MateraCor is developing effective and practical therapies for advanced heart failure, one of the most challenging unmet medical needs worldwide. Heart failure is a progressive, debilitating condition where patients experience a decline in physical and cognitive abilities because the heart is too weak to pump sufficient blood through the body. Once it reaches the advanced stage, it is difficult to control and leads to repeated hospitalization and eventual death. In fact, heart failure is the most common cause of hospitalizations in older adults and prognosis is poor. In the US, there are more than 6 million Heart Failure patients and 670,000 new cases are diagnosed every year.
The weakening of the heart may be triggered by many different causes including cardiovascular complications such as myocardial infarcts but also unrelated conditions such as diabetes, cancer treatments, viral infections, and others. Over the course of time, the damaged heart muscle either thickens abnormally, or it stretches and thins out like an over-inflated balloon, increasing tension and reducing the ability to contract. Known as cardiomyopathy, this is the condition that we aim to repair.
How do we do it? In over 10 years of research including human clinical trials, our investigators developed a treatment whereby a hydrogel is injected into specific areas of the heart muscle. This hydrogel is inert and well tolerated by the local tissue and it remains in the ventricle muscle wall as a string of permanent implants. What is the effect? As thoroughly shown in preclinical and clinical research, the hydrogel implants lead to reduced tension, improved contractility, and better oxygen uptake of the heart muscle.
But what does it mean to individual patients? A randomized controlled clinical trial showed that they had a significant improvement in exercise capacity looking at various parameters including the 6-minute walk test and peakVO2. Peak VO2, an objective measure of oxygen consumption and cardiorespiratory fitness, is especially important because it correlates with clinical symptoms, hospitalization, and mortality. With improved exercise capacity, treated patients transitioned from having severe physical limitations and symptoms to only slight limitations during ordinary activity. Quality of life and heart failure – related hospitalizations also improved clearly and the response was steady with a one-year follow-up.
The trials done in the past required the hydrogel to be injected through an open chest surgery that is risky for many of the elderly and frail heart failure patients. To be applicable more broadly, a minimally invasive delivery method was required. With its partners, MateraCor has now developed a successful solution. Inserted into the body through a smakll incision in the groin area, our endocardial injection system navigates through the aorta into the heart’s left ventricle. Once it is positioned properly, it attaches to the muscle wall and injects the hydrogel. The procedure can be performed by an interventional cardiologist using conventional methods and equipment.
Having completed pre-clinical testing, MateraCor is now preparing for the clinical development of the combined catheter and hydrogel system. Keep in mind that the hydrogel already showed safety and efficacy in heart failure patients. We are simply changing the delivery method to allow use in interventional cardiology labs and broader patient eligibility and product adoption. For patients, the procedure is extremely convenient in that it has to be performed only once, it does not require surveillance, and it does not interfere – and in fact may be synergistic – with other drugs and devices.