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Catheter Development for Epicardial Atrial Gene Painting

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41TR002425-01
Agency Tracking Number: R41TR002425
Amount: $260,403.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NCATS
Solicitation Number: PAR17-036
Timeline
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-08-15
Award End Date (Contract End Date): 2019-08-14
Small Business Information
14640 OLD FREDERICK RD
Woodbine, MD 21797-8620
United States
DUNS: 080333039
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 JOHN DONAHUE
 (774) 455-3866
 jkdonahue@rithimbiologics.com
Business Contact
 JOHN DONAHUE
Phone: (410) 213-5030
Email: jkdonahue@rithimbiologics.com
Research Institution
 UNIV OF MASSACHUSETTS MED SCH WORCESTER
 
55 LAKE AVENUE NORTH
WORCESTER, MA 01655-0002
United States

 Nonprofit college or university
Abstract

ABSTRACT
Atrial fibrillationAFis the most common rhythm disturbance in the US and other developed countriesAF
significantly affects the lives of the afflictedcausing symptoms that range from palpitations to fatigueweakness and activity intoleranceand substantially increasing the risks of strokecongestive heart failure and
deathThe impact on public health is substantialwith more thanhospital admissions per year and
$billion in healthcare costsAdding to the problems caused by AF is the lack of safe and effective therapies
for this rhythm disorderPharmacotherapy for AF has a long history of poor efficacy and potentially lethal side
effectsAblation strategies are making inroads in paroxysmal AFbut they are longdifficult procedures with
less than optimal success rates and too frequent adverse eventsWe propose gene therapy as a new strategy
to treat AFWe have published efficacy and safety data in a pig model of AF showing that interventions to
prevent or reverse electrical and structural remodeling can eliminate the ability of the atria to fibrillateTo dateour atrial gene painting delivery method has required chest opening surgery which will ultimately limit clinical
utilityHerewe propose development of a delivery catheter that will allow atrial gene painting from a
percutaneous approach to the pericardial spaceTo develop this catheterwe propose the following specific
aimsto verify performance of the gene painting catheter in bench top testingto confirm complete and
specific atrial painting with the percutaneous catheter in acute animal studiesSuccessful completion of these
aims will provide critical design and feasibility data that will move us toward our ultimate goal of curing AF with
gene therapy Project Narrative
Atrial fibrillationAFis the most common rhythm disturbance in the US and other developed countriesAF
significantly affects the lives of the afflictedcausing symptoms that range from palpitations to fatigueweakness and activity intoleranceand substantially increasing the risks of strokecongestive heart failure and
deathThe impact on public health is substantialwith more thanhospital admissions per year and
$billion in added healthcare costsAdding to the problems caused by AF is the lack of safe and effective
therapies for this rhythm disorderPharmacotherapy for AF has a long history of poor efficacy and potentially
lethal side effectsNewer ablation strategies are making inroads in paroxysmal AFbut they are longdifficult
procedures with less than optimal success rates and too frequent adverse eventsThis proposal focuses on
developing gene therapy to treat and potentially cure AFWe have published efficacy and safety data showing
that gene therapies can eliminate AFTo dateall of our data have been acquired using an atrial gene painting
method that requires open chest surgeryIn this proposalwe will develop a catheter that will allow
percutaneous access to the pericardium for atrial gene paintingThis advance will substantially increase
clinical utility of the atrial gene painting method

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

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