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A Device to Quantify Sweat of Single Sweat Glands to Diagnose Neuropathy

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42NS071979-02
Agency Tracking Number: R42NS071979
Amount: $2,561,843.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 107
Solicitation Number: PA12-089
Timeline
Solicitation Year: 2013
Award Year: 2013
Award Start Date (Proposal Award Date): 2013-04-15
Award End Date (Contract End Date): 2017-03-31
Small Business Information
4103 E LAKE ST, Minneapolis, MN, 55406-2259
DUNS: 832721133
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 WILLIAM KENNEDY
 (612) 625-1431
 kenne001@umn.edu
Business Contact
 DANIEL KENNEDY
Phone: (612) 728-8080
Email: kenne042@umn.edu
Research Institution
 UNIVERSITY OF MINNESOTA
 100 CHURCH ST SE
MINNEAPOLIS, MN, 55455-0149
 Nonprofit college or university
Abstract
DESCRIPTION provided by applicant We devised a new generation highly sensitivity method to diagnosis peripheral neuropathy early when the probability for reversal is greatest Cancer chemotherapy and diabetes are the most common causes of neuropathy in the USA Both cause decreased sweating abnormal circulation peripheral numbness pain and weakness If diagnosed early both are potentially treatable Unfortunately the minimal changes in function that first signal impending neuropathy or response to treatment escape detection by current tests Early recognition would provide a better opportunity to treat halt or reverse neuropathy than later discovery after significant nerve degeneration Our sensitive sweat test SST detects early dysfunction of sudomotor nerves that activate sweat glands SGs by measuring the rate and volume of water secreted from each of andgt individual SGs per image The innovative feature of the SST was placement of starch coated Scotch R tape on the iodine coated skin Tape forces the sweat droplets to flow centrifugally in a flat expanding spot made densely black by reaction of the sweat wetted starch and iodine The rate of expansion of the black spot is proportional to the sweat rate of that SG Spot area is proportional to volume from the same SG The sweat spots are imaged by miniature device at image sec for seconds counted and rates and volumes calculated Each SG appears to have its own characteristic secretion rate Dysfunction of secretion at the level of the single gland is an earler indicator of beginning neuropathy than the current QSART measure of total water skin area The SST appears capable of measuring progression of neuropathy and potential to record degrees of recovery by recording small incremental changes of sweat rate and volume from single SGs The SST can make diagnosis and evaluation of neuropathy faster more convenient and less expensive Phase I has been highly successful We constructed a compact computer mouse size sensitive device that we used to test controls and patients with diabetic and chemotherapy neuropathy Sweat spot counts their distribution and individual SG rate and volume of water secreted correlated with severe neuropathy on the foot and calf In Phase II we will construct a market ready device that is convenient affordable hand held and easily used in medical clinics at the bedside or in the home We will obtain control values from large numbers of healthy persons and test patients with CIPN diabetic neuropathy and other neuropathies in MN and from three collaborating institutions Commercialization will be in partnership with the WR Co Inc a MN medical device company that markets other medical devices PUBLIC HEALTH RELEVANCE Neuro Devices will manufacture test and market a miniature highly sensitive sweat test SST device to measure rate and nano liter volumes of sweat secreted by andgt single sweat glands for earlier diagnosis and detection of progression or recovery with treatment of patients with chemotherapy induced diabetic and other neuropathies

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

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