Sam Brusco, Associate Editor01.27.23
Alleviant Medical, a company developing a no-implant interatrial shunt for heart failure, has cloased a $75 million equity financing round, co-led by S3 Ventures and RiverVest Venture Partners.
The funding will fund the company’s ALLAY-HF (Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure) pivotal trial. ALLAY-HF aims to demonstrate safety and effectiveness of the Alleviant system to treat heart failure through left atrial decompression.
“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,” Adam Berman, CEO of Alleviant Medical told the press. “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.”
The ALLAY-HF trial will evaluate the system in chronic heart failure patients with preserved (HFpEF) and mildly reduced (HFmrEF) ejection fraction (EF ≥ 40%) who remain symptomatic despite stable guideline-directed medical therapy. The trial will enroll 400 to 700 patients worldwide. The trial’s composite primary endpoint analysis will be conducted at one year.
“The Alleviant team is a real force in trailblazing novel solutions for heart failure,” said Brian R. Smith, managing director, S3 Ventures. “The team’s thoughtful approach to the ALLAY-HF trial demonstrates great insight into heart failure modalities and we remain bullish about their long-term prospects.”
“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,” said Jay Schmelter, managing director, RiverVest Venture Partners. “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.”
The Alleviant system was granted Investigational Device Exemption (IDE) by the FDA in November 2022. To date, its shown significant clinical improvement (functional and symptomatic) in studies across 38 heart failure patients. Shunt durability in these studies was confirmed through six months and sustained improvement was shown through 12 months.
The funding will fund the company’s ALLAY-HF (Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure) pivotal trial. ALLAY-HF aims to demonstrate safety and effectiveness of the Alleviant system to treat heart failure through left atrial decompression.
“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,” Adam Berman, CEO of Alleviant Medical told the press. “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.”
The ALLAY-HF trial will evaluate the system in chronic heart failure patients with preserved (HFpEF) and mildly reduced (HFmrEF) ejection fraction (EF ≥ 40%) who remain symptomatic despite stable guideline-directed medical therapy. The trial will enroll 400 to 700 patients worldwide. The trial’s composite primary endpoint analysis will be conducted at one year.
“The Alleviant team is a real force in trailblazing novel solutions for heart failure,” said Brian R. Smith, managing director, S3 Ventures. “The team’s thoughtful approach to the ALLAY-HF trial demonstrates great insight into heart failure modalities and we remain bullish about their long-term prospects.”
“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,” said Jay Schmelter, managing director, RiverVest Venture Partners. “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.”
The Alleviant system was granted Investigational Device Exemption (IDE) by the FDA in November 2022. To date, its shown significant clinical improvement (functional and symptomatic) in studies across 38 heart failure patients. Shunt durability in these studies was confirmed through six months and sustained improvement was shown through 12 months.