PulseHaler™: A Novel Treatment Device for COPD.

Chronic Obstructive Pulmonary Disease (COPD) is a progressive, debilitating disease that causes airway constriction, loss of lung function, and chronic hyper-secretion of mucus. It severely impairs quality of life of the patients it afflicts and of their families. It affects over 50M people in the EU and kills over 160,000 every year. Globally it is the 4th leading cause of death. Drug therapy has had limited effect on patients because bronchodilators work on smooth muscle surrounding the airways. However, the small airways at the periphery of the lung, where much of the disease occurs, has no smooth muscle to target. Other therapies, such as vibration devices, pulmonary rehabilitation, oxygen therapy, and surgery, are each limited in some way (limited effectiveness, limited applicability, side effects, etc.). The annual cost burden of COPD in Europe is €141B, yet every year, the burden of COPD increases. There is an extreme need for a new tool in the battle against COPD. If Pulsehaler™ can reduce the cost burden by the same magnitude to which it has been demonstrated to improve patient’s exercise capacity, these costs could be reduced by up to €21B annually.

Respinova Ltd. has created the Pulsehaler™ technology for treating the core patho-physiology of COPD, “small airway disease”. Pulsehaler™ provides a stream of low pressure, high frequency, pressure pulses into the airway while the patient breathes on it. These pulses gently pry open the airways, while the pressure keeps them open. The frequency of the pulses also changes the viscosity of mucus making it more fluid and easier to expel. Pulsehaler™’s effectiveness was proven in a clinical study which showed that exercise capacity improved more than double the clinical gold standard difference, and more than 4x the reported improvement of drugs. Quality of life and lung function were also substantially improved.

The overall objectives of the project are to complete the design and manufacturing ramp up of the Pulsehaler, obtain regulatory approval in initial launch jurisdictions, and complete a clinical trial to drive adoption.

We completed the design of Pulsehaler™ addressing market requirements and regulatory requirements. We completed the mechanical, software, and electronics design, completed the test and regulatory phase, and passed verification testing. We made design improvements for molding and mass production, as well as to improve product performance. We implemented our internal ISO13485 Quality Management System and passed our ISO13485 audits as well as our regulatory audit under the new EU Medical Device Regulations (MDR). We also passed several annual surveillance audits to maintain our certification. We applied for and received clearance from the US FDA for Pulsehaler™, and passed the review of our Notified Body of our technical file for CE Mark. We initiated the clinical trial of the Pulsehaler™, and we increased awareness of Pulsehaler™ among KOLs, patients, potential distributors, and other stakeholders

Pulsehaler™ will greatly advance the state of the art with respect to COPD treatment, as no current device or therapy targets the re-opening of the small airways, which is the most important component of COPD. The potential impacts continue to include significantly reduced cost burden in the EU for treating such patients, and a dramatic improvement in the Quality of Life of these patients and their families.

Periodic Reporting for period 4 - STOP-COPD (PulseHaler™: A Novel Treatment Device for COPD.)

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