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A Novel Two-in-One Approach to Administer Surfactant and Provide Airway Support to VLBW Infants

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HD097969-01
Agency Tracking Number: R41HD097969
Amount: $223,271.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: PAR17-200
Timeline
Solicitation Year: 2017
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-26
Award End Date (Contract End Date): 2020-08-31
Small Business Information
1736 STOCKTON ST, San Francisco, CA, 94133-2961
DUNS: 826337250
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 CHRISTINA BERNSTEIN
 (415) 450-0515
 tina@bbmedicalsurgical.com
Business Contact
 CHRISTINA BERNSTEIN
Phone: (415) 450-0515
Email: tina@bbmedicalsurgical.com
Research Institution
 LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
 1124 WEST CARSON ST
TORRANCE, CA, 90502-2006
 Domestic nonprofit research organization
Abstract
PROJECT SUMMARYABSTRACT Every yearvery low birth weightVLBWandltginfants are born in the U SThe use of surfactant dramatically decreases morbidity and mortality due to respiratory distress syndromeRDSin VLBW infantsCurrent standards for surfactant administration require the infant to be intubatedso that surfactant can be delivered to the trachea and lungsIntubating a VLBW infant is challenging and time consumingand can lead to serious complicationsThere is an urgent need for less invasive ways to deliver surfactantwithout endotracheal intubationETIThe purpose of this project is to develop a secureeffectivefasterand easily placed Surfactant Administration Airway for VLBW InfantsSAAVIThe SAAVI is designed for delivering surfactant to VLBW infants without ETIIt also serves as a rescue airway when the infant needs more ventilatory supportIn the SAAVI designthere is an oral cavity balloon and an esophageal cuffso that surfactant and air can be directed to the trachea via an oropharyngeal apertureWe have fabricated working prototypes and tested them successfully on mannequins and animalsOur long term goal is to improve survival and decrease morbidity of VLBW infants through a device that is bettersaferand easier to use for surfactant delivery and airway rescueOur aims are totest the SAAVI for surfactant delivery and ventilation in a rabbit surfactant depletion modelandfinalize the SAAVI device insizes for VLBW infants weighing andltgandgTo determine the optimal dimensions for the SAAVIwe will obtain anatomical measurements fromfetuses atweeks of gestation by ultrasoundIn the animal studyweek old rabbits will be used as the model for testing and validating the SAAVIThe rabbits will be randomized togroupsin the ETI groupandin the SAAVI groupSurfactant will be labeled with CDPPCand will be administered via the ET tube or SAAVISurfactant delivery and distribution in the lungs will be measured by radioactivityTo assess efficacy of surfactant delivery and SAAVI as an airwaywe will compare pulmonary function between thegroupsCompletion of the aims will result in validated SAAVI devices of appropriate sizesready for human testingAs soon as the Phase I milestones are achievedwe will move quickly to commercialize the SAAVI byapplying for Phase II funding for clinical trialsstarting the process for anksubmission to the FDAandapproaching investors for funding commercialization PROJECT NARRATIVE Every yearvery low birth weightVLBWandltginfants require the surfactant therapy to prevent complications due to immature lungsSurfactant is currently delivered to VLBW infants by an endotracheal tubebut placing a tube in the trachea in small infants is invasivedifficultand potentially injuriousIn this proposalwe will develop a new secureeffectivefasterand easily placed devicethe Surfactant Administration Airway for VLBW InfantsSAAVIto solve this problem

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

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