Nocira is on the
Nocira is on the
A Widely Disabling Disease and Global Health Problem
Migraines rank as the 3rd most prevalent (and 6th most disabling) illness in the world, affecting 40 million people in the US and 1 billion worldwide. 12% of the population, and 1 in 4 US households, are affected – including 18% of women, 6% of men, and 10% of children. >20% of all migraineurs are disabled, and >4 million adults have migraines daily (or >15 migraines monthly). Nocira’s initial target addressable patients comprise about 50 million people in the industrial world who are diagnosed and prescribed drugs by their doctor for chronic or frequent episodic migraines.
Contrary to common public belief, Migraines are more than just headaches. A migraine is almost always associated with other features, including sensitivity to light, sound and smell, nausea, vomiting, and auras. Most migraine sufferers are unable to work, attend to household duties or attend social functions during a migraine attack.
Other Current Acute Migraine Treatment Options
Current migraine treatment options are dominated by medications, which fall into two categories: acute (or abortive) medications (used to minimize migraines when they occur) and preventative (or prophylactic) medications, taken to lower the chance of getting migraines. Satisfaction with current treatment options is generally very low, largely due to poor effectiveness and medication side-effects.
A few devices have also recently been cleared and come to market for the both acute and prophylactic treatment of migraine. These approaches include delivering an electrical current or energy field to the head or neck in order to stimulate a specific nerve target for pain modulation, while another device is held by the patient against the back of their head to deliver transcranial magnetic pulses to the brain. These approaches can also be unappealing (and in some cases even painful) to use.
Remarkably, published clinical data for many of the leading drugs and devices for acute migraine treatment show only about ONE-THIRD of migraine patients achieve pain freedom from those treatments.
Nocira’s Investigational Migraine Therapy Solution
NOCIRA™, LLC is conducting an advanced clinical investigation of a new, non-invasive medical device system that is designed to treat migraines by making subtle pressure changes in the ear to stimulate multiple sensory nerve impulses into the central pain cortex of the brain. A recent survey conducted by Nocira indicated that most migraine sufferers would prefer to use a device rather than medication or injections, provided it was safe, had few side effects, and was effective. Nocira hopes that our investigational new platform might provide just such a therapy in the future.
Published pilot clinical study results for the Nocira platform demonstrated that TWO-THIRDS of the study patients achieved pain freedom within 2 hours from Nocira treatment – and with most of those patients also reporting a comfortable experience from the therapy. A more rigorous pivotal trial in more patients is now being planned in the near future and in order to confirm the safety and effectiveness of the novel approach for migraine treatment.
Nocira’s Mission is to Positively Disrupt how Migraines are Treated.
Commitment to the Promise of Smart Technologies in Healthcare.
More than proposing a novel treatment option for migraine, Nocira’s investigational mobile platform is also being designed to harness the power of smart technology to position our therapy system to learn and improve as it engages with a growing population of users who need it.
Still more than this, however, the Nocira system is being designed as a real world platform that is expected to contribute to future learning about Migraine and other brain-based conditions, and potentially contributing to an on-going path toward safer and more effective solutions.
Nocira The Company – Corporate Background & Current Focus
Nocira was originally co-Founded in 2014 by its early co-founders David George (see current management section), David Sullivan, George Buckler, and its lead investor and current Board Chairman, Tim Crown (see current management section). Their original vision and mission continue onward in Nocira’s objectives still today:
(1) to develop a potentially disruptive new acute migraine treatment solution that is fast-acting, safe, effective, appealing & pleasant to use, and affordable; and
(2) to specifically achieve these goals by delivering precisely controlled, gentle air pressure changes in the ear in order to stimulate the ear’s uniquely rich neural sensory anatomy to reset pain centers in the brain.
Millions of dollars of private equity investments since 2014 have been led by AZ Crown Investments LLC, and followed also by numerous other private accredited investors. This critical funding has supported years of development for the controlled device system and related therapy, in addition to initial clinical feasibility and pilot investigational clinical studies. The results of these earlier efforts have also encouraged the Company to further advance product development and clinical evaluations – and to expand its management & operations team, and funding, in support of a growing momentum and trajectory.
Nocira’s primary current focus is now to conduct a multi-center, double-blinded, randomized, placebo-controlled Pivotal Trial to formally evaluate the safety and effectiveness of the Company’s primary investigational device system and related acute migraine therapy. This trial, with IRB approval and under patient informed consent, is currently planned to be launched in the United States in the latter half of 2018. Nocira then plans to reference those results, if successful as hoped, to support submissions for regulatory review and hopeful clearance of this novel system and therapy in the future.
Toward these objectives, Nocira is also currently:
· finalizing the Pivotal Trial protocol for multi-center IRB review and approval;
· evaluating potential clinical investigators and sites for that multi-center Pivotal Trial;
· continuing to pursue additional financings (i.e. private placements with qualified accredited investors only); and
· evaluating and conducting dialogues and initial negotiations with potential strategic partners.
Parties interested to potentially become a Nocira clinical investigator or site, accredited investor, or strategic partner should please contact the Company to inquire.1