Periodic Reporting for period 3 - CVTVT (A Non-Surgical Treatment to Restore Heart Valve Function)
Okres sprawozdawczy: 2021-10-01 do 2022-10-31
BACKGROUND: The past decade has witnessed a revolution in the treatment on heart valve disease. For aortic valve treatment, patients no longer need to have their chest cut open and their heart stopped in order to have their valve function restored. As recent clinical studies have shown, most aortic valve patients now receive non-invasive, catheter based implantation of a prosthetic valve, restoring their quality of life within days . While the same revolution is already underway for the mitral valve, the tricuspid valve has remained largely forgotten due to the unique challenges required to treat it. Although there are 550,000 new tricuspid valve cases diagnosed every year in the US and EU, less than 1% of tricuspid valve patients are treated. Caring for these patients costs over €8 billion per year, and 3 out of every 5 patients will die within 3 years .
CURRENT TREATMENT IS INEFFECTIVE: As more clinical data is gathered, physicians are now realizing that tricuspid valve disease MUST be treated. However, doing so is very challenging. Surgical repair is not a good option, as up to 35% of these patients die postoperatively . With no non-surgical options, all that can be done is to manage their symptoms with diuretics. These patients face progressive loss of quality of life and eventually die. A non-surgical treatment is therefore urgently needed.
INNOVATIVE TECHNOLOGY: CroíValve has developed a non-invasive device uniquely tailored to the challenges of the tricuspid valve. Delivered via a catheter through a neck vein, it is positioned between the tricuspid valve leaflets to restore function. An innovative adjustable anchor holds the device in position, and sits away from the fragile heart tissue, avoiding any tissue-penetrating hooks. A robust patent portfolio has been developed to protect this novel approach. The implant procedures takes less than 45 minutes using conventional techniques.
VALIDATED CLINICAL BENEFIT: A detailed clinical needs assessment with physicians and payers has confirmed our value proposition. The CroíValve device will improve patients’ symptoms from severe to mild. It will provide physicians a safe (>95% freedom from in & post-operative care) and straightforward (<45 min procedure using conventional techniques & equipment) treatment option. It will reduce hospitalisations by 70% in the 1st year, and will save €27,000 per patient treated. This value proposition is now supported by the clinical data generated during this project.
ADDRESSABLE MARKET: CroíValve’s market analysis has determined that there are over 110,000 patients in the EU and US that will benefit from the technology, giving a total addressable market of > €2.5Bn/year. Because of the recent realization that TR must be treated, and the complexity to develop suitable technologies, this market is almost completely underserved but the excitement about transcatheter therapies in the clinical community means the timing is right for the CroiValve DUO System.
PHASE 2 PROJECT: With H2020 SMEi funding, this Phase 2 Innovation project supported the activities necessary to complete clinical implants and demonstrate safety and efficacy for the device. This included extensive pre-clinical verification and validation testing to refine the device and ensure it was ready for patient implants. Significantly this also included a first in human study of this device in 5 patients that has demonstrated significant symptomatic improvement for these patients, along with a very straightforward procedure verified by multiple users.
CONCLUSIONS: During this Phase 2 project, the design was finalized, with comprehensive testing to prove it meets all requirements necessary to place the device in a patient's heart. A successful clinical study to prove the impact of this technology was designed and executed. This has demonstrated a very easy device to use, a safe technology and one that can completely transform patients' lives by addressing most of their symptoms. The route to market, scalability requirements and organization have all been developed to position this technology to maximize market penetration. This project has been instrumental in bringing this novel technology to patients and market.
CURRENT TREATMENT IS INEFFECTIVE: As more clinical data is gathered, physicians are now realizing that tricuspid valve disease MUST be treated. However, doing so is very challenging. Surgical repair is not a good option, as up to 35% of these patients die postoperatively . With no non-surgical options, all that can be done is to manage their symptoms with diuretics. These patients face progressive loss of quality of life and eventually die. A non-surgical treatment is therefore urgently needed.
INNOVATIVE TECHNOLOGY: CroíValve has developed a non-invasive device uniquely tailored to the challenges of the tricuspid valve. Delivered via a catheter through a neck vein, it is positioned between the tricuspid valve leaflets to restore function. An innovative adjustable anchor holds the device in position, and sits away from the fragile heart tissue, avoiding any tissue-penetrating hooks. A robust patent portfolio has been developed to protect this novel approach. The implant procedures takes less than 45 minutes using conventional techniques.
VALIDATED CLINICAL BENEFIT: A detailed clinical needs assessment with physicians and payers has confirmed our value proposition. The CroíValve device will improve patients’ symptoms from severe to mild. It will provide physicians a safe (>95% freedom from in & post-operative care) and straightforward (<45 min procedure using conventional techniques & equipment) treatment option. It will reduce hospitalisations by 70% in the 1st year, and will save €27,000 per patient treated. This value proposition is now supported by the clinical data generated during this project.
ADDRESSABLE MARKET: CroíValve’s market analysis has determined that there are over 110,000 patients in the EU and US that will benefit from the technology, giving a total addressable market of > €2.5Bn/year. Because of the recent realization that TR must be treated, and the complexity to develop suitable technologies, this market is almost completely underserved but the excitement about transcatheter therapies in the clinical community means the timing is right for the CroiValve DUO System.
PHASE 2 PROJECT: With H2020 SMEi funding, this Phase 2 Innovation project supported the activities necessary to complete clinical implants and demonstrate safety and efficacy for the device. This included extensive pre-clinical verification and validation testing to refine the device and ensure it was ready for patient implants. Significantly this also included a first in human study of this device in 5 patients that has demonstrated significant symptomatic improvement for these patients, along with a very straightforward procedure verified by multiple users.
CONCLUSIONS: During this Phase 2 project, the design was finalized, with comprehensive testing to prove it meets all requirements necessary to place the device in a patient's heart. A successful clinical study to prove the impact of this technology was designed and executed. This has demonstrated a very easy device to use, a safe technology and one that can completely transform patients' lives by addressing most of their symptoms. The route to market, scalability requirements and organization have all been developed to position this technology to maximize market penetration. This project has been instrumental in bringing this novel technology to patients and market.
The project comprises work packages 2-7 detailed below, and involved extensive technology development and testing, first in human clinical evaluation of the novel implant, as well as a full analysis of the business potential, clinical approach and route to market for the CroíValve Duo Tricuspid Transcatheter System.
WP2 Pre-Clinical Evaluation: Completion of all testing for submission to the Ethics Committee to verify and validation the device is ready for clinical trials
WP3 Clinical Evaluation: Completion of a 5patient first in human study to demonstrate the safety, efficacy and ease of use of the device
WP4 Regulations and Certifications: Quality and Regulatory alignment, including with key suppliers, necessary to ensure a successful CE submission
WP5 Customer & Market Development: Development and dissemination of product marketing material. Significant increase in early adopter engagement. Data gathering defined for health economic assessments and reimbursement.
WP7 Project Management: Project monitoring & control to achieve target milestones, regular project meetings; project risk-assessment/mitigation; planning, effective communication, collaboration and balancing project demands.
WP2 Pre-Clinical Evaluation: Completion of all testing for submission to the Ethics Committee to verify and validation the device is ready for clinical trials
WP3 Clinical Evaluation: Completion of a 5patient first in human study to demonstrate the safety, efficacy and ease of use of the device
WP4 Regulations and Certifications: Quality and Regulatory alignment, including with key suppliers, necessary to ensure a successful CE submission
WP5 Customer & Market Development: Development and dissemination of product marketing material. Significant increase in early adopter engagement. Data gathering defined for health economic assessments and reimbursement.
WP7 Project Management: Project monitoring & control to achieve target milestones, regular project meetings; project risk-assessment/mitigation; planning, effective communication, collaboration and balancing project demands.
Minimally invasive devices are the future of heart valve disease. There are two other minimally invasive approaches to fix the tricuspid valve: Repair and Replacement
- Repair: Reducing the size of the expanded/dilated valve back closer its healthy size or clamping the leaflets together to help leaflet coaptation and sealing
- Replacement: Fully replacing the tricuspid valve with a prosthetic valve
However, repair & replacement don’t address key clinical requirements (patient suitability and ease of use) and so will see limited market penetration. CroiValve DUO system is a disruptive approach combining the advantages of both repair and replacement, without their complications: implanting a valved spacer to work in tandem with the native valve.
The CroíValve device will improve patients’ symptoms from severe to mild. It will provide physicians a safe and straightforward treatment option. It will reduce hospitalisations by 70% in the 1st year, and will save €27,000 per patient treated .
- Repair: Reducing the size of the expanded/dilated valve back closer its healthy size or clamping the leaflets together to help leaflet coaptation and sealing
- Replacement: Fully replacing the tricuspid valve with a prosthetic valve
However, repair & replacement don’t address key clinical requirements (patient suitability and ease of use) and so will see limited market penetration. CroiValve DUO system is a disruptive approach combining the advantages of both repair and replacement, without their complications: implanting a valved spacer to work in tandem with the native valve.
The CroíValve device will improve patients’ symptoms from severe to mild. It will provide physicians a safe and straightforward treatment option. It will reduce hospitalisations by 70% in the 1st year, and will save €27,000 per patient treated .