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Application of PPODA QT for embolization of aneurysms

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41NS097069-01A1
Agency Tracking Number: R41NS097069
Amount: $220,109.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 101
Solicitation Number: PA15-270
Timeline
Solicitation Year: 2015
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-02-01
Award End Date (Contract End Date): 2018-07-31
Small Business Information
21525 S. 217TH ST., Queen Creek, AZ, 85142-5292
DUNS: 078877613
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 TIM BECKER
 (928) 523-1468
 tim.becker@nau.edu
Business Contact
 TIMOTHY BECKER
Phone: (928) 814-4085
Email: becker.mail@icloud.com
Research Institution
 NORTHERN ARIZONA UNIVERSITY
 1395 SOUTH KNOLES DRIVE
FLAGSTAFF, AZ, 86011-4130
 Nonprofit college or university
Abstract
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 of patients die from an aneurysm rupture even before receiving medical attention and 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 million and million Americans have cerebral aneurysms and approximately 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 The goal is to optimize a novel medical device to treat aneuryms in the brain Ruptured aneurysms cause mortality in over of affected patients and current treatments do not permanently remove the aneurysm threat Aneuvas Technology s device can be delivered quickly using current minimally invasive techniques It promotes a bioactive healing response that can permanently eliminate the aneurysm s threat of rupture

* Information listed above is at the time of submission. *

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