Descripción del proyecto
Un dispositivo innovador para el tratamiento de la enfermedad pulmonar obstructiva crónica
La enfermedad pulmonar obstructiva crónica (EPOC) constituye un grupo de afecciones respiratorias debilitantes, como el enfisema y la bronquitis crónica, caracterizadas por limitaciones en el flujo de aire pulmonar, tos y una menor capacidad pulmonar funcional. La EPOC podría estar asociada con el tabaquismo y la exposición a polutantes atmosféricos y, cada año, provoca la muerte de millones de personas en todo el mundo. La empresa israelí Respinova ha desarrollado un dispositivo para el tratamiento de la EPOC a través de la apertura de las vías respiratorias pequeñas, que se suelen colapsar en los enfermos con EPOC, lo que crea dificultades para respirar. El prototipo del dispositivo superó el ensayo clínico y mejoró la capacidad pulmonar funcional de enfermos con EPOC. En el proyecto PulseHaler, financiado con fondos europeos, se llevará a cabo un estudio de viabilidad que incluye análisis de mercado, una evaluación de riesgos clínicos y técnicos y la identificación de partes interesadas.
Objetivo
Chronic obstructive pulmonary disease (COPD) is a group of progressive, debilitating respiratory conditions, including emphysema and chronic bronchitis, characterized by difficulty breathing, lung airflow limitations, cough, and markedly reduced functional capacity. COPD often is associated with a history of cigarette smoking or exposure to pollutants. It kills approximately 270,000 people in the EU annually, equivalent to the size of the entire city of Venice. It affects 4% and 10% of adults in Europe (Halbert et al., 2003). World-wide 5-10% are affected and 3 million die each year (source: WHO). In the developing countries, COPD has been growing dramatically due to increased air pollution, smoking and massive use of biomass fuels for cooking.
Respinova has developed a novel non-invasive technology and medical device named the PulseHaler™, that aims to treat the core of the COPD pathophysiology – small airway collapse.
The technology was successfully validated in two clinical studies. In the first study, PulseHaler was evaluated for its ability to open small airways. Clinical results demonstrated unprecedented improvements in the 6 minute walk test (6MW), spirometry lung functions tests and in the feeling of dyspnoea. All of these effects were above and beyond the effect of standard pharmaceutical care.
In the second study, PulseHaler™ was successfully used as a new means for improved delivery of inhaled drugs to the terminal bronchioles and the alveolar zone in COPD patients. It resulted in three-fold enhancement of penetration index, a measure of efficiency of drug delivery. By improving the drug delivery, PulseHaler technology can enhance efficacy & safety of drug delivery. It can reduce the amount of drug required, ensure less drug goes to non-lung areas (mouth, stomach etc.), and reduce time required to deliver the drugs.
Ámbito científico
Programa(s)
- H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme
- H2020-EU.3.1.4. - Active ageing and self-management of health
- H2020-EU.2.1.1. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Information and Communication Technologies (ICT)
- H2020-EU.2.3.1. - Mainstreaming SME support, especially through a dedicated instrument
- H2020-EU.3.1.6. - Health care provision and integrated care
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-SMEINST-1-2016-2017
Régimen de financiación
SME-1 - SME instrument phase 1Coordinador
4672408 Herzliya Pituach
Israel
Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención.