Periodic Reporting for period 1 - Avodes-Biotech (Avodes - biotechnological menstrual product for Candidiasis prevention)
Berichtszeitraum: 2022-06-01 bis 2022-11-30
372 million women globally have a silent torturer - recurrent vulvovaginal candidiasis (VVC).
Despite therapeutic advances, VVC remains a common problem worldwide, affecting all strata of society and being
the second largest gynaecological infection. If it is left untreated, many complications have been appointed as its consequence, such
as infertility, subsequent preterm delivery, suppression of the immune system, pelvic inflammatory disease, ectopic pregnancy, pelvic
abscess, menstrual disorders and miscarriage.
Avodes has developed an innovative medical device - a patented anatomically shaped “moist sponge” made of
completely natural, biodegradable materials (biodegradable within 1 month). It protects innate defence mechanisms of vaginal
microflora during most vulnerable period – menstruation. Unique Avodes biotechnological solution
preserves women’s natural vaginal microbiota in the same time selectively inhibiting growth of pathogenic microorganisms. It
inhibits Candida by 85 % thus treating and preventing the disease. Avodes effectively disrupts the vicious cycle of ”microbiota
disbalance –> infection –> antibiotic/fungicidal treatment–> microbiota disbalance” and offers break-through solution which
protects women’s health and the environment.
Women Tech EU programme supported company in upgrading the business model, business and marketing plan, market
validation and helped to find partners (clinical, manufacturing and commercial) as well as to prepare funding strategy. Successful
project implementation provided much needed tailwind to our company to bring the product to the market.
Despite therapeutic advances, VVC remains a common problem worldwide, affecting all strata of society and being
the second largest gynaecological infection. If it is left untreated, many complications have been appointed as its consequence, such
as infertility, subsequent preterm delivery, suppression of the immune system, pelvic inflammatory disease, ectopic pregnancy, pelvic
abscess, menstrual disorders and miscarriage.
Avodes has developed an innovative medical device - a patented anatomically shaped “moist sponge” made of
completely natural, biodegradable materials (biodegradable within 1 month). It protects innate defence mechanisms of vaginal
microflora during most vulnerable period – menstruation. Unique Avodes biotechnological solution
preserves women’s natural vaginal microbiota in the same time selectively inhibiting growth of pathogenic microorganisms. It
inhibits Candida by 85 % thus treating and preventing the disease. Avodes effectively disrupts the vicious cycle of ”microbiota
disbalance –> infection –> antibiotic/fungicidal treatment–> microbiota disbalance” and offers break-through solution which
protects women’s health and the environment.
Women Tech EU programme supported company in upgrading the business model, business and marketing plan, market
validation and helped to find partners (clinical, manufacturing and commercial) as well as to prepare funding strategy. Successful
project implementation provided much needed tailwind to our company to bring the product to the market.
Objectives achieved: Conducted market validation and prepared a detailed business plan involved:
1. Updated the business plan and growth strategy.
2. Market validation.
3. Connected commercial, clinical partners and investors.
1. Market entry preparation:
1.1. Finetuned market entry strategy and business model. IP protection and FTO.
1.2. Market traction research and user feedback.
1.3. Expansion of potential commercial partners (distributers, manufacturers etc.).
2. Clinical preparation:
2.1. Refined regulatory and clinical validation strategy.
2.2. KOL feedback and supporting KOL network expansion (gynaecologists).
2.3. Clinical partners – network of clinics in EU for clinical trial expanded.
3. Funding:
3.1. Funding strategy prepared and submitted EIC grant application.
3.2. Approached potential corporate partners within the industry and beyond.
3.3. Approached potential angel investors, VC funds, other funding partners.
1. Updated the business plan and growth strategy.
2. Market validation.
3. Connected commercial, clinical partners and investors.
1. Market entry preparation:
1.1. Finetuned market entry strategy and business model. IP protection and FTO.
1.2. Market traction research and user feedback.
1.3. Expansion of potential commercial partners (distributers, manufacturers etc.).
2. Clinical preparation:
2.1. Refined regulatory and clinical validation strategy.
2.2. KOL feedback and supporting KOL network expansion (gynaecologists).
2.3. Clinical partners – network of clinics in EU for clinical trial expanded.
3. Funding:
3.1. Funding strategy prepared and submitted EIC grant application.
3.2. Approached potential corporate partners within the industry and beyond.
3.3. Approached potential angel investors, VC funds, other funding partners.
Disease treatment and prevention with natural solutions provide a direct response to the market needs. We have already confirmed interest in the product from users. The initial prototype was already tested in pilot clinical trials, which is strong foundation for final product development and validation. There is a high unmet medical need due to low treatment efficacy, relapse rates.
A goal driven and experienced development team strengthened with new members is fully capable of bringing the technology to the market. The strong support of KOLs will help leverage market entry and communication. Strong IP position will create barriers for competitors. The timing for market entry is perfectly aligned with market trends. Entering the market as the first product for gynaecological infections treatment and prevention of their recurrence will help to establish strong brand position and will accelerate market uptake.
The key needs to ensure further uptake and success may be fulfilled by ensuring adequate funding for the project, therefore, securing EIC funding for the project is of utmost importance. So far, the company succeeded in securing capital for initial product development and testing in pre-clinical and clinical trials, however, funding for commercialisation and market entry poses a real challenge. Delays in securing funding will cause delays in regulatory approvals and market entry.
A goal driven and experienced development team strengthened with new members is fully capable of bringing the technology to the market. The strong support of KOLs will help leverage market entry and communication. Strong IP position will create barriers for competitors. The timing for market entry is perfectly aligned with market trends. Entering the market as the first product for gynaecological infections treatment and prevention of their recurrence will help to establish strong brand position and will accelerate market uptake.
The key needs to ensure further uptake and success may be fulfilled by ensuring adequate funding for the project, therefore, securing EIC funding for the project is of utmost importance. So far, the company succeeded in securing capital for initial product development and testing in pre-clinical and clinical trials, however, funding for commercialisation and market entry poses a real challenge. Delays in securing funding will cause delays in regulatory approvals and market entry.