Friday, October 3, 2025 10/3/2025

3D Printed Airway Splints: Pre-clinical and Clinical In Vivo Degradation and Tissue Response

Award Number: R01HL179686
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2025
PERIOD OF PERFORMANCE END DATE: 06/30/2030

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3D Printed Airway Splints: Pre-clinical and Clinical In Vivo Degradation and Tissue Response - Abstract Tracheobronchomalacia (TBM) in children is a congenital or acquired deficiency of tracheobronchial cartilages that causes dynamic airway collapse, respiratory difficulties, and, in severe cases, acute life-threatening events and death. A previous study tested a bellowed 3D printed polycaprolactone (PCL) airway splint (denoted Airway Support Device – ASD) to treat TBM with a solid arch under fatigue in vitro, in a Yucatan swine in vivo model for 1 and 2 years, and lastly to treat patients with TBM under FDA Expanded Access clearance. Both in vitro fatigue and in vivo results demonstrated that this design had a risk for fracture under growth, and in addition restricted airway growth in the pre-clinical animal model. The goal of this proposal is to 1) develop new flexible ASD designs that allow radial and longitudinal growth while reducing fracture risk and 2) develop a new computational simulation combining growth, degradation and PCL elastic-plastic damage models to predict airway growth and ASD damage both in a pre-clinical model for Aims 2 and 3 as well as for a clinical model in Aim 4. It is hypothesized that a new auxetic design will allow more airway growth and show less damage than the current ASD designs. It is also hypothesized that the new growth/degradation simulation will correctly predict the effects of ASD design on airway growth and device damage. Both hypotheses will be tested using a 6-month and 2-year large pre-clinical animal study. Patient implantation to treat TBM will be continued under expanded access. Finally, data obtained in this study will be used to support an Investigational Device Exemption (IDE) to the FDA.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $709,172 )
2025	2025	GEORGIA TECH RESEARCH CORP	926 DALNEY ST NW	ATLANTA	GA	30318	FULTON	USA	Lung Diseases Research	000	1	8/22/2025	NEW	$709,172
														Subtotal = $709,172

Grand Total All Awards = $709,172

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3D Printed Airway Splints: Pre-clinical and Clinical In Vivo Degradation and Tissue Response

Award Number: R01HL179686

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2025

PERIOD OF PERFORMANCE END DATE: 06/30/2030

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