Nocira
A Fast-Acting Soothing Therapy to Ease Migraine

It’s an eye-opener to know that more than 39 million people in the US suffer from migraine – which affects about as many people as diabetes and osteoarthritis combined. It is an extraordinarily pervasive neurological condition that disrupts all aspects of a person’s life. Migraine has also been linked to sleep disorders, anxiety, depression, and opioid misuse and is one of the leading causes of ER visits. When people with occasional migraines are not treated successfully, they can often progress to become chronic and even more difficult to treat. With migraine catapulting to the top rungs of the most disabling diseases, the resulting burden is huge. It has increased cost for payers due to patients frequently visiting ER and resulted in low employee productivity for employers with employees calling in sick more often.

Unfortunately, the ability to treat migraines reliably & effectively has remained among the largest & most urgent unmet clinical needs in all medicine. Treatments have long been dominated by a class of prescribed drugs called triptans, and a few other new drugs have been introduced in just the past couple years. However, these current drugs do not provide complete migraine relief in most patients, and can often also have unwanted side effects, poor tolerance, and contraindications against being used at all. The first few migraine treatment devices were also recently introduced, and which apply electricity or magnetic energy to stimulate a targeted nerve pathway (or “neuromodulation”) into a pain regulation area of the brain. However, most of these new devices have failed to gain meaningful adoption, in part due to similarly low effectiveness as the drugs, and some can also be uncomfortable or unpleasant to use (and also with contraindications). The quest thus continues for a faster acting, more reliably effective, and more widely adoptable migraine therapy to lessen the societal burdens while improving the landscape for patients, their families, employers, and payers alike.

Against this challenging backdrop, Arizona-based Nocira is proving to be a springboard of renewed hope for countless migraine sufferers. Nocira is revolutionizing migraine therapy with its novel, yet surprisingly simple approach to neuromodulation: controlling gentle puffs of air in the ear. Nocira calls this “automated variable pulse insufflation” or “AVPI” therapy. Despite its simplicity in concept and use, the neurologic mechanisms for why this works are highly complex and years of advanced clinical development and evaluations have confirmed it is highly effective for rapid, complete migraine relief in most

patients. Nocira’s endeavors indicate a giant stride forward in new therapeutic possibilities for migraine - one that is safe, fast-acting, highly effective for complete relief in most patients, easy and even pleasant to use, and also cost effective.

Nocira’s revolutionary healing touch for migraine therapy began with a unique understanding of the neural anatomy of the ear and its rich population of pressure sensors that connect with multiple nerve pathways into multiple different areas of the brain that regulate headache pain and other migraine symptoms.

“Nocira essentially harnesses the ear’s very unique neurophysiologic design for responding to pressure changes in nature–but in a therapeutic way by artificially changing pressures in the ear to activate these multiple pathways for rapidly effective migraine relief,” says Jim Peacock, CEO of Nocira. “Nocira uniquely accesses each of these multiple therapeutic pathways simultaneously. Where we treat (the ear), how we treat (gentle pressure changes in the outer ear), and why this works so well therapeutically (simultaneously activating multiple therapeutic nerve pathways), all differentiate our approach as a novel, disruptive game changer.”

Simple, Comfortable, Pleasant Therapy for Complete Migraine Freedom in Minutes

Nocira’s medical device constitutes Right/Left earbuds at two split ends of a simple tube assembly that is connected at the other end into a pocketable device with an air pressure pump. The device is controlled via Bluetooth® by a downloadable mobile phone ‘app’ to control the gentle air pressure changes through the earbuds in the outer ear canals. These pressure changes are controlled to be safe and comfortable, but while also optimally therapeutic for stimulating the neuromodulatory pain relief.

Our device offers an impressive speed and reliability for complete migraine relief that’s never been seen before with any drug or device.

The app also provides graphical user interface (GUI) screens for the patient to briefly enter information about their migraine headache and other symptoms. The app then customizes the personalized therapy to optimize relief for each migraine attack in each patient. The app is also connected to a backoffice engine via the cloud, and is being designed to integrate with other resources (e.g. wearables), for capturing relevant patient data related to their individual condition, and for integrating AI into the platform for continual optimization, personalization and customization per patient (and across all patients). “The current form of Nocira’s personalized treatment platform has performed remarkably well for rapidly & completely relieving most clinical trial patients. But we don’t end there. We will continue to develop the AI engine around the big data of patients in the marketplace, and to improve the algorithms for continually optimizing results in patients into the future,” informs Peacock.

In a surprisingly short time, the pre-market device showcased exceptional positive results in 90 percent of users. In the outcomes from 4 clinical studies and in over 100 patients treated by Nocira so far, the majority of patients were completely pain-free in less than only 20 minutes from starting the therapy; and within 2 hours, about 2/3 of patients were completely pain free (and >90 percent of them had at least 50 percent pain reduction). This compares against only about 20-40 percent pain freedom shown in published outcomes for other current drugs or devices. “Put simply, in clinical trials thus far, the Nocira device has demonstrated an impressive speed and extent of relief that’s never been seen before with any other drug or device,” remarks Peacock.

What’s more, patients don’t look or feel like they are undergoing medical therapy when using the Nocira device. “Instead, this looks just like you are listening to music. The discreet device also enables patients to experience a relaxing therapy - which is more like getting a spa treatment than a medical procedure,” explains Peacock. The Nocira team has worked hard to design the product as a home personal use product that physicians can prescribe to patients to use in their daily life as needed. The hands-free device allows the patient to relax whilst passively receiving the therapy. “The patients just have to place an ear bud in each of their ears, then touch a phone app screen, follow the prompts, sit back and relax while the product comfortably does its job,” says Peacock.

Riding on its growing progression of clinical successes, Nocira is soon planning a triple blinded, randomized placebo controlled, multi-center pivotal trial in a larger number of patients. That is intended for FDA submission and pre-market review for hopeful clearance in the second half of 2022. Nocira is also already working on pathways for driving rapid uptake with some insurance reimbursement early in its commercialization. As Nocira continues to evolve toward becoming a commercial entity, a glimpse into its organizational culture reflects a virtually run company (even pre-pandemic) focused on hiring the best skill set for each job irrespective of a person’s location.

Unique Yet Universal

Elaborating on their long-term vision, Peacock draws attention to the migraine remedies currently available in the market. “There are two types of migraine products—preventative and acute. We are focused on the acute treatment, although we have anecdotal evidence and reasons to believe that our platform would also be very effective for prevention,” says Peacock.

In current practice for acute treatment, triptans are typically first prescribed unless contraindicated for a given patient. If a patient responds unfavorably, then other drugs or devices are prescribed. “Nocira is well positioned to rapidly become the leading second-line standard of care for patients who have sub-optimal response, tolerance issues, or are contraindicated for triptans. But there are also many reasons this should directly challenge triptans as the first line standard,” states Peacock. “The overall adoptability of the comfortable & easy-to-use platform for personal home use, and cost effectiveness, are also critical. In today’s day and age, in the setting of home health and personal use, a device has to not only be more effective and safer but also be cost-effective and user-friendly to the patients.”

As Nocira strides ahead to accelerate its go-to-market strategies and deliver relief to the masses, Peacock adds a concluding note, “We never perceive this as a job, but truly a calling and mission to help people’s lives - and we are committed to that mission, deep down in our bone marrow, each and every day we go to work.”