Launched or under launch (2013-2015) : Australia, Canada, Dubai, Egypt, Hungary, India, Israel, Lebanon, Malaysia, Middle East, Philippines, Saudi Arabia, South Africa, Tunisia, Vietnam…
20mL Class I Medical Device for the treatment of Radiotherapy & Chemotherapy-induced Oral Mucositis (Official Indication)
Physiopathology of Oral Mucositis: Oral mucositis is a very common side effect of cancer chemotherapy. The oral mucosa being one of the fastest growing tissues in the body, cytostatic effect of cancer therapies on oral mucosa cells blocks cellular growth and causes mucositis lesions which cannot heal as long as the cancer treatment continues.
>20 proteolytic enzymes (MMPs) are secreted to clean the ulcers but they also destroy the cellular matrix & stop cell growth. Microbial growth starts, circulating chemicals infiltrate the lesions, causing severe irritation & pain, and the patient suffers until anticancer treatment is stopped.
Ideal Treatment Approach:
1. Clean the ulcer of microbial contaminants
2. Remove continuously the toxic infiltrating chemicals to minimize pain & irritation
3. Identify & neutralize specific Extra-cellular Matrix (ECM)-destroying MMPs (Matrix Metallo-Proteinases) so as to provide an intact cellular matrix for new cell growth.
Currently Available Treatments: Only symptomatic treatments (antiseptics, anesthetics, growth factors,…)
VITROBIO‘s Completely NEW Therapeutic Approach: Employing in vitro technology, Vitrobio identified ECM-destroying MMPs involved in oral Mucositis, and used procyanidins (PCDs), which are very big & inert natural plant molecules having a strong affinity for specific proteins, to neutralize these MMPs. A restored ECM rapidly stimulates cell growth & the healing process can resume.
These PCDs were incorporated into a hypertonic viscous liquid (VB-Gy), 18 times more osmotically active than sea water yet NONIRRITANT (International patent 1997: PCT/FR99/01340). A new patent on a filmogen VB-Gy solution was recently filed (N°PCT/EP2013/061835). When applied as a thin layer on the Mucositis ulcer, OROSOL instantly forms a film & creates a strong outward flow of hypotonic liquid, instantaneously detaching all the contaminants, PCD-MMP conjugates, and infiltrating chemicals from the injury. A clean environment reduces pain, stimulates partial ulcer healing, and minimizes new ulcer formation & expansion.
OROSOL is the 1st specific treatment for Oral Mucositis.
Product Presentation: 20mL Spray.
Posology: 4-5 sprays every 2 h in the beginning of treatment, then 3-4 times a day.
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 the pediatric population under 3 years of age. Totally safe during pregnancy or lactation.
Side Effects: Slight burning sensation for about 1 min following product
Clinical Efficacy: Full article in J Cancer Res & Treatment (1) 4-11, 2013. DOI:
Conclusion: Marked reduction in mucositis grade, burning
sensation, pain, infection, ulcer expansion, & overall mucositis.