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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: $1,858,400.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 100
Solicitation Number: PA18-575
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
United States
DUNS: 832721133
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (612) 625-1431
Business Contact
Phone: (612) 728-8080
Research Institution
MINNEAPOLIS, MN 55455-0149
United States

 Nonprofit College or University

The Bumps: A Device for Rapid, Non-Invasive Quantification of Touch Sensation
!Our proposal describes an elegant device called the Bumps that quantifies finger pad touch sensation at
low micron levels. The objectives are to diagnose peripheral neuropathy near its onset, when the possibility for
reversal is highest, and to monitor either progression or reversal of neuropathy during treatment. Early
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 diagnosis.The Bumps is a deceivingly simple, coat pocket size device without power or moving parts that
quantifies finger pad touch in 5-7 minutes. The device is a smooth surface marked into checkerboard-like
squares. Each square contains five colored circles. One circle in each square contains a tiny coin-shaped particle
(a bump). Subjects search the circles of each square with the finger pad in search of the one circle that contains
a bump. Bump height is different in each square. The test is objective because the subject must locate a bump
from among several possible locations. The 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 input. Other tests of touch sensation are subjective. For example, an examiner touches the
skin with a von Frey monofilament or probe, then asks the subject if they felt the probe, yes or no, felt or not
felt.In Phase I, we demonstrated feasibility of the device. In Phase II, we tested healthy control subjects and
subjects with peripheral neuropathy with the original device to start a database with mean control thresholds for
sex and age ± std. dev. and cutoff values for customers to use as standards to compare with results from their
patients. At the onset of Phase II, we worked with four different companies each using their special techniques
as they attempted (unsuccessfully) to construct a Bumps device with the precision required at nanometer levels.
After an extensive search, we found 10X Technology LLC, an 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 clinics, hospitals and other health care settings.Phase IIB goals are: 1) Construct a market-ready Bumps device. 2) Compare the results obtained from
the new Bumps device with results from the original ground-glass prototype #1 in a large cohort, 3) determine
the sensitivity and specificity of the new Bumps device to discriminate between healthy and neuropathic
subjects; 4) continue to develop a normative database of test values and “cut off” values for diagnosis of
neuropathy; and 5) Work with a marketing partner to commercialize the device. The grant period is 24 months.The Bumps: A Device for Rapid, Non-Invasive Quantification of Touch
The Bumps is a deceivingly simple, hand-held, pocket-sized medical device that objectively
quantifies finger pad touch sensation at the low micrometer level in 5 to 7 minutes. The
purpose is early recognition, grading and monitoring progression or reversal of peripheral
neuropathy secondary to diabetes, chemotherapy and other neuropathic disorders. The
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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