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 centers 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.
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Nocira’s Mission is to 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
1 Please see important Notice section.
MANAGEMENT TEAM
Jim Peacock, Esq
Chief Executive Officer | Board Director
Jim Peacock (San Carlos, CA) has founded and managed five med-tech companies launched in funded operations via more than $200 million of investment capital raised since 1997, and with multiple successful exits and disruptive products brought successfully to market. He is a named inventor on more than 45 issued U.S. Patents, and has co-authored numerous awarded abstracts, podium presentations, and grants in various scientific fields. He is also a frequent speaker, panelist/judge, and guest lecturer about high tech start-ups at graduate law, business, and engineering schools. Mr. Peacock is also a Registered Patent Attorney and member of the California State Bar. He continues to advise other start-ups as Of Counsel consultant to Mahamedi IP Law LLP, and was previously Of Counsel to O’Banion & Ritchey LLP and an Associate Attorney at Morrison & Foerster LLP. In October 2015, Mr. Peacock was honored by the Silicon Valley Leadership Group as a “Featured Innovator” at the launch celebration for the Silicon Valley Regional Office of the United States Patent and Trademark Office. Earlier in his career, he was a Senior R&D Engineer at Guidant Corp, and previously an R&D Engineer at Baxter American Edwards.
David George
Chief Scientific Officer | Vice President Product Development | Board Director | Co-Founder
An entrepreneur, inventor, educator and clinician, David George is one of Nocira’s co-Founders and co-Inventors who also continues to lead the Company’s product development and related inventive process for a continually expansive portfolio of product features and refinements, pipeline technologies, and related intellectual property. With a passion for clinical neuroscience and innovation, David is focused on developing solutions in neurorehabilitation, neuro-diagnostic technology, and neuromodulation. He’s a named inventor on a growing international patent portfolio and is a highly regarded expert in integrative approaches to physical rehabilitation. Besides inventing devices and solutions to advance neuroscience and pain management, David has founded and co-founded several private businesses, clinics and hospital-based service companies, including Saxon Medical, Nova Neura and FNOR.
Tim Crown
Board Chairman | Lead Investor | Co-Founder
One of the four original co-Founders of Nocira, Tim Crown led Nocira’s financings since 2014, with nearly $3M invested through Arizona Crown Investments, LLC. His executive leadership also included serving as Nocira’s CEO through 2017, and still continues as Nocira’s Chairman and via operational support he leads via the cross-functionally skilled AZ Crown support team. Tim is also highly respected as a business executive and leader with a long-standing track record of notable, significant successes; including, in particular, as the co-Founder and Chairman of Insight Enterprises, Inc., (Nasdaq: NSIT), a multi-Billion dollar leading IT solutions provider.
Melissa Walker | Graematter
Regulatory/Quality/Clinical Affairs
Skilled senior executive with proven expertise in regulatory affairs, quality systems, healthcare compliance, and clinical research. Melissa, has been recognized for strategic business focus and innovative approaches to regulatory strategies and process development/improvement. She is former Chairman of the Board of the Regulatory Affairs Professionals Society and served on the Board of Directors from 1997 to 2001. She has also served as the industry representative on the FDA Medical Devices Dispute Resolution Panel. She possesses a uniquely broad base of business, regulatory, quality and clinical research experience working with a variety of medical products, in therapeutic areas that include cardiology, electrophysiology, immunology, dermatology, ophthalmology, oncology, gastroenterology, diabetology, and gynecology. Melissa is also the President and Founder of Graematter, Inc., where she provides her expert consulting and regulatory intelligence services leveraging a unique, proprietary database. Previous roles include the Vice President Regulatory Affairs at Topera, Inc.,Senior VP Regulatory, Quality, & Compliance at Stereotaxis, Executive Vice President of Regulatory Affairs at Bausch & Lomb, and Director of Regulatory Affairs at Ethicon Endo-Surgery.
Harshal Deshpande
Chief Commercial Officer
Harshal brings with him an exemplary track record of successful commercialization experiences wherein he led new franchise launches, build commercial infrastructure and teams, launched new products, enabled business/corporate development and delivered strong revenue and share growth in a highly competitive markets. Harshal brings a deep expertise in the migraine market along with other areas of Neurology. Prior to him joining Nocira, he was the Head of Neurology Marketing at Promius Pharma/Dr. Reddy's Labs and held positions of increasing responsibilities at Novo Nordisk and Pfizer Inc.
He graduated with a MS degree in Chemical Engineer from Missouri University of Science and Technology and an MBA degree from Saint Louis University.
CAUTION: INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE ONLY.
NOT CE MARKED. NOT AVAILABLE FOR MEDICAL USE IN THE EU UNTIL CE MARK IS COMPLETED.
PATENTED AND PATENT PENDING PRODUCTS AND METHODS. NOCIRA® IS A REGISTERED TRADEMARK OF NOCIRA LLC. COPYRIGHT 2018 © NOCIRA LLC. (ALL RIGHTS RESERVED)
IMPORTANT NOTICE: This site and its content is not a promotion, solicitation, or offer to sell any securities, or product or service of the Company. Forward looking statements are estimates only and are subject to change without notice, and are not a representation or warranty of actual future performance (which may differ from forecasts). Factual statements regarding performance data or other observations from clinical trials, including any testimonials, are not a representation or warranty of future performance or that similar results might be achieved in other individual patients or groups of patients in the future. Whether or not the company’s intended products might be appropriate for any current or future planned investigational or clinical use, and the potential results of such use, may vary between patients and their particular condition. Statements regarding features or benefits of the Company’s investigational products, as currently being evaluated or intended or planned for the future, are not a representation or warranty that such features will be provided nor that such benefits will be achieved in any product or use thereof in the future. Any such statements are not a promotion or claim regarding any such future product, which would only be promoted and/or made available in the future (if ever) after an appropriate pre-market regulatory agency review and clearance if and as may be required in any geographic territory.