Helicobacter pylori is a bacterium of the stomach which affects on average 50% of the world population, reaching up to 70% in some EU Countries. Once diagnosed, it has to be eradicated, since it is a carcinogen agent and around 90% of all gastric cancers can be attributable to its infection.
The only available treatment is a pharmacological therapy based on proton-pump inhibitor and a mix of 3 antibiotic drugs. The treatment for the bacterium eradication has severe side-effects due to the assumptions of several antibiotics for 14 days and has been proven to have negative impact on the gut microbiota. Due to increasing antibiotic resistance rates to the main antibiotics used for treatment, up to 20% of the affected population cannot be cured, despite several cycles of antibiotic therapy and usually endoscopic biopsy. Besides the social impact of such refractory cases, National Health Systems and patients have also to bear several costs linked to the repeated cycles of therapies, clinic visits and exams.
Probiomedica is a spin-off of the University of Florence and Scuola Superiore Sant’Anna, which has developed and patented CapsuLight, the first ingestible capsule able to eradicate H. pylori infection through intragastric photodynamic therapy, that is through the power of light. The device is based on the established technology and safety of endoscopic capsules, and our preliminary in vitro tests showed 97% efficacy in killing the bacterium. The advantages for infected population are unparalleled: the possibility to eradicate the bacterium for those who cannot be cured due to antibiotic resistance; the higher efficacy rate, no side effects due to antibiotic cycles, and easy posology for all the infected population (secondary market). CapsuLight will also provide high economic savings to National Healthcare Systems, by reducing drug therapies cycles and endoscopic biopsies and related costs. The objectives of the Phase 1 SME project were to define the final design of the capsule, set up a work plan for reaching the CE mark and certifications needed, study the market size and define the business model for producing, distributing and marketing the product. Probiomedica has presented the product to several gastroenterology centers and will optimize the capsule design for further miniaturization and mass production, undergoing the necessary clinical validation for getting the CE mark.
