Periodic Reporting for period 1 - HD4HF (Heart Damper: a revolutionary device for Heart Failure)
Okres sprawozdawczy: 2018-12-01 do 2019-05-31
Eucardia intends to address one of the most growing disease that is already a major public health issue: Heart failure (HF).
Heart failure is a chronic, progressive condition that prevents the heart from pumping enough blood to meet the body’s needs. In EU and US HF affects about 15 million people, with an expected growth of about 38% by 2030. Two million of these patients are affected by advanced systolic heart failure (SHF): a phase in which the pharmacological therapies alone are no longer sufficient to manage the symptoms
Needless to say, HF has a significant social cost: i.e. the US costs related to the loss of work and household productivity are estimated at $ 8.2 billion / year (by 2030, $ 12.3 billion / year).
It is important to know that the actual wide diffusion and rising of HF is due to the combined effect of the aging of the population and the strong improvement of infarction treatments. In fact, by mitigating the short-term damages of ischemic events and improving survival, the number of patients which lately develop HF today is increasing. In addition, HF has no actual cure apart from heart transplantation, which is very rare (<10,000 patients / year / world) and not allowed to people over 65 (80% of HF patients).
Currently available treatments have staggering healthcare cost ($ 108 billion a year in the world; by 2030, $ 150 billion/year) and depend on the type and severity of the condition.
Eucardia is bringing to market a breakthrough implantable cardiac device: the Heart Damper (HD), which is intended to provide a simple, personalized, quick and cost-effective solution to treat patients affected by SHF, irrespective of their age. The HD is designed to be stably fitted into the left ventricle by a simple transapical surgical procedure, and to provide an increase in the ejection fraction and cardiac efficiency. Once in place, the device does not require any external power source.
Eucardia’s mission is to develop and industrialize the Heart Damper, ultimately giving SHF patients a longer and better life expectancy, while tackling the healthcare costs associated with medical treatments. In order to do that, the Company’s objective is to validate its technology in order to sign licensing agreements with MedTech industries to commercialise the product, according to a B2B business model.
Heart failure is a chronic, progressive condition that prevents the heart from pumping enough blood to meet the body’s needs. In EU and US HF affects about 15 million people, with an expected growth of about 38% by 2030. Two million of these patients are affected by advanced systolic heart failure (SHF): a phase in which the pharmacological therapies alone are no longer sufficient to manage the symptoms
Needless to say, HF has a significant social cost: i.e. the US costs related to the loss of work and household productivity are estimated at $ 8.2 billion / year (by 2030, $ 12.3 billion / year).
It is important to know that the actual wide diffusion and rising of HF is due to the combined effect of the aging of the population and the strong improvement of infarction treatments. In fact, by mitigating the short-term damages of ischemic events and improving survival, the number of patients which lately develop HF today is increasing. In addition, HF has no actual cure apart from heart transplantation, which is very rare (<10,000 patients / year / world) and not allowed to people over 65 (80% of HF patients).
Currently available treatments have staggering healthcare cost ($ 108 billion a year in the world; by 2030, $ 150 billion/year) and depend on the type and severity of the condition.
Eucardia is bringing to market a breakthrough implantable cardiac device: the Heart Damper (HD), which is intended to provide a simple, personalized, quick and cost-effective solution to treat patients affected by SHF, irrespective of their age. The HD is designed to be stably fitted into the left ventricle by a simple transapical surgical procedure, and to provide an increase in the ejection fraction and cardiac efficiency. Once in place, the device does not require any external power source.
Eucardia’s mission is to develop and industrialize the Heart Damper, ultimately giving SHF patients a longer and better life expectancy, while tackling the healthcare costs associated with medical treatments. In order to do that, the Company’s objective is to validate its technology in order to sign licensing agreements with MedTech industries to commercialise the product, according to a B2B business model.
Within SMEI Phase 1 implementation Eucardia was able to positively assess technical and economic feasibility of the HD, shaping its business idea and perfecting the path to HD commercialization.
As regards technical feasibility, Eucardia has been intensely engaged into an in-vivo animal study was indeed important for the positive development of the project.
The study has been conducted on both healthy and pathological ovine models with the following objectives:
• to evaluate the HD device implant procedure
• to assess the device interaction with the left ventricle, the heart, and animal physiology
• to assess survival and most relevant hemodynamic parameters in pathological models post-implant.
Eucardia also initiate contacts with two clinical specialists and begin to collect and study a few cardiac CT imaging data set of SHF patients. These preliminary activities were very useful to enter into technical issues as well as process issues. Some progresses have been also made on the development of a virtual device, obtaining preliminary models that could accommodate HD shape based on cardiac cycle.
As regards economic viability, the Company has:
• deepened its market analysis, updating data and identified new economic indicators. Various factors and conditions affecting the marketing options of the Technology and the related business opportunities were analysed
• defined a solid IP exploitation strategy. it is possible to assert that the IP portfolio has a strong short- and long-term purpose and it will be useful to assure a solid position in existing markets.
• consolidated its relationships with upstream (supply chain and manufacturing) and downstream (scientific, marketing and distribution) stakeholders
• identified the business model. The Company will likely rely on a B2B strategy, involving relevant Medtech companies in the commercial exploitation of the device. With this purpose, the Company has identified conditions of licensing commercial programs with those partners
• performed learning activities on the new EU Regulation 745/2017
• made economic forecasts (2019-2024) that will lead to business model operationalization
As regards technical feasibility, Eucardia has been intensely engaged into an in-vivo animal study was indeed important for the positive development of the project.
The study has been conducted on both healthy and pathological ovine models with the following objectives:
• to evaluate the HD device implant procedure
• to assess the device interaction with the left ventricle, the heart, and animal physiology
• to assess survival and most relevant hemodynamic parameters in pathological models post-implant.
Eucardia also initiate contacts with two clinical specialists and begin to collect and study a few cardiac CT imaging data set of SHF patients. These preliminary activities were very useful to enter into technical issues as well as process issues. Some progresses have been also made on the development of a virtual device, obtaining preliminary models that could accommodate HD shape based on cardiac cycle.
As regards economic viability, the Company has:
• deepened its market analysis, updating data and identified new economic indicators. Various factors and conditions affecting the marketing options of the Technology and the related business opportunities were analysed
• defined a solid IP exploitation strategy. it is possible to assert that the IP portfolio has a strong short- and long-term purpose and it will be useful to assure a solid position in existing markets.
• consolidated its relationships with upstream (supply chain and manufacturing) and downstream (scientific, marketing and distribution) stakeholders
• identified the business model. The Company will likely rely on a B2B strategy, involving relevant Medtech companies in the commercial exploitation of the device. With this purpose, the Company has identified conditions of licensing commercial programs with those partners
• performed learning activities on the new EU Regulation 745/2017
• made economic forecasts (2019-2024) that will lead to business model operationalization
Thanks to SMEI Phase 1, the Company was able to evolve the strategic vision of HD project, drafting the following roadmap to commercialisation (subtasks have been deleted for confidentiality reasons)
a) Proof of evidence & design freeze
During this step, the technological potential of the device will be consolidated through mechanical test tests and In-Vivo tests with animals.
The main subtasks of this phase are:
o Prototype manufacturing and mechanical testing
o In-Vivo Animal Test
o Quality Management System & Regulatory Activities
b) Pre-Clinical Validation
This activity will have the objective t complete the Technical Dossier that will be submitted to Notified Body review and to Ethical Committees’ approval in order to get the authorization for the First in Human implants. Its main subtasks are:
o Quality Management System (according to ISO 13485 and FDA regulation 21 CFR Part 820)
o Preclinical Verification and Validation
o Animal Trial
c) First in Human implants
FIH studies will provide the further evidences of the feasibility, safety and efficacy of the Heart Damper device and will consequently allow the set-up of human clinical trials to achieve the CE mark and FDA authorizations.
The main subtasks of this phase are:
o Preliminary Activities for the First in Human study (FIH)
o First in Human study
d) CE and FDA market approval
As regards potential impacts, Eucardia's vision is to become the global reference player for the heart failure treatment, giving patients a longer and better life expectancy. According to cardiologists and insiders, the Company has the potential to revolutionize a branch of traditional medicine, contributing to improve the quality of life for millions of people suffering from heart failure -reducing at the same time healthcare costs for their assistance- and laying the foundation for the creation of a new relevant market segment.
a) Proof of evidence & design freeze
During this step, the technological potential of the device will be consolidated through mechanical test tests and In-Vivo tests with animals.
The main subtasks of this phase are:
o Prototype manufacturing and mechanical testing
o In-Vivo Animal Test
o Quality Management System & Regulatory Activities
b) Pre-Clinical Validation
This activity will have the objective t complete the Technical Dossier that will be submitted to Notified Body review and to Ethical Committees’ approval in order to get the authorization for the First in Human implants. Its main subtasks are:
o Quality Management System (according to ISO 13485 and FDA regulation 21 CFR Part 820)
o Preclinical Verification and Validation
o Animal Trial
c) First in Human implants
FIH studies will provide the further evidences of the feasibility, safety and efficacy of the Heart Damper device and will consequently allow the set-up of human clinical trials to achieve the CE mark and FDA authorizations.
The main subtasks of this phase are:
o Preliminary Activities for the First in Human study (FIH)
o First in Human study
d) CE and FDA market approval
As regards potential impacts, Eucardia's vision is to become the global reference player for the heart failure treatment, giving patients a longer and better life expectancy. According to cardiologists and insiders, the Company has the potential to revolutionize a branch of traditional medicine, contributing to improve the quality of life for millions of people suffering from heart failure -reducing at the same time healthcare costs for their assistance- and laying the foundation for the creation of a new relevant market segment.