The ALLAY-HF trial is designed to study the safety and effectiveness of its Alleviant System for the treatment of heart failure through left atrial decompression with a less invasive approach
US-based medical device company Alleviant Medical has secured $75m in an equity financing round that was jointly led by venture capital firms S3 Ventures and RiverVest Venture Partners.
The proceeds from the funding round will be used towards the company’s ALLAY-HF trial of the company’s Alleviant System.
The global study intends to assess the safety and efficacy of the Alleviant System for no-implant interatrial shunt creation in patients suffering from chronic heart failure. Its objective is to demonstrate the safety and effectiveness of the system via left atrial decompression using a less invasive approach.
Alleviant Medical CEO Adam Berman said: “Alleviant’s mission is to bring a safe, effective no-implant treatment option to millions of patients suffering from heart failure, and this highly informed study is a critical step forward.
“We could not ask for a stronger group of institutional and strategic healthcare investors as we accelerate our global efforts to bring this technology to patients.”
ALLAY-HF will be a multicentre, randomised, sham-controlled, double-blinded, adaptive trial involving 400-700 patients at select sites around the world.
The trial will feature chronic heart failure patients with preserved (HFpEF) and mildly reduced (HFmrEF) ejection fractions who showed no improvement in their symptoms despite medical therapy.
At the completion of one year, the trial’s composite primary endpoint analysis will be performed, Alleviant Medical said.
The Alleviant System secured investigational device exemption (IDE) from the US Food and Drug Administration (FDA) in November last year and breakthrough device designation in 2021.
As of now, the system has shown significant clinical improvement in trials involving 38 heart failure patients. These investigations showed that shunt durability was confirmed through six months, while sustained improvement was seen through 12 months.
RiverVest Venture Partners managing director Jay Schmelter said: “Alleviant Medical is poised to significantly improve the quality of life for millions of heart failure patients for whom there has been a lack of meaningful options.
“Alleviant Medical is poised to significantly improve the quality of life for millions of heart failure patients for whom there has been a lack of meaningful options.”