NeoLight, an empathy-driven medical device company that designs, engineers, and manufactures technologies to treat infants with life-threatening medical conditions, announces today interim data from an ongoing clinical study on the efficacy of NeoLight’s Skylife™, a neonatal phototherapy device recently cleared by the U.S. Food and Drug Administration (FDA) to treat hyperbilirubinemia, commonly known as Jaundice.
The two-armed, randomized, controlled, post-marketing study which started earlier this year, is being conducted at HonorHealth Scottsdale Shea Medical Center, in parallel with another study underway at Lucile Packard Children’s Hospital Stanford. The Shea Medical Center will enroll up to 60 healthy newborns, (>35 weeks gestational age) in a comparison of Skylife™ to the GE BiliSoft Phototherapy System under a hospital setting in the treatment of hyperbilirubinemia. Patients were randomly assigned to either Skylife and GE BiliSoft Phototherapy System group. Comparisons were made between patient data from both groups that included bilirubin levels, pressure ulcer, and body temperature evaluated at baseline, 12-hours post-intervention, 24 hours post-intervention and at discharge.
An interim analysis on 16 patients from HonorHealth, Skylife™ is shown to considerably reduce the neonatal phototherapy discharge time, up to 40%, which would be of clinical, operational and economic significance to hospitals, insurance providers and patients.
“A parent of a newborn is always on edge when separated from their baby during the treatment for any kind of condition,” said Dr. Matthew Abrams, Medical Director of Neonatology for HonorHealth Shea Medical Center and a lead investigator in the study. “The sooner you can release a newborn back to the loving arms of their parents creates a win-win for everyone. Thus far, we are seeing promising improvements in discharge times utilizing the Skylife™ system. Skylife™ is compatible with most of the commonly used neonatal enclosures and its stackable form factor makes efficient use of storage space. For the hospital, being able to potentially provide excellent care with improved patient accessibility by reducing the equipment around the patient beds is an exciting prospect.”
NeoLight’s co-founder and Chief Executive Officer Vivek Kopparthi added, “Physicians and parents want the best for newborns, which is why we are conducting this post-marketing study versus the standard of care. The current observation is showing that infants treated with Skylife™ are being discharged about 9.3 hours faster. With no adverse events or safety concerns observed, we feel confident that Skylife™ can present a compelling clinical case for the hyperbilirubinemia phototherapy treatment. We look forward to collecting more data to bolster the case.”
It is also important to note that current phototherapy devices often lack the required treatment dosage and ergonomic considerations for maintenance and operations, forcing hospitals to use multiple phototherapy devices at the same time, colloquially called double or triple phototherapy. This not only creates a negative monetary impact on both the hospital and patient, but patients receiving insufficient dosage could cause longer hospital stays and patients often experience dehydration due to warm conditions produced under these devices.
Nearly 60% of full-term newborns become clinically jaundiced in the first week of life. That number jumps to 80% in preterm births. Unconjugated (indirect) hyperbilirubinemia is the result of excessive bilirubin formations due to the infant’s inability to clear bilirubin quickly enough from the blood. While most newborns with jaundice are healthy, they do need to be monitored as bilirubin can be toxic to the central nervous system. Elevated levels, left unchecked, can cause serious problems. Visible light, specifically the blue-light wavelengths of approximately 400 to 520 nanometers, photochemically reduces unconjugated bilirubin to water-soluble products that can be excreted. Phototherapy devices are commonly used in hospitals to treat neonatal hyperbilirubinemia.