Application of PPODA-QT for embolization of aneurysms

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42NS097069-02A1
Agency Tracking Number: R42NS097069
Amount: $763,805.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 101
Solicitation Number: PA18-575
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-08-01
Award End Date (Contract End Date): 2021-07-31
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
 (928) 523-1468
Business Contact
Phone: (928) 814-4085
Research Institution
FLAGSTAFF, AZ, 86011-4130
 Nonprofit college or university
PROJECT SUMMARY ABSTRACTA cerebral aneurysm is an abnormal enlargement or pouch that forms from a weakened vessel segment in the brainOften going unnoticed and untreatedan aneurysm can cause a sudden and catastrophic hemorrhage or strokeApproximatelyof patients die from an aneurysm rupture even before receiving medical attention andof patients die despite medical treatmentPatients that survive typically suffer from various levels of morbidityThusonly one in four patients who suffer a ruptured aneurysm will fully recoverIt is estimated that betweenmillion andmillion Americans have cerebral aneurysmsand approximatelypeople in the United States suffer hemorrhage each yearWhile there have been notable recent advances in providing minimally invasive access to aneurysms using advanced micro catheter systemsthere is a paucity of equally high performing embolization materials that can be delivered through these catheters to effectively treat clinically challenging lesionsThe purpose of this venture is to provide an innovative biomaterialPPODA QTfor the endovascular treatment of aneurysms in order to significantly increase therapeutic effectiveness while minimizing surgical risksThe Phase I proposal developed techniques to test PPODA QT s visualization during injection and its mechanical stability and resistance to particulation and downstream migrationSuccessful testing of PPODA QT leads to this Phase II proposalto characterize and optimize PPODA QT for stability and biocompatibility testing and submission to the FDA for Investigational Device ExemptionIDEapprovalPreliminary 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 an aneurysmOur 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 devicesThe outcomes of the proposed investigations in this STTR Phase II applicationcombined with our previously published research resultswill help jump start the preclinical assessment of PPODA QT for endovascular embolization of aneurysms PROJECT NARRATIVE The goal is to optimize a novel medical device to treat aneuryms in the brainRuptured aneurysms cause mortality in overof affected patientsand current treatments do not permanently remove the aneurysm threatAneuvas Technology s device can be delivered quickly using current minimally invasive techniquesIt 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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