The investigational Nocira device includes a small pocketable pump connected by a thin tube to comfortable earpieces, similar to in-ear audio earpieces. A Nocira mobile phone app controls the system to deliver precisely controlled air pressure pulses into the external ear canal. The subtle pressure changes are believed to stimulate a uniquely rich population of pressure-activated sensors in the external and middle ear. This, in turn, is believed to stimulate multiple nerves that target the brain’s pain centers to essentially ‘reset’ overactive pain-generating areas back to a calmed, non-painful state.

More specifically, this stimulation is believed to include sensory branches of both the vagal and trigeminal nerves, among other nerves, that have been associated with pain modulation. These multiple sensory nerves all uniquely converge in the ear unlike any other known place in the body. Nocira believes that this targeted stimulation of these parallel mechanisms via the single portal of the ear might provide distinct advantages in the speed and extent of achieving a desired therapeutic effect. This is also in stark contrast versus other recently approved migraine treatment devices that target a single nerve mechanism (e.g. vagal or trigeminal) at other target locations (e.g. specific sites along the neck or head).

What does all that mean? Nocira proposes a novel and potentially disruptive solution that targets the activation of multiple migraine relief mechanisms by simply making small pressure changes in the ear. This may be a true case of “Less is More.”

Simple as it might first appear to be, the air pressure modulation of the Nocira system is not really just ‘simple’ puffs of air. Nocira has conducted extensive development in the precise control by which the air pressure changes are delivered to the ear. This is intended to enhance the ability to achieve maximum therapeutic effect, yet while also remaining comfortably within the published range limit standards for safe pressure changes in the ear.

There are many medical procedures that have long involved changing pressures within patients’ ears. These include fairly standard and routine diagnostic procedures that use manual “insufflation” devices with baffles or “bulbs” that a medical professional squeezes to change pressure through an earpiece seated in the ear. Nocira has conducted its own internal testing with such standard manual insufflation devices to evaluate the range of pressures they are capable of achieving when manually actuated. These test results revealed that such manual insufflations are capable of over-pressurization up to several times above the standard maximum safe pressure guidelines for the ear. While manual ear insufflation is generally considered safe in the hands of skilled medical professionals trained in safely conducting such procedures, Nocira believes it could pose significant safety risks in the hands of a patient who might try to self-treat their own ears. Hence the high priority that has been placed on requiring precise pressure control in Nocira’s design.

Nocira’s precise pressure control is also fundamental to the investigational therapy itself. The Nocira ‘puffs of air’ are actually delivered as changing pressure “patterns.” This approach is intended to optimize therapeutic effect by varying the sensory stimuli within the ear, and also to reduce the potential for habituation (i.e. a physiologic desensitization to a repetitive stimulus).