RHINOSINUSITIS
Physiopathology:
Usually starting as a viral infection: the virus infects the nasal cavity, and then extends to the sinuses where it multiplies and leads to secondary bacterial infections and formation of bacterial biofilm which blocks the sinus openings, trigger nasal inflammation, intrasinusal pressure & pain.
Ideal Treatment Approach:
should protect nasal mucosa, remove contaminants, open blocked sinuses & drain the contaminants to relieve sinus pain & inflammation. Should act topically to avoid side effects without being irritant.
Currently Available Treatments:
- Topical Anti-Virals: none (Cyclovirs & Tamiflu act intracellularly & can’t reach the sinuses).
- Sinus-blocking bacterial biofilm buster: none
- Symptomatic (9 out of 10 OTC ORL/ENT products sold in pharmacies). Best one available: Sea Water, but not efficient to break open the sinus-blocking biofilm due to insufficient osmotic activity & have poor cleaning properties.
15mL Class I Medical Device for the treatment of Rhinosinusitis
1st topical Non-Irritant Instant Spray to treat Rhinosinusitis
VITROBIO‘s NEW Therapeutic Approach:
In topical virus infections, most virus particles are present on the biological surface. The virus attaches to the cells through specific surface Glycoproteins (GPs) such as the Hemagglutinin & Neuraminidase (H1N1, H6N9) on the flu virus & enters the cell. Virus grows & kill the cells, liberating millions of free virus particles on the nasal mucosa which continue attacking new healthy cells. Dead & dying cells create a favorable environment for microbial growth which enter the sinuses & make the infection chronic. A good therapy should clean the nasal mucosa, open & drain the sinuses, & repair damaged mucosa.
VITROBIO conceived a glycerol-based viscous liquid, 18 times more osmotically active than sea water yet NON-IRRITANT (International patent 1997: PCT/FR99/01340). This film was rendered adherent, absorbent, and stable over a period of few hours (2-6 depending upon the nasal flow) when applied on the nasal surface (N° PCT/EP2013/061835). Being hypertonic, the film exerts a strong osmotic pressure over the surface, attracting all the free floating nasal surface contaminants such as bacteria, viruses, protein molecules involved in inflammation thereby reducing pain, irritation, & itching and reducing the need for antibiotics.
The osmotic pressure exerted over the sinus blocking bio-membrane may break-open the sinuses which can be evedient by & sudden & strong nasal discharge followed by instant reduction in sinus pain. Results are based on a mechanical approach, are nearly instant (5-min) and without any undesired effect or nasal irritation. (For detailed mode of action: please contact Vitrobio)
Product Presentation: 15mL Spray
Posology: 3-4 sprays per nostril, 2-3 applications per day or more if necessary, until complete recovery.
Regulatory Status: Due to the mechanical topical filmogen activity without any pharmacological, biological, metabolic or immunological interaction with the cellular structure: Class I (Class II a or IIb as per new MDR rules) Medical Device in Europe.
Contraindications: Not to be used in pediatric population under 12 years of age.
Side Effects: Slight irritation or tingling sensation during the first 20-30 seconds following application.
Clinical Efficacy:
Full trial published in American Journal of Pharmatech Research, 2013: Comparison of a Hypertonic Tannin-rich Solution vs 3% NaCl Solution as Treatment for Rhinosinusitis
Full trial published in Journal of Clinical Respiratory Diseases and Care, 2017: Clinical Efficacy of a New Filmogen Polymeric Glycerol Solution for the Treatment of Rhinosinusitis
