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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: $266,698.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: PA19-029
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-26
Award End Date (Contract End Date): 2021-08-31
Small Business Information
San Francisco, CA 94133-2961
United States
DUNS: 826337250
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (415) 450-0515
Business Contact
Phone: (415) 450-0515
Research Institution
TORRANCE, CA 90502-2006
United States

 Domestic Nonprofit Research Organization

Every year, 50,000 very low birth weight (VLBW, andlt;1,500 g) infants are born in the U.S. The use
of surfactant dramatically decreases morbidity and mortality due to respiratory distress syndrome
(RDS) in VLBW infants. Current standards for surfactant administration require the infant to be
intubated, so that surfactant can be delivered to the trachea and lungs. Intubating a VLBW infant
is challenging and time consuming, and can lead to serious complications. There is an urgent
need for less invasive ways to deliver surfactant, without endotracheal intubation (ETI). The
purpose of this project is to develop a secure, effective, faster, and easily placed Surfactant
Administration Airway for VLBW Infants (SAAVI). The SAAVI is designed for delivering surfactant
to VLBW infants without ETI. It also serves as a rescue airway when the infant needs more
ventilatory support. In the SAAVI design, there is an oral cavity balloon and an esophageal cuff,
so that surfactant and air can be directed to the trachea via an oropharyngeal aperture. We have
fabricated working prototypes and tested them successfully on mannequins and animals. Our
long-term goal is to improve survival and decrease morbidity of VLBW infants through a device
that is better, safer, and easier to use for surfactant delivery and airway rescue. Our aims are to:
(1) test the SAAVI for surfactant delivery and ventilation in a rabbit surfactant depletion model;
and (2) finalize the SAAVI device in 2 sizes for VLBW infants weighing andlt;1000 g, and 1000-1500
g. To determine the optimal dimensions for the SAAVI, we will obtain anatomical measurements
from 70 fetuses at 24-34 weeks of gestation by ultrasound. In the animal study, 4-week old rabbits
will be used as the model for testing and validating the SAAVI. The rabbits will be randomized to14
2 groups -- 10 in the ETI group, and 10 in the SAAVI group. Surfactant will be labeled with C-
DPPC, and will be administered via the ET tube or SAAVI. Surfactant delivery and distribution in
the lungs will be measured by radioactivity. To assess efficacy of surfactant delivery and SAAVI
as an airway, we will compare pulmonary function between the 2 groups. Completion of the aims
will result in validated SAAVI devices of appropriate sizes, ready for human testing. As soon as
the Phase I milestones are achieved, we will move quickly to commercialize the SAAVI by: (1)
applying for Phase II funding for clinical trials; (2) starting the process for an 510 (k) submission
to the FDA; and (3) approaching investors for funding commercialization.PROJECT NARRATIVE
Every year, 50,000 very low birth weight (VLBW, andlt;1,500 g) infants require the surfactant therapy
to prevent complications due to immature lungs. Surfactant is currently delivered to VLBW infants
by an endotracheal tube -- but placing a tube in the trachea in small infants is invasive, difficult,
and potentially injurious. In this proposal, we will develop a new secure, effective, faster, and
easily placed device -- the Surfactant Administration Airway for VLBW Infants (SAAVI) -- to solve
this problem.

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

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