Corvia Medical has raised $55m to complete an ongoing clinical trial of its atrial shunt system for heart failure.
The US-based company’s trial began in 2022 and is currently underway at more than 65 institutions across three continents with 750 patients enrolled, according to the trial’s listing on Clinicaltrials.gov.
Increasing Corvia’s current funding to around $150m, the latest set of funds originated from the company’s existing investment syndicate of Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, along with two strategic investors.
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Corvia anticipates the double-blind, randomised, sham-controlled confirmatory RESPONDER-HF (NCT05425459) trial of the Corvia atrial shunt system, which is being evaluated to treat heart failure with preserved and mildly reduced ejection fraction (HFpEF/HFmrEF), to generate the final clinical data required to support a regulatory filing with the US Food and Drug Administration (FDA).
The atrial shunt works by creating a small passage between the heart’s left and right atria, enabling blood to flow from the high-pressure left side to the lower-pressure right side.
Trial patients randomised to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transoesophageal echocardiography (TEE) guided trans-septal puncture and with the Corvia atrial shunt implant procedure. In addition, patients randomised to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.
Upon completion, patients will be evaluated at pre-specified time intervals and followed for five years.
Corvia CEO George Fazio said: “We are profoundly grateful for the unwavering support of our longstanding investors as we advance toward FDA submission of the Corvia atrial shunt.
“Their commitment furthers our mission to bring this transformative heart failure treatment to millions of patients worldwide.”
The funding will provide Corvia with the resources needed to navigate the approval process for the Corvia shunt system and introduce the therapy to the market, added Corvia board chair Paul LaViolette.
Research indicates that around 65 million people worldwide have heart failure, with a majority affected by HFpEF.
In October 2023, Corvia announced positive safety and efficacy results from its REDUCE LAP-HF II (NCT03088033) randomised Phase III trial of its atrial shunt. In comparison to the sham control, patients showed a 50% reduction in the rate of heart failure events and a sustained improvement in quality of life as measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ).
