Nocira
Potential Game Changer in Migraine Treatment

In the dynamic world of medical devices, one of the biggest challenges can be changing standards of care, even if they underserve the market, with disruptive technology. This is especially true for transforming drug-dominated markets toward new device alternatives. Such new devices must show improved performance, and cost effectiveness, and also be well-timed to succeed in breaking barriers of the status quo. Prescribing physicians and payers must be convinced to change practices away from existing drug standards, and patients must be willing to use a device instead of popping a pill. Such landmark transformations also don’t always happen overnight. They often evolve as a new product “category” via a growing trend of new competing products – which conspire to erode intrinsic resistance to change, and to build momentum in a new direction - until a well-timed and positioned “breakthrough” product finally reaches a critical mass inflection point as a new standard of care.

Incidentally, the migraine therapeutics market is undergoing such a transformational process that continues to ripen for disruptions. Traditionally dominated by a class of drugs called “triptans” for nearly three decades, migraine treatment is gradually pivoting toward a new wave of tech-based migraine therapy. During just the past six years, the groundwork has already been laid by the entry of the first five FDA-approved medical devices for migraine treatment. Meanwhile, newer drugs have also been introduced with major public media marketing campaigns. Yet, all current migraine drugs and devices still have limited effectiveness, with most patients failing to achieve complete relief, and can also have unwanted side effects, contraindications, and/or otherwise be unpleasant to use. The migraine market remains wildly underserved. But with the growing momentum from these new trends, it is also more poised than ever for dramatic change. Keen to strike the iron while it's still hot, one enterprise is gearing up pre-commercial development of its innovative, non-invasive migraine treatment device that proposes new hope for migraine patients – Nocira.

The pre-market medical device manufacturer brings to the table a novel portable device that offers pain relief from migraines through a deceptively simple method – a few air puffs into the ear. Adopting a brand-new approach to neuromodulation, Nocira's game-changing device provides quick relief through Automated Variable Pulse Insufflation™ (AVPI™). Not reliant on drugs, the device non-invasively creates subtle pressure changes in the outer ear by harnessing the distinctive pressure-responsive neuroanatomy of the ear.

An Elegantly Simple Solution

Nocira’s breakthrough in migraine therapy arose from the unique insight that pressure sensors in the ear are connected to a confluence of neural pathways into areas of the brain that regulate pain and other symptoms associated with migraine. In fact, changes in barometric pressure are known triggers for migraines. An axiom of neuromodulation is that the same neural pathways that can trigger a condition can also be harnessed by artificial stimulation to instead treat that same condition. Nocira’s AVPI approach applies subtle air pressure changes in the ear to stimulate multiple ear-brain neural pathways into these regulatory centers in the brain to thereby relieve migraine symptoms. Indeed, most migraines treated in Nocira’s clinical trials were completely relieved with complete pain freedom in only a matter of minutes.

Who knew a condition as complex as migraines could have such an elegantly simple solution?

"The best inventions are ones that are simple, but solve a major problem," says Jim Peacock, CEO of Nocira. It's this simplicity, along with promising clinical trial results and opportunistic timing of the migraine market, which attracted him to become a part of Nocira's journey to provide a revolutionary remedy to patients suffering from migraines.

The best inventions are ones that are simple, but solve a major problem

With a background in biomedical engineering and law, Peacock has donned several hats as an engineer, scientist, inventor, patent attorney, and serially successful med-tech entrepreneur in interventional cardiology, cardiac electrophysiology, spine/back pain, and imaging/diagnostics. Peacock now augments Nocira’s visionary founders and leadership team by bringing deep med-tech experience and insights to Nocira's commercial trajectory into the migraine market.

Riding on the coattails of predecessors in the neuromodulation-based medical device space, Nocira is ushering in the second wave of neuromodulation devices for migraine treatment. Traditionally, most neuromodulation techniques involve implantable or transdermal electrical or transcranial magnetic approaches, with electrical stimulation being the most common procedure. However, these have not significantly improved over the performance of leading drugs, are typically limited to only single nerve pathways (where transdermal electricity can also have limited effect), can be unpleasant to use with potential side effects, and have multiple contraindications. These shortcomings of this first migraine device “wave” are where Nocira proposes to make a world of difference with a neuromodulation device whose distinctive working principle resulted from a serendipitous discovery.

It all began in 2013, when Dr. David Sullivan, one of Nocira's co-founders, sought a possible cure for migraine symptoms. To that end, he used a manual pneumatic “otoscope” to deliver a series of pressure pulses to the external ear canals of 13 patients experiencing a migraine attack. This relieved the pain very quickly, and a high percentage of patients reported a significant reduction in their headaches, with most enjoying complete pain freedom, with no notable side effects. This became the first-ever published case study involving ear insufflation to treat migraines. The success of this ground-breaking initial study served as a springboard for Nocira’s formation to develop an automated, controlled ear pressure regulation system that is safer, even more therapeutic, and more adoptable for widespread personal home use.

A Trailblazing Pocket-sized Pain Freedom Device

Nocira's avant-garde AVPI device adopts this pioneering approach to neuromodulation through insufflation. However, Nocira automated the insufflation process in the device since manual insufflators could unwittingly over-pressurize the ear beyond safety limits when self-administered by patients without supervision. The AVPI controls those pressures to remain safe, yet while also optimizing for therapeutic response. The new automated, sleek-looking, hands-free device comes with a pair of earbuds and hollow air tubes that can be worn like earphones and can easily fit into clutch purses or pant pockets.

Connected via Bluetooth® to a downloadable mobile app, the device uses AI to deliver personalized migraine treatment to patients by controlling variable patterns of ear pressure changes, and while allowing for only passive participation from the wearer. The app’s user interface displays an avatar of the patient's head that they can touch to indicate the areas and severity of pain during a migraine attack. The device's algorithms then customize the ear pressure therapy to suit the patient's specific migraine patterns. The patient can enter this information within seconds, put the earbuds in their ears, and then sit back and let the device do its job. "We also adapt the therapy to the patient's periodic responses during treatment, enabling them to go back to the avatar and adjust their changing pain levels," Peacock states. "This continually adaptive, customized, personalized form of medical therapy is very unique, and which we believe is one of the reasons this has performed so well clinically."

A randomized, sham-controlled pilot trial using the first-generation prototype of the company's improved AVPI device showed impressive results while treating 30 patients (vs. 29 sham treatments) during moderate to severe migraine attacks. "This study was done under controlled conditions with striking results. Nearly two out of three patients had complete pain freedom by the time they finished the 20-minute treatment," informs Dr. Tim Smith, VP of the National Headache Foundation and prolific clinical trialist in migraine. In fact, Nocira’s 67 percent pain freedom rate far exceeds the published 20-45 percent pain freedom rates for current drugs and devices at 2 hours; while a whopping 90 percent of Nocira patients had at least 50 percent reduction in their headache pain by the end of the treatment and sustained through 24 hours. "This advanced AVPI treatment also showed high success rates in the majority of patients for treating other primary associated migraine symptoms of nausea, photophobia, and phonophobia," shares Dr. David George, Nocira’s original co-inventor/founder, and chief science officer. “These results, plus the absence of any safety issues, confirmed the decision to advance the AVPI technique to provide an optimally safe and effective platform.”

An Eventful Journey to Bring Migraine Relief

The road to creating the novel AVPI device wasn't traversed overnight. Though the publication of Dr. Sullivan's study led to Nocira's founding in 2014, it wasn't until 2019 that its true extent was recognized. The recognition came when Nocira presented its investigatory clinical data at the International Headache Society in Dublin, Ireland, and was first formally announced to the neurology community. This put Nocira in the spotlight in the scientific and medical innovation marketplace, leading to expanding engagements with key opinion leaders as advisors and champions for Nocira in neurology, headache, and migraine. "The Nocira team, our investigators, and key opinion leaders continue to see impressive results in each step we take in clinical trials," notes Peacock.

While the pandemic has slowed down Nocira's clinical trial progression over the past 1.5 years, this delay has proved to be a blessing in disguise, as it has enabled further optimization of the AVPI system. However, Peacock also recognizes the importance of “striking the right balance between always having new ideas for potential improvements, which can perpetuate a never-ending development project, versus identifying when a first-gen product offers sufficient benefit to freeze and advance it to commercial launch.” With that in mind, Nocira expects to complete pre-market clinical trial of its current AVPI device, and to navigate the regulatory pre-market review processes within the next 18 months, and for hopeful market-release by late 2022 or early 2023.

Bringing to market a safe, affordable, easily manufactured, sophisticated yet simple device that solves a major health problem is a challenge that Nocira is well-equipped to meet. Through extensive clinical development and evaluation of its AVPI device, Nocira will be continually working to make further refinements and improvements, taking the view that no new platform is truly ever 'finished' in its development for refinements. At each step, the prospects are getting brighter for Nocira, as evidenced by its progressively positive clinical trial results and high user satisfaction. As Nocira is poised to take its next steps toward the commercial market, millions of underserved migraine sufferers worldwide today can enjoy new hope that Nocira’s revolutionary new device is designed to finally bring them rapid, effective relief – remarkably, with just a few puffs of air.