Periodic Reporting for period 2 - Contraband (ContraBand: the only heart failure medical device that is placed outside the heart)
Período documentado: 2023-12-01 hasta 2024-11-30
Globally, 26M people suffer from CHF, a chronic condition that progressively worsens over time and leads to frequent hospitalisations. It is associated with staggering healthcare costs and a significant reduction of quality of life (QoL). Management algorithms have evolved for the use of pharmacotherapies and device-based therapies depending on severity of symptoms. Sadly, middle- and late-stage patients are largely symptomatic and undertreated as pharmacotherapies start facing limitations and patients may not yet qualify for heart surgery involving existing medical devices and/or heart transplants. Despite the significant advances in therapies, mortality and morbidity are still high and QoL is poorer than in most other chronic conditions, including cancer. There is a large unmet need for a CHF treatment that meets clinical end points in restoring heart functioning, improving QoL, reducing mortality and hospitalisation, whilst reducing healthcare costs and bed/ICU congestion.
Our first target users are moderate-to-severe stage congestive heart failure patients with left ventricular systolic dysfunction (about 25% of all 6 million sufferers in Europe alone.
ContraBand is an implant, is inserted into the pulmonary arteries by a minimally invasive procedure using a transcatheter delivery system, designed to treat congestive heart failure (CHF). It is the only CHF treatment device that is placed outside the heart itself, and the therapy is 100% reversible by a simple ballooning procedure at all times, This very unique safety feature provides high confidence both to the patients and physicians .
Heart failure is the largest unmet clinical and financial need today in Europe and worldwide. Contraband has a realistic potential to prevent disease escalation and, reduce hospitalisations, and even diminish drug intake over time, decreasing costs and risks of side-effects associated with chronic use.
Healthcare expenditures attributed to HF are enormous and surmount to 1-2% of total healthcare costs in both Europe and North America. Costs are mainly driven by hospitalisation (up to 4% of all hospitalisations in the EU are due to HF). In 2012 HF was responsible for an estimated global health expenditure of around €96
billion. Readmissions are common as patients are generally discharged with unresolved problems: around 25% hospitalised in the following month, 10% die, and 67% return to intensive care within one year.
By mitigating disease progression, we will significantly reduce the need for hospitalisation. In addition, our therapy has the potential to eliminate the need for costly and high-risk procedures such as heart transplants by halting or substantially slowing down disease escalation. 10% of all HF patients are diagnosed with end-stage heart failure, so there is a persistent need to provide end-stage heart failure support to this expanding population, as the financial demands associated with transplantation are considerable. Duration of hospital stay for admitted HF patients is on average 5-6 days, out of which 16% of the hospitalisation is at the ICU. After the ContraBand procedure, the patient only needs to stay in the hospital for observation 1-2 days.
Our first target users are moderate-to-severe stage congestive heart failure patients with left ventricular systolic dysfunction (about 25% of all 6 million sufferers in Europe alone.
ContraBand is an implant, is inserted into the pulmonary arteries by a minimally invasive procedure using a transcatheter delivery system, designed to treat congestive heart failure (CHF). It is the only CHF treatment device that is placed outside the heart itself, and the therapy is 100% reversible by a simple ballooning procedure at all times, This very unique safety feature provides high confidence both to the patients and physicians .
Heart failure is the largest unmet clinical and financial need today in Europe and worldwide. Contraband has a realistic potential to prevent disease escalation and, reduce hospitalisations, and even diminish drug intake over time, decreasing costs and risks of side-effects associated with chronic use.
Healthcare expenditures attributed to HF are enormous and surmount to 1-2% of total healthcare costs in both Europe and North America. Costs are mainly driven by hospitalisation (up to 4% of all hospitalisations in the EU are due to HF). In 2012 HF was responsible for an estimated global health expenditure of around €96
billion. Readmissions are common as patients are generally discharged with unresolved problems: around 25% hospitalised in the following month, 10% die, and 67% return to intensive care within one year.
By mitigating disease progression, we will significantly reduce the need for hospitalisation. In addition, our therapy has the potential to eliminate the need for costly and high-risk procedures such as heart transplants by halting or substantially slowing down disease escalation. 10% of all HF patients are diagnosed with end-stage heart failure, so there is a persistent need to provide end-stage heart failure support to this expanding population, as the financial demands associated with transplantation are considerable. Duration of hospital stay for admitted HF patients is on average 5-6 days, out of which 16% of the hospitalisation is at the ICU. After the ContraBand procedure, the patient only needs to stay in the hospital for observation 1-2 days.
The main technical and scientific work that was done as part of the project relates to the clinical and R&D / technical activities.
Clinical: The clinical procedures and follow ups on treated patients are in the core development as they establish our proof of concept, help us answer our clinical question and be prepared for later and more comprehensive clinical studies. During the period of M1 to date we treated 9 new patients, conducted 6-Months follow up on 10 patients and 12-Months follow up on 8 patients. In addition, we opened 5 new clinical sites that will join the study and enroll more patients
Technical: On the technical side we improved our manufacturing infrastructure in order to support the R&D and clinical needs. To date as part of the project we built 124 ContraBand systems for R&D for the scope of testing, development, trainings) and 54unites for clinical use in order to support the ongoing study. In addition, we improved our testing capabilities by building new fixtures and developing test methods to test the system’s long-term durability, mechanical properties and performance and to mitigate all possible risks as required by the FDA. As a result, the verification and validation campaign, which includes XX different testing, started and testingis ongoing as planned after systems were manufactured, pre- conditioned according to official protocols in light of ISO guidelines.
Both testing and manufacturing were done with high quality standards that were improved during the period of the project
In addition, we presented our clinical outcomes at leading cardiovascular conferences such as Euro PCR in Paris, HFA in Madrid and PCR in Boston. These sessions contribute to our effort to promote this technology across the EU clinical centres and investors
Clinical: The clinical procedures and follow ups on treated patients are in the core development as they establish our proof of concept, help us answer our clinical question and be prepared for later and more comprehensive clinical studies. During the period of M1 to date we treated 9 new patients, conducted 6-Months follow up on 10 patients and 12-Months follow up on 8 patients. In addition, we opened 5 new clinical sites that will join the study and enroll more patients
Technical: On the technical side we improved our manufacturing infrastructure in order to support the R&D and clinical needs. To date as part of the project we built 124 ContraBand systems for R&D for the scope of testing, development, trainings) and 54unites for clinical use in order to support the ongoing study. In addition, we improved our testing capabilities by building new fixtures and developing test methods to test the system’s long-term durability, mechanical properties and performance and to mitigate all possible risks as required by the FDA. As a result, the verification and validation campaign, which includes XX different testing, started and testingis ongoing as planned after systems were manufactured, pre- conditioned according to official protocols in light of ISO guidelines.
Both testing and manufacturing were done with high quality standards that were improved during the period of the project
In addition, we presented our clinical outcomes at leading cardiovascular conferences such as Euro PCR in Paris, HFA in Madrid and PCR in Boston. These sessions contribute to our effort to promote this technology across the EU clinical centres and investors
The strong clinical data which was accumulated as part of the project so far will be leveraged to start much wider effort that will take the ContraBand to market. The next clinical phase will be a pivotal study that will be held in the US and Europe. This larger scale study witll create traction that will bring investors and potential buyers. The pivotal study will be used for commercial submissions in EU ( CE Mark) and the US (PMA) The go-to-market plan includes building an infrastructure of sales, marketing regulatory and clinical in multiple countries across Europe. Few of the main activities that will be required in order to enter the market:
• Regulatory and legal – Gain market approvals in each relevant geographical region and establish a supply chain, manufacturing and distribution. This will require extensive legal work.
• Clinical and training – Train clinical teams, e.g. to proctor physicians, train nurses on device preparation, train echocardiographers on imaging.
• Sales and marketing - In order to spread the ContraBand technology across the EU and IL, we will build and train dedicated teams that will be responsible for Upstream marketing (working with future operators and at conferences to build traction and write publications) and for the Downstream marketing and sales (dedicated teams located in various countries) which will promote sales and market penetration locally in a direct hands-on approach.
• Regulatory and legal – Gain market approvals in each relevant geographical region and establish a supply chain, manufacturing and distribution. This will require extensive legal work.
• Clinical and training – Train clinical teams, e.g. to proctor physicians, train nurses on device preparation, train echocardiographers on imaging.
• Sales and marketing - In order to spread the ContraBand technology across the EU and IL, we will build and train dedicated teams that will be responsible for Upstream marketing (working with future operators and at conferences to build traction and write publications) and for the Downstream marketing and sales (dedicated teams located in various countries) which will promote sales and market penetration locally in a direct hands-on approach.