By Benjamin Boettner, Wyss Institute

Boston, Mass. - August 22, 2018 - Today the Wyss Institute for Biologically Inspired Engineering at Harvard University and Prapela, Inc. announced that the Institute’s clinically validated Stochastic Vibro-tactile Stimulation (SVS) technology will be commercialized by the startup to develop a range of devices designed to improve infant health. The announcement follows a licensing agreement between Harvard’s Office of Technology Development (OTD) and Prapela.

Some infants are born with, or develop, instabilities in their heart and lung (cardiorespiratory) function. Newborn infants most frequently affected include those suffering from neonatal abstinence syndrome (NAS), which is caused by withdrawal from drugs like opioids that their mothers consumed during their pregnancies.

Prapela will use the technology developed at the Wyss Institute to design an inexpensive, SVS hospital bassinet pad and a next-generation "baby box." The original baby box was developed in Finland to provide all infants, regardless of their families’ social background, with a safe sleeping environment until they can transition to a crib.

Besides infants suffering from NAS, cardiorespiratory instabilities are also seen in premature infants with apnea and infants born with congenital heart disorders, or those that are colicky. These conditions often disrupt infants’ sleep, can interfere with their health and early development, and even put their lives at risk. In addition, they can be devastating for families that require significant health care resources to appropriately care for their newborns.

To help normalize cardiorespiratory functions in infants, Wyss Institute researchers and engineers in close collaboration with physicians and researchers from the University of Massachusetts Medical School (UMMS), Massachusetts General Hospital, and Beth Israel Deaconess Medical Center (BIDMC) have developed an SVS technology platform and initially validated it in newborn infants suffering from apnea of prematurity.

The SVS strategy is based on the principle of “stochastic resonance,” the idea that the addition of white noise can boost weak signals in neuronally controlled and other biological processes, and is related to early work by David Paydarfar, M.D., a former Wyss Institute Associate Faculty member and Scientific Lead of the infant SVS technology platform. In a series of publications, Paydarfar and colleagues hypothesized and then demonstrated first in animal models and later in clinical studies with apneic infants that subtle random vibratory stimulation (noise) can enhance the rhythmicity of breathing by stabilizing the function of pacemaker neurons.

“Our initial and more recent clinical studies demonstrate that SVS can provide a non-invasive, non-pharmacological solution to improve cardiorespiratory stability in preterm apneic infants,” said David Paydarfar, who now is Professor and Chair of Neurology at Dell Medical School at The University of Texas at Austin.

“Encouraged by the studies in apneic infants, we extended the SVS-based strategy as a treatment to help reduce drug withdrawal in infants with Neonatal Abstinence Syndrome (NAS), which led to promising results in opioid-exposed newborns,” said Elisabeth Bloch-Salisbury, Ph.D., who worked on Paydarfar’s clinical team on the earlier apnea studies and now is an independent Research Associate Professor of Pediatrics at UMMS. She currently leads a National Institutes of Health (NIH) multi-site clinical trial looking at both short- and long- term outcomes in NAS infants who receive SVS.

“Our SVS devices made it possible to deliver precise gentle stimulation to these infants, in either the home or hospital setting, in a standard infant mattress,” said James Niemi, M.S., Lead Senior Staff Engineer who led the development of the SVS technology at the Wyss Institute.

“Prapela is honored to bring SVS technology to healthcare professionals and caregivers at home. With a singular focus on SVS we have the potential to help remedy colic, apnea of prematurity and other infant sleep-disordered breathing issues,” said John Konsin, Co-founder and CEO of Prapela.

To kick off its development efforts, Prapela has received funding from the Charles H. Hood Foundation, which is dedicated to improving the health and quality of life for all children by identifying and funding innovative pediatric advancements. “We look forward to Prapela’s contribution to improving the clinical course of infants diagnosed with NAS,” said John Parker, Trustee of the Charles H. Hood Foundation. Additionally, over the past year, the company has won awards from Johnson & Johnson, the Children’s National Health System with the FDA and the National Institutes of Health.

“We are all excited that the innovative SVS technology developed by our faculty and talented engineering staff is moving from the lab into the marketplace, where we hope it will provide a new therapeutic option for infants – the smallest and most helpless patients affected by this ever growing opioid epidemic,” said Wyss Institute Founding Director Donald Ingber, M.D., Ph.D., who is also the Judah Folkman Professor of Vascular Biology at HMS and the Vascular Biology Program at Boston Children’s Hospital, as well as Professor of Bioengineering at Harvard John A. Paulson School of Engineering and Applied Sciences.