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Phase IIB: Percutaneous deliverable biomaterial for treating myocardial infarction

Award Number: R44HL108459
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/01/2011
PERIOD OF PERFORMANCE END DATE: 12/07/2016

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Phase IIB: Percutaneous deliverable biomaterial for treating myocardial infarction - ¿ DESCRIPTION (provided by applicant): Heart failure following a myocardial infarction (MI) continues to remain a leading killer in the western world. In the United States, the estimated annual incidence of myocardial infarction (MI) is 745,000 new and 410,000 recurrent episodes. There is a critical need to develop new therapies since end-stage heart failure is only treated through heart transplantation or left ventricular (LV) assist devices, and current pharmaceutical regimens do not adequately prevent post-MI negative LV remodeling. As an alternative to total heart transplantation, cellular cardiomyoplasty, or cell transplantation, has been explored for the treatment of MI and heart failure; however, more recently acellular biomaterials have shown great promise in providing similar functional benefit without the complications associated with cell delivery. Biomaterial products have the key advantages of being off-the-shelf available and relatively inexpensive to manufacture. Existing materials have however been limited since none have been specifically designed for the myocardium, and none mimic the degraded post-MI extracellular matrix (ECM) they are intended to replace. The materials suffer from 1) their inability to be delivered via current catheter technology, and/or 2) their lack of complex, myocardial specific ECM cues, which promote repair. The material used for the Ventrix product is the first example of a myocardial-specific material that can be delivered via catheter to promote repair in the post-MI environment. This material is liquid at room temperature and forms a porous and fibrous scaffold upon injection into the myocardium. We have shown that it promotes cell influx, increases areas of surviving cardiomyocytes, and preserves LV geometry and cardiac function in a rat MI model, and can be delivered through a transendocardial catheter approach in a porcine model. In our Phase I and II SBIRs, we demonstrated that VentriGelTM increased cardiac muscle, improved cardiac function, and prevented negative LV remodeling in a porcine MI model. We also determined a safe dose, confirmed safety of the transendocardial approach, and performed extensive toxicology and biocompatibility studies. In the new Phase IIB SBIR proposal we will initiate studying VentriGelTM in patients, which is a key step in bringing a biomaterial product to market, which will be complementary or mostly parallel to the current MI pharmaceutical market. In our Phase IIB SBIR, we will complete a Phase I clinical trial to test the safety and feasibility of delivering VentriGel via a percutaneou transendocardial approach in patients post-ST elevation MI.


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: 2017 ( Subtotal = -$1,026,130 )
2017	2016	VENTRIX INCORPORATED	3231 HILL ST	SAN DIEGO	CA	92106	SAN DIEGO	USA	Cardiovascular Diseases Research	000	4	12/15/2016	COMPETING CONTINUATION	-$1,026,130
														Subtotal = -$1,026,130

Issue Date FY: 2016 ( Subtotal = $1,026,130 )
2016	2016	VENTRIX INC	3231 HILL STREET	SAN DIEGO	CA	92106	SAN DIEGO	USA	Cardiovascular Diseases Research	000	4	7/11/2016	COMPETING CONTINUATION	$1,026,130
														Subtotal = $1,026,130

Issue Date FY: 2014 ( Subtotal = $720,276 )
2014	2014	VENTRIX INC	3231 HILL STREET	SAN DIEGO	CA	92106	SAN DIEGO	USA	Cardiovascular Diseases Research	000	3	5/30/2014	NON-COMPETING CONTINUATION	$720,276
														Subtotal = $720,276

Issue Date FY: 2013 ( Subtotal = $1,339,549 )
2013	2013	VENTRIX INC	3231 HILL STREET	SAN DIEGO	CA	92106	SAN DIEGO	USA	Cardiovascular Diseases Research	000	2	7/25/2013	COMPETING CONTINUATION	$1,339,549
														Subtotal = $1,339,549

Grand Total All Awards = $2,059,825

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Phase IIB: Percutaneous deliverable biomaterial for treating myocardial infarction

Award Number: R44HL108459

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/01/2011

PERIOD OF PERFORMANCE END DATE: 12/07/2016

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