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PulseHaler: Improving the Lives of COPD Patients

Periodic Reporting for period 1 - PulseHaler (PulseHaler: Improving the Lives of COPD Patients)

Reporting period: 2017-12-01 to 2018-04-30

Chronic Obstructive Pulmonary Disease (COPD) is a progressive, debilitating, disease of the lungs which kills almost 300,000 Europeans every year.

Respinova Ltd., has invented a device, called PulseHaler™, to treat COPD by opening the small airways which are known to collapse in COPD patients thereby making it increasingly difficult to breathe.

In a clinical trial, a prototype of the PulseHaler™ was shown to be safe and effective in substantially improving the functional capabilities of COPD sufferers.

In this Phase I grant project, Respinova conducted a feasibility study using market analysis, clinical and technical risk assessment, and customer acceptance validation. The company interviewed key opinion leaders to identify issues with introduction of the PulseHaler product, and conducted initial reimbursement assessments for key markets. The company also analysed key competitors, both direct and indirect, to identify potential risks and develop risk mitigations. Stakeholders and potential partners were identified, and issues with go to market strategy were identified.
During the analysis, the company identified technical weak points in the product, which will lead to design improvements prior to launch. We were also able to streamline our product line to address patient requirements with fewer models than initially contemplated. We identified initial target markets and go-to-market partners. The company also identified an important need for additional clinical information to support customer acceptance and reimbursement, leading to rapid growth of the technology both in Europe and World Wide. Improving the product from a usability standpoint, with new features and functionalities, will allow us to have a market ready product by Q3 2019, pending additional funding.
We conducted market research to size the addressable patients for PulseHaler, which we consider to include initially, patients classified as GOLD (Global Obstructive Lung Disease) II (Moderate) through IV (very severe), who would not otherwise be contraindicated for a treatment such as PulseHaler™ . We identified priority target markets for initial commercialization primarily considering a combination of market size, growth, and ease of market entry, including regulatory requirements. We researched competition through a combination of industry player interviews and online research, and performed a SWOT analysis.

We further developed our Technology and Innovation Roadmap by analyzing feedback from KOL’s regarding our planned product roadmap as well as use-case scenarios. We identified additional applications for our technology as well as features that can be added to current products to enhance functionality.