Periodic Reporting for period 2 - Cardio-kit (A disruptive medical device to enable proton therapy as non-invasive and automated treatment of heart arrhythmias)
Período documentado: 2022-01-01 hasta 2023-08-31
Problem
Ventricular tachycardia, or VT, is when the lower chambers of the heart beat rapidly. This reduces the efficiency of the pumping heart and can cause sudden cardiac arrest, requiring immediate medical attention. There are multiple causes of VT, but it is most caused by damages to the heart tissue, for example after a heart attack, or inflammation.
Atrial Fibrillation, or AF, is with the upper chambers of the heart and it is the most common cardiac arrhythmias and increased the chance to cause stroke by 500%.
Cardiac arrhythmias are already a major socioeconomic concern, and the prevalence of these diseases are increasing due to the aging of these populations. Currently over 5 million individuals worldwide suffer from VT, and over 33 million people suffer from AF. This has been predicted to more than double by 2030, making it a very and immediate socio-economic concern.
Today, pharmacological treatment is the first line treatment of heart arrhythmia, however, it leads to toxicity and results are never long term. The second line treatment for VT patients is an implantable defibrillator. They deliver special shocks however, reduce the quality of life of the patients.
The current standard of care is a surgical procedure called ablation. Major drawbacks of surgical VT ablations are as follows:
- It is an invasive procedure involving inserting catheters in the heart. It is painful and the patients require partial or total anaesthesia;
- It is challenging to perform, has high short-term mortality, and several severe side effects. There is a high risk of complications due to the catheters and the long duration of the procedure. 31-day mortality reaches 5% and this can be explained by the co-morbidities of the patients, as well as what physicians do to the patients during the procedure;
- Requires at least 2 days of hospitalization and costing up to €16,500 per procedure.
- The execution of the procedure is different in different hospitals. Catheter ablation is only effective in 50% of cases, usually there is a need of a 2nd procedure
- Long-term mortality reaches 35% mainly due to VT recurrence and progression of heart failure. This is because the source of the problem often cannot be eliminated with existing solutions.
Overall objectives of the program are to create a better patient experience for VT treatment, enable a totally non-invasive procedure, so that we can also treat fragile patients in the future, and make it overall safer:
- Ablation will be achieved through a non-invasive procedure without catheters, by simple external radiation using Proton Equipment.
- The procedure will take less than an hour, with a standardized workflow making it both reproducible and highly effective.
- A single fraction (dose) of protons delivered in less than 10 minutes, supported by 1 -2 technicians, meaning it can be performed in an out-patient setting.
- Highly effective procedure with a high dose of radiation, well controlled by the Proton Machine, we aim to safely reduce by 90% VT burden and improved quality of life. The physiologic explanation is that the EP effect is closely related to apoptotic cell death & fibrosis.
- Increased survival compared to invasive ablation procedures. This is because the source of the problem is eliminated by Protons, and the delivered radiation dose optimized by the CardioKit
Ventricular tachycardia, or VT, is when the lower chambers of the heart beat rapidly. This reduces the efficiency of the pumping heart and can cause sudden cardiac arrest, requiring immediate medical attention. There are multiple causes of VT, but it is most caused by damages to the heart tissue, for example after a heart attack, or inflammation.
Atrial Fibrillation, or AF, is with the upper chambers of the heart and it is the most common cardiac arrhythmias and increased the chance to cause stroke by 500%.
Cardiac arrhythmias are already a major socioeconomic concern, and the prevalence of these diseases are increasing due to the aging of these populations. Currently over 5 million individuals worldwide suffer from VT, and over 33 million people suffer from AF. This has been predicted to more than double by 2030, making it a very and immediate socio-economic concern.
Today, pharmacological treatment is the first line treatment of heart arrhythmia, however, it leads to toxicity and results are never long term. The second line treatment for VT patients is an implantable defibrillator. They deliver special shocks however, reduce the quality of life of the patients.
The current standard of care is a surgical procedure called ablation. Major drawbacks of surgical VT ablations are as follows:
- It is an invasive procedure involving inserting catheters in the heart. It is painful and the patients require partial or total anaesthesia;
- It is challenging to perform, has high short-term mortality, and several severe side effects. There is a high risk of complications due to the catheters and the long duration of the procedure. 31-day mortality reaches 5% and this can be explained by the co-morbidities of the patients, as well as what physicians do to the patients during the procedure;
- Requires at least 2 days of hospitalization and costing up to €16,500 per procedure.
- The execution of the procedure is different in different hospitals. Catheter ablation is only effective in 50% of cases, usually there is a need of a 2nd procedure
- Long-term mortality reaches 35% mainly due to VT recurrence and progression of heart failure. This is because the source of the problem often cannot be eliminated with existing solutions.
Overall objectives of the program are to create a better patient experience for VT treatment, enable a totally non-invasive procedure, so that we can also treat fragile patients in the future, and make it overall safer:
- Ablation will be achieved through a non-invasive procedure without catheters, by simple external radiation using Proton Equipment.
- The procedure will take less than an hour, with a standardized workflow making it both reproducible and highly effective.
- A single fraction (dose) of protons delivered in less than 10 minutes, supported by 1 -2 technicians, meaning it can be performed in an out-patient setting.
- Highly effective procedure with a high dose of radiation, well controlled by the Proton Machine, we aim to safely reduce by 90% VT burden and improved quality of life. The physiologic explanation is that the EP effect is closely related to apoptotic cell death & fibrosis.
- Increased survival compared to invasive ablation procedures. This is because the source of the problem is eliminated by Protons, and the delivered radiation dose optimized by the CardioKit
Key Achievements
- Proof-of-Concept of Proton Therapy for Treatment of Arrhythmias -Mayo’s Publications
- Strong team in place ( ~100 years of commercial and technical expertise in the fields of proton therapy, cardiology devices, radiotherapy, software development and business development)
- Set up of an Advisory Board
- Cardiac Motion User Survey involving 25 Cardiac Radio Ablation Experts
- Light Quality Management System in place
- Functional System Prototype – CardioKit MVP (Minimum Viable Product)
- Cardiac Deep Learning Algorithm validated in 350 cardiology patient datasets
- Initial testing in Humans
- Completed testing on animals
- Initial meeting with FDA
- Established partnerships with several partners for clinical validation activities and development
CardioKit is a treatment system using protons that can be easily and reliably implemented in the clinical environment. The system combines hardware and software solutions to monitor and react to heart movement in all its components: cyclical heart-beat and respiratory motion, non-cyclical position change between “planning day” and “treatment day” and position drift during treatment.
CardioKit is composed of:
- An ultrasound imager, which tracks the heart movement in real-time to determine when it is best to ablate, and the area to be treated
o The patented ultrasound technology includes Artificial Intelligence (AI) to provide 3D Motion Information, mm accuracy at 40Hz
- A real-time proton beam controller, which processes the cardiac images in real-time, and automatically adjusts the Stop/Go signal to the proton therapy machine at the correct timing.
Over the course of the reporting period, the company has developed various generation of prototypes (hardware and software) and performed the following testing:
• Cardiac Phase Identification Study/AI algorithm training
• Motion and treatment planning studies
• Calibration tests with phantoms
• Gating compatibility studies with oncological equipment
• Animal Motion Studies
Data are being processed and publications are being prepared as well.
- Proof-of-Concept of Proton Therapy for Treatment of Arrhythmias -Mayo’s Publications
- Strong team in place ( ~100 years of commercial and technical expertise in the fields of proton therapy, cardiology devices, radiotherapy, software development and business development)
- Set up of an Advisory Board
- Cardiac Motion User Survey involving 25 Cardiac Radio Ablation Experts
- Light Quality Management System in place
- Functional System Prototype – CardioKit MVP (Minimum Viable Product)
- Cardiac Deep Learning Algorithm validated in 350 cardiology patient datasets
- Initial testing in Humans
- Completed testing on animals
- Initial meeting with FDA
- Established partnerships with several partners for clinical validation activities and development
CardioKit is a treatment system using protons that can be easily and reliably implemented in the clinical environment. The system combines hardware and software solutions to monitor and react to heart movement in all its components: cyclical heart-beat and respiratory motion, non-cyclical position change between “planning day” and “treatment day” and position drift during treatment.
CardioKit is composed of:
- An ultrasound imager, which tracks the heart movement in real-time to determine when it is best to ablate, and the area to be treated
o The patented ultrasound technology includes Artificial Intelligence (AI) to provide 3D Motion Information, mm accuracy at 40Hz
- A real-time proton beam controller, which processes the cardiac images in real-time, and automatically adjusts the Stop/Go signal to the proton therapy machine at the correct timing.
Over the course of the reporting period, the company has developed various generation of prototypes (hardware and software) and performed the following testing:
• Cardiac Phase Identification Study/AI algorithm training
• Motion and treatment planning studies
• Calibration tests with phantoms
• Gating compatibility studies with oncological equipment
• Animal Motion Studies
Data are being processed and publications are being prepared as well.
Market
EBAMed identified the unique opportunity to create a new market segment at the intersection of the global heart arrythmia and the global proton therapy markets: the heart arrythmia proton therapy market.
The global cardiac ablation market was valued at $5.7B in 2019 and is growing a CAGR of 13% since 2016. The global proton therapy market is currently consisting of 250 treatment rooms and is projected to reach 1000 Installs by 2030 (CAGR of 11%).
CardioKit would facilitate a painless out-patient procedure. Hence, the procedure will be suitable for any age and health condition patient.
CardioKit would enable 3 times more patients to be treated (only in the USA, 160’000 patients/year would benefit from it).
CardioKit would not require any hospitalization or sedation. Hence the procedure will help saving heath care costs.
CardioKit will obtain FDA Approval and a CE Mark
CardioKit will be sold to Proton Therapy Centers either directly or through Distribution Partners, which will install the technology to the emerging proton therapy centres.
EBAMed will leverage the existing contacts and reputation with key opinion leaders to gain market traction and gradually seek for reimbursement for procedures in the target countries.
Revenue will be such that breakeven will be achieved in the first 2 year of commercialization.
In addition, CardioKit can be optimized for treatment of targets affected by motion in the abdomen, such as lung, liver, and prostate among others, hence widening its use cases.
The stereotactic radiotherapy enables a non-invasive, outpatient therapy to be performed in under one hour. The EBAMed CardioKit is a Unique Upgrade to Current Proton Equipment to address their Current Lack of Motion Management Solutions, that is limiting their potential. Its plug & play nature allows broad compatibility with existing proton machines.
EBAMed identified the unique opportunity to create a new market segment at the intersection of the global heart arrythmia and the global proton therapy markets: the heart arrythmia proton therapy market.
The global cardiac ablation market was valued at $5.7B in 2019 and is growing a CAGR of 13% since 2016. The global proton therapy market is currently consisting of 250 treatment rooms and is projected to reach 1000 Installs by 2030 (CAGR of 11%).
CardioKit would facilitate a painless out-patient procedure. Hence, the procedure will be suitable for any age and health condition patient.
CardioKit would enable 3 times more patients to be treated (only in the USA, 160’000 patients/year would benefit from it).
CardioKit would not require any hospitalization or sedation. Hence the procedure will help saving heath care costs.
CardioKit will obtain FDA Approval and a CE Mark
CardioKit will be sold to Proton Therapy Centers either directly or through Distribution Partners, which will install the technology to the emerging proton therapy centres.
EBAMed will leverage the existing contacts and reputation with key opinion leaders to gain market traction and gradually seek for reimbursement for procedures in the target countries.
Revenue will be such that breakeven will be achieved in the first 2 year of commercialization.
In addition, CardioKit can be optimized for treatment of targets affected by motion in the abdomen, such as lung, liver, and prostate among others, hence widening its use cases.
The stereotactic radiotherapy enables a non-invasive, outpatient therapy to be performed in under one hour. The EBAMed CardioKit is a Unique Upgrade to Current Proton Equipment to address their Current Lack of Motion Management Solutions, that is limiting their potential. Its plug & play nature allows broad compatibility with existing proton machines.