Unmet clinical and public health needs

• Prevention

Beyond basic warming and feeding, care of premature newborn infants currently focuses on mitigation of unpreventable injuries to vital organs. Clinicians can only use information that they can access. Prevention cannot occur when a problem occurs because clinicians are not aware of the risk, or have no effective means of intervening. Lacking a means of detecting cellular hyperoxia before it causes harm, clinicians cannot develop effective prevention strategies or request development and deployment of more effective therapeutic medical devices.

• Lifelong disability reduction

The lifetime cost of attempting to compensate for the disabilities incurred during the first few days of a premature infant’s life often exceeds $1M. Adding to that, the lost contributions to their generation based on their genetic legacy, and the cost of the injuries to each infant becomes a huge societal burden.

• Systems-level monitoring gaps

Safe and effective physiologic monitoring needs to center on the most relevant and useful biometrics. Familiar vital signs, including heart rate, breathing rate, and pulse oximetry, detect highly conserved parameters, which only change when the sequence of deterioration is well established. These modes cannot detect the more responsive cellular oxygen status, low or high, and cannot detect cellular adaptations to changes in oxygen supply, all of which play pivotal, but little understood, roles in the pathologies currently associated with oxygen therapy. The inability of existing pulse oximeter monitors to recognize the pattern of periodic breathing in NICU patients leaves clinicians blind to impending episodes of prolonged apnea. Likewise, lacking the means of monitoring for periodic breathing during sleep of vulnerable infants at home has led to the current perception that infant death during sleep is "sudden" and "unexplained."

• Standardization

Historically, public health improves dramatically when breakthrough advancements become standard practice and are made widely available, such as has happened with vaccines and sanitation. The high initial cost of deployment of these advancements rapidly decreases with expanding access, and especially with embodiments that address the needs of remote and economically-challenged populations.

• Translational medicine

Creating and widely deploying cost-effective and user-friendly preventive care has, historically, been far more successful than attempting to expand access to mitigation of injury and rehabilitation by highly trained sub-specialists in metropolitan medical centers. One of the greatest challenges with successful preventive measures is quantification of effectiveness. Business transactions are measured by return on investment and profit. Treatment of diagnosed illness is typically evaluated by the rate and success of recovery. However, it is much more difficult to evaluate the effectiveness of vaccines, sanitation, and other preventive measures because the incidence of exposure to the threat is seldom detectable when the prevention mechanism is successful. This cause-effect disconnect may lead to a decline in perceived value of the prevention effort and even to open opposition to its imposition on the general population as a public health measure.