Revolutionizing Infant Care - Show #140

John Konsin is co-founder and CEO of Prapela, a company pioneering noninvasive stimulation to improve infant breathing and oxygenation. The company’s infant mattress technology has already received two Breakthrough Device designations from the US FDA, which expedites clearance for clinical usage. Prapela expects to debut an additional application based on the technology in 2025. 

John and Wendy connected at the Redefining Early Stage of Investment (RESI) Conference in Boston, which Life Science Nation hosted. (Wendy recently interviewed Dennis Ford, founder and CEO of Life Science Nation, which specializes in fundraising for life sciences companies.) In this episode, John describes three clinical applications for Prapela’s technology and outlines the company’s global expansion strategy, focusing on providing valuable insight into navigating international markets, regulatory challenges, and cross-cultural communication. 

The Science Behind Safer Sleep 

At the heart of Prapela's innovation is that 62% of healthy infants experience irregular breathing patterns and oxygen desaturation in their first three months of life. The Collaborative Home Infant Monitoring Evaluation (CHIME) study monitored over 1,000 healthy infants at home using hospital-grade equipment to track their respiration, cardiac activity, movement, and oxygen saturation levels. Episodes varied in frequency, severity, and duration among babies—some experienced them once, while others showed multiple occurrences. 

Most significantly, these breathing irregularities occurred not just in at-risk infants but in otherwise healthy babies, highlighting a previously unrecognized challenge in early infant development. (Ramanathan, R., et al. (2001). Cardiorespiratory events recorded on home monitors: Comparison of healthy infants with those at increased risk for SIDS. JAMA, 285(17), 2199-2207.) 

Prapela's infant mattress helps to regulate babies' breathing through a gentle, barely perceptible vibration. The innovation grew out of research by Dr. David Paydarfar, who, in the 1990s, discovered that a specific type of random vibration, known scientifically as "stochastic" vibration, could improve the “pacemaker function,” the neurons in a baby's brain that controls automatic breathing. The vibration is so subtle it moves less than half the diameter of a human hair, making it effective and non-disruptive to sleep patterns. 

The Hospital-First Strategy 

The company has secured over $8 million in funding through grants and awards, allowing them to maintain control while developing their technology. John says this will enable the company to seek equity investment from a position of strength, with FDA clearance on the horizon and a clear path to commercialization. 

Their market strategy began in hospitals, aiming to directly and immediately impact infant care in critical settings. This approach is grounded in decades of successful medical device launches, which built a foundation of clinical credibility before venturing into the broader consumer landscape. The technology has already demonstrated its potential, reducing reliance on supplemental oxygen and minimizing the need for traditional breathing interventions. 

John envisions a future where "Prapela Inside" becomes as recognizable in infant care as "Intel Inside" is in computers, starting with the 52 global manufacturers of hospital bassinets and incubators: 

[W]e we can make this mattress fit any infant sleep device worldwide. So it doesn't matter if it's an incubator, bassinet, crib, or cot, as they use the term in international markets, right? We can make it fit those products. So, our strategy is similar to that of Intel with the microchip. You'll see a little badge when you buy a computer from Dell or some other company. It says Intel inside. 

By positioning their technology as a vital component that transforms standard infant care equipment into advanced breathing support systems, Prapela aims to revolutionize hospital infant care worldwide. Following FDA approval, Prapela plans to pursue regulatory clearance in other markets, initially focusing on Europe, India, and the Middle East. The sequential approach allows them to leverage their FDA clearance while adapting to local regulatory requirements in each new market. 

Cultural Intelligence in Global Marketing 

John offers valuable insight into cross-cultural communication and marketing. He emphasizes several key principles for successful global expansion: 

1. Language Simplification: English is widely spoken in international business, but vocabulary depth varies significantly. John advocates using simpler terms and friendly comm