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Improving ALS Diagnosis using Needle I-EMG

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41NS112029-01A1
Agency Tracking Number: R41NS112029
Amount: $224,999.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 103
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-30
Award End Date (Contract End Date): 2021-03-29
Small Business Information
Brookline, MA 02446-2236
United States
DUNS: 081309695
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (617) 667-3057
Business Contact
Phone: (617) 388-5550
Research Institution
BOSTON, MA 02215-5400
United States

 Domestic Nonprofit Research Organization

PROJECT SUMMARY Needle electromyographyEMGremains the standard approach for assessing neuromuscular diseaseWhile the technique has proven to be clinically valuable over the lastyearsit has important limitationsThese include its not being sensitive to alterations in muscle composition and structureits inability to assess the contractile apparatus of muscleand its subjective nature with an inter rater reliability of onlyand a specificity for disease of onlyOne technology that could be incorporated seamlessly into the EMG needle to overcome its limitations is electrical impedance myographyEIMBy combining EIM and EMG into a single needle device there is the potential for greatly enhancing the accuracy of EMGthe clinical standardultimately yielding asmarter EMGtechnology to evaluate neuromuscular disordersThe development of this newsmarter EMGtechnology has been termed needle impedance electromyographyI EMGand it is the main focus of Haystack DiagnosticsInca small business concern based in BostonMAIn Aimof this PhaseSBIR applicationHaystack DiagnosticsIncwill perform finite element simulations to design different I EMG needles topologiesThese needles will be then manufactured on a fee for service basis by FHCIncBowdoinMEa company with which we have previously worked with expertise in custom needle manufactureIn Aimwe will test the needle designs in phantom mediasaline and agarand in groups of healthywild type mice and amyotrophic lateral sclerosisALSmiceWe will evaluate the EIM and EMG data both independently and together to identify the most effective and robust designboth in terms of repeatability and in differentiating healthy from diseased musclecomparing to standard EMG as a referenceAt the conclusion of this workHaystack DiagnosticsIncwill be well positioned to pursue a PhaseSBIR application seeking to develop and test I EMG technology in patients with a variety of neuromuscular diseasesincluding ALSWith expressed interest from the medical community and Natus MedicalIncthe world s largest commercial EMG manufacturerwe believe that if successfulHaystack DiagnosticsInctechnology could ultimately find wide application in clinical neuromuscular disease practice PROJECT NARRATIVE In this applicationHaystack DiagnosticsIncseeks to develop an enhanced needle technology for the evaluation of neuromuscular diseaseswith a focus on amyotrophic lateral sclerosisThe proposed work includes developing and testing in animals a novel needle device combining electrical impedanceIand electromyographyEMGAt the conclusion of this workwe will be well prepared to pursue a PhaseSBIR in which we will develop a disposable I EMG needle and test it in neuromuscular disease patients

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

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