Eclipse

An estimated 1.6 million people in the United States have moderate to severe tricuspid regurgitation (TR), a condition in which the tricuspid valve leaflets do not coapt, creating an orifice that allows blood to flow backwards from the right ventricle into the right atrium. If left untreated, this condition can cause edema, liver congestion, shortness of breath, and right heart failure, among other complications that significantly reduce patient quality of life. The one-year survival rate for severe TR patients is a mere 64%. Despite the severe implications of TR, the disease is largely under-treated in the medical community since the current treatment carries too high of a risk. The standard of care is an open-heart surgery in which an annuloplasty ring is secured around the valve annulus to reduce dilation, allowing the leaflets to coapt. Operational mortality rates for this procedure range from 8-12% for a patient’s first open heart procedure and 10-25% for a reoperation. The alternative to surgery is medical management with diuretics, which does little to improve patient quality of life. Of the 340,000 patients diagnosed with moderate-severe TR annually, only 10,000 receive the surgical treatment that they need. Our team is developing a low-risk percutaneous (catheter-based) treatment system in order to address the large underserved patient population with severe functional TR. There has been substantial development in such percutaneous intervention technologies in the structural heart space over the past 15 years. In the tricuspid space, companies have recently begun developing percutaneous solutions that either replicate sub-optimal surgical techniques or have yet to prove long-term efficacy. The surgical technique that our solution is replicating percutaneously, ring annuloplasty, has been proven surgically to significantly reduce the degree of tricuspid regurgitation, provide the highest freedom from recurrence of TR, and has the highest durability compared to other approaches. We are currently working through the iterative loop of designing, manufacturing, and testing in ex vivo pig hearts with the goal of soon being ready for in vivo implantation of our device in animals. We will continue to iterate based on the results. All aspects of our design will be continually validated by our team of physicians in order to ensure that we are developing a solution that will be safe, efficacious, and has the potential to become widely adopted.