R44HL170779
Project Grant
Overview
Grant Description
Cell Directed Immunomodulation Therapy as a Bridge to Left Ventricular Device Implantation in Chronic Heart Failure Patients - Abstract
The problem. Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic heart failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system but also the renal, neuroendocrine and immune systems.
No effective therapy is currently available to treat the most severe subset of CHF patients that have progressed to acute decompensated HF. An innovative approach to reduce the cardio-depressant effects associated with the chronic inflammatory state of CHF may provide a breakthrough for this disorder.
This proposal will evaluate the safety and probable benefit to improve cardiac or renal function with an immunomodulatory device to bridge patients to left ventricular assist device (LVAD) implantation deemed ineligible for this life sustaining procedure.
If the trial is successful, a pathway to commercialization via a Humanitarian Device Exemption (HDE) would be available for rapid use in this patient population whose life expectancy is days to weeks.
The product. The Selective Cytopheretic Device (SCD) is an immuno-regulating, extracorporeal, membrane device targeted to modulate the cardio-depressant effects that are associated with CHF. SCD is a platform technology focused on immunomodulation of acute and chronic inflammation associated with acute and chronic organ dysfunction.
SCD membranes selectively sequester activated systemic leukocytes as they flow through the cartridge via an extracorporeal circuit. Pre-clinical results show SCD treatment results in a 25% improvement in ejection fraction in a canine CHF model.
Innovation. SCD is an innovative approach to treat CHF. Rather than utilizing small molecules to improve myocardial contractility, SCD acts as an immunomodulatory device to dampen the cardio-depressant effects of the chronic pro-inflammatory state of CHF.
This proposal will provide the first clinical support for the use of immunomodulatory treatment for chronically inflamed CHF patients.
Phase II hypothesis. SCD treatment will demonstrate safety and probable benefit as a bridge to LVAD implantation in a previously ineligible CHF patient population.
This Phase II plan is based upon results demonstrating SCD treatment improved cardiac contractility in a canine model of CHF and an ongoing clinical trial demonstrating first in human, proof of concept of successful bridge to LVAD in an ineligible patient with severe CHF with improvement of cardiac performance.
Aim. To expand a current single center IDE clinical trial to a multicenter trial to enroll 20 patients in 4 centers for evaluation of safety and probable benefit of SCD treatment for a Humanitarian Device Exemption (HDE) application for a severely ill patient population to bridge to a life sustaining LVAD implantation.
Commercial opportunity. This proposed single clinical trial which demonstrates safety and probable benefit will support a HDE submission for FDA approval and commercialization.
The problem. Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic heart failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system but also the renal, neuroendocrine and immune systems.
No effective therapy is currently available to treat the most severe subset of CHF patients that have progressed to acute decompensated HF. An innovative approach to reduce the cardio-depressant effects associated with the chronic inflammatory state of CHF may provide a breakthrough for this disorder.
This proposal will evaluate the safety and probable benefit to improve cardiac or renal function with an immunomodulatory device to bridge patients to left ventricular assist device (LVAD) implantation deemed ineligible for this life sustaining procedure.
If the trial is successful, a pathway to commercialization via a Humanitarian Device Exemption (HDE) would be available for rapid use in this patient population whose life expectancy is days to weeks.
The product. The Selective Cytopheretic Device (SCD) is an immuno-regulating, extracorporeal, membrane device targeted to modulate the cardio-depressant effects that are associated with CHF. SCD is a platform technology focused on immunomodulation of acute and chronic inflammation associated with acute and chronic organ dysfunction.
SCD membranes selectively sequester activated systemic leukocytes as they flow through the cartridge via an extracorporeal circuit. Pre-clinical results show SCD treatment results in a 25% improvement in ejection fraction in a canine CHF model.
Innovation. SCD is an innovative approach to treat CHF. Rather than utilizing small molecules to improve myocardial contractility, SCD acts as an immunomodulatory device to dampen the cardio-depressant effects of the chronic pro-inflammatory state of CHF.
This proposal will provide the first clinical support for the use of immunomodulatory treatment for chronically inflamed CHF patients.
Phase II hypothesis. SCD treatment will demonstrate safety and probable benefit as a bridge to LVAD implantation in a previously ineligible CHF patient population.
This Phase II plan is based upon results demonstrating SCD treatment improved cardiac contractility in a canine model of CHF and an ongoing clinical trial demonstrating first in human, proof of concept of successful bridge to LVAD in an ineligible patient with severe CHF with improvement of cardiac performance.
Aim. To expand a current single center IDE clinical trial to a multicenter trial to enroll 20 patients in 4 centers for evaluation of safety and probable benefit of SCD treatment for a Humanitarian Device Exemption (HDE) application for a severely ill patient population to bridge to a life sustaining LVAD implantation.
Commercial opportunity. This proposed single clinical trial which demonstrates safety and probable benefit will support a HDE submission for FDA approval and commercialization.
Awardee
Funding Goals
NOT APPLICABLE
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Ann Arbor,
Michigan
481089623
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 176% from $1,314,026 to $3,625,359.
Innovative Biotherapies was awarded
Immunomodulation Therapy for CHF Patients - Bridge to LVAD
Project Grant R44HL170779
worth $3,625,359
from National Heart Lung and Blood Institute in June 2024 with work to be completed primarily in Ann Arbor Michigan United States.
The grant
has a duration of 3 years and
was awarded through assistance program 93.837 Cardiovascular Diseases Research.
The Project Grant was awarded through grant opportunity PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required).
SBIR Details
Research Type
SBIR Phase II
Title
Cell Directed Immunomodulation Therapy as a Bridge to Left Ventricular Device Implantation in Chronic Heart Failure Patients
Abstract
Abstract The Problem. Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system but also the renal, neuroendocrine and immune systems. No effective therapy is currently available to treat the most severe subset of CHF patients that have progressed to acute decompensated HF. An innovative approach to reduce the cardio-depressant effects associated with the chronic inflammatory state of CHF may provide a breakthrough for this disorder. This proposal will evaluate the safety and probable benefit to improve cardiac or renal function with an immunomodulatory device to bridge patients to Left Ventricular Assist Device (LVAD) implantation deemed ineligible for this life sustaining procedure. If the trial is successful, a pathway to commercialization via a Humanitarian Device Exemption (HDE) would be available for rapid use in this patient population whose life expectancy is days to weeks. The Product. The Selective Cytopheretic Device (SCD) is an immuno-regulating, extracorporeal, membrane device targeted to modulate the cardio-depressant effects that are associated with CHF. SCD is a platform technology focused on immunomodulation of acute and chronic inflammation associated with acute and chronic organ dysfunction. SCD membranes selectively sequester activated systemic leukocytes as they flow through the cartridge via an extracorporeal circuit. Pre-clinical results show SCD treatment results in a 25% improvement in ejection fraction in a canine CHF model. Innovation. SCD is an innovative approach to treat CHF. Rather than utilizing small molecules to improve myocardial contractility, SCD acts as an immunomodulatory device to dampen the cardio-depressant effects of the chronic pro-inflammatory state of CHF. This proposal will provide the first clinical support for the use of immunomodulatory treatment for chronically inflamed CHF patients. Phase Il Hypothesis. SCD treatment will demonstrate safety and probable benefit as a bridge to LVAD implantation in a previously ineligible CHF patient population. This Phase Il plan is based upon results demonstrating SCD treatment improved cardiac contractility in a canine model of CHF and an ongoing clinical trial demonstrating first in human, proof of concept of successful bridge to LVAD in an ineligible patient with severe CHF with improvement of cardiac performance. Aim. To expand a current single center IDE clinical trial to a multicenter trial to enroll 20 patients in 4 centers for evaluation of safety and probable benefit of SCD treatment for a Humanitarian Device Exemption (HDE) application for a severely ill patient population to bridge to a life sustaining LVAD implantation. Commercial Opportunity. This proposed single clinical trial which demonstrates safety and probable benefit will support a HDE submission for FDA approval and commercialization.
Topic Code
NHLBI
Solicitation Number
PA23-231
Status
(Ongoing)
Last Modified 6/22/26
Period of Performance
6/1/24
Start Date
5/31/27
End Date
Funding Split
$3.6M
Federal Obligation
$0.0
Non-Federal Obligation
$3.6M
Total Obligated
Activity Timeline
Transaction History
Modifications to R44HL170779
Additional Detail
Award ID FAIN
R44HL170779
SAI Number
R44HL170779-55087879
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Small Business
Awarding Office
75NH00 NIH National Heart, Lung, and Blood Institute
Funding Office
75NH00 NIH National Heart, Lung, and Blood Institute
Awardee UEI
T5BFF2BJ8SE3
Awardee CAGE
3S6E5
Performance District
MI-06
Senators
Debbie Stabenow
Gary Peters
Gary Peters
Modified: 6/22/26