PulseHaler™: A Novel Treatment Device for COPD.

ended

Chronic Obstructive Pulmonary Disease (COPD) is a progressive, debilitating, disease of the lungs which affects 50M Europeans and kills 160,000 every year, with an annual cost burden of €141B. Respinova Ltd. has invented a novel device, called PulseHaler™, to treat COPD in a revolutionary way by opening the small airways, which are known to collapse in COPD patients thereby making it increasingly difficult to breathe. No other COPD treatment in the market today can effectively open the small airways. In a clinical trial, the PulseHaler™ was shown to substantially improve the functional capabilities and quality of life of COPD sufferers. If PulseHaler™ can reduce costs by the same magnitude to which it has been demonstrated to improve patient’s exercise capacity (the strongest predictor of morbidity and mortality), the current cost burden of COPD in Europe could be reduced by up to €21B annually. After winning a SMEi-1 grant and receiving a Seal of Excellence certificate for our first SMEi-2 application, we intend to complete several actions which will bring the PulseHaler™ to the commercial market in this SMEi-2 project. The design of the device will be finalized incorporating features and functions identified in our successful SMEi-1 project. We will then prepare the PulseHaler™ for large scale manufacturing. We will test the PulseHaler™ in a clinical study of COPD patients across several sites, to gather additional efficacy and usability data identified by KOLs in SMEi-1 as important to support uptake of the product in the market. We will continue to develop our reimbursement strategy for initial markets, finalize distribution arrangements in those markets, obtain regulatory approval, and proceed to launch the PulseHaler™. Respinova Ltd. is a 10 year old SME based in Israel with 7 employees. We have a seasoned management team with decades of combined medical device, business and leadership experience.