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Pediatric ECMO Oxygenator with Integrated Monitoring

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HD102245-01
Agency Tracking Number: R43HD102245
Amount: $223,362.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NICHD
Solicitation Number: PA19-272
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-04-23
Award End Date (Contract End Date): 2021-03-31
Small Business Information
Dexter, MI 48130-1563
United States
DUNS: 806687406
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (734) 995-9089
Business Contact
Phone: (734) 995-9089
Research Institution

ABSTRACTExtracorporeal membrane oxygenation (ECMO) is becoming increasingly utilized to provide
cardiopulmonary support in patients due to its versatility, immediate benefit, and relatively low cost. However,
there continues to be significant morbidity and mortality related to hemostatic complications, especially in the
neonatal and pediatric population. A few pediatric oxygenators are used in ECMO; however, all of these
devices only have short term approval and are currently used off label in ECMO. In addition, a variety of
monitors are needed in an ECMO circuit, which can add to the complexity of the work flow, as well as
introducing access sites that can disrupt the blood flow path. Currently, there is no such oxygenator approved
for this indication in pediatrics.The goal of this project is to develop a pediatric ECMO oxygenator with integrated sensors that is
optimized for long term use in pediatric ECMO. The proposed MC3 Ped-ECMO Oxygenator (PedOxy) will be
designed specifically with a flow path that minimizes clotting by avoiding areas of high shear as well as
stagnant zone. In addition, a simplified monitoring system will be integrated into the disposable oxygenator that
will provide real-time diagnostics, minimize blood path disruptions and simplify workflows. Phase I will include
optimizing the blood flow path and integrated sensor module. The manufacturing processes for creating the
unique flow path will be advanced. Feasibility will be established by evaluating performance of the PedOxy
against specific criteria unique to usage in the pediatric application. Phase II funding, if granted, will be
sufficient to complete verification/validation testing, transfer to manufacture, and FDA and CE mark
submissions. We have assembled a synergistic team of experts, clinicians, marketers, manufacturers and
engineers who are uniquely qualified to carry out the proposed work.NARRATIVEThere are approximately 3,000 neonatal and pediatric ECMO cases performed each year in the US. There
are a few pediatric oxygenators used in ECMO, but only have short term (6 hour approval). The goal of this
project is to develop a pediatric ECMO oxygenator with integrated monitoring that is optimized for long term
use in pediatric ECMO.

* Information listed above is at the time of submission. *

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