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Novel Self-closing 12F Mitral Valve Repair System to Percutaneously Treat Moderate to Severe Regurgitation Using Transcatheter Edge-to-Edge Repair (TEER) Technique Via Femoral Vein Access.

Award Number: SB1HL174244
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2024
PERIOD OF PERFORMANCE END DATE: 03/31/2026

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Novel Self-closing 12F Mitral Valve Repair System to Percutaneously Treat Moderate to Severe Regurgitation Using Transcatheter Edge-to-Edge Repair (TEER) Technique Via Femoral Vein Access. - Project Summary The MEDFREE® Valve Repair System will innovatively improve upon the current market leading MitraClip device, while leveraging and building on the proven Transcatheter Edge-to-Edge Repair technique. We aim to address this vastly unmet percutaneous structural heart market by delivering a simpler, easier-to-use device in a smaller 12F catheter system that can be used by a single operator. MEDFREE has already completed preclinical GLP studies in porcine model (Cohort A: n=2, 30 days; Cohort B: n=5, 140 days) with outstanding results. MRI and Durability (fatigue) studies were also completed with outstanding results. We are now seeking funds via NIH Commercialization Readiness Program, in preparation for EFS/FIH clinical studies.


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 = $219,295 )
2025	2025	MEDFREE INC	9165 RUDDER WAY	NEWARK	CA	94560	ALAMEDA	USA	Cardiovascular Diseases Research	000	2	3/5/2025	NON-COMPETING CONTINUATION	$219,295
														Subtotal = $219,295

Issue Date FY: 2024 ( Subtotal = $275,530 )
2024	2024	MEDFREE INC	9165 RUDDER WAY	NEWARK	CA	94560	ALAMEDA	USA	Cardiovascular Diseases Research	000	1	3/21/2024	NEW	$275,530
														Subtotal = $275,530

Grand Total All Awards = $494,825

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Novel Self-closing 12F Mitral Valve Repair System to Percutaneously Treat Moderate to Severe Regurgitation Using Transcatheter Edge-to-Edge Repair (TEER) Technique Via Femoral Vein Access.

Award Number: SB1HL174244

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2024

PERIOD OF PERFORMANCE END DATE: 03/31/2026

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