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Wireless withdrawal detection and monitoring system for neonatal abstinence syndrome.

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DA049615-01A1
Agency Tracking Number: R41DA049615
Amount: $280,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIDA
Solicitation Number: PA19-029
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-07-01
Award End Date (Contract End Date): 2021-06-30
Small Business Information
Agoura Hills, CA 91301-1517
United States
DUNS: 116867398
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (949) 878-1023
Business Contact
Phone: (949) 878-1023
Research Institution
IRVINE, CA 92697-0001
United States

 Nonprofit College or University

Neonatal abstinence syndrome (NAS) is an opioid withdrawal syndrome that develops shortly after birth to in
utero-exposed neonates. The cost of NAS is high: newborns with NAS are typically receive care in the Neonatal
Intensive Care Unit (NICU), where the daily cost of care is high. Nearly 22,000 infants are born with NAS each
year at a cost of $1.5 billion1. Moreover, medication-based interventions for the treatment of NAS, used in up to
80% of opioid-exposed infants, carry their own risks of toxicity and drug interactions2. Despite the medical cost,
high societal impact of NAS, and the risks of treatment, the tools to assess the severity of NAS can be subjective
and suffer from examiner bias3. There is an urgent need for innovative new methods to diagnose NAS and
assess the efficacy of responses to treatment.
Flexible, low-cost wearable devices (worn on the skin) that can report measures of systemic biochemical and
biomechanical processes offer a simple and economical solution. In NAS, surges of sympathetic nervous system
activity produce increased heart rate, skin conductance, unstable temperature, and tremor. These manifest in
increased infant sweating, seizures, tremors, unstable body temperature, and more—events that must
continually monitored and assessed by nurses. The unsupervised, objective detection/quantification of the bodily
response of neonates suffering from NAS could drive the development of new, objective scoring tools that can
guide the initiation, intensity, and duration of therapies for NAS2. Such tools could significantly reduce medical
costs and improve patient outcomes by reducing patient time in NICU, reducing nurse load, improving outpatient
monitoring, and helping to assist in the optimization of patient treatments. Critically, we believe such a tool may
be able to objectively capture events that may go unnoticed by nurses or while the infant is sleeping (minor
tremors, poor oxygenation, temperature fluctuations, dehydration).
This proposal seeks to develop interlinked, infant-targeted wearable biosensor-systems capable of continuously
monitoring the biochemical to biophysical parameters of opioid-dependent neonates under treatment for NAS.
Our team has outstanding experience in all areas necessary to this investigation. Our business unit has
extensive NIH funded experience in wearable biosensing, in the detection of sympathetic nervous system activity
in opioid withdrawal, pediatrics, business development, and intellectual property. Our academic partners have
broad experience in novel biosensor development.PROJECT NARRATIVE
Rekovar is developing a low cost wearable device that integrates wirelessly with a mobile device to allow real-
time monitoring of the baby’s physical and physiological state and its ability to sleep, eat, and be nurtured while
undergoing neonatal abstinence syndrome (NAS). This device has significant impact in helping reduce both
hospital stay and costs as neonates receiving pharmacological treatment are usually in the NICU away from
family and non-pharmacological care. Our interest lies with respect to proper neonatal care, where separate
procedures occur for essential neonatal needs and needs for neonates undergoing withdrawal, and by using
this monitoring device to assess addicted neonates undergoing withdrawal, caregivers are provided the better
ability of treating the right neonatal needs with the appropriate procedure in hospitals.

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

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