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Development of VBI-1 as a novel treatment protocol for outpatient cardiac arrest

Award Number: R41HL174360
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2024
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Development of VBI-1 as a novel treatment protocol for outpatient cardiac arrest - PROJECT SUMMARY Cardiac arrest (CA) is a life-threatening condition that can lead to loss of pulse, cessation of breathing, and unconsciousness. In the US alone, over 805,000 people are affected annually by CA, with the average survival rate being as low as 10.4%. CA is usually caused by reduced blood flow and ineffective cardiac output, which can result in post-cardiac arrest brain injury if not treated promptly. To improve clinical outcomes and survival rates, it's crucial to restore effective blood flow as soon as possible while minimizing the risk of reperfusion injury. Currently used resuscitation fluids are not effective in increasing blood pressure and may even contribute to further injury. Therefore, there is an urgent need for efficient interventions to improve coronary artery perfusion pressure and reduce reperfusion injury to minimize organ damage and ensure better survival of patients. Vivacelle Bio Inc. has developed a proprietary formulation called VBI-1, which is composed of micelles and liposomes. It acts as a colloidal volume expander, absorbs excessive nitric oxide and free radicals, and carries and releases oxygen. This formulation is specifically designed to address cardiac ischemia reperfusion injury. In a previous study using a rat model of cardiac arrest and clinical death due to rapid and severe blood loss, we demonstrated that VBI-1 infusion via the femoral artery was superior to all other fluids, including shed blood, in restoring spontaneous respiration and elevating blood pressure 4 hours after infusion. Our goal is to expand the use of intra-arterial infusion of VBI-1 to more common causes of cardiac arrest. In Phase II, Vivacelle Bio will perform Further preclinical validation, including biodistribution and bioavailability studies leading to IND application. Optimization of VBI-1 will be guided by studies of its mechanism or that of a modified form of VBI-1.


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	2024	VIVACELLE BIO INC	2300 MAIN ST	KANSAS CITY	MO	64108	JACKSON	USA	Cardiovascular Diseases Research	000	1	10/23/2024	NEW	$0
2025	2024	VIVACELLE BIO INC	2300 MAIN ST	KANSAS CITY	MO	64108	JACKSON	USA	Cardiovascular Diseases Research	001	1	8/14/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $279,569 )
2024	2024	VIVACELLE BIO INC	2300 MAIN ST	KANSAS CITY	MO	64108	JACKSON	USA	Cardiovascular Diseases Research	000	1	8/23/2024	NEW	$279,569
														Subtotal = $279,569

Grand Total All Awards = $279,569

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Development of VBI-1 as a novel treatment protocol for outpatient cardiac arrest

Award Number: R41HL174360

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2024

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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