Periodic Reporting for period 1 - Seedchrony (Detecting the right moment to do embryo transfer in In Vitro Fertilisation treatments.)
Période du rapport: 2023-06-01 au 2024-02-29
Infertility, affecting one in every six couples worldwide, is on the rise due to factors like delayed childbearing, lifestyle, chronic conditions, and environmental influences. In assisted reproduction, In Vitro Fertilization (IVF) is increasingly preferred, with growing awareness and demand. Egg Freezing procedures are also gaining popularity among younger generations, indicating a rising demand for IVF in the future. Despite nearly a million IVF cycles performed annually in Europe (3 million globally), only 40% result in pregnancy. This low success rate extends the process to an average of three cycles, with each costing around 10,000 euros, creating financial burdens. Emotionally, the journey can be devastating, with a 50% dropout rate among patients.
In high-income countries, high costs and limited healthcare coverage contribute to healthcare inequity, particularly for single individuals, those in same-sex relationships, and women facing secondary infertility. Meanwhile, in low and middle-income countries, IVF is often entirely out of reach due to prohibitive costs, lack of financing, and inadequate services. The disparities in accessing infertility treatments represent a marked social injustice, amplifying the burden on women.
One of the leading causes of IVF failure is embryo transfer (ET), with a live birth rate below 30%. The success of ET hinges on two key factors: embryo quality and endometrial receptivity. While advancements have been made in selecting high-quality embryos, assessing the uterine readiness for ET remains a challenge. Currently this assessment relies on counting days, assuming a synchronic development between the embryo and the endometrium. Ensuring greater accuracy in detecting uterine receptivity and achieving embryo-uterine synchrony are pivotal for enhancing embryo implantation rates and overall IVF success. To meet this urgent and unmet clinical need, we have developed Seedchrony: a groundbreaking medical device specifically designed to non-invasively and immediately detect uterine readiness for embryo transfer. Our vision is to advance reproductive health rights by making IVF treatment more accessible and affordable.
The primary goal of the project, financed by the Women TechEU grant, was to gain understanding and clarity in three strategic pathways within the medical device industry: IP protection, regulation, and clinical investigation. This knowledge was essential for the strategic planning and execution of these pathways.
In high-income countries, high costs and limited healthcare coverage contribute to healthcare inequity, particularly for single individuals, those in same-sex relationships, and women facing secondary infertility. Meanwhile, in low and middle-income countries, IVF is often entirely out of reach due to prohibitive costs, lack of financing, and inadequate services. The disparities in accessing infertility treatments represent a marked social injustice, amplifying the burden on women.
One of the leading causes of IVF failure is embryo transfer (ET), with a live birth rate below 30%. The success of ET hinges on two key factors: embryo quality and endometrial receptivity. While advancements have been made in selecting high-quality embryos, assessing the uterine readiness for ET remains a challenge. Currently this assessment relies on counting days, assuming a synchronic development between the embryo and the endometrium. Ensuring greater accuracy in detecting uterine receptivity and achieving embryo-uterine synchrony are pivotal for enhancing embryo implantation rates and overall IVF success. To meet this urgent and unmet clinical need, we have developed Seedchrony: a groundbreaking medical device specifically designed to non-invasively and immediately detect uterine readiness for embryo transfer. Our vision is to advance reproductive health rights by making IVF treatment more accessible and affordable.
The primary goal of the project, financed by the Women TechEU grant, was to gain understanding and clarity in three strategic pathways within the medical device industry: IP protection, regulation, and clinical investigation. This knowledge was essential for the strategic planning and execution of these pathways.
With the execution of this project, we have accomplished significant milestones for our company's development:
1. Developed a robust IP strategy and completed a Freedom To Operate study. We have submitted the PCT protecting our innovation in discovering a new biomarker of endometrial receptivity, obtained a positive International Search Report (ISR), and will enter national phases in May 2024. The FtO study was favorable, and we are working on establishing the foundation to protect the company's trade secrets: data and algorithms derived from the Pilot clinical investigation.
2. Designed the regulatory strategy and pathway based on the new Medical Device Regulation (MDR).
3. Planned and obtained approval to conduct a Pilot clinical investigation with the Seedchrony Minimum Viable Product (MVP) in compliance with ISO 14155. The Pilot has started in February 2024 in Vall d'Hebron Hospital and involved 72 IVP patients.
1. Developed a robust IP strategy and completed a Freedom To Operate study. We have submitted the PCT protecting our innovation in discovering a new biomarker of endometrial receptivity, obtained a positive International Search Report (ISR), and will enter national phases in May 2024. The FtO study was favorable, and we are working on establishing the foundation to protect the company's trade secrets: data and algorithms derived from the Pilot clinical investigation.
2. Designed the regulatory strategy and pathway based on the new Medical Device Regulation (MDR).
3. Planned and obtained approval to conduct a Pilot clinical investigation with the Seedchrony Minimum Viable Product (MVP) in compliance with ISO 14155. The Pilot has started in February 2024 in Vall d'Hebron Hospital and involved 72 IVP patients.
The applicability of the project results could have a profound impact on the treatment of IVF patients. Currently, there is a lack of tools capable of accurately detecting the window of implantation or assessing endometrial receptivity non-invasively just before embryo transfer. Therefore, Seedchrony is anticipated to have a significant global impact. We are pioneering innovative technological advancements in the Medtech industry, merging life sciences, engineering, biosensing, and data science. This innovation will enhance the quality of life for IVF patients. Additionally, and more in the basic-research arena, the receptive endometrium has been like a black box in reproductive medicine. We expect Seedchrony could shed light on this critical process in women's reproductive health.
To successfully bring Seedchrony to the market, several risks and challenges must be addressed and overcome:
1. Finalising the Pilot Clinical investigation (ongoing) with a positive evaluation of the predictive capacity of Seedchrony in determining the success of embryo transfer.
2. Evolving the Seedchrony Minimum Viable Product (MVP) into a final product ready for manufacturing.
3. Developing the Embryo Transfer recommendation algorithm to enhance Seedchrony's effectiveness.
4. Demonstrating the clinical value of the recommendation algorithm through a pivotal multicentric clinical investigation.
5. Obtaining the CE-mark, ensuring compliance with European regulatory standards.
6. Validating the pricing and business model to ensure business viability, garner support from IVF clinics, and maintain affordability for patients.
7. Implementing sales and internationalization strategies, including navigating regulatory approval processes in different countries.
Addressing these risks and challenges will be crucial for the successful market launch and adoption of Seedchrony.
To successfully bring Seedchrony to the market, several risks and challenges must be addressed and overcome:
1. Finalising the Pilot Clinical investigation (ongoing) with a positive evaluation of the predictive capacity of Seedchrony in determining the success of embryo transfer.
2. Evolving the Seedchrony Minimum Viable Product (MVP) into a final product ready for manufacturing.
3. Developing the Embryo Transfer recommendation algorithm to enhance Seedchrony's effectiveness.
4. Demonstrating the clinical value of the recommendation algorithm through a pivotal multicentric clinical investigation.
5. Obtaining the CE-mark, ensuring compliance with European regulatory standards.
6. Validating the pricing and business model to ensure business viability, garner support from IVF clinics, and maintain affordability for patients.
7. Implementing sales and internationalization strategies, including navigating regulatory approval processes in different countries.
Addressing these risks and challenges will be crucial for the successful market launch and adoption of Seedchrony.