15mL Class I Medical Device for the treatment of Rhinitis, Rhinosinusitis and Nasal Congestion (Official Indication)
Ideal Treatment Approach: Rupture and break up the bacterial biofilm, remove bacteria, stop and prevent further intrasinusal virus multiplication.
RHINITIS, RHINOSINUSITIS & NASAL CONGESTION
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, blocking the sinus openings, causing inflammation and intrasinusal pressure & pain.
Currently Available Treatments:
• Topical Anti-Virals: none (Cyclovirs & Tamiflu act intracellularly).
• Sinus-blocking bacterial biofilm buster: none
• Symptomatic (9 out of 10 OTC ENT products sold in pharmacies). Best one available: Sea Water, but irritant & not efficient to break open the sinus-blocking biofilm due to insufficient osmotic activity.
VITROBIO‘s Completely NEW Therapeutic Approach: Protein Hypothesis as Topical Anti-Viral & Anti-Bacterial drugs.
In topical virus infections, most virus particles are present on the biological surface. Virus attaches to the cells through specific surface Glycoproteins (GPs) such as the Hemagglutinin & Neuraminidase (H1N1, H6N9) on the flu virus, continues infecting new cells from outside and maintaining the infection. As certain polymers (HPM for ex) have a strong affinity for proteins & other macromolecules (such as bacterial Lipopolysaccharides-LPS), Vitrobio identified & used natural polymers as a new therapeutic approach to neutralize infection on the surface. (Ref: Vitrobio new anti-viral hypothesis – Shrivastava et al: Int. J. Virology, ISSN 1816-4900 / DOI: 10.3923/ijv.2011).
These polymers are incorporated into a glycerol-based viscous liquid, 18 times more osmotically active than sea water yet NON-IRRITANT (International patent 1997: PCT/FR99/01340). A new patent on the film retention properties of this solution was recently filed (N° PCT/EP2013/061835). Spraying NESOSPRAY-HE on the nasal mucosa instantly forms a film, attracts hypotonic liquid, breaks the biofilm within 15-20 min, opens & drains sinuses, relieves intra-sinusal pressure & reduces pain. NESOSPRAY-HE also contains a synergistic association of essential oils which provides a pleasant, refreshing & soothing sensation, and helps to further minimize mucosal irritation, redness & bacterial growth, thereby reducing the need for antibiotherapy.
Product Presentation: 15mL Spray
Posology: 2-3 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 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 with closely similar product (identical mode of action) published in Am. J PharmTech Res. 3(2), 2013:
Conclusion: 1st topical spray to instantly relieve the signs & symptoms of rhinosinusitis and rhinitis.