Project Summary/Abstract Migraine is the most common neurological disorder and the 3rd cause of disability in people under 50, according to the World Health Organization49. The annual healthcare and lost productivity costs are approximately $36 billion in the US.31 6 million people in the US are chronic migraineurs who have migraines for more than 50% of the month 28,32 of which 78% of them are severely disabled.61 Current therapies help many sufferers, however nearly 1 million of sufferers in the US do not respond to the therapy initial or stop responding over time; this is referred to as Intractable Chronic Migraine (ICM)17,18 These ICM patients who have exhausted traditional therapeutic options and are often desperate for relief typically progress to more invasive therapies such as Occipital Nerve Stimulation (ONS). ONS involves the surgical implantation of an Implantable Pulse Generator (IPG) and stimulation leads (electrical wires) under the skin which deliver low-level electrical stimulation to the occipital nerves. ONS has been effectively used off-label for two decades to treat a variety of headache disorders and is successful in reducing the number of headache days per month with superior efficacy to that of the “gold standard” preventative treatments1-15 where 65% of patients reported excellent or good headache relief after 1 year.12 Unfortunately, ONS therapy has an unacceptable number of device and procedural adverse events (~70%) which are attributable to a large degree to the off-label use of Spinal Cord Stimulation (SCS) systems not designed for this application. Using non-standardized implantation, the protocols, the off-label SCS devices are implanted below the neck with the leads traversing the neck to the occipital nerves located in the head. There currently does not exist an implantable stimulation system that has been designed, developed and qualified for ONS. There consequently exists a significant unmet need in the medical device arsenal for a specialized ONS device and standardized implantation techniques. Until this unmet need is addressed, chronic migraine sufferers will continue to be faced with inadequate and costly treatment options that often create the need for repeated surgical interventions and continued patient suffering. Our long-term goal is to establish a safe, reliable and efficacious ONS chronic migraine treatment proven through extensive bench testing and rigorous clinical studies that support FDA approval, reimbursement and ultimately commercial adoption. NeoGenesis proposes that the key to the clinical and commercial success of ONS therapy is the development of a microIPG system specifically designed for implantation in the back of the head, above the neck joint and closer to the target stimulation tissue (occipital nerves). In the previous Phase 1, Neogenesis successfully completed critical feasibility research to determine the IPG form factor and size for a head-based local stimulation of the occipital nerves. These key inputs comprise the foundational basis for the Phase 2 efforts. Our overall objective for Phase 2 is the design, development and qualification of the Talon microIPG system. We will accomplish this objective by designing and developing the microIPG mechanical packaging and stimulation lead for occipital placement, building and testing the IPG and leads, and validating the system design via pre-clinical studies.

Project Narrative Chronic Migraine is a serious, painful and debilitating neurological disorder afflicting millions of Americans. Chronic Migraine imparts a great cost to patients and their families by robbing them of their quality of life; there is also a great cost to society due to their reduced productivity. In this Phase 2 SBIR NeoGenesis proposes the development of an innovative, implantable nerve stimulation device to treat patients with severe forms of Chronic Migraine providing an effective therapy currently not available today.