SBIR-STTR Award

SonoHeal: Smart Resonating Closed-loop Airway Clearance Technology
Award last edited on: 2/19/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$1,749,964
Award Phase
2
Solicitation Topic Code
838
Principal Investigator
Rajoshi Biswas

Company Information

Cognita Labs LLC

6666 Harwin Drive Suite 680
Houston, TX 77036
   (949) 266-4083
   info@cognitalabs.com
   www.cognitalabs.com
Location: Single
Congr. District: 09
County: Harris

Phase I

Contract Number: 1R43HL152912-01
Start Date: 4/1/2020    Completed: 7/31/2021
Phase I year
2020
Phase I Amount
$197,130
Cystic Fibrosis is a genetic disorder that affects 30,000 patients in the USA with an average life span of 37 years and the majority (85%) of the mortality is a result of lung disease. Airway Clearance Therapies (ACT) are extensively used by patients for forceful mechanical clearance of mucus accumulated in airways using high pressure and high frequency vibrations. However, the use of ACTs is intrusive, painful, uncomfortable, and poses tremendous burden on patients who are required to perform ACTs daily for 1-2 hours. Without effective ACT, the mucus-plugged airways trap bacteria causing infections, inflammations, respiratory failures, and other complications. ACT is also used by patients with lung conditions where mucus clearance is necessary (e.g. bronchiectasis, COPD, Asthma). ACT works on the principle of vibrating the lungs to increase mucus mobility. Ideally, the therapy needs to be individualized and continuously adaptive for effective clearance. However, none of the current ACT devices and techniques, including chest physiotherapy, high-frequency chest compression, oscillation, and acoustic vibration therapies, are adaptive. The challenges with current ACT devices: 1. Brute-force approach: Patients have diverse airway geometry, mucus accretion levels, and obstruction locations. Optimal therapy requires input frequencies to match the resonant frequency of specific airways to target mucus clearance. Current ACT devices work on a set vibration pattern (Vest, oPEP, CPT) or a "feeling- based" subjective tweaking of input frequencies and airway location (Frequencer, VibraLung), often rendering them ineffective. 2. Subjective Assessment: None of the current devices measure lung function to provide a quantitative assessment of the airway obstruction or therapy progress putting the burden on the patient to determine treatment effectiveness. 3. Poor Quality of Life: As a result, patients perform uncomfortable ACT for long durations to see a positive effect, leading to poor adherence to ACT. Further, home ACTs are considered ineffective for a large segment of the patient population due to the lack of personalized treatment. Cognita Labs's proposed solution, SonoHeal, will be the first device to adapt the treatment in real-time based on the patient's lung status, such that the right airways are targeted for stimulation/vibration to reduce the reliance on patient's guesswork as well as provide effective therapy by localizing airway clearance. SonoHeal will utilize Cognita's patent-pending airway monitoring technology that measures airway obstruction in real- time. Combined with quantified lung response with mucus localization information, SonoHeal will algorithmically tune the right resonant frequency to target patient's airways and promote effective mucus removal. In this proposal, Cognita's team will bring years of airway modeling, device technologies and commercialization experience to conduct in-vitro experimentation on multiple lung models to show the feasibility and efficiency of the SonoHeal device in a lab setup.

Public Health Relevance Statement:
PROJECT NARRATIVE Airway Clearance Therapies (ACT) are critical daily requirement for Cystic Fibrosis patients to remove mucus from the lungs and avoid infections and pulmonary exacerbations. Current ACT devices work on the principals of violently vibrating/shaking the lung which leads to ineffective, uncomfortable and long therapy times. Cognita's SonoHeal will be the first closed- loop innovation that will listen to the lung response while adaptively changing acoustic vibrating pressure waves to target the resonant frequencies of the individual airways and provide most efficient and effective therapy.

Project Terms:
Acoustics; Acoustic; Affect; airway obstruction; airflow limitation; airflow obstruction; airway limitation; obstructed airflow; obstructed airway; Algorithms; Breathing; Respiratory Aspiration; Respiratory Inspiration; inspiration; Asthma; Bronchial Asthma; Bacteria; Bronchiectasis; Cystic Fibrosis; Mucoviscidosis; Disease; Disorder; Elasticity; In Vitro; Infection; Inflammation; Knee; Longevity; Length of Life; life span; lifespan; Lung; Lung Respiratory System; pulmonary; 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; mortality; Movement; body movement; Mucins; Mucus Glycoprotein; Mucous body substance; Mucus; mucous; Obstruction; Pain; Painful; Legal patent; Patents; Patients; Physics; pressure; Probability; Quality of life; QOL; Respiratory physiology; lung function; respiratory function; Technology; Testing; Time; Violence; violent; violent behavior; Work; Measures; Treatment Effectiveness; Dataset; Data Set; Electrical Impedance; Impedance; electric impedance; base; Ensure; Training; Individual; Phase 2 Clinical Trials; phase II protocol; Phase II Clinical Trials; machine learned; Machine Learning; mechanical; Mechanics; Hour; Dimensions; Frequencies; Complex; Home; Home environment; Pattern; Techniques; System; Location; vibration; age group; experience; novel; Devices; Abscission; Extirpation; Removal; Surgical Removal; resection; Excision; Thorace; Thoracic; Thorax; Chest; Modeling; response; Intervention Strategies; interventional strategy; Intervention; Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physiotherapy; Physical therapy; patient safety; High Frequency Chest Wall Oscillation; High-Frequency Chest Compression; High-Frequency Chest Wall Compression; pulmonary failure; respiratory insufficiency/failure; Respiratory Failure; Adherence; Data; Germ; Localized Therapy; Local Therapy; Monitor; feelings; Feeling; CF patients; individuals with CF; individuals with cystic fibrosis; patients with CF; patients with cystic fibrosis; cystic fibrosis patients; innovate; innovative; innovation; prototype; commercialization; patient population; effective treatment; effective therapy; flexible; flexibility; 3-D print; 3-D printer; 3D printer; 3D printing; three dimensional printing; 3D Print; Geometry; personalization of treatment; personalized therapy; personalized treatment; personalized medicine; experiment; experimental research; experimental study; genetic condition; genetic disorder; Genetic Diseases; optimal therapies; optimal treatments; mucus clearance; learning algorithm; adaptation algorithm; ventilation

Phase II

Contract Number: 2R44HL152912-02A1
Start Date: 4/1/2020    Completed: 11/30/2023
Phase II year
2022
(last award dollars: 2023)
Phase II Amount
$1,552,834

Cystic Fibrosis is a genetic disorder that affects 30,000 patients in the USA with an average life span of 37 years and the majority (85%) of the mortality is a result of lung disease1. Airway Clearance Therapies (ACT) are extensively used by patients for forceful mechanical clearance of mucus accumulated in airways using high pressure and high frequency vibrations2. However, the use of ACTs is tedious, inconvenient, and poses a tremendous burden on patients who are recommended to perform ACTs several times daily4,5. Without effective ACT, the mucus-plugged airways trap bacteria causing infections, inflammations, respiratory failures, and other complications. ACT is also used by patients with lung conditions where mucus clearance is necessary (e.g. bronchiectasis, COPD, Asthma). ACT works on the principle of vibrating the lungs to increase mucus mobility. Ideally, the therapy needs to be individualized and continuously adaptive for effective clearance. However, none of the current ACT devices and techniques, including chest physiotherapy, high-frequency chest compression, oscillation, and acoustic vibration therapies, are adaptive. The challenges with current ACT devices: 1. Brute-force approach: Patients have diverse airway geometry, mucus accretion levels, and obstruction locations. Optimal therapy requires input frequencies to match the resonant frequency of specific airways to target mucus clearance. Current ACT devices work on a set vibration pattern (Vest, oPEP, CPT) or a "feeling-based" subjective tweaking of input frequencies and airway location (Frequencer, VibraLung), often rendering them ineffective. 2. Subjective Assessment: None of the current devices measure lung function to provide a quantitative assessment of the airway obstruction or therapy progress putting the burden on the patient to determine treatment effectiveness. 3. Poor Quality of Life: As a result, patients perform uncomfortable ACT for long durations to see a positive effect, leading to poor adherence to ACT. Further, home ACTs are considered ineffective for a large segment of the patient population due to the lack of personalized treatment. Cognita Labs's proposed solution, SonoHeal, will be the first device to adapt the treatment in real-time based on the patient's lung status, such that the right airways are targeted for stimulation/vibration to reduce the reliance on patient's guesswork as well as provide effective therapy by localizing airway clearance. SonoHeal will utilize Cognita's patent-pending airway monitoring technology that measures airway obstruction in real-time. Combined with quantified lung response with mucus localization information, SonoHeal will algorithmically tune the right resonant frequency to target patient's airways and promote effective mucus removal. In this proposal, Cognita's team will bring years of airway modeling, device technologies and commercialization experience to build the devoce, conduct in-vitro experimentation on multiple lung models and validate in a human trial. Sonoheal's goal is to improves adherence, delivers ACT adaptively, comfortably in a shorter period and quantitatively for each patient individualized to their physiology.

Public Health Relevance Statement:
PROJECT NARRATIVE Airway Clearance Therapies (ACT) are critical daily requirement for Cystic Fibrosis patients to remove mucus from the lungs and avoid infections and pulmonary exacerbations. Current ACT devices work on the principals of violently vibrating/shaking the lung which leads to ineffective, uncomfortable and long therapy times. Cognita's SonoHeal will be the first closed- loop innovation that will listen to the lung response while adaptively changing acoustic vibrating pressure waves to target the resonant frequencies of the individual airways to reduce therapy time, intensity and promote adherence.

Project Terms:
sensing technology; Genetic Diseases; genetic condition; genetic disorder; optimal treatments; optimal therapies; mucus clearance; learning algorithm; algorithm development; Home; wireless; machine learning model; machine learning based model; Chronic Obstructive Pulmonary Disease; COPD; Chronic Obstruction Pulmonary Disease; Chronic Obstructive Lung Disease; design verification; design validation; Acoustics; Acoustic; Affect; airway obstruction; airflow limitation; airflow obstruction; airway limitation; obstructed airflow; obstructed airway; respiratory airway obstruction; Airway Resistance; Algorithms; Asthma; Bronchial Asthma; Bacteria; Bronchiectasis; Cystic Fibrosis; Mucoviscidosis; Disease; Disorder; Feasibility Studies; Feedback; Goals; Human; Modern Man; In Vitro; Infection; Inflammation; Joints; Knee; Learning; Longevity; Length of Life; life span; lifespan; Lung; Lung Respiratory System; pulmonary; Modernization; mortality; Movement; body movement; Mucous body substance; Mucus; mucous; Obstruction; Patents; Legal patent; Patients; PEFR; Peak Expiratory Flow Rate; Physiology; pressure; Probability; QOL; Quality of life; Reinforcement; Psychological reinforcement; Study Type; study design; Research Design; Rewards; Pigs; Suidae; Swine; porcine; suid; Family suidae; Technology; Time; Translations; Violence; violent; violent behavior; Work; Generations; Measures; Device Designs; Device Safety; Schedule; Treatment Effectiveness; Vent; base; human subject; improved; Phase; Training; lung function; pulmonary function; Individual; satisfaction; Cross-Over Designs; Crossover Design; machine learned; Machine Learning; programs; mechanical; Mechanics; Frequencies; Complex; Pattern; Techniques; System; 3-D; 3D; three dimensional; 3-Dimensional; Location; vibration; experience; Performance; success; Animal Models and Related Studies; model of animal; model organism; Animal Model; Proxy; novel; Devices; Abscission; Extirpation; Removal; Surgical Removal; resection; Excision; Thorace; Thoracic; Thorax; Chest; Modeling; response; Intervention Strategies; interventional strategy; Intervention; Physical therapy; Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physiotherapy; High Frequency Chest Wall Oscillation; High-Frequency Chest Compression; High-Frequency Chest Wall Compression; lung failure; pulmonary failure; Respiratory Failure; Adherence; Data; Germ; Local Therapy; Localized Therapy; Validation; Monitor; Feeling; feelings; three-dimensional modeling; 3-D modeling; 3D modeling; design; designing; Outcome; human study; cystic fibrosis patients; CF patients; individuals with CF; individuals with cystic fibrosis; patients with CF; patients with cystic fibrosis; Population; innovation; innovate; innovative; Resistance; resistant; usability; prototype; commercialization; patient population; standard of care; effective therapy; effective treatment; 3D Print; 3-D print; 3-D printer; 3D printer; 3D printing; three dimensional printing; Geometry; personalized medicine; personalization of treatment; personalized therapy; personalized treatment; resistance frequency; experimental study; experiment; experimental research; sensor technology