Pulmonator

Airway Clearance Techniques (ACT) and associated devices is the globally recommended line of treatment for COVID-19 for patients where ARDS patients are on mechanical ventilators and also secretion is the issue. Automatic ACT devices which can be practiced with limited training by health workers are simply not available in India.

The present invention Pulmonator is patented sound wave based device that makes the lung vibrate at a resonant frequency. This allows the easy movement of mucous, sputum and hence the overall respiration is improved. This device is the mainline treatment for managing COVID-19 treatment for 36% patients where the impact on speedy recovery is proven.

The imported substitute costs INR 1.3 million whereas the Pulmonator costs INR 30,000 in India. Additionally, Pulmonator is being planned as pay per use model at INR 200/patient/treatment, so that hospitals don't have to buy it.

COVID-19 is the syndrome arising out of SARS-CoV-2 virus. Majority of deaths occurring in COVID-19 are due to pneumonia and Acute Respiratory Distress Syndrome (ARDS). Both of these things are related to lungs and its overall effect on the way respiration is carried out by the body. 36% of patients in COVID-19 show symptoms of productive cough where the mucus or sputum in the respiratory system creates the challenge to respiration. Also, the fluid filled in lungs due to viral infection creates further challenges to respiration.

In both of these cases, it is important that the fluid filled in the lungs and mucus in the respiratory system is made more flowable and taken out. This respiratory treatment has the direct impact during the treatment and also helps in speedy recovery of COVID-19 patients. Speedy recovery is more important in today's scenario to quickly turn around patients where the healthcare system is under the stress.

In lung related diseases including ARDS, the functioning of the lungs is affected because of mucous, sputum, inflammation, fluid filled lungs. In these situations, apart from medicines and ventilators, the additional line of respiratory support is providing Airway Clearance Techniques. Whereas the physical and breathing methods need skilled physiotherapists in ICUs, mechanical devices can be used with limited training. These devices also avoid direct contact of medical health workers with COVID-19 patients.

One of the mechanical methods for Airway Clearance is the sound based vibrations to lungs. These vibrations are the proven method to loosen the mucous, sputum, fluid filled in the lungs by lowering the viscous properties of these fluids. Once these fluids become loose, they come out of our body by coughing to improve respiration.

Science behind Pulmonator:

1. Identify resonant frequency of the lung based on Hahn et al. 1990

2. Produce the desired resonant frequency

3. Provide the sound waves to the lung for 20 minutes

Pulmonator does all these three steps with mobile operated hardware. The device scans the individual’s lung to identify the resonant frequency and works accordingly for each individual making it very specific to the case. The entire device: hardware, algorithm and software is Indian.

We intend to unable proliferation of Airway Clearance devices through hospitals and front line health workers in India.

1. Only Indian player to ensure local availability an accessibility to BOP market

2. 50X cost reduction as compared to market available options

3. Pay per use service model available for avoiding capital cost to Hospitals or ICUs

4. Direct recommendation for COVID-19 with proven benefit for 36% cases

5. Own intellectual property and Indian patent filed

At present, airway clearance techniques are provided either as breathing exercises or manually by physiotherapists trained for ICUs. Pulmonator can be used by anyone either patient, nurse or any ICU attendants. This is a simple device where one needs to hold over the chest and it starts operating.

India has become the fourth country globally in terms of total cases of COVID-19 and Pulmonator will come out to be direct contribution or fast recovery of patients.

Unique product and business value propositions:

1. Only Indian player 
2. Minimum 50X cost reduction than market available options (e.g Dymedso Frequencer)
3. Pay per use service model available for avoiding capital cost to Hospitals or ICUs
4. Direct recommendation for COVID-19 with proven benefit for 34% cases

5. Own intellectual property and patent

One of the mechanical methods for Airway Clearance is the sound based vibrations to lungs. These vibrations are the proven method to loosen the mucous, sputum, fluid filled in the lungs by lowering the viscous properties of these fluids. Once these fluids become loose, they come out of our body by coughing. This way the overall respiration levels are improved.

The science behind the Pulmonator is based on three stages:

1. Identify resonant frequency of the lung based on 1990’s research by Hahn et al.

2. Produce the desired resonant frequency

3. Provide the sound waves to the lung

Pulmonator does all these three steps with mobile operated hardware. The device scans the individual’s lung to identify the resonant frequency and works accordingly for each individual making it very specific to the case. The entire device: hardware, algorithm and software is Indian.

Competition:

Automatic Airway Clearance Devices are not manufactured in India. In India, breathing exercises by the patient himself are done or the trained physiotherapists do manual treatments. At the global level, following companies produce them outside India and these devices are imported to India at prohibitively high cost.

1. DyMedso: Canada and USA: Direct Competition: INR 1.3 million base price

2. ElectroFlow 500: USA: Indirect Competition: Not available in India

3. Hill-Rom: Indirect competition: INR 600,000 base price

Development Status:

Pulmonator prototyping, testing and patient level trials have been done successfully. The key performance parameters of desired frequency range, intensity and smooth operations have been done with patient trials. The product’s intellectual property has been protected via patent.

Today: 110

1 Year: 300,000

5 Year: 5 million

1. Regulatory challenge: Standards, compliance and certifications
2. Distribution challenge: For small startup this is a challenge

1. Regulatory challenge: Obtained CDSCO No Objection. In the process of applying for FDA 501k pre market validation.
2. Distribution challenge: Partner with pan India medical device distributors and pharmaceutical companies.

Full Time: 5
Part Time: 3

Diverse interdisciplinary team with business experience

• Medical doctor is on board
• Engineering team is in place
• Business and management expertise is available in the team

Partnerships

• Hedgewar hospital and KEM Hospital Mumbai
• Research technology partner ICT Mumbai and IIT Bombay

The Pulmonator is developed by a consortium of start-ups under the COVID emergency. The intellectual property is owned by Dr. Aditya Vaidya who is Masters in Physiotherapy and the head of the department, Dr. Hedgewar Hospital and Research Center. The commercial part is led by S4S Technologies (Mumbai) in association with CareNX Innovations (Mumbai), Institute of Chemical Technology (Mumbai and Bhubaneswar), Dr. Shital Munde- Masters in Pathology and Afferent Technologies (Pune).