The Bumps: A Device for Rapid, Non-Invasive Quantification of Touch Sensation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42TR000462-04A1
Agency Tracking Number: R42TR000462
Amount: $1,011,590.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 100
Solicitation Number: PA18-575
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-04-11
Award End Date (Contract End Date): 2021-03-31
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
The BumpsA Device for RapidNon Invasive Quantification of Touch Sensation Abstract !Our proposal describes an elegant device called the Bumps that quantifies finger pad touch sensation at low micron levelsThe objectives are to diagnose peripheral neuropathy near its onsetwhen the possibility for reversal is highestand to monitor either progression or reversal of neuropathy during treatmentEarly discovery of functionally impaired touch provides a better chance to halt or reverse neuropathy than later discovery by tests that rely on the effects of nerve degeneration for diagnosisThe Bumps is a deceivingly simplecoat pocket size device without power or moving parts that quantifies finger pad touch inminutesThe device is a smooth surface marked into checkerboard like squaresEach square contains five colored circlesOne circle in each square contains a tiny coin shaped particlea bumpSubjects search the circles of each square with the finger pad in search of the one circle that contains a bumpBump height is different in each squareThe test is objective because the subject must locate a bump from among several possible locationsThe unique feature of the Bumps is that the subject continuously uses the very motor and sensory nerves suspected of being neuropathic to control the search with the finger pad and monitor the sensory inputOther tests of touch sensation are subjectiveFor examplean examiner touches the skin with a von Frey monofilament or probethen asks the subject if they felt the probeyes or nofelt or not feltIn Phase Iwe demonstrated feasibility of the deviceIn Phase IIwe tested healthy control subjects and subjects with peripheral neuropathy with the original device to start a database with mean control thresholds for sex and agestddevand cutoff values for customers to use as standards to compare with results from their patientsAt the onset of Phase IIwe worked with four different companies each using their special techniques as they attemptedunsuccessfullyto construct a Bumps device with the precision required at nanometer levelsAfter an extensive searchwe foundX Technology LLCan Illinois company that is capable of constructing a master mold that will be used in Phase IIB to produce the final Bumps product in larger quantities at a reasonable price for providers in clinicshospitals and other health care settingsPhase IIB goals areConstruct a market ready Bumps deviceCompare the results obtained from the new Bumps device with results from the original ground glass prototypein a large cohortdetermine the sensitivity and specificity of the new Bumps device to discriminate between healthy and neuropathic subjectscontinue to develop a normative database of test values andcut offvalues for diagnosis of neuropathyandWork with a marketing partner to commercialize the deviceThe grant period ismonths The BumpsA Device for RapidNon Invasive Quantification of Touch Sensation Narrative The Bumps is a deceivingly simplehand heldpocket sized medical device that objectively quantifies finger pad touch sensation at the low micrometer level intominutesThe purpose is early recognitiongrading and monitoring progression or reversal of peripheral neuropathy secondary to diabeteschemotherapy and other neuropathic disordersThe Bumps device is a member of a new generation of highly sensitive devices that permit earlier diagnosis and grading of neurological disorders and quantitative monitoring to evaluate the effectiveness of therapies and pharmaceuticals

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

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