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Rhinosinusitis

Launched or under launch (2014-2015) : France, Egypt, Poland, South Korea, Turkey, Vietnam….

RHINITIS, RHINOSINUSITIS & NASAL CONGESTION
15mL Class I Medical Device for the treatment of Rhinitis, Rhinosinusitis and Nasal Congestion (Official Indication)

Physiopathology: usually begins with 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.

An Ideal Treatment should :

  1. Neutralize free virus particles
  2. Stop inflammation
  3. Open the blocked sinuses
  4. Act rapidly
  5. Be totally safe

Currently Available Treatments

  • Topical Anti-Virals: none (Cyclovirs & Tamiflu act intracellularly but the viruses are present on the nasal mucosa).
  • Sinus-opening drugs: none
  • Symptomatic (9 out of 10 OTC ENT products sold in pharmacies). Best one available: Sea Water, hypertonic but irritant & not efficient to break open the sinus-blocking membrane due to insufficient osmotic activity.

VITROBIO‘s Completely NEW multi-factorial Therapeutic Approach:

In topical virus infections almost all the 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 & VP1,2,3,4 on the Rhinovirus. Virus grows in the cells & is then expulsed on the nasal mucosa. Destruction of nasal mucosa leads to the secretion of other proteins (the cytokines such as Interleukins), producing inflammation.

VITROBIO elaborated a natural, glycerol-based, viscous liquid, 18 times more osmotically active than sea water yet NON-IRRITANT (International patent 1997: PCT/FR99/01340). The osmotic solution was then rendered filmogen through adition of polymeric extracts for a long-lasting activity (Patent N° PCT/EP2013/061835). Spraying Nesospray on the nasal mucosa instantly forms a film, attracts hypotonic liquid, exerts sufficient osmotic pressure over sinus-blocking membrane to open & drain the sinuses. Relieving intra-sinuses pressure reduces pain. Cleaning bacterial contamination minimizes the need for antibiotherapy and subsequently allows to curb local inflammation. Some NESOSPRAY formulations also contains an association of slow-release & long-lasting Essential oils for a pleasant and soothing application.

Product Presentation: 15mL Spray. Totally safe. Class I medical device in EU. Ready to market.

Clinical Efficacy: See publications: (1) Shrivastava et al. J Clin Respir Dis Care 2017; 3:doi:10.4172/2472-1247.1000130.

(2) Shrivastava et al. Am J PharmTech Res. 2013; 3(2), 1-9. ISSN: 2249-3387

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:  Topical & Mechanical Anti-Viral & Anti-Bacterial & Anti-Inflammatory.
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.
VITROBIO elaborated 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, mucosal irritation, redness & bacterial growth, thereby reducing the need for antibiotherapy. NESOSPRAY-HE also contains an association of slow-release essential oils which provides a pleasant, refreshing & soothing sensation, and helps to further enhance the filmogenicity of the product for a longer activity on the nasal mucosa.

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 (due to the mode of action).
Clinical Efficacy: Full trial with closely similar product (identical mode of action) published in Am. J PharmTech Res. 3(2), 2013: