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Technology for the non-invasive surveilance of post-traumatic compartment syndrome

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AR074345-01
Agency Tracking Number: R41AR074345
Amount: $225,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAMS
Solicitation Number: PA17-303
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-20
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Davie, FL 33328-5308
United States
DUNS: 831290577
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (617) 388-5550
Business Contact
Phone: (617) 388-5550
Research Institution
BOSTON, MA 02215-5400
United States

 Domestic Nonprofit Research Organization

PROJECT SUMMARYAcute compartment syndromeACSremains one of the most devastating and often overlooked traumatic
musculoskeletal disorders in clinical practiceIn this conditionpressure increases in one of the body s spacelimited compartmentsdue most commonly to direct trauma or bone fractureresulting ultimately in an ischemic
injury to all of the compartment s contentsincluding muscle and nerveOnce a full blown compartment
syndrome developsthe consequences are uniformly catastrophicwith permanent muscle and nerve losssometimes necessitating amputation of the entirely non functional limbIf caught before irrevocable damage is
doneaggressive surgical decompressionvia fasciotomycan be performed to relieve the pressure in the
compartment and allowing the muscles and nerves to recoverHowevercurrent approaches for assessing the
development of ACSoutside of the physical examinationare limitedThe standard method involves the
insertion of a pressure monitorThere are no effective approaches for the continuous surveillance for the
development of ACS after an injuryOne technology that may be especially sensitive to the development of
ACS is that of electrical impedance myographyEIMIn EIMa weakhigh frequency electrical current is
passed between a number of electrodes overlying a muscle or muscle group of interest and the resulting
surface voltages measured by a second set of electrodesThe health status of the underlying muscle impacts
the measured voltages in consistent and predictable fashionFor instanceincreasing myofiber edema and
injury would be expected to lead to reductions in the impedance resistance measureThe development of EIM
for medical and broader health use is the underlying focus of MyolexInca small business concern based in
San Francisco and BostonTo datethe technology has been shown to be effective in a wide variety of
disorders that impact the muscle either directly or indirectlyincluding muscular dystrophyamyotrophic lateral
sclerosisand sarcopeniamuscle wasting in the elderlyAdditional work has also suggested that EIM is
sensitive to primary muscle injuryIn this study we propose to extend this workseeking to develop EIM as a
non invasiveconvenient monitoring tool to assess the development of ACSThis will allow health care
professionals to monitor compartments for ACS after predisposing injury intervene and to intervene at a
sufficiently early pointso as to avoid permanent injuryIn our first specific aimwe will use a rat ACS model to
assess changes in EIM values and the corresponding alterations in pathology at several severities of injury to
establish a time course of change and the relationship to impedance valuesIn Specific Aimusing tissue
data obtained in Aimand anatomic modelswe will design electrode arrays that will be most effective at
detecting the development of ACS in a porcine model and in human subjects for use in our planned Phasestudies PROJECT NARRATIVEAcute compartment syndromeACSremains one of the most devastating and easily overlooked
musculoskeletal disorders in clinical practiceIn this conditionpressure increases in one of the body s spacelimited compartmentsdue to trauma or bone fractureresulting ultimately in necrosis and death to all the
compartment s contentsincluding muscle and nerveMyolexInc proposes to develop an electrical impedance
based system for monitoring the development of compartment syndrome with initial testing in a rat model

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

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