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

Physiopathology: usually begins due to 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 Therapeutic Approach: Protein antagonists as topical Anti-Viral, Anti-Bacterial & Anti-inflammatory drugs

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 &then expulsed on the nasal mucosa. Destruction of nasal mucosa leads to the secretion of other proteins (the cytokines such as Interleukins), producing inflammation

In 1994, a few scientists observed that skin proteins are blocked using tannins to convert skin into leather. A new hypothesis was generated: Tannins or polymers can be used to block virus proteins & stop virus entry into the cells and inflammatory proteins can be blocked to stop inflammation. After 18 years of R&D, specific non-toxic & safe, protein antagonist polymers were discovered. The polymers are inert, specific with respect to protein binding, and can neutralize up to 87% influenza virus along with 91% inflammatory proteins in less than an hour. 1st topical protease inhibitors are discovered in 2010.

These polymers are incorporated into a natural viscous liquid, 18 times more osmotically active than sea water yet NON-IRRITANT (International patent 1997: PCT/FR99/01340). The polymeric solution was then rendered filmogen for a long-lasting activity