Advancing Commercial Readiness of a No-implant Interatrial Shunt Therapy to Treat Heart Failure

ABSTRACT Congestive heart failure (CHF) is a progressive condition that currently affects over 6 million patients in the US. It accounts for over $35B in annual healthcare expenditure and is responsible for over one million hospitalizations each year. Approximately half of all patients with CHF have a left ventricular ejection fraction (EF) greater than 40% and are categorized as having heart failure with preserved ejection fraction (HFpEF, EF ≥ 50%) or mid- range ejection fraction (HFmrEF, 40% ≤ EF < 50%). The prognosis for these patients is poor: due to a paucity of treatment options, patients have 5-year and 10-year mortality rates of 50% and 90%, respectively. Although existing pharmacological therapies have demonstrated symptomatic improvement and mortality benefit in patients with reduced ejection fraction heart failure, there are currently limited FDA-approved treatment options (pharmacological or device-based) for the HFpEF/HFmrEF patient population. The concept of interatrial shunting has gained attention as a potential therapeutic option for patients with CHF. By creating a connection between the high-pressure left atrium to the low-pressure right atrium elevated left atrial pressure (LAP) may be effectively lowered thereby relieving CHF symptoms. Thus far, interatrial shunt implants have demonstrated positive safety signals and positive reported outcomes, including significant reduction in left atrial filling pressure, improvements in 6-minute walk test, quality of life, and New York Heart Association classification and most importantly, heart failure events. Nonetheless intracardiac implants carry proven clinical risks including clot formation, device fracture and migration, implantation failure, and interference with future cardiac interventional therapies. There is currently no device available that can provide therapeutic left atrial decompression without the long-term clinical risks and concerns of leaving behind a foreign body in the heart. Alleviant Medical has developed a novel transcatheter approach to relieve left atrial pressure by creating an interatrial shunt without the need for a cardiac implant. Following the success of design verification testing and positive results from a 38-patient first-in-human clinical study, Alleviant received FDA IDE approval to investigate the safety and efficacy of a no-implant interatrial shunt for patients with heart failure in a pivotal randomized controlled trial which is currently underway. The goal of this Commercial Readiness Pilot proposal has two aims: (1) implement high-volume manufacturing capabilities and establish production readiness of the ALV1 System, and (2) execute reimbursement and marketing initiatives to establish value to payers and promote disease and therapy awareness. To achieve this goal, Alleviant will procure and complete injection mold qualifications for scaled production of critical components, implement design for manufacturing process modifications, de-risk single source supply chain elements, and increase the sterilization throughput capacity. Alleviant will develop and execute a strategy for achieving reimbursement through the Centers for Medicaid and Medicare Systems for a no-implant interatrial shunt therapy. Successful execution of this proposal will result in a commercial ready System with an established pathway reimbursement.