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Pilot Clinical Study to Assess Safety and Efficacy of External Ventricular Drainage with Cerebrospinal Fluid Water Removal Osmotherapy for Traumatic Brain Injury-Induced Cerebral Edema

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1U44NS121557-01A1
Agency Tracking Number: U44NS121557
Amount: $1,515,121.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 106
Solicitation Number: NS18-012
Solicitation Year: 2018
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-06-15
Award End Date (Contract End Date): 2024-05-31
Small Business Information
Minneapolis, MN 55419-1134
United States
DUNS: 116649792
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (612) 490-4201
Business Contact
Phone: (612) 490-4201
Research Institution

Project Summary
Significance: Cerebral edema develops in a large percentage of severe traumatic brain injury (TBI) cases and
may lead to worsened morbidity. The importance of osmotic gradients as the cause of edema has been
described. Published reports indicate cerebral edema remains refractory in many patients to all currently
available treatments. Translational research has identified reversal of the osmotic gradient as a requirement
for treating cerebral edema; therefore, there is a critical need for new cerebral edema therapies to manage
both osmotic and hydrostatic pressure gradients.
Innovation: Reductive Ventricular OsmoTherapy (RVOT) manages osmotic pressure gradients by removing
free water from the cerebrospinal fluid (CSF) in the brain ventricles. CSF water is removed by pervaporation
through embedded hollow fiber membranes, as a dry air sweep gas removes water vapor. Increased
ventricular osmotic pressure then causes water movement out of the tissue and into the ventricles where it is
removed by the RVOT catheter by either continued pervaporation or a hydrostatic bulk drainage mechanism.
Hypothesis: Our hypothesis is ventricular osmotherapy will reduce cerebral edema by hydrostatic and osmotic
mechanisms, and thereby provide a safe and efficacious aid to improve TBI management.
Preliminary Data: This hypothesis is based on published preliminary data with a large animal experimental
TBI study demonstrating that RVOT can significantly increase CSF osmolality. RVOT treatment resulted in
improved Apparent Diffusion Coefficient and other evidence of reduced cerebral edema.
Expected Impact: RVOT will provide clinicians a new tool in combination with current and future interventions
to improve TBI patient outcomes.
SBIR Phase I: Obtain clinical study approval with pre-clinical test data.
SBIR Phase II: Assess RVOT clinical safety and efficacy as an ICP management aid device. Phase 1 First-
In-Human Safety Study: Enroll 10 severe TBI patients with insertion and management of RVOT catheter to
assess safety as primary endpoint. Phase 2a Randomized Controlled Pilot Trial: Enroll 40 severe TBI
patients randomized 3:1 to RVOT (n=30) or standard-of-care external ventricular drain (n=10) therapy to
assess RVOT safety, efficacy and economic feasibility endpoints, with the overall objective of enabling an
SBIR Phase III pivotal study to obtain market authorization and RVOT System product commercial launch.
Commercialization Plan: This SBIR Fast Track project offers a highly credible commercialization pathway
based on a significant unmet medical need supported with a large animal feasibility study, corporate partner
prospects, and experienced neurotrauma device, clinical, and commercial team.

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

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