Periodic Reporting for period 2 - AVeta (Hormone-free solution for vaginal atrophy)
Berichtszeitraum: 2023-04-01 bis 2024-12-31
Vaginal Atrophy (VA) is a chronic and progressive condition that is a consequence of reduced oestrogen production. VA impacts on the quality of life, relationships, everyday activities and confidence of women sufferers. It is associated with thinning, drying and inflammation of the vaginal tissue as moisture, elasticity and blood flow is reduced. VA increases RUTIs as pH levels are high. It is experienced by 80% of all women globally and is the most common symptom of the menopause. Over 70% of BCSs will also suffer from VA due to side effects of chemotherapy and the cancer-blocker drugs they take further exacerbate VA symptoms. Current treatment options for VA, are either ineffective or poorly tolerated. In the EU and US, 3.6m patients reject existing treatments. A further, 6m women are using HT but are not happy with its safety concerns or side effects but have no alternative. Women with VA is rising, driven by aging populations, longer life expectancies, better BC survival rates and a more educated informed demographic who want hormone-free options.
This EIC-funded project will facilitate the consortium to generate a viable solution called AVeta.
AVeta -
•A safe, hormone-free solution.
•Low risk, simple treatment.
•Suitable for all patient groups.
• Natural healing therapy / drug free.
•Specific targeted therapy for VA-treats the underlying physiology cause of VA.
•Therapy is immediate and long lasting (4wks). •Long-term therapeutic benefits for VA.
•Suitable for long-term use. •No clinical side effects / safety issues.
•A universal / inclusive solution for all VA sufferers.
• Affordable.
•Improve quality of life-relief to chronic symptoms & RUTIs.
•Convenient- fits into a woman’s lifestyle- monthly, 15 min home therapy.
•Clinically prescribed, personalised, monitored treatment.
•Reduce RUTIs, vaginal infections- leading to decrease use of antibiotics.
•Improve compliance.
•Renewal prescriptions and reviews can be conducted in clinic or via telemedicine platforms.
•Improve health care outcomes –via app, subscription model and community forum.
This EIC-funded project will facilitate the consortium to generate a viable solution called AVeta.
AVeta -
•A safe, hormone-free solution.
•Low risk, simple treatment.
•Suitable for all patient groups.
• Natural healing therapy / drug free.
•Specific targeted therapy for VA-treats the underlying physiology cause of VA.
•Therapy is immediate and long lasting (4wks). •Long-term therapeutic benefits for VA.
•Suitable for long-term use. •No clinical side effects / safety issues.
•A universal / inclusive solution for all VA sufferers.
• Affordable.
•Improve quality of life-relief to chronic symptoms & RUTIs.
•Convenient- fits into a woman’s lifestyle- monthly, 15 min home therapy.
•Clinically prescribed, personalised, monitored treatment.
•Reduce RUTIs, vaginal infections- leading to decrease use of antibiotics.
•Improve compliance.
•Renewal prescriptions and reviews can be conducted in clinic or via telemedicine platforms.
•Improve health care outcomes –via app, subscription model and community forum.
Technology/knowledge to be developed under this project in the 24 months from project start (May 2022 - April 2024):
•Clinical: clinical data to drive adoption at US trial sites and de-risk the EU clinical trials in year 1 post EIC. Map out opportunities for further clinical studies to drive adoption.
•IP: further foreground IP filed with new inventions for other woman’s health indications. Enables defense of the technology and reduces the risk for private investors looking to provide follow on equity finance in Years 3-5 post project.
•Commercial: refine market geography expansion plan with US clinical sites to drive adoption.
•Regulatory: FDA clearance will enable marketing of the device with unique indications in the US with first patient being treated in month 6 post project. This will enable cashflow for US market entry and EU FIW clinical study and CE approval.
•Financial: private investment to support US commercialisation and EU clinical trials in Year 1 and subsequent CE market approval and EU launch in year 2.
•Recruitment: US Sales reps, logistics partner and marketing.
Prior to EIC Accelerator AVeta project awarding, past technology achievements include:
TRL1-2: Awarded >€600k in grant funding, to support the development.
Q1 2018 TRL3: Preliminary testing to optimise design and characterise the micro-trauma process with ex vivo ovine tissue. A range of tip geometries and pressure levels were analysed.Q4 2018
TRL4/5: Experimental proof of concept validated on ex-vivo ovine carcass- sizing, pressure levels optimised. In-vivo rodent model testing confirmed no evidence of pain during micro-trauma therapy.
Q1 2019 TRL6: Preclinical studies conducted in ovine models (ovariectomised to induce VA). Pressure of 500mmHg applied and maintained for 3mins. Testing confirmed efficacy of the micro-trauma therapy- rejuvenation of the vaginal tissue. No fibrosis from therapy.
Q2 2020 TRL6: Human exploratory studies conducted on healthy vagina tissue using an approved medical suction device (Surgimark). A US IRB feasibility study approved for the development of AVeta device using an approved medical suction device with similar geometry to AVeta.
•Clinical: clinical data to drive adoption at US trial sites and de-risk the EU clinical trials in year 1 post EIC. Map out opportunities for further clinical studies to drive adoption.
•IP: further foreground IP filed with new inventions for other woman’s health indications. Enables defense of the technology and reduces the risk for private investors looking to provide follow on equity finance in Years 3-5 post project.
•Commercial: refine market geography expansion plan with US clinical sites to drive adoption.
•Regulatory: FDA clearance will enable marketing of the device with unique indications in the US with first patient being treated in month 6 post project. This will enable cashflow for US market entry and EU FIW clinical study and CE approval.
•Financial: private investment to support US commercialisation and EU clinical trials in Year 1 and subsequent CE market approval and EU launch in year 2.
•Recruitment: US Sales reps, logistics partner and marketing.
Prior to EIC Accelerator AVeta project awarding, past technology achievements include:
TRL1-2: Awarded >€600k in grant funding, to support the development.
Q1 2018 TRL3: Preliminary testing to optimise design and characterise the micro-trauma process with ex vivo ovine tissue. A range of tip geometries and pressure levels were analysed.Q4 2018
TRL4/5: Experimental proof of concept validated on ex-vivo ovine carcass- sizing, pressure levels optimised. In-vivo rodent model testing confirmed no evidence of pain during micro-trauma therapy.
Q1 2019 TRL6: Preclinical studies conducted in ovine models (ovariectomised to induce VA). Pressure of 500mmHg applied and maintained for 3mins. Testing confirmed efficacy of the micro-trauma therapy- rejuvenation of the vaginal tissue. No fibrosis from therapy.
Q2 2020 TRL6: Human exploratory studies conducted on healthy vagina tissue using an approved medical suction device (Surgimark). A US IRB feasibility study approved for the development of AVeta device using an approved medical suction device with similar geometry to AVeta.
This scientific work plan is compiled of 8WPs each focusing on specific deliverable and milestones to bring the AVeta product to market. WP1-6 outline how this EIC grant funding will produce a sophisticated device solution, at TRL 8 with robust clinical evidence.
WP7 and 8 outlines how equity funding will be utilised, with WP7 addressing market deployment and scale-up activities with an AVeta device (TRL 9) and WP8 outlines the management of the private investment covered by the equity funding.
The work plan follows a carefully mapped timeline to achieve regulatory requirements for launch in the US and subsequently in the EU.
An overview of the technology/knowledge to be developed under this project in the 24 months from project start (May 2022 - April 2024) is shown across the main areas of: clinical, IP, Commercial, Regulatory, Financial and Recruitment.
•Clinical: clinical data to drive adoption at US trial sites and de-risk the EU clinical trials in year 1 post EIC. Map out opportunities for further clinical studies to drive adoption.
•IP: further foreground IP filed with new inventions for other woman’s health indications. Enables defense of the technology and reduces the risk for private investors looking to provide follow on equity finance in Years 3-5 post project.
•Commercial: refine market geography expansion plan with US clinical sites to drive adoption.
•Regulatory: FDA clearance will enable marketing of the device with unique indications in the US with first patient being treated in month 6 post project. This will enable cashflow for US market entry and EU FIW clinical study and CE approval.
•Financial: private investment to support US commercialisation and EU clinical trials in Year 1 and subsequent CE market approval and EU launch in year 2.
•Recruitment: US Sales reps, logistics partner and marketing.
WP7 and 8 outlines how equity funding will be utilised, with WP7 addressing market deployment and scale-up activities with an AVeta device (TRL 9) and WP8 outlines the management of the private investment covered by the equity funding.
The work plan follows a carefully mapped timeline to achieve regulatory requirements for launch in the US and subsequently in the EU.
An overview of the technology/knowledge to be developed under this project in the 24 months from project start (May 2022 - April 2024) is shown across the main areas of: clinical, IP, Commercial, Regulatory, Financial and Recruitment.
•Clinical: clinical data to drive adoption at US trial sites and de-risk the EU clinical trials in year 1 post EIC. Map out opportunities for further clinical studies to drive adoption.
•IP: further foreground IP filed with new inventions for other woman’s health indications. Enables defense of the technology and reduces the risk for private investors looking to provide follow on equity finance in Years 3-5 post project.
•Commercial: refine market geography expansion plan with US clinical sites to drive adoption.
•Regulatory: FDA clearance will enable marketing of the device with unique indications in the US with first patient being treated in month 6 post project. This will enable cashflow for US market entry and EU FIW clinical study and CE approval.
•Financial: private investment to support US commercialisation and EU clinical trials in Year 1 and subsequent CE market approval and EU launch in year 2.
•Recruitment: US Sales reps, logistics partner and marketing.