NOCIRA® Grows Patent Portfolio for Personalized, Adaptive Migraine Treatments

• Nocira's recent patent grants, spanning three continents, relate to personalizing how each unique migraine is treated based on the migraine symptoms.
  
  
• Published clinical results showed most migraines are completely pain-free within only 20 minutes from a personalized treatment using Nocira's non-invasive, FDA-designated "Breakthrough Device."

TEMPE, Ariz., Jan. 6, 2025 /PRNewswire/ -- Nocira LLC, a privately owned, Arizona-based medical device company (the "Company"), is pleased to announce that it was granted patents in the United States, Europe, and Japan for pioneering inventions that relate to personalizing how migraines are treated based on the migraine symptoms. These recent grants also add to Nocira's portfolio of fourteen patents in the U.S. and forty-seven worldwide related to disruptive new approaches for treating migraine attacks and other neurological disorders.

"Migraine headaches are typically experienced as intense pain that is focused in one or more areas of the head.  Those pain locations and intensities can vary between attacks, and can also change during a single attack. This variability in pain patterns suggests that the neurologic mechanisms causing the pain might also vary, possibly reflecting different subtypes of migraine that have not yet been recognized.  And if the underlying mechanisms causing the pain can vary, it would seem logical that the mechanisms of action targeted by treatments to relieve that pain should also vary accordingly," explains Dr. David George, one of the original Inventors and Founders, and Chief Science Officer, for Nocira. 

"This revelation suggests that, for a single product to be reliably effective for rapid, complete relief across a wide array of uniquely different migraine headaches, it probably needs to: (a) harness multiple different relief mechanisms that correspond with different underlying mechanisms that might cause the headache pain, and (b) personalize, and adapt during treatment, the therapy in order to optimize relief for each migraine attack, at different stages of its progression, in each person," adds Dr. George.

"Yet, each of the current drugs and devices essentially treats all migraines the same way, without accounting or adapting for the unique characteristics of each attack or each patient's response to the therapy itself.  This might explain, at least in part, why none of the current products has been shown to provide complete relief for most migraines."

The Leap Forward to Personalized, Adaptive Migraine Treatment:  Nocira is pioneering its personalized migraine treatment by first allowing patients to tap on areas of a head avatar, shown on the touchscreen of a remote control device, to map the locations and intensity of their headache pain. Control software then uses this information to wirelessly control how Nocira's device uses neuromodulation to optimize relief for the specific headache pattern.  That personalization also includes real-time adjustments to adapt the neuromodulation approach to changes in the patient's evolving relief response along the course of therapy.

More specifically, Nocira applies this approach via its patented, non-invasive neuromodulation platform called "Automated Variable Pulse Insufflation™"(AVPI™).  AVPI modulates patterns of gentle air pressure changes, essentially controlled "puffs of air," through comfortable audio-style earbuds in the ears. This simultaneously stimulates physiological pressure sensors in the ears that are connected by multiple pressure-responsive nerve pathways into areas of the brain that regulate pain and other symptoms of migraine (and other neurological disorders).  The Nocira control software personalizes and adapts how, where, and when these gentle pressure changes are applied in the ears.  

This personalized AVPI therapy has resulted in rapid, complete pain freedom within only about 20 minutes, and with sustained pain freedom for at least 24 hours, for most migraines treated in multiple clinical trials.  Those results suggest that Nocira's AVPI approach might be much more effective and faster acting vs. the published results for current migraine drugs and devices that (a) are neither personalized nor adaptive to the unique characteristics of patients' specific migraine attacks, and (b) generally target only one respective relief mechanism.  Nocira's clinical trials have also demonstrated no significant side effects, adverse events, or contraindications, and also a user friendly and even pleasant experience, from using the Nocira device.  Accordingly, Nocira received "Breakthrough Device" designation from the FDA for using the AVPI device to acutely treat migraine.

Tim Smith, M.D. is a certified headache specialist and Owner/President of Study Metrix, a clinical research organization that has conducted migraine trials for decades and in which Dr. Smith has treated thousands of migraines.  Dr. Smith was also Principal Investigator for Nocira's most recent trials.  According to Dr. Smith, "The speed and extent of complete relief in Nocira's trial subjects have been truly remarkable.  It also makes a lot of sense to me that the multiple relief mechanisms and personalization of the AVPI approach could really make a difference. Patients also really seem to appreciate the fact that the therapy is adaptive to optimize relief for their own specific headache - it really is a 'WOW!' factor for them."

"Recent advances in migraine, such as new drugs that are more tolerable and with fewer contraindications, are commendable," states Jim Peacock, CEO for Nocira. "However, most patients still fail to get reliable, fast, complete relief for most of their migraines. Nocira is increasingly encouraged that our first ever personalized and adaptive AVPI therapy, validated yet again for its novelty per these recent patents on multiple continents, might truly be a game-changer for a more reliably relieving, faster acting, and widely adoptable migraine solution."

Nocira is currently raising its next financing to support applying for FDA approval and CE Mark and then commercialize the AVPI platform to potentially help millions of migraine patients and their prescribing doctors and other healthcare providers.  Nocira also plans to continue investing in clinical trials and development, including to expand the AVPI platform for other indications to address other major medical conditions.

About Nocira LLC

Nocira is an Arizona-based medical device company committed to developing safe and rapidly effective, drug-free treatments for neurological disorders. Nocira has continued to innovate and conduct clinical research for its pioneering new ear pressure-based neuromodulation platform for more than half a decade, which has been designated a "Breakthrough Device" by the FDA for acutely treating migraine attacks.  The platform is also continuing to evolve through a growing portfolio of product features and related proprietary technology assets, including for (among other areas): personalized medicine, artificial intelligence and machine learning, and other digital health assets.  Nocira was awarded "Emerging Neurology Device Company of the Year" and a "Top 10 Neuromodulation Solution Provider" by MedTech Outlook®.  More information is available at www.nocira.com. 

Notices & Disclaimers

Patented and patent pending products related to one or more of the following issued United States patents of Nocira, LLC (and other pending US patent applications, and granted patents and pending patent applications in other territories, that are published elsewhere for public notice): 9,039,639; 9,186,277; 10,076,464; 10,251,790; 10,278,868; 10,760,566; 10,772,766; 11,090,194; 11,096,828, 11,246,793; 11,859,606; 12,016,816; 12,102,506.  NOCIRA^® is a registered trademark, and other terms marked with "™" are also trademarks, of Nocira, LLC. Copyright^© 2024 Nocira LLC (All Rights Reserved)

CAUTION:  Investigational Device. Limited by Federal Law to Investigational Use Only. Product is not CE Marked and is not available for commercial sale or use in the European Union or other CE Mark-observing countries until a CE Mark is granted.

NOTICE & DISCLAIMERS: Forward-looking statements are estimates only; actual future performance may vary from forecasts. Clinical trial results are not necessarily predictive of similar results in different people, which may vary from the trial population or related outcomes. Comparisons between products are based on comparing published trial results or other public information, and are not intended to claim actual superiority or inferiority of any product versus another unless specifically referenced to reflect results from a direct head-to-head comparison trial. The descriptions provided with this notice are intended only to disseminate certain information related to the Company, its scientific discoveries, and the development of its intended future products and other assets and plans, in order to contribute to and advance the general public knowledge, and is not intended to solicit any investment in, nor to market or promote any product of, Nocira LLC.

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SOURCE Nocira