We are proud to announce that our BREATH project has been selected under the "Booster for Life Science – TRL Advancement" call, a strategic initiative by the Friuli Venezia Giulia Region aimed at funding industrial research and experimental development projects in high-tech sectors. The goal of this call is to support the validation of ideas and technologies by raising their Technology Readiness Level (TRL), facilitating the market entry of innovative solutions in the Life Sciences field. This important recognition gives momentum to an ambitious project dedicated to developing next-generation medical devices targeting “Cough & Cold” conditions, compliant with MDR regulations.
In the health sector, medical devices represent much more than simple tools: they are fundamental technologies for the diagnosis, prevention, and treatment of diseases and chronic conditions. Today, over 500,000 medical devices are authorized in Europe, used daily by millions of people.
Furthermore, the segment dedicated to seasonal respiratory disorders, such as cough and cold, is among the most dynamic in the sector. The increasing incidence of respiratory infections and the demand for safe solutions are driving the global market, which is estimated to grow by 6.5% annually through 2026, reaching a value exceeding 4.5 billion dollars.
It is in this context that BREATH is born, a multidisciplinary project that will develop at least four new medical devices with innovative formulations and advanced delivery methods. Among these, one will be specifically designed for pediatric use, ensuring safety, efficacy, and ease of use for children.
The objectives are clear:
Effectively manage dry and productive cough, cold, and sinusitis.
Prevent the onset of related respiratory complications.
Selected functional ingredients — such as hyaluronic acid, botanical extracts, and hypo/hypertonic saline solutions — will be at the core of the research. Supporting development are planned in vitro and clinical studies, stability testing, and process validations to ensure high-quality, safe, and durable products.
Furthermore, sustainability will be an integral part of the project, with the adoption, where possible, of eco-friendly packaging that is easily recyclable or biodegradable, designed to respect the environment without compromising formulation efficacy.
The BREATH devices — nasal sprays, oral sprays, nebulization solutions, and syrups — will be designed to meet diverse therapeutic needs, offering a simple and pleasant user experience.
With standardized manufacturing processes fully compliant with MDR regulations, BREATH aims to become a benchmark for a new generation of medical devices: natural, safe and effective.
The Biofarma Group team behind the development of the BREATH project
