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Development of a Neonatal Jaundice Treatment Accelerator by Circumferential Redirection of Unused Phototherapy Light onto the Infants Untreated Skin Surface

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HD093478-01A1
Agency Tracking Number: R41HD093478
Amount: $229,235.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: PA18-576
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-04-01
Award End Date (Contract End Date): 2021-03-31
Small Business Information
Plymouth, MI 48170-2475
United States
DUNS: 080324698
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (612) 873-2680
Business Contact
Phone: (248) 302-3686
Research Institution
701 Park Ave, Suite PP7.700
MINNEAPOLIS, MN 55415-1623
United States

 Domestic Nonprofit Research Organization

PROJECT SUMMARY ABSTRACT Neonatal jaundice continues to be a significant global problem affectingof preterm andof term neonates while severe neonatal jaundice affects at leastneonates annuallyJaundice and jaundice related complications like Kernicterus Spectrum DisorderKDSare gaining recognition among the worldandapos s health policy leaders as an important area for further research and developmentThe long term sequelae of KSD include choreoathetoid cerebral palsysensorineural hearing lossand upward gaze palsyKSD is irreversible resulting in a lifetime of physicalemotionalsocial and economic challengesAccess to costeffective methods of improving pediatric jaundice care along with improved circumferentialfull bodyillumination technologies is an affirmed objective of the AAPAmerican Academy of PediatricsWe hypothesize that unused therapy lightirradiancesurrounding the neonate using an existing single lamp bank phototherapy device is sufficient in quantity and if redirected onto the patients untreated or poorly illuminated skin surfacesit will accelerate metabolism and excretion of bilirubinThe product of this STTR application therefore redirects unused phototherapy light sideways onto the neonate body using an open faced ring approachThe technology will illuminate previously unexposed and poorly exposed skin regions where treatable bilirubin existsA transparent inner guard protects the neonateandapos s head from rolling on the lightreflective surfacesPreliminary data support the validity of our approachThe device is superior to current PT devices in that it converts existing waste light into treatment efficacy while integrating into existing overhead lamp systems offsetting the purchase of secondary devices that are often expensive and create hospital complexitycost and inefficiency issuesA further benefit of the device will be reduced ambient blue light spillover in patient care areasan ongoing concern for medical staffThe Phase I Specific Aims are toSAconstruct a clinically testable prototype andSAconduct a clinical trial onneonates to establish safety and efficacyThe Phase II objective will be a randomized superiority trial study which will also demonstrate reduced hospitalization timeearly parent bonding and breast feeding initiationA survey of responding pediatricians indicated andgthad a strong willingness to adopt the proposed device with proof of safety and efficacy PROJECT NARRATIVE In this STTR Phase IArbor Grace will further the development of our patent pending neonatal jaundice treatment accelerator using circumferential redirection of unused phototherapy light onto an infants untreated skin surfacesThe redirected light will cost effectively accelerate the treatment of jaundice thereby protecting the infant from irreversible KSDbrain damage by yellow stainingthat results from poorly treated pediatric jaundiceThe solution will provide improved standards of care in highmiddleand low income regions

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

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