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Self crosslinkable hydrogel as an embolic agent for traumatic hemorrhage control

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41GM123805-01
Agency Tracking Number: R41GM123805
Amount: $225,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 300
Solicitation Number: PA16-303
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-30
Award End Date (Contract End Date): 2019-09-29
Small Business Information
17127 80TH PL N
Maple Grove, MN 55311-1785
United States
DUNS: 047447929
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 JAFAR GOLZARIAN
 (612) 625-5147
 golzarian@umn.edu
Business Contact
 TREVOR BIEBER
Phone: (763) 398-5125
Email: trevorb@embomedics.com
Research Institution
 UNIVERSITY OF MINNESOTA
 
100 CHURCH ST SE
MINNEAPOLIS, MN 55455-0149
United States

 Nonprofit College or University
Abstract

ABSTRACT
Trauma is the th leading cause of morbidity and mortality after heart disease malignancies and lower
respiratory illnesses in the United States Blunt abdominal trauma BAT is commonly caused by vehicular
accidents and falls Uncontrolled bleeding is a major factor in early mortality after trauma contributing to to
of trauma related deaths Transcatheter arterial embolization TAE techniques play a significant role in
the comprehensive modern treatment of traumatic vascular injuries to solid organs and extremities Current
embolic agents have proven to be problematical with regard to non resorbability or unpredictable resorption
catheter clogging or cytotoxicity due to the presence of organic solvents Thus there is a need for a new multi
potent embolic agent formulated with biocompatible components that addresses these issues to more
effectively manage hemorrhage in trauma patients
The long term goal is to obtain a simple safe and more effective treatment method for traumatic hemorrhage
control after BAT EmboMedics is developing a resorbable hydrogel that will improve clinical practice by
providing an embolotherapeutic solution that is well suited to a trauma care setting being easy to mix and
inject self crosslinkable resorbable nontoxic and travelling distally from the site of injection
Preliminary data show that the hydrogel has an adjustable gelation time and resorption rate is non cytotoxic to
endothelial cells and capable of occluding arteries which is promising for hemorrhage control Compared with
Gelfoam a commonly used embolic agent for trauma this hydrogel would obviate the need for manual cutting
to size prior to use Compared to liquid local hemostatic agents such as N butyl cyanoacrylate super glue and
Onyx the hydrogel is advantageous as it is easier to manipulate resorbable and non cytotoxic While not
radiopaque this novel hydrogel can be loaded with contrast to ensure visibility during embolization Therefore
EmboMedicsandapos hypothesis is that its novel hydrogel can serve as a naturally derived nontoxic and completely
biodegradable embolic agent that is more effective than existing agents for hemorrhage control
The objective of the proposed research is to validate the use of this novel hydrogel as an embolic
agent for the control of internal bleeding that occurs with BAT
This project will evaluate the efficacy of the resorbable hydrogel in a porcine renal model Specific Aim
This will be accomplished by creating a trauma model in the porcine kidney following an established procedure
Aim A This will be used to test the efficacy of the hydrogel as compared to a non resorbable embolic
product in hemorrhage control Aim B The long term hemorrhage control and resorbability of the embolics
will be evaluated over weeks Aim C Necropsy and histopathological analysis of the tested kidneys will
be performed to evaluate the extent of infarction non target embolization hydrogel resorption recanalization
and tissue response Aim D NARRATIVE
Uncontrolled bleeding is a major factor in early mortality after blunt trauma where transcatheter arterial
embolization TAE techniques play a significant role in the comprehensive modern treatment of traumatic
vascular injuries Current embolic agents have proven to be problematical with regard to non resorbability or
unpredictable resorption catheter clogging or cytotoxicity due to the presence of organic solvents Thus there
is a need for a new multi potent embolic agent formulated with biocompatible components to manage
hemorrhage in trauma patients This project will evaluate the safety efficacy and long term effects of a novel
hydrogel that would serve as an embolic agent for the control of vascular bleeding following laceration of
porcine kidney as a trauma model

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

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