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Application of PPODA-QT for embolization of aneurysms

Award Number: R41NS097069
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2017
PERIOD OF PERFORMANCE END DATE: 07/31/2018

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Application of PPODA-QT for embolization of aneurysms - A cerebral aneurysm is an abnormal enlargement or pouch that forms from a weakened vessel segment in the brain. Often going unnoticed and untreated, an aneurysm can cause a sudden and catastrophic hemorrhage or stroke. Approximately 15 % of patients die from an aneurysm rupture even before receiving medical attention and 25 % of patients die despite medical treatment. Patients that survive typically suffer from various levels of morbidity. Thus, only one in four patients who suffer a ruptured aneurysm will fully recover. It is estimated that between 3 million and 6 million Americans have cerebral aneurysms, and approximately 20,000 people in the United States suffer hemorrhage each year. While there have been notable recent advances in providing minimally invasive access to aneurysms using advanced micro-catheter systems, there is a paucity of equally high performing embolization materials that can be delivered through these catheters to effectively treat clinically challenging lesions. The purpose of this venture is to provide an innovative biomaterial (PPODA-QT) for the endovascular treatment of aneurysms in order to significantly increase therapeutic effectiveness while minimizing surgical risks. This Phase I proposal will develop techniques to test PPODA-QT’s visualization during injection and its mechanical stability and resistance to particulation and downstream migration. The primary objective of this project is to characterize and optimize PPODA-QT for submission to the FDA for Investigational Device Exemption (IDE) approval. Preliminary studies have shown that PPODA-QT can be formulated and delivered to effectively occlude long-term animal aneurysm models while also promoting a positive bioactive healing response that may permanently stablize the aneurysm. Our goal is to begin validation of these preliminary PPODA-QT results by following the comprehensive procedures laid-out by the FDA to promote safety and efficacy from new liquid embolic devices. The outcomes of the proposed investigations in this SBIR Phase I application, combined with our previously published research results, will help jump-start the pre- clinical assessment of PPODA-QT for endovascular embolization of aneurysms.


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: 2019 ( Subtotal = $0 )
2019	2017	ANEUVAS TECHNOLOGIES, INC.	2225 N GEMINI RD	FLAGSTAFF	AZ	86001	COCONINO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	1/6/2019	NEW	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $220,109 )
2017	2017	ANEUVAS TECHNOLOGIES, INC.	2225 N GEMINI RD	FLAGSTAFF	AZ	86001	COCONINO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	2/3/2017	NEW	$4,573
2017	2017	ANEUVAS TECHNOLOGIES, INC.	2225 N GEMINI RD	FLAGSTAFF	AZ	86001	COCONINO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	1/18/2017	NEW	$215,536
														Subtotal = $220,109

Grand Total All Awards = $220,109

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Application of PPODA-QT for embolization of aneurysms

Award Number: R41NS097069

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/01/2017

PERIOD OF PERFORMANCE END DATE: 07/31/2018

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