Articles from Alleviant Medical, Inc.

Alleviant Medical, Inc., a privately held medical device company developing a no-implant atrial shunt for heart failure, today announced a $90 million financing to fund its second pivotal trial. Led by Gilde Healthcare, the round also adds Omega Funds and includes participation from existing shareholders S3 Ventures, RiverVest Venture Partners, Vensana Capital, Longview Ventures, Gilmartin Capital, TMC Venture Fund, and undisclosed strategic investors. The new pivotal trial, ALLAY-HFrEF, will be the first prospective sham-controlled trial focused on patients with heart failure and reduced ejection fraction (HFrEF) in the atrial shunt space.

Alleviant Medical, Inc., a privately held medical device company pioneering a no-implant atrial shunt for heart failure, today announced two significant milestones from the U.S. Food and Drug Administration (FDA). The FDA has granted the company investigational device exemption (IDE) approval to begin a pivotal trial focused on patients with one of the most common forms of heart failure, reduced ejection fraction (HFrEF). The agency also designated the technology with breakthrough status for this patient population.

Alleviant Medical, Inc., a privately-held medical device company developing a no-implant interatrial shunt for heart failure, today announced the closing of a $75 million equity financing co-led by S3 Ventures and RiverVest Venture Partners. This financing will fund the company’s global pivotal trial, ALLAY-HF (Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure). ALLAY-HF is designed to demonstrate the safety and effectiveness of the Alleviant System for the treatment of heart failure through left atrial decompression.