SBIR-STTR Award

Portable Noninvasive Positive Airway Device for COPD Patient Therapy
Award last edited on: 2/19/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$1,919,359
Award Phase
2
Solicitation Topic Code
838
Principal Investigator
Robert J Knuesel

Company Information

Koronis Biomedical Technologies Corporation (AKA: KBTC~KBT)

861 East Hennepin Avenue Unit 410
Minneapolis, MN 55414
   (763) 447-6115
   info@koronisbiotech.com
   www.koronisbiotech.com
Location: Single
Congr. District: 05
County: Hennepin

Phase I

Contract Number: 1R44HL154932-01
Start Date: 8/15/2020    Completed: 7/31/2022
Phase I year
2020
Phase I Amount
$251,772
Koronis Biomedical Technologies proposes to develop and fully evaluate a novel, on-demand handheld bi-level positive airway pressure (BiPAP) ventilator to treat Chronic Obstructive Pulmonary Disease (COPD) patients suffering from exertional dyspnea ("breathlessness"). It is well known that dyspnea trends severe COPD patients as they age towards inactivity, resulting in peripheral muscle deconditioning that further increases the risk of experiencing dyspnea, establishing a vicious cycle of recurrent fear of dyspnea, further inactivity and potential social isolation. The proposed Bi-level Rapid Emergency Airway THErapy (BREATHE) system will be optimized to provide proven BiPAP therapy to rapidly relieve acute dyspnea in a miniaturized, portable handheld form factor. This system will allow for therapy on the go, untethering the patient and increasing their confidence to engage in activities of daily living.

Public Health Relevance Statement:
Narrative Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death by disease in the United States. More than 16 million people have been diagnosed with the progressive lung disease. COPD's main symptom is chronic exertional dyspnea, which is a physiological and perceptional barrier that limits engagement in daily activities. COPD patients often unconsciously adopt a sedentary lifestyle due to the distressing exertional dyspnea. This sedentary condition leads to physical deconditioning of the peripheral muscles, which manifests a vicious cycle contributing to the debilitation of COPD patients.

Project Terms:
Activities of Daily Living; Activities of everyday life; daily living functionality; functional ability; functional capacity; Age; ages; Air; Breathing; Respiratory Aspiration; Respiratory Inspiration; inspiration; Blood; Blood Reticuloendothelial System; Carbon Dioxide; CO2; Carbonic Anhydride; Cause of Death; Charge; Clinical Research; Clinical Study; Clinical Trials; Critical Care; Data Reporting; data representation; Mental Depression; depression; Diagnosis; Disease; Disorder; Dyspnea; Breathlessness; Emergency Situation; Emergencies; Exercise; Exertion; Fright; Fear; Health; Health behavior; Hospitalization; Hospital Admission; Human; Modern Man; Intervention Studies; intervention research; interventional research; interventional study; interventions research; Lip structure; Lip; Lung diseases; Pulmonary Diseases; Pulmonary Disorder; Respiratory Disease; Respiratory System Disease; Respiratory System Disorder; disease of the lung; disorder of the lung; lung disorder; Chronic Obstructive Airway Disease; COPD; Chronic Obstruction Pulmonary Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; mange; Medicine; Miniaturization; Miniaturisations; Muscle; Muscle Tissue; muscular; Office Visits; physician office visit; Patients; Perception; Play; pressure; Recurrence; Recurrent; Research; Research Personnel; Investigators; Researchers; Resources; Research Resources; Respiration; respiratory mechanism; Risk; Role; social role; Social isolation; Computer software; Software; Unconscious State; Unconscious; Unconsciousness; consciousness loss; United States; Universities; Work of Breathing; Self Management; Ventilator; Exercise Tolerance; base; improved; Peripheral; Acute; Chronic; Clinical; sedentary; Phase; Physiologic; Physiological; Ensure; Evaluation; Training; Physical activity; Distress; Collaborations; mechanical; Mechanics; Scientist; Adopted; Route; Techniques; System; respiratory; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Operative Surgical Procedures; Consult; experience; novel; novel technologies; new technology; Modality; Devices; Touch; tactile sensation; Touch sensation; Biomedical Technology; Thorace; Thoracic; Thorax; Chest; miniaturize; portability; Intervention Strategies; interventional strategy; Intervention; preventing; prevent; Symptoms; Ph.D.; PhD; Doctor of Philosophy; Economic Burden; SBIR; Small Business Innovation Research; Small Business Innovation Research Grant; trend; Principal Investigator; Chairman; Chairwoman; Chairperson; developmental; Development; pathway; Pathway interactions; designing; design; Population; prospective; innovate; innovative; innovation; usability; prototype; Systems Development; lung rehabilitation; pulmonary rehabilitation; Sedentary behavior; Sedentary life-style; sedentary lifestyle; deconditioning; exercise training; common symptom; phase 2 evaluation; phase II evaluation; phase II testing; phase 2 testing; Data Management System; Data Management Resources; ventilation

Phase II

Contract Number: 4R44HL154932-02
Start Date: 8/15/2020    Completed: 7/31/2024
Phase II year
2022
(last award dollars: 2023)
Phase II Amount
$1,667,587

Koronis Biomedical Technologies proposes to develop and fully evaluate a novel, on-demand handheld bi-level positive airway pressure (BiPAP) ventilator to treat Chronic Obstructive Pulmonary Disease (COPD) patients suffering from exertional dyspnea ("breathlessness"). It is well known that dyspnea trends severe COPD patients as they age towards inactivity, resulting in peripheral muscle deconditioning that further increases the risk of experiencing dyspnea, establishing a vicious cycle of recurrent fear of dyspnea, further inactivity and potential social isolation. The proposed Bi-level Rapid Emergency Airway THErapy (BREATHE) system will be optimized to provide proven BiPAP therapy to rapidly relieve acute dyspnea in a miniaturized, portable handheld form factor. This system will allow for therapy on the go, untethering the patient and increasing their confidence to engage in activities of daily living.

Public Health Relevance Statement:
Narrative Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death by disease in the United States. More than 16 million people have been diagnosed with the progressive lung disease. COPD's main symptom is chronic exertional dyspnea, which is a physiological and perceptional barrier that limits engagement in daily activities. COPD patients often unconsciously adopt a sedentary lifestyle due to the distressing exertional dyspnea. This sedentary condition leads to physical deconditioning of the peripheral muscles, which manifests a vicious cycle contributing to the debilitation of COPD patients.

Project Terms:
Activities of Daily Living; Activities of everyday life; daily living functionality; functional ability; functional capacity; Age; ages; Air; Breathing; Respiratory Aspiration; Respiratory Inspiration; inspiration; Blood; Blood Reticuloendothelial System; Carbon Dioxide; CO2; Carbonic Anhydride; Cause of Death; Charge; Clinical Research; Clinical Study; Clinical Trials; Critical Care; Data Reporting; data representation; Mental Depression; depression; Diagnosis; Disease; Disorder; Dyspnea; Breathlessness; Emergency Situation; Emergencies; Exercise; Exertion; Fright; Fear; Health; Health behavior; health related behavior; Hospitalization; Hospital Admission; Human; Modern Man; Intervention Studies; intervention research; interventional research; interventional study; interventions research; Lip structure; Lip; Lung diseases; Pulmonary Diseases; Pulmonary Disorder; disease of the lung; disorder of the lung; lung disorder; mange; Medicine; Miniaturization; Miniaturisations; Muscle; Muscle Tissue; muscular; Persons; physician office visit; Office Visits; Patients; Perception; Play; Recurrent; Recurrence; Research; Investigators; Researchers; Research Personnel; Research Resources; Resources; respiratory mechanism; Respiration; Risk; social role; Role; Social isolation; Software; Computer software; Unconscious State; Unconscious; Unconsciousness; consciousness loss; United States; Universities; Work of Breathing; Self Management; Ventilator; Exercise Tolerance; base; improved; Peripheral; Acute; Chronic; Clinical; sedentary; Phase; Physiological; Physiologic; Ensure; Evaluation; Training; Physical activity; Distress; Collaborations; mechanical; Mechanics; Scientist; Adopted; Route; Techniques; System; respiratory; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Operative Surgical Procedures; Consult; experience; novel; novel technologies; new technology; Modality; Devices; Touch; tactile sensation; Touch sensation; Biomedical Technology; Thorace; Thoracic; Thorax; Chest; miniaturize; portability; Intervention Strategies; interventional strategy; Intervention; preventing; prevent; Symptoms; Ph.D.; PhD; Doctor of Philosophy; Economic Burden; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; trend; Principal Investigator; Chairperson; Chairman; Chairwoman; Development; developmental; Pathway interactions; pathway; design; designing; Population; prospective; innovation; innovate; innovative; usability; prototype; Systems Development; pulmonary rehabilitation; lung rehabilitation; sedentary lifestyle; Sedentary behavior; Sedentary life-style; deconditioning; exercise training; common symptom; phase 2 testing; phase 2 evaluation; phase II evaluation; phase II testing; Data Management Resources; Data Management System; ventilation; Chronic Obstructive Pulmonary Disease; COPD; Chronic Obstruction Pulmonary Disease; Chronic Obstructive Lung Disease; positive airway pressure