Prapela

Prapela, Inc. is a medical device company established to address critical unmet needs in neonatal care through a novel, non-pharmacological therapy. Founded on July 14, 2017, by John Konsin, Dr. David Paydarfar, and Jim Niemi, the company is built upon decades of research into stochastic resonance, a scientific principle where gentle, random vibrations can enhance physiological signals. This foundational work was pioneered by Dr. Paydarfar, who, as early as 1995, proposed that specific gentle stimulation could positively influence respiratory rhythms in infants. The technology was further developed at the Wyss Institute for Biologically Inspired Engineering at Harvard University and the University of Massachusetts Medical School. John Konsin, who has 40 years of experience in life sciences, was motivated to found the company after his stepson suffered from an opioid overdose, driving his focus toward helping newborns experiencing withdrawal.

The company's core offering is a hospital bassinet pad that delivers Stochastic Vibrotactile Stimulation (SVS), a barely perceptible, randomized vibration designed to improve breathing regularity and oxygenation in newborns. This prescription-only device serves as an adjunctive therapy for two primary patient populations in a hospital setting: preterm infants with apnea of prematurity and newborns suffering from Neonatal Opioid Withdrawal Syndrome (NOWS). For infants with NOWS, the SVS pad helps stabilize breathing and heart rates, reduces hyperirritability, and has been shown in clinical trials to lower the need for morphine treatment and shorten hospital stays. The therapy works by resonating with nerve endings to boost the brain's control over the nervous system, movement, and sleep, without disturbing the infant's sleep cycles.

Prapela operates on a B2B business model, selling its FDA-cleared bassinet pads directly to hospitals and specialty care centers. The company has received significant non-dilutive funding, including over $8 million in grants and awards from institutions like the National Institutes of Health (NIH), the FDA, and Johnson & Johnson Innovation, which has funded prototype development and extensive clinical trials. Prapela has achieved major milestones, including receiving two FDA Breakthrough Device Designations, which expedite the review process for devices addressing life-threatening conditions. On April 4, 2025, the Prapela SVS hospital bassinet pad became the first device to be granted FDA marketing authorization for treating opioid-exposed newborns. Looking forward, the company is developing partnerships with leading manufacturers to integrate its technology into a wider range of neonatal equipment, such as incubators and radiant warmers. Keywords: neonatal care, medical device, stochastic resonance, apnea of prematurity, neonatal opioid withdrawal syndrome, non-pharmacological therapy, infant health, vibrotactile stimulation, respiratory support, FDA-cleared