Texas medical device firm Alleviant Medical has secured $90m to fund a second pivotal trial of the company’s heart system for patients living with heart failure and reduced ejection fraction (HFrEF).
The funding will be used to drive the company’s second trial, dubbed the ALLAY-HFrEF trial, examining the Alleviant ALV1 system, the company’s atrial shunt system, in approximately 350 randomised patients with reduced left ventricular ejection fraction who remain symptomatic despite guideline-directed medical therapy (GDMT).
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The ALLAY-HFrEF trial will support the company’s first pivotal trial, ALLAY-HF (NCT05685303), which is testing the safety and efficacy of the system and is due to finalise enrolment by the end of next year.
The financing was led by US investment firm Gilde Healthcare, with additional investors including Omega Funds and existing shareholders S3 Ventures, RiverVest Venture Partners and Ventana Capital, among others. As a result of this funding, the company claims it is the only arterial shunt developer carrying out trials across the full range of heart failure indications.
Adam Berman, CEO of Alleviant Medical, said: “We are committed to developing an effective treatment for patients suffering from heart failure with our minimally invasive, no-implant approach.
“We are incredibly grateful to partner with a top-tier investor syndicate as we advance this mission together for patients while building a leading healthcare company focused on this massive market opportunity. We welcome Gilde Healthcare and Omega to this strong partnership.”
One of the lead investigators Gregg Stone, director of academic affairs and professor of population health sciences and policy at the Icahn School of Medicine at Mount Sinai in New York, said: “We are fortunate to have the results from a prior study that demonstrated substantial clinical benefits in high-risk HFrEF patients with an implanted permanent atrial shunt. These findings informed the design of the ALLAY-HFrEF trial, which is testing a novel device that creates an atrial shunt and leaves no permanent implant behind.”
Elsewhere in the arterial graft space, Capstan Medical has raised $110m to advance its robotic platform for cardiac disease treatment for patients living with heart failure. Meanwhile, Endospan has completed enrolment in the primary arm of a clinical trial evaluating its stent graft for the treatment of aortic arch disease.
