In addition, MedInvent has obtained ISO 13485 and CMDCAS certification. These certifications, together with CE Marking, enable MedInvent to expand the market for the NasoNeb II Nasal Nebulizer to the member countries of the European Union and to seek regulatory approval in countries around the world.
The NasoNeb System has been the delivery device of choice in multiple peer-reviewed trials, where it has demonstrated positive outcomes in chronic sinusitis and allergic rhinitis patients. The System is a controlled intranasal delivery system whereby its unique combination of droplet size, airflow, and fluid volume allows delivery solely to the nasal and paranasal sinus cavities.
In addition, the NasoNeb offers broad intranasal drug deposition, high intranasal drug retention, and no pulmonary deposition. Other delivery devices reach a limited area of the nasal cavity, deliver a weak solution, or deliver a portion of the medication to the lungs, which can cause unwanted side effects.
“We look forward to working with European physicians treating patients who suffer with sinus conditions,” said William Flickinger, MedInvent Managing Partner. “In particular, for those people who have not responded to therapy in the way their physicians would have expected, despite their physician’s best efforts, the NasoNeb System represents a promising new delivery method to ensure that a high concentration of medication is delivered throughout the nasal and paranasal sinus cavities.”
In the US, the NasoNeb System is available through the member pharmacies of the NasoNeb Pharmacy Network.