The medical device manufacturer is developing a no-implant interatrial shunt for heart failure, which is the leading cause of hospital admissions worldwide. Alleviant expects to sign up 400–700 patients at various sites worldwide for a trial of their medicine.
With this funding, the health-tech startup will be able to complete its ALLAY-HF global pivotal trial, which aims to show the Alleviant System’s efficacy and safety in treating heart failure by decompressing the left atrium.
According to the company’s news release, the ALLAY-HF is a global prospective, multicenter, randomised, sham-controlled, double-blinded, adaptive trial.
In this trial, chronic heart failure patients who continue to have symptoms despite stable, guideline-directed pharmacological therapy will have their safety and effectiveness of the Alleviant System assessed.
“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,” said Adam Berman, CEO of Alleviant Medical.
Alleviant is developing a treatment for chronic heart failure
A minimally invasive, implant-free device designed by Alleviant Medical, Inc. for treating chronic heart failure is now being tested in clinical settings. In 2021, the US FDA designated the Alleviant System as a breakthrough device.
“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. We are thrilled to be part of a strong investment syndicate supporting Alleviant’s talented, experienced management team as they drive forward this truly innovative technology,” said Jay Schmelter, managing director RiverVest Venture Partners.
The Alleviant System, which the U.S. Food and Drug Administration (FDA) approved as an investigational device exemption (IDE) in November 2022, has so far shown a significant clinical improvement (functional and symptomatic) in investigations involving 38 heart failure patients.
These investigations showed that shunt durability might last six months, and sustained improvement could last for an entire year.
Alleviant is a privately held firm with its corporate headquarters in Austin, Texas. S3 Ventures, RiverVest Venture Partners, Vensana Capital, Broadview and Longview Ventures, Gilmartin Capital, ShangBay Capital, TMC Venture Fund, and unidentified strategic investors support the company.