refills
Each Nerivio unit includes an embedded battery and is designed for a set number of treatments – which is 18.
When users receive a refill (prescription required), they are sent a brand-new device – essentially a fresh unit with full functionality. The user simply activates the new device via the app and continues treatment.
In the VA system, the refill process is even more streamlined to reduce the need for veterans to make frequent on-site clinic visits.
- Patients are often prescribed multi-unit packages containing 3, 6, or 12 Nerivio units.
- This means they receive the initial device and several refills at once, allowing for consistent access to treatment over an extended period.
- Once the 12-month prescription expires—or if additional refills are needed within that period—patients schedule a follow-up appointment with their VA healthcare provider to renew the prescription.
MM: Nerivio has FDA approval?
AI: Nerivio was approved by the FDA in 2019 and by the VA in 2021.
The wide recognition among VA clinicians that Nerivio is safe and effective means that, if you see a vet that has migraines, there is probably no reason for him or her not to have this therapy.
MM: In addition to ending the pain, Nerivio is indicated for preventative treatment as well?
AI: Initially, the Nerivio treatment was indicated for acute treatment or to abort migraines. Patients only used it when they felt symptoms coming on. In 2022, we developed the indication approved by the FDA to use Nerivio for prevention.
You can clearly see a significant increase in prescriptions for Nerivio beginning in April 2023, and I think that had to do with prevention.
MM: Talk about why Nerivio has become such an important breakthrough for active-duty military and veterans.
AI: The prevalence of migraines among veterans is about twice as high as the general population. Sometimes the injury that causes a condition such as PTSD heals – it does not exist anymore – but the patient still carries the symptoms, and this is when it becomes chronic.
MM: One aspect of Nerivio you consistently reference is the fact there are no side effects. Why is that particularly relevant to veterans?
AI: Typically, migraines have been treated with drugs and medications. There are all kinds of ways to handle pain and some of them were not so successful – such as opioids.
The hit that veterans took during the opioid crisis was much, much larger than the general population. It was bad overall, but it was especially worse within the VA.
My hypothesis is that the opioid pandemic made senior clinicians at the VA more open to a non-pharmaceutical approach – more so than many at other health care systems.
The VA was very positive about a solution that was drug free and had no side effects or risks of addiction.
With Nerivio there are no side effects.
MM: Where is Nerivio available?
AI: Nerivio is available in all U.S. states with a prescription.
We also signed a commercial collaboration agreement with an international pharmaceutical company called Dr. Reddy’s Laboratory which is based in India.
The agreement gives Dr. Reddy’s Laboratory exclusive rights to market and sell Nerivio in certain countries; they started with their home market of India and have moved into South Africa, the United Kingdom, Germany and Spain.
We hope to have similar commercialization in China later this year.
MM: You say Nerivio is available in all 50 states. How can a veteran get Nerivio?
AI: If you are a veteran, and use the VA, you have full coverage.
In fact, the VA was the first organization to include this therapy as part of its medical benefit coverage. The VA is our number one customer in the U.S.
If you are a veteran and choose not to use the VA, whichever health insurance you have – private or state insurance – covers some or all of the costs. Over the past 15 months, we have expanded into commercial systems, so we have coverage from Anthem, Blue Cross Blue Shield and companies like that.
If you are a vet and are not covered by insurance, Theranica has a patient assistance program. You can talk to one of our agents and usually you can participate in this program and that means practically you have to pay very little – a very little co pay at a very reasonable price.
We probably have 120,000 Americans prescribed for Nerivio – a lot of them veterans.
We are at the point where 25 percent of the U.S. population is covered for this. Hopefully soon 100 percent of patients will have access to this device.
My vision for the company is that we make this technology available to everybody – all people who suffer from migraines.
MM: Where is Theranica located?
AI: We are an Israeli company. We operate a fully owned subsidiary in Bridgewater where we are headquartered.
In Israel, we do the R&D and the clinical development – hardware and software.
The clinical trials are done in the United States, but the team managing the trials is in Israel. The U.S. teams focus on sales and marketing and customer support.
MM: What other idiopathic medical conditions is Theranica working to treat?
AI: We have trials coming up for migraines because there are a lot of nuances to them – different types of migraines , different subpopulations.
We are also working in the domain of other idiopathic pain disorders, including fibromyalgia, temporal mandibular joint disorder, irritable bowel syndrome.
It is a long process, but we are pretty persistent.
