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Soft-Focused HIFU Treatment of Common Peroneal Nerve Injury

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43NS107076-01A1
Agency Tracking Number: R43NS107076
Amount: $230,149.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 105
Solicitation Number: PA18-574
Timeline
Solicitation Year: 2018
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-30
Award End Date (Contract End Date): 2019-09-29
Small Business Information
208 BURWASH AVE
Savoy, IL 61874-9510
United States
DUNS: 606222896
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 EVERETTE BURDETTE
 (217) 239-0900
 clifb@acousticmed.com
Business Contact
 JENNIFER WILLIAMS
Phone: (217) 239-0900
Email: jwilliams@acousticmed.com
Research Institution
N/A
Abstract

ABSTRACT
The economic burden of chronic pain in the U Sis staggeringIn the cases of medically refractory chronic
neuropathic painneuromodulationsuch as spinal cord stimulationSCSand or dorsal root ganglionDRGstimulationis a non opioid based optionThough neuromodulation is typically electricalhere we examine an
alternative with pulsed high intensity focused ultrasoundHIFUDelivering HIFU at lower doses in a pulsed
fashion has been shown to temporarily block compound action potentials in pre clinical modelsThough the
blockage lasts seconds to minutesour lab has shown that using either invasive or external HIFUthe antinociceptive responses induced by the thermal energy last for days in multiple rodent pain modelsFurtherthe antinociceptive effects of external pulsed HIFU on the DRG and its exiting nerve rootsENRsare dose
dependent and have similar effects with repeated treatments in rodent modelsPostmortem histology reveals
no damage to nerves or ganglion cells after treatmentThusthis is truly a neuromodulatory strategy rather
than an ablative oneCurrentlyour device lacks the ability to visualize the target and directly monitor thermal
effects at the targetIn this projectwe will develop a fully external HIFU system which can visualize the
targetmonitor thermal energy delivery and provide treatment for chronic neuropathic painSpecificallywe
aim to develop a state of the art directional noninvasive application specificsoft focusedHIFU device that is
able to treat chronic neuropathic pain in the clinic within minutesAs we aim for this procedure to be done in
the clinic under local anesthetic within minutes and to be completely externalwe will augment our existing
device using a clinical diagnostic ultrasound imaging probe which can be used for image guidancetargetingand monitoring the therapy using quantitative ultrasound imaging techniquesThis capability will be integrated
into our external HIFU device via an iterative process of simulation modelingbench testing and animal work
in a swine neuropathic pain modelPhasestudies will be developed to culminate in a pilot first in man trial PROJECT NARRATIVE
The economic burden of chronic pain in the U Sis staggeringIn the cases of medically refractory chronic
neuropathic painneuromodulationsuch as spinal cord stimulationSCSis a non opioid based optionThough neuromodulation is typically electricalhere we examine an alternative with pulsed high intensity
focused ultrasoundHIFUWe propose a fully external application specificsoft focusedHIFU device
incorporating an integrated ultrasound imaging probe which can noninvasively pulse modulate thermal energy
to treat chronic neuropathic pain and also guide monitor the therapy

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

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