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Portable Low Cost Pulmonary Forced Oscillation Technique Instrument Using a Novel Sensor Design

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44HL132816-01A1
Agency Tracking Number: R44HL132816
Amount: $224,482.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA16-302
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-06-15
Award End Date (Contract End Date): 2018-05-15
Small Business Information
6901 EAST FISH LAKE ROAD, SUITE #188
Maple Grove, MN 55369-5457
United States
DUNS: 140696332
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 PATRICK LICHTER
 (612) 730-1091
 plichter@koronisbiotech.com
Business Contact
 PATRICK LICHTER
Phone: (763) 515-5321
Email: plichter@koronisbiotech.com
Research Institution
N/A
Abstract

Abstract
Koronis Biomedical Technologies and its collaborators propose to develop and fully test a low cost portable
respiratory assessment device using the forced oscillation technique FOT leveraging the development of a
new flexible thin film airflow sensor technology The proposed FOT device requires zero skill for the subject
and operator making it ideal for occupational health screening physician office use and home monitoring The
current gold standard for accurate and repeatable measurement of lung function is spirometry Spirometry is a
pulmonary function test that measures the volume and rate of air flow a patient can maximally exhale into a
tube attached to a precise air flow meter The role of spirometers has been limited due to their reliance on
technique adherence Unlike many medical diagnostic tests where the patient is essentially a passive
participant spirometry requires active patient participation The procedure requires the patient to take the
deepest breath possible and then exhale as hard as possible for as long as possible The test is normally
repeated to ensure reproducibility Spirometry results are highly dependent on patient cooperation and effort
Patients often face a significant learning curve Some patients cannot or will not produce interpretable results
FOT measures pulmonary airway resistance and reactance In contrast to traditional spirometry the key
clinical advantage of FOT is that the technique is passive and does not require the patient to breathe forcefully
on command In Phase I the team will refine a thin film sensor design and construct a prototype FOT device A
human study will be conducted comparing the performance of the prototype to a commercial clinic based
oscillometry device In Phase II all components of the pre production system will be finalized and evaluated for
usability and performance in human evaluations Narrative
Asthma is a major chronic disease that affects million Americans and presents an enormous burden to the
healthcare system The condition is responsible for one quarter of all emergency room visits in the U S In
there were million outpatient asthma visits to physicians offices million visits to emergency
departments for asthma asthma hospitalizations and deaths It is well accepted in the
management of asthma that chronic monitoring for worsening inflammation of airways is important A low cost
lung function assessment technology that requires minimal effort to operate properly would fill an unmet need
in the management of this disease

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

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