Summary
"There is a large unmet medical need for an efficient and highly accessible solution that can simultaneously treat and prevent BV and VVC, while removing the abuse of antibiotic and antimycotic drugs to avoid further antimicrobial resistance. The inefficacy of current solutions is demonstrated by the huge burden that BV/VCC bring to the society in terms of economic expenses (more than €3.8Bn annually), preterm births (5.4M per year), the huge prevalence of both diseases (more than 500M cases per year) and the deteriorated QoL for women. Gedea has developed pHyph, a patented pessary that due to its safe profile will be highly accessible as a first line OTC solution. pHyph is an antimicrobial-free dual solution with a new mode of action that targets both the treatment and prevention of BV and VVC, without the need of pathogen identification. pHyph will be commercialized as an OTC product in pharmacies and drug stores – where 90% of women with VI look for a treatment to the infection. The business model targeted for pHyph is a well-established and successful B2B2C model for this type of product. Our business model is highly scalable via planned partnerships with distributors and pharma companies, that will facilitate accelerated commercial deployment & scale up of our business throughout Europe & beyond. Gedea core team is composed by 9 persons with over 250 years of experience combined, including experts in clinical research, bioorganic chemistry, regulatory affairs, marketing, and business development. The company received the award ""Rapidus Company of the Year"" and appeared on Labiotech's list ""The 20 European Biotech Companies to Watch in 2022"".
During this project, Gedea will perform the necessary clinical trials, CE-Mark Certification and pre-market activities to commercialize pHyph (TRL 9 by 2026). In order to do so, Gedea requires an estimated expenditure of €11.9M, which is requested to the EIC through both Grant and Equity fund."
During this project, Gedea will perform the necessary clinical trials, CE-Mark Certification and pre-market activities to commercialize pHyph (TRL 9 by 2026). In order to do so, Gedea requires an estimated expenditure of €11.9M, which is requested to the EIC through both Grant and Equity fund."
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More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/101164403 |
| Start date: | 01-04-2024 |
| End date: | 31-07-2026 |
| Total budget - Public funding: | 3 799 375,00 Euro - 2 499 999,00 Euro |
Cordis data
Original description
"There is a large unmet medical need for an efficient and highly accessible solution that can simultaneously treat and prevent BV and VVC, while removing the abuse of antibiotic and antimycotic drugs to avoid further antimicrobial resistance. The inefficacy of current solutions is demonstrated by the huge burden that BV/VCC bring to the society in terms of economic expenses (more than €3.8Bn annually), preterm births (5.4M per year), the huge prevalence of both diseases (more than 500M cases per year) and the deteriorated QoL for women. Gedea has developed pHyph, a patented pessary that due to its safe profile will be highly accessible as a first line OTC solution. pHyph is an antimicrobial-free dual solution with a new mode of action that targets both the treatment and prevention of BV and VVC, without the need of pathogen identification. pHyph will be commercialized as an OTC product in pharmacies and drug stores – where 90% of women with VI look for a treatment to the infection. The business model targeted for pHyph is a well-established and successful B2B2C model for this type of product. Our business model is highly scalable via planned partnerships with distributors and pharma companies, that will facilitate accelerated commercial deployment & scale up of our business throughout Europe & beyond. Gedea core team is composed by 9 persons with over 250 years of experience combined, including experts in clinical research, bioorganic chemistry, regulatory affairs, marketing, and business development. The company received the award ""Rapidus Company of the Year"" and appeared on Labiotech's list ""The 20 European Biotech Companies to Watch in 2022"".During this project, Gedea will perform the necessary clinical trials, CE-Mark Certification and pre-market activities to commercialize pHyph (TRL 9 by 2026). In order to do so, Gedea requires an estimated expenditure of €11.9M, which is requested to the EIC through both Grant and Equity fund."
Status
SIGNEDCall topic
HORIZON-EIC-2023-ACCELERATOROPEN-01Update Date
26-12-2024
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