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.
