Periodic Reporting for period 2 - GrownValve (A prosthetic heart valve for adults and children, made from the patient’s own tissue, a replacement heart valve that lasts a lifetime)
Okres sprawozdawczy: 2023-10-01 do 2025-07-31
The Context:
By opening and closing, heart valves allow the unidirectional flow of blood during the cardiac cycle, while preventing the backflow of blood. Since defective or diseased heart valves are unable to recover, patients face severe risks of progressive heart failure and death. Pediatric patients face an even more challenging prognosis since they also require re-operations due to the out-growth of their prostheses. Currently, the only treatment option for heart valve dysfunctions is surgical or interventional replacement, of which 200,000 are conducted annually worldwide. Additionally, 1% of all newborns suffer from congenital heart disease, of which 30% concern the heart valves.
Commercially available heart valve prostheses are made from either artificial materials (mechanical valves) or biological materials from foreign sources (xeno- or homo-grafts). While both types show benefits and drawbacks for adult patients, there is no heart valve prosthesis available which meet the needs of pediatric patients.
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.
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 quality of life for patients and their families
- 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 innovative technology that aims to provide a permanent solution. This aligns with both patient care and healthcare efficiency, aiming for a substantial, lasting medical impact, transforming lives and healthcare systems.
Pathway to Impact:
Our patient specific approach ensures 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 durable heart valve replacements, making a lasting medical impact.
By opening and closing, heart valves allow the unidirectional flow of blood during the cardiac cycle, while preventing the backflow of blood. Since defective or diseased heart valves are unable to recover, patients face severe risks of progressive heart failure and death. Pediatric patients face an even more challenging prognosis since they also require re-operations due to the out-growth of their prostheses. Currently, the only treatment option for heart valve dysfunctions is surgical or interventional replacement, of which 200,000 are conducted annually worldwide. Additionally, 1% of all newborns suffer from congenital heart disease, of which 30% concern the heart valves.
Commercially available heart valve prostheses are made from either artificial materials (mechanical valves) or biological materials from foreign sources (xeno- or homo-grafts). While both types show benefits and drawbacks for adult patients, there is no heart valve prosthesis available which meet the needs of pediatric patients.
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.
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 quality of life for patients and their families
- 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 innovative technology that aims to provide a permanent solution. This aligns with both patient care and healthcare efficiency, aiming for a substantial, lasting medical impact, transforming lives and healthcare systems.
Pathway to Impact:
Our patient specific approach ensures 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 durable heart valve replacements, making a lasting medical impact.
GrOwnValve’s EIC project has been marked by an intensive and highly productive period of R&D. Our work has focused on advancing the technical and clinical foundations of the technology, with a strong emphasis on scientific validation and translational progress, including:
1. Development activities (WP1-WP4):
WP1: Concentrated on the finalization of our Minimal Viable Product (MVP), which consists of our own core products as well as purchased products
WP2: Application and start of the first clinical study to collect data on the safety and feasibility of the GrOwnValve procedure 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 corresponding products 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 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 field of heart valve replacement. Our most important achievements were the successful ISO 13485 certification, the preclinical testing of our bioresorbable stents, and the first successful clinical procedures (FiH).
1. Development activities (WP1-WP4):
WP1: Concentrated on the finalization of our Minimal Viable Product (MVP), which consists of our own core products as well as purchased products
WP2: Application and start of the first clinical study to collect data on the safety and feasibility of the GrOwnValve procedure 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 corresponding products 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 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 field of heart valve replacement. Our most important achievements were the successful ISO 13485 certification, the preclinical testing of our bioresorbable stents, and the first successful clinical procedures (FiH).
Our EIC project mission was to redefine the gold standard in treatment of heart valve disease by causing an update of the medical guidelines, especially in heart valve replacement.
Key achievements include:
1. Development of various components that enable treating physicians to manufacture and re-implant the first transcatheter-based autologous heart valve during one procedure at bedside in the operating room.
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.
Key achievements include:
1. Development of various components that enable treating physicians to manufacture and re-implant the first transcatheter-based autologous heart valve during one procedure at bedside in the operating room.
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.