Successful Debut of Catheter Protection and Securement Product For Babies in Intensive Care

LifeBubble device protects fragile newborns from risks of umbilical catheter-related complications.

South San Francisco, CA • June 20, 2019


Novonate, a start-up medical device company spun out of the Stanford Byers Center for Biodesign, announced that its flagship device, LifeBubble, has been used successfully on 20 neonates in the neonatal intensive care unit (NICU). LifeBubble is a new product that secures and protects the insertion site of umbilical cord catheters for babies in intensive care. These catheters serve as lifelines that provide both nutrients and medication, but they also present risks for life-threatening complications.


“In all other patients, central lines lay flat against the skin surface and are secured with occlusive and sterile dressings. Umbilical cord catheters, however, rise from the umbilical cord perpendicular to the skin, and until now, could only be secured in place through a system of tape and adhesives that does not protect the insertion site potentially exposing it to the neonates diaper region,” said Dr. Janene Fuerch, neonatologist and advisor to Novonate. This results in the risk of a wide range of concerning clinical complications, including catheter migration and infections [1-3]. Researchers have found that up to two-thirds of umbilical venous catheters migrate after initial placement. In addition, 20% of neonates with umbilical catheters develop catheter-related complications and 95% of them have malpositioned catheters. [4]


Novonate’s LifeBubble is a sterile silicone product that sits over the umbilical catheter insertion site to provide an unparalleled level of protection and catheter stabilization while simultaneously allowing for natural desiccation of the stump. LifeBubble was developed by neonatologists, surgeons, and engineers with extensive design input from NICU nurses to revolutionize the way that umbilical catheters are held in place given the complications that can arise from migrating catheters. LifeBubble is a commercial product that is FDA registered and is available to United States NICUs.


“We are incredibly excited to have launched LifeBubble after years of hard work. Nurses, physicians, and babies deserve a better and safer way to secure and protect these critical lifelines. Our team is committed to solving problems in neonatal care, and we want LifeBubble to be the new standard of care for umbilical catheter securement and protection,” said Eric Chehab, co-founder and CEO of Novonate.



ABOUT NOVONATE

Novonate Inc., is a medical device company dedicated to designing products that improve neonatal care. LifeBubble, the first device developed by Novonate, protects and stabilizes the umbilical catheter in neonates, and standardizes the process of stabilization for healthcare providers. The company is based in South San Francisco, California. For more information, visit www.novonate.com.



[1] Gupta R, et al. American Journal of Perinatology 2016, 33:600-604.

[2] Dubbink-Verheij GH et al. Neonatology 2019, 115:205-210.

[3] CDC. American Journal of Infection Control 1996, 24:262-293.

[4] Mutlu M, et al. The Journal of Maternal-Fetal & Neonatal Medicine 2016, 29:2817-2822.

© 2020 Novonate, Inc.

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