First Bite

Our mission is to improve breathing (endotracheal) tube securement for intubated infants in the neonatal and pediatric intensive care units (NICU and PICU) by redefining airway securement through a safer, non-adhesive, and developmentally supportive solution. First Bite utilizes a pacifier design to mechanically secure the endotracheal tube while providing the patient with a therapeutic/soothing device. The secondary securement strap is non-adhesive and prevents removal of the pacifier while in use. We aim to set a new standard of care for the NICU and PICU by enhancing safety, comfort, and long-term health outcomes for these highly vulnerable, often overlooked patients.

Each year, thousands of critically ill infants enter the NICU and PICU unable to breathe on their own, relying on endotracheal (ET) tubes to survive. However tube displacement as low as 0.25 cm can severely compromise ventilation, leading to airway instability, organ damage, prolonged hospitalization, and even death (~15% of cases). Unplanned extubation (UE), or dislodgement of the ET tube, remains the fourth most common adverse event in the NICU making it a persistent and dangerous complication, with consequences that are both clinically and financially taxing. Ventilation alone can cost upwards of $2,000 per day, and studies from Johns Hopkins and Vanderbilt found that a single extubation event can add an average of $36,000-$50,000 to hospital costs while extending length of stay by an average of six days. Currently, estimated UE in the US alone adds over 22,000 hospital days and more than $16 million in hospital costs. However, costs go beyond procedures – lives are at stake, which introduces liability. A 2019 study from Brown reported that UE related malpractice lawsuits resulted in an average case payout of $7.6 million from hospitals to patients. Despite the need for better securement, innovation in this space has been limited, leaving clinicians dependent on outdated and unreliable solutions. ET tube holders on the market rely on adhesives for securement, which are highly susceptible to failure due to moisture, heat, and patient movement, all of which are commonplace in the NICU and PICU. In fact 10% of UEs are due to tape failure. Even with proper use, adhesives require frequent replacement, every 4 to 6 hours, which can damage fragile infant skin and the replacement procedure accounts for 20% of UEs. Intubation is associated with the development of oral aversion, a condition where patients refuse to eat/drink. Children with oral aversion suffer from malnutrition and stunted intellectual and physical development. Current devices have no mechanism to prevent oral aversion and in some cases contribute to its development. First Bite eliminates adhesives altogether, removing the primary source of failure in current holders. This increases the device’s lifespan from hours to days, making it low maintenance and reliable for clinicians, reducing risk and liability. The design combines the concept of a pacifier, a device used to soothe infants, and an ET tube holder to create a device that provides both tube securement and oral soothing to prevent oral aversion. Compared to existing products, First Bite offers adhesive-free securement, with low maintenance, oral soothing, and multi-tube compatibility, making it optimal for both clinicians and parents as shown by our pending letter of interest from the Midwest Device Consortium. Economically, our business model of partnering with an existing manufacturer allows us to maintain low overhead costs while capitalizing on established hospital relations. Our potential manufacturers anticipate unit costs of $1.65 with sales of $30 per device, giving our device 90% gross margins.