Photo - Respinova Ltd / Pulsehaler
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Respinova Ltd / Pulsehaler

A Novel Respiratory Medical Device for Treating COVID-19

Israel
Market: Medicine
Stage of the project: Prototype or product is ready

Date of last change: 13.04.2020
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Idea

Pulsehaler is a clinically proven device initially developed for treating chronic lung disease. It can be used 3 ways in the battle vs COVID-19:
1. delaying or even preventing the progression of moderate/serious COVID-19 patients (who do not yet require mechanical ventilation) to a state where they require ICU ventilation
2. improving lung function and reducing residual effects of infection by treating COVID-19 patients post infection
3. reducing the need for hospitalization or the risk of secondary infection, by pre-treating high risk COPD patients at home prior to infection.

Current Status

Product is developed. Near production rampup. Clinical trials in COPD completed. Near to FDA / CE submission.

Market

COVID-19: 1 million patients and growing
COPD: 350 million patients worldwide, growing 4% per year.

Problem or Opportunity

COVID-19 is devastating the world, infected over 1 million people, and has killed over 100,000 people already. COPD, chronic lung disease, kills 3 MILLION people every year and affects over 350 million. In COPD, small airways get inflamed, fill with mucus, and collapse. No therapy on the market can re-open collapsed airways.

In COVID-19, recent data from autopsies showed that COVID-19 patients also have thick sticky mucus in their airways (https://www.taiwannews.com.tw/en/news/3878418). Furthermore, inflammation caused by the virus can also cause small airway constriction and collapese.

Solution (product or service)

Pulsehaler™ administers sequences of multi-frequency positive air pressure pulsations throughout a patient’s breathing cycle. Pulsehaler™ generates a pre-programmed protocol of pressure pulsations which have specific frequencies, waveform, pressure amplitude, and duration. It delivers these pressure pulses directly to the airway via a mouthpiece.

Pulsehaler™ is the first device to combine pressure pulses at a wide variety of frequencies, with its own positive pressure generator, and a unique method of air pressure pulse generation via air chopping. The initial trial of Pulsehaler™, conducted at Hadassah Medical Center, Israel was conducted on COPD patients. This trial demonstrated a significant improvement in exercise capacity (more than 2.5x the minimum clinical important difference ), inspiratory capacity, and FVC, as well as Borg Dyspnea Score and Mastery Score.

Investigators observed in many subjects a substantial increase in mucus production and decrease in mucus viscosity, together with improvement in mucus color. Pulsehaler™’s pulsating positive pressure air waves at these frequencies appear to help restore the proper function of respiratory cilia responsible for moving mucus out of the airway, and reduce mucus viscosity in the small airways. Furthermore, use of positive pressure during the breathing cycle prevents airway closure, allowing the cilia the time they require to resynchronize.

Chopping the airflow in a patented way produces pulse shapes, pressure amplitudes, and harmonic frequencies that have been demonstrated clinically to open airways, improve exercise capacity, and decrease breathlessness. In our COPD trial, the investigators observed enhancement of mucus clearance, although the degree was not quantified in this study. Mucus viscosity is affected by Pulsehaler™ through a thixotropic effect , whereby viscosity of a liquid can be changed by shaking or vibration (like shaking a ketchup bottle to make it more liquid).

Competitors

Direct competitors include various vibration devices from a number of companies. (eg. aerobika, acapella, flutter, lung flute). For COVID, there are other methods of treatment but nothing directly competitive to Pulsehaler that intends to treat moderate/severe patients pre-ICU.

Advantages or differentiators

Pulsehaler™ has numerous advantages over other treatment devices, including other oscillation devices, CPAP, and BIPAP:
1. Relies on patient’s normal breathing – Other airway oscillation devices require the patient to generate high flows and pressures to achieve oscillations.
2. Positive Pressure Support – By using a built-in turbine blower, rather than relying on patient-generated pressure, Pulsehaler™ provides positive pressure support to the patient during treatment, while the oscillations re-open closed airways and clear mucus.
3. Demonstrated Clinical Efficacy for Re-opening airways – See above
4. Easy for Patients to self-administer – awake patients can easily use Pulsehaler™ with a few minutes of training, and can use the device at home to prevent or slow the need for treatment in hospital. Treatments only 20 minutes, not needed continuously.
5. Multi-Patient Use – All patient contact parts and the patient filter can be removed and retained by patients, while the Base Unit and Hand Unit can be disinfected with viracide wipe-down. Pulsehaler™ is being adapted for use in COVID-19 to contain an exhalation filter to prevent virus spread.
6. Reduced Cost / Increased Effectiveness – Our estimate for the price of a Pulsehaler™ compares very favorably to the cost of ventilators ($10K-50K) and other therapies. Also, each Pulsehaler™ can be used in the hospital setting to treat multiple patients because of its short treatment time, thus further spreading the per-patient cost. Using Pulsehaler™ in the home setting to pre-treat high risk COPD patients can reduce hospital burden costs and the number of patients that need to be admitted.

Finance

Available to qualified investors upon signing a CDA.

Business model

We sell Pulsehaler systems and consumables to hospitals, nursing homes, and to patients. Either direct or via distributor depending on launch phase and market.

Money will be spent on

Clinical trial for COVID, FDA and CE approval.

Offer for investor

SAFE with discount to Series B valuation.

Team or Management

Risks

Adoption of new medical technologies always takes time and funding to continuously develop enough clinical data to support reimbursement and establishment as standard of care.

Incubation/Acceleration programs accomplishment

NA

Won the competition and other awards

Winners of Horizon 2020 SME Phase I (50K) and Phase II (2.4M EUR) grants.

Invention/Patent

14 issued patents from 6 patent families, another 10 applications pending.
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Idea
Current Status
Market
Problem or Opportunity
Solution (product or service)
Competitors
Advantages or differentiators
Finance
Invested in previous rounds, $
Business model
Money will be spent on
Offer for investor
Team or Management
Mentors & Advisors
Lead investor
Risks
Incubation/Acceleration programs accomplishment
Won the competition and other awards
Invention/Patent
Photos
Product Video