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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: 2R44HD102245-02
Agency Tracking Number: R44HD102245
Amount: $1,658,070.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NICHD
Solicitation Number: PA20-260
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-08-05
Award End Date (Contract End Date): 2024-07-31
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 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 add to the complexity of the workflow and introduce access sites that can disrupt the blood flow
path. Currently, there is no such oxygenator approved for long term use 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. In Phase I, the MC3 Ped-ECMO Oxygenator (PedOxy) was
designed specifically with an optimized flow path that minimizes clotting by avoiding areas of high shear as well
as stagnant zones. A non-heparin coating, Balance Biosurface, has been selected to prevent thrombosis and
preserve platelet function. In addition, a simplified monitoring system was integrated into the disposable
oxygenator that will provide real-time diagnostics, minimize blood path disruptions and simplify workflows. The
manufacturing processes for creating the unique flow path was advanced. Prototypes of the PedOxy were
demonstrated to match competitors’ gas exchange while showing superior clotting performance in
vitro.With Phase II funding, the MC3 PedOxy will reach design freeze, verification/validation testing will be
completed, and the design will be transferred to in-house MC3 manufacturing. Pilot in vivo studies will be
performed to prepare for the GLP study that is required for regulatory submissions for the ECMO pathway in
the US and CE Mark in accordance with the new European Medical Device Regulation. We have assembled a
team of experts, clinicians, marketers, manufacturers and engineers who are uniquely qualified to carry out the
proposed work.

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

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