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Device for Treatment of Cardiac No-Option Patients

Award Number: R44HL129586
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2016
PERIOD OF PERFORMANCE END DATE: 07/31/2022

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Device for Treatment of Cardiac No-Option Patients - ABSTRACT Of the nearly 1 million US patients suffering from myocardial infarction each year, 15-20% are poor candidates for CABG or PCI because of diffuse CAD, multiple stents, and failed CABG and are therefore considered "no- option" patients. These patients suffer daily from severe angina, shortness of breath, fatigue, and the like and are frequently untreatable by CABG or PCI which has been shown to have very poor outcomes under these conditions. Without a heart transplant, the no-option patient typically progresses to CHF. The Company’s technology enables a revascularization therapy for the no-option patient that is not reliant on repairing the arterial system. The therapy is a staged approach which uses a novel venous pressure preconditioning (VPP) device to prime the coronary vein for retroperfusion via coronary vein bypass graft (CVBG). Development of the VPP device has focused on overcoming limitations associated with coronary retroperfusion that have stemmed from abrupt increases in perfusion pressure, leading to edema and hemorrhage of the myocardium. Our approach avoids acutely raising the pressure in the coronary veins from venous (10-20 mmHg) to arterial values (100-120 mmHg) in a single step and instead, regulates the pressure at an intermediate level (between arterial and venous levels). Importantly, results from our Phase I studies have shown safe and selective pre-arterialization of the left anterior descending coronary vein using the percutaneously delivered VPP devices. This proof-of-concept was demonstrated by thicker vessel walls and with greater degree of functional smooth muscle cells (i.e., respond to pharmacological agonist and antagonist) in the preconditioned vessels occluded by the VPP device compared to normal veins. Our previous studies have demonstrated that veins with this degree of remodeling safely enable retroperfusion at full arterial pressure without edema or hemorrhage. To advance these outstanding findings, the chronic retroperfusion therapeutic approach must be challenged under clinically relevant conditions that resemble the multiple comorbidities of “no-option” patients. Accordingly, this Phase II proposal advances this promising technology in two specific aims: 1) To demonstrate efficacy of chronic retroperfusion enabled by the VPP device in a chronic animal study of a translational animal model of DCAD and focal ischemia comorbidities; and 2) To collect GLP safety data in a chronic animal study for an IDE submission to the FDA. This Phase II study addresses a highly significant clinical need for providing revascularization for “no-option” patients and can reach across various NIH Institutes and Centers.


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: 2023 ( Subtotal = -$18,842 )
2023	2019	3DT HOLDINGS, LLC	11107 ROSELLE ST STE 213	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cardiovascular Diseases Research	000	3	9/28/2023	NON-COMPETING CONTINUATION	-$18,842
														Subtotal = -$18,842

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	3DT HOLDINGS, LLC	11107 ROSELLE ST, STE 213	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cardiovascular Diseases Research	000	3	8/4/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $991,925 )
2019	2019	3DT HOLDINGS, LLC	11107 ROSELLE ST, STE 213	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cardiovascular Diseases Research	001	3	8/8/2019	NON-COMPETING CONTINUATION	$991,925
2019	2018	3DT HOLDINGS, LLC	11107 ROSELLE ST, STE 213	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cardiovascular Diseases Research	000	2	2/14/2019	COMPETING CONTINUATION	$0
														Subtotal = $991,925

Issue Date FY: 2018 ( Subtotal = $1,432,551 )
2018	2018	3DT HOLDINGS, LLC	11107 ROSELLE ST, STE 213	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cardiovascular Diseases Research	000	2	8/9/2018	COMPETING CONTINUATION	$1,432,551
														Subtotal = $1,432,551

Grand Total All Awards = $2,405,634

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Device for Treatment of Cardiac No-Option Patients

Award Number: R44HL129586

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/15/2016

PERIOD OF PERFORMANCE END DATE: 07/31/2022

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