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Polymer use in Preservation of Tissue Perfusion to Address Sepsis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41GM143995-01
Agency Tracking Number: R41GM143995
Amount: $256,492.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 300
Solicitation Number: PA20-265
Timeline
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-14
Award End Date (Contract End Date): 2022-09-13
Small Business Information
3002 HUGH SMITH CT
Herndon, VA 20171-4058
United States
DUNS: 117508220
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MARTIN MANGINO
 (804) 628-3226
 martin.mangino@vcuhealth.org
Business Contact
 GERARD ELDERING
Phone: (703) 283-7164
Email: gerard@perfusionmedical.com
Research Institution
 VIRGINIA COMMONWEALTH UNIVERSITY
 
BOX 980568
RICHMOND, VA 23298-0568
United States

 Nonprofit College or University
Abstract

Perfusion Medical is commercializing a novel pipeline product called PEG-20k IV Solution. The
company believes this may be the first therapeutic to directly treat lethal complications of sepsis,
and as such, support new thinking on the basic mechanisms of the disease. Sepsis or septic
syndrome leads to a spectrum of illnesses and occurs at a frequency of 1.7 million people in the
US each year and septic shock kills over 270,000 Americans each year. Sepsis, caused by
direct bacterial infection or by leak of lipopolysaccharide (LPS) from a compromised splanchnic
circulation, produces a complex cascade of immunological and non-immunological reactions.
These ultimately lead to multiple systems organ failure and death. There are no medications
specifically used to mitigate any underlying basis for sepsis other than infection and source
control. The company asserts that the combination of restoration of tissue perfusion in early
sepsis and breaking down endothelial cell glycocalyx, will be a radically new approach that
prevents the vicious cycle and the attendant fatal multiple organ failure. The STTR involves two
AIMS. AIM 1 will determine regional capillary perfusion in LPS-induced and polymicrobial
peritonitis-induced septic shock and the effects of PEG-20k resuscitation. The researchers will
seek to demonstrate that the massive perfusion defect associated with LPS or bacterial sepsis
is reversed by PEG-20k IV solution and that restoring perfusion in early course of sepsis averts
multiple organ failure and mortality by preserving vital tissue oxygen exchange. AIM 2 will
determine the integrity of the glycocalyx in sepsis and the effect of PEG-20k resuscitation. The
team intends to demonstrate that PEG-20k nonspecifically binds to and protects / rebuilds the
endothelial glycocalyx during sepsis and multiple organ failure, which limits secondary cellular
inflammatory end-organ injury. At the end of this study, the company will have proof-of-concept
data showing that a major determinant of septic shock mortality and organ failure is secondary
to severe malperfusion of vital tissues and that early correction with PEG-20k can avert
devastating downstream consequences leading to critical illness and death. If successful, the
solution will be shown to be effective with two mechanisms of addressing sepsis – either of
which will make PEG-20k a strong candidate as a therapeutic product.Perfusion Medical is commercializing a novel pipeline product called PEG-20k IV Solution and
believes this has the potential to be the first therapeutic to directly treat lethal complications of
sepsis. The company seeks to show that the combination of restoration of tissue perfusion in
early sepsis and breaking down endothelial cell glycocalyx, will be a radically new approach that
prevents the vicious cycle and the attendant fatal multiple organ failure.

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

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