CED Life Science Conference 2018 - presenting at the Coulter Investment Forum
Sub-sector: Medical Devices
Year Founded: 2017
Novonate is a device company that is made up of a diverse group of engineers and physicians who are passioniate about solving problems in neonatal care. Novonate spun out of the Stanford Byers Center for Biodesign in early 2017, leveraging several years of research that was completed within Stanford University on non-dilutive funding.
Umbilical catheterization is a lifeline for delivering medication and nutrition to critically-ill newborns in the neonatal intensive care unit (NICU), but the procedure is associated with an infection rate that is at least five times that of adult central lines. The current standard of care to secure umbilical catheters is a suture and non-sterile adhesive, which do not at all protect the catheter insertion site. This is in stark contrast to the adult central line standard of care, which involves both effective securement and physical protection of the central line.
Novonate is currently developing LifeBubble, a device that standardizes and simplifies umbilical catheter securement, protects the umbilical catheter-stump interface, and minimizes umbilical catheter translation. LifeBubble dramatically improves upon the current standard of care to ultimately reduce central line-associated bloodstream infections and maintains the current NICU workflow for catheter insertion and securement. The device was designed from in depth user feedback, engineering testing, and in vitro biologic testing.
Planned indications for use relate to catheter securement and insertion site protection, which are similar to other products classified as “intravascular catheter securement devices” by the FDA. This will allow for the most rapid path to commercialization as a Class I medical device with General Controls; no 510(k) submission or clinical trial will be necessary. Novonate expects to complete research and development in order to commercialize LifeBubble very quickly and with cost-efficiently.
Eric Chehab, PhD - CEO
James Wall, MD
Ross Venook, PhD
KEY MILESTONES TO DATE
- Received over $300k in grant-based funding and non-dilutive resources
- Closed $1MM Series Seed
- Produced aluminum molds to manufacture one-piece full-silicone LifeBubble
- Secured worldwide exclusive license for technology from Stanford University
- Filed patent applications in US and six international territories
MedTech Venture Partners; National Science Foundation; Atlantic Pediatric Device Consortium; Stanford Byers Center for Biodesign; Rosenman Institute; StartX
Palo Alto, CA
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