Periodic Reporting for period 1 - GrownValve (A prosthetic heart valve for adults and children, made from the patient’s own tissue, a replacement heart valve that lasts a lifetime)
Reporting period: 2022-04-01 to 2023-09-30
The Context:
Heart valve defects are a globally recognized challenge, with a staggering 1.3 million children born with congenital heart defects annually. In parallel, lifestyle habits and the natural aging process contribute to 1 in 8 adults developing valve defects. The implications of these statistics are profound: patients undergo multiple, risky surgeries, face a diminished quality of life. For children, the situation is even graver: they require valve substitutions every 3-5 years due to growth, lacking a sustainable solution tailored to them.
Project Objectives:
GrOwnValve aims to revolutionize heart valve replacement:
Objectives are to transform heart valve replacement with a one-time, patient-specific treatment. This innovation aims to:
1. Provide a Lifelong Solution: Eliminating the need for repeat surgeries, especially beneficial for children as the valve grows with them.
2. Improve Patient Quality of Life: Reducing surgical risks, tissue rejection, and eliminating the need for anticoagulants.
3. Offer Economic and Operational Benefits: Shortening hospital stays and reducing ICU occupancy, potentially saving €16B/year in Europe, thus easing healthcare systems' economic burden.
4. Benefit Stakeholders: Enhancing life quality for patients and offering hospitals cost savings and improved care reputation.
• Citizens: They will benefit immensely as the risks of frequent surgeries and complications diminish, enabling them to lead a more fulfilling life.
• Consumer/Client (Hospitals): Adopting GrOwnValve translates to substantial cost savings, elevating their reputation by showcasing a commitment to patient well-being and holistic care.
GrOwnValve stands out with its non-toxic crosslinker, ensuring valve compatibility and functionality. This aligns with both patient care and healthcare efficiency, aiming for a substantial, lasting medical impact, transforming lives and healthcare systems. GrOwnValve is more than a technological advancement; it's a life and system changing solution.
Pathway to Impact:
GrOwnValve stands out with patient specific valve shaping and GrOwnValves non-toxic, proprietary crosslinker, ensuring optimal valve function and patient compatibility. Our innovation addresses patient and healthcare needs, aligning with medical care's social aspects. We aim to transform lives and healthcare systems with sustainable heart valve replacements, making a lasting medical impact.
Heart valve defects are a globally recognized challenge, with a staggering 1.3 million children born with congenital heart defects annually. In parallel, lifestyle habits and the natural aging process contribute to 1 in 8 adults developing valve defects. The implications of these statistics are profound: patients undergo multiple, risky surgeries, face a diminished quality of life. For children, the situation is even graver: they require valve substitutions every 3-5 years due to growth, lacking a sustainable solution tailored to them.
Project Objectives:
GrOwnValve aims to revolutionize heart valve replacement:
Objectives are to transform heart valve replacement with a one-time, patient-specific treatment. This innovation aims to:
1. Provide a Lifelong Solution: Eliminating the need for repeat surgeries, especially beneficial for children as the valve grows with them.
2. Improve Patient Quality of Life: Reducing surgical risks, tissue rejection, and eliminating the need for anticoagulants.
3. Offer Economic and Operational Benefits: Shortening hospital stays and reducing ICU occupancy, potentially saving €16B/year in Europe, thus easing healthcare systems' economic burden.
4. Benefit Stakeholders: Enhancing life quality for patients and offering hospitals cost savings and improved care reputation.
• Citizens: They will benefit immensely as the risks of frequent surgeries and complications diminish, enabling them to lead a more fulfilling life.
• Consumer/Client (Hospitals): Adopting GrOwnValve translates to substantial cost savings, elevating their reputation by showcasing a commitment to patient well-being and holistic care.
GrOwnValve stands out with its non-toxic crosslinker, ensuring valve compatibility and functionality. This aligns with both patient care and healthcare efficiency, aiming for a substantial, lasting medical impact, transforming lives and healthcare systems. GrOwnValve is more than a technological advancement; it's a life and system changing solution.
Pathway to Impact:
GrOwnValve stands out with patient specific valve shaping and GrOwnValves non-toxic, proprietary crosslinker, ensuring optimal valve function and patient compatibility. Our innovation addresses patient and healthcare needs, aligning with medical care's social aspects. We aim to transform lives and healthcare systems with sustainable heart valve replacements, making a lasting medical impact.
Our journey in the EIC project has been intensive and prolific. Centered around technical and clinical advancements, here is a breakdown of the core activities we have undertaken, and the milestones achieved:
1. Development of GrOwnValve MVP (WP1 - WP4):
• WP1: Concentrated on the finalization of our Procedure Pack for the Minimal Viable Product (MVP)
• WP2: Application and start of the first clinical study to collect data on the safety of the GrOwnValve method and core components of the procedure pack.
• WP3: Work on adapting the MVP for paediatric applications. Key tasks include the development and pre-clinical testing of the growth-compatible Procedure Pack including a bio-absorbable stent and modifications to the catheter delivery system to fit the smaller blood vessels.
• WP4: Managing the Regulatory risk, built a quality management system (QMS), contract with a notified body and agree on a timeline for certification of the company and its products. Work on the relation with key opinion leaders as part of the pre-commercial activities and prepare material for dissemination activities.
2. Technical Highlights in short: Our technical and scientific journey has been marked by continuous innovation, collaboration and relentless drive to revolutionize the heart valve replacement realm.
1. Development of GrOwnValve MVP (WP1 - WP4):
• WP1: Concentrated on the finalization of our Procedure Pack for the Minimal Viable Product (MVP)
• WP2: Application and start of the first clinical study to collect data on the safety of the GrOwnValve method and core components of the procedure pack.
• WP3: Work on adapting the MVP for paediatric applications. Key tasks include the development and pre-clinical testing of the growth-compatible Procedure Pack including a bio-absorbable stent and modifications to the catheter delivery system to fit the smaller blood vessels.
• WP4: Managing the Regulatory risk, built a quality management system (QMS), contract with a notified body and agree on a timeline for certification of the company and its products. Work on the relation with key opinion leaders as part of the pre-commercial activities and prepare material for dissemination activities.
2. Technical Highlights in short: Our technical and scientific journey has been marked by continuous innovation, collaboration and relentless drive to revolutionize the heart valve replacement realm.
Our EIC project mission was to redefine medical standards, especially in heart valve replacement. Key achievements include:
1. Innovative Procedure Pack: We've revolutionized interventional tools, introducing unique components like molds, crosslinkers, delivery systems, crimping tools, and stents.
2. Advanced Stent Design: Our bioresorbable stent merges material science with medical innovation, surpassing current market offerings.
3. Pediatric-Focused Solutions: We've tailored solutions for children, including bio-absorbable stents and specialized delivery mechanisms.
Impacts:
• Economic Efficiency: GrOwnValve could save Europe's healthcare system €16B/year.
• Improved Patient Well-being: Our solution reduces surgeries, enhancing patient life quality.
• Boosted Hospital Reputation: Adopting GrOwnValve elevates hospital status and trust.
Needs for Success:
• Ongoing Research: Essential for meeting evolving medical and patient requirements.
• Market Access and Finance: Key for broad demographic reach.
• IPR and Standardisation: Crucial for protecting innovation and ensuring consistent results.
• Regulatory Collaboration: Vital for efficient adoption and patient benefit.
• International Expansion: Aims to extend our impact beyond Europe.
In summary, GrOwnValve transcends current practices, aiming for a future with efficient, patient-centric, globally accessible heart valve replacements.
1. Innovative Procedure Pack: We've revolutionized interventional tools, introducing unique components like molds, crosslinkers, delivery systems, crimping tools, and stents.
2. Advanced Stent Design: Our bioresorbable stent merges material science with medical innovation, surpassing current market offerings.
3. Pediatric-Focused Solutions: We've tailored solutions for children, including bio-absorbable stents and specialized delivery mechanisms.
Impacts:
• Economic Efficiency: GrOwnValve could save Europe's healthcare system €16B/year.
• Improved Patient Well-being: Our solution reduces surgeries, enhancing patient life quality.
• Boosted Hospital Reputation: Adopting GrOwnValve elevates hospital status and trust.
Needs for Success:
• Ongoing Research: Essential for meeting evolving medical and patient requirements.
• Market Access and Finance: Key for broad demographic reach.
• IPR and Standardisation: Crucial for protecting innovation and ensuring consistent results.
• Regulatory Collaboration: Vital for efficient adoption and patient benefit.
• International Expansion: Aims to extend our impact beyond Europe.
In summary, GrOwnValve transcends current practices, aiming for a future with efficient, patient-centric, globally accessible heart valve replacements.