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Novel Therapy System for Atrial Fibrillation

Award Number: R44HL154937
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/02/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2024

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Novel Therapy System for Atrial Fibrillation - Project Summary/Abstract We propose the development and evaluation of a novel implantable low-energy device, using an innovative low-energy approach, to achieve tolerable, nearly pain free treatment of atrial fibrillation. Atrial fibrillation (AF) is a global epidemic. Approximately 33.5 million individuals are affected worldwide and close to 5 million new cases occur each year costing the US healthcare system between $6 and $26 billion annually. Atrial fibrillation is a progressive disease with many patients first developing paroxysmal atrial fibrillation (PAF). Left untreated, PAF can progress to persistent or permanent AF. Because of rapid changes in the atria after AF onset, a therapy to treat AF soon after onset may slow the progressive nature of atrial fibrillation. There exists great enthusiasm in the medical community for AF interventions. Limitations in both pharmacologic and other device-based efforts to treat AF have been disappointing. An effective atrial defibrillator was previously developed; however, it was abandoned due to pain associated with shocks. A tolerable, nearly pain-free, device-based AF therapy approach would address a major unmet medical need. Prior canine and early stage human studies have observed that the proposed therapy approach significantly lowers the energy required for atrial defibrillation. The goal of this proposed direct to phase II project is to develop a prototype AF therapy device and evaluate its performance in a human clinical trial under FDA IDE.


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 = $0 )
2025	2021	NATIONAL BIOMEDICAL, LLC	861 E HENNEPIN AVE STE 430	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Cardiovascular Diseases Research	000	3	12/29/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	CARDIALEN INC	6160 SUMMIT DR N	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	001	2	8/31/2023	NON-COMPETING CONTINUATION	$0
2023	2021	CARDIALEN, INC.	6160 SUMMIT DR N STE 450	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	000	2	10/28/2022	NON-COMPETING CONTINUATION	$0
2023	2021	NATIONAL BIOMEDICAL LLC	861 E HENNEPIN AVE	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Cardiovascular Diseases Research	003	3	9/7/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$650,906
2023	2021	CARDIALEN INC	6160 SUMMIT DR N	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	002	2	9/6/2023	NON-COMPETING CONTINUATION	-$650,906
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	CARDIALEN, INC.	6160 SUMMIT DR N STE 450	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	000	2	3/15/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $1,177,936 )
2021	2021	CARDIALEN, INC.	6160 SUMMIT DR N STE 450	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	001	2	8/22/2021	NON-COMPETING CONTINUATION	$1,177,936
2021	2020	CARDIALEN, INC.	6160 SUMMIT DR N STE 450	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	000	1	8/20/2021	NEW	$0
														Subtotal = $1,177,936

Issue Date FY: 2020 ( Subtotal = $1,605,396 )
2020	2020	CARDIALEN, INC.	6160 SUMMIT DR N STE 450	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	000	1	9/2/2020	NEW	$1,605,396
														Subtotal = $1,605,396

Grand Total All Awards = $2,783,332

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Novel Therapy System for Atrial Fibrillation

Award Number: R44HL154937

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/02/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2024

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