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Non-toxic, nature-inspired perfusion and high subzero ice-free isochoric technologies for extending heart preservation

Award Number: R43HL145934
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/24/2019
PERIOD OF PERFORMANCE END DATE: 09/19/2023

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Non-toxic, nature-inspired perfusion and high subzero ice-free isochoric technologies for extending heart preservation - ABSTRACT Current methods of heart and lung preservation offer extremely limited time between organ donation and transplantation into the recipient. The maximum tolerable cold ischemic times for hearts and lungs are generally considered less than or up to 6 hours, and preferred by cardiac transplant surgeons to be less than 3 hours in clinical practice. In this SBIR project, the goal is to develop a system to preserve donor hearts for a least 24 hours and beyond, allowing unprecedented storage durations of donated hearts. Fully realized, the system will give patients greater access to compatible donor hearts and may substantially reduce the costs associated with urgent and extreme logistics (i.e. allow more time to coordinate the patient, surgeon, and donor heart). At Sylvatica Biotech, the foundation for our approach comes from mechanisms observed in freeze tolerant species combined with principles from bioengineering. The three pillars of innovation in this proposal are isochoric (constant volume) chamber storage, cold storage solution formulations with cryoprotective agents (CPAs) inspired by nature, and advanced multi-thermic machine perfusion. These technologies will be integrated to achieve ice-free, subzero storage of whole hearts. More broadly, the approach can be applied to other organs to prevent ischemic injury and help alleviate key bottlenecks in the development and use of tissue engineered constructs and `humanized' xeno organs. In preliminary work we have demonstrated that a combination of nature-inspired cryoprotective agents (CPAs) and isochoric storage resulted in functional hearts after reaching temperatures as low as -10°C. To our knowledge, this is the first demonstration of ventricular function recovery in a whole heart following storage as low as -10°C. In this Phase I project, the Sylvatica Biotech team, led by Dr. Michael Taylor and supported by collaborators at UC-Berkeley, the Medical University of South Carolina, and thought leaders in organ preservation, will build on these results. The overall objective is to demonstrate feasibility for the target heart preservation system by storing whole rat hearts at temperatures as low as -20°C for at least 24 hours, representing at least a 4x increase over the current standard methods. This will be accomplished in three specific aims: 1) Identify heart-optimized CPA formulations and isochoric temperature control protocols in an in vitro cellular heart model, 2) Develop protocols for preparing whole hearts for isochoric storage using machine perfusion, and 3) Combine the CPA formulations and machine perfusion methods with isochoric storage to prepare whole hearts for subzero storage, store them for at least 24 hours, and recover for functional assessment. Achieving the milestones associated with these aims will show feasibility for the preservation system and justify translating the approach toward human use. In Phase II we will apply these successes to adapt the system to porcine heart and other models of human heart transplant, and work with our established commercialization partners to begin prototyping a clinically-relevant device to prepare and store human donor hearts.


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: 2024 ( Subtotal = $0 )
2024	2019	SYLVATICA BIOTECH INC	4401 LEEDS AVE	NORTH CHARLESTON	SC	29405	CHARLESTON	USA	Cardiovascular Diseases Research	000	1	3/14/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2019	SYLVATICA BIOTECH, INC.	3973 RIVERS AVE STE 101	NORTH CHARLESTON	SC	29405	CHARLESTON	USA	Cardiovascular Diseases Research	000	1	2/23/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2019	SYLVATICA BIOTECH, INC.	3973 RIVERS AVE STE 101	NORTH CHARLESTON	SC	29405	CHARLESTON	USA	Cardiovascular Diseases Research	000	1	11/9/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	SYLVATICA BIOTECH, INC.	2231 TECHNICAL PKWY STE D	NORTH CHARLESTON	SC	29406	CHARLESTON	USA	Cardiovascular Diseases Research	000	1	12/12/2019	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $231,940 )
2019	2019	SYLVATICA BIOTECH, INC.	2231 TECHNICAL PKWY STE D	NORTH CHARLESTON	SC	29406	CHARLESTON	USA	Cardiovascular Diseases Research	000	1	9/23/2019	NEW	$231,940
														Subtotal = $231,940

Grand Total All Awards = $231,940

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Non-toxic, nature-inspired perfusion and high subzero ice-free isochoric technologies for extending heart preservation

Award Number: R43HL145934

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/24/2019

PERIOD OF PERFORMANCE END DATE: 09/19/2023

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