What Alleviant Medical does

Alleviant Medical, Inc. is a privately held, clinical-stage medical device company headquartered in Austin, Texas, founded in 2017. The company is developing the Alleviant System (ALV1), an investigational, minimally invasive, implant-free interatrial shunt device designed to create a small passageway between the upper chambers of the heart. The intended mechanism is to relieve excess pressure buildup within the heart and lungs in patients with chronic heart failure, particularly those with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF) who remain symptomatic despite optimal guideline-directed medical therapy.

The technology is being evaluated through two FDA-approved pivotal clinical trials — ALLAY-HF and ALLAY-HFrEF — enrolling patients in the United States, Canada, Australia, and New Zealand. Early multicenter pilot feasibility data (n≈27 patients) reported 67% reduction in heart failure symptoms, 93% improvement in quality of life, and 96% freedom from heart failure hospitalization at six months. The company holds three issued US patents covering its interatrial shunt architecture and is built around a single core product rather than a broader portfolio. Clinical leadership includes a cardiothoracic surgeon serving as Chief Medical Officer and engagement with academic key opinion leaders such as Tufts Medical Center and Boston Medical Center.

Alleviant is pre-revenue: the device is investigational and not cleared, authorized, or approved for commercial use in any geography, so commercial economics will only begin after FDA approval and commercialization. The company has raised approximately $165 million across two disclosed equity rounds ($75M in January 2023 co-led by S3 Ventures and RiverVest Venture Partners; $90M in January 2025 led by Gilde Healthcare with Omega Funds participation). Go-to-market during the clinical phase is event-driven, funneling patients into trials via allayhf.com and a center-locator tool across participating medical centers; the eventual commercial model has not been disclosed.

Name

Alleviant Medical

Legal name

Alleviant Medical, Inc.

Website

https://alleviantmedical.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

Alleviant Medical is a clinical-stage medical device company developing the Alleviant System (ALV1), a no-implant interatrial shunt for chronic heart failure in HFpEF/HFmrEF patients. Pre-revenue, running two FDA-approved pivotal trials across the US, Canada, Australia, and New Zealand.

Ownership category

akta.pro rank

Product category

Interventional Cardiology Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation) (HLAHAFAL)

akta.pro secondary industry

Interventional Radiology & Image-Guided Therapy Systems (HLAHABAG)

Keywords

• Interatrial shunt therapy
• Heart failure devices
• Transcatheter cardiology
• No-implant shunt
• Minimally invasive cardiac

Headquarters

HQ city

Austin

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel

Revenue model

1. Pre-commercial / Investigational Stage: The Alleviant System is an investigational device currently limited to clinical investigation. The company is not generating commercial revenue as the device is not cleared, authorized, or approved for commercial use in any global geography. Revenue will only be possible upon successful FDA approval and commercialization.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Alleviant Medical is developing the Alleviant System (ALV1), an investigational, minimally invasive transcatheter device that creates a no-implant interatrial shunt — a small passageway between the upper chambers of the heart — to reduce excess pressure buildup in the heart and lungs for patients suffering from chronic heart failure. The device is currently investigational and is being evaluated in two FDA-approved clinical trial programs (ALLAY-HF and ALLAY-HFrEF) and is not cleared, authorized, or approved for commercial use in any global geography.

Product overview

Alleviant Medical is a medical device company developing the Alleviant System (ALV1), a single core product — an investigational, no-implant interatrial shunt device for treating chronic heart failure. The device is designed to create an interatrial shunt through a minimally invasive procedure without requiring open heart surgery or leaving behind a permanent implant. The company is currently conducting two FDA-approved clinical trial programs (ALLAY-HF and ALLAY-HFrEF) to evaluate the safety and effectiveness of this device in heart failure patients who are symptomatic despite optimal approved therapies.

Differentiator

Problem solved

Functional benefit

Products and services

• Alleviant System (ALV1) An investigational, minimally invasive, implant-free interatrial shunt device designed to treat chronic heart failure by creating a small passageway between the upper chambers of the heart to reduce excess pressure buildup, without requiring open-heart surgery or leaving behind a permanent implant. Intended for heart failure patients (HFpEF/HFmrEF) symptomatic despite optimal approved therapies, accessible only through FDA-approved clinical trial programs at participating medical centers.
• ALLAY-HF and ALLAY-HFrEF Clinical Trial Programs Two FDA-approved clinical trial programs (ALLAY-HF and ALLAY-HFrEF) through which qualified heart failure patients can access the Alleviant System at participating medical centers, with ongoing follow-up by heart failure specialists over a 5-year period. Patients enroll through the allayhf.com portal and locate sites via the company's Find a Center feature.

Quantifiable outcome

• 67% reduction in HF symptoms after 6 months (n=18/27 patients)
• +2 more outcomes

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Corvia Medical: Direct competitor developing an implantable interatrial shunt device (IASD) for heart failure with preserved ejection fraction (HFpEF). Most directly comparable by indication, mechanism, and target patient population.
• V-Wave: Developer of an interatrial shunt device (Ventura) for HFpEF/HFmrEF. Competes head-to-head with Alleviant in the same no-implant-or-minimally-invasive interatrial shunt category.

Broad incumbents

• Edwards Lifesciences: Global structural heart leader with deep heart failure and transcatheter franchises. Represents both a potential strategic acquirer and the dominant incumbent whose commercial reach Alleviant would face at launch.
• Abbott: Broad cardiovascular incumbent with structural heart, heart failure (CardioMEMS), and interventional cardiology franchises. Directly relevant as a potential acquirer/partner and competitive threat in HFpEF device space.
• Medtronic: Diversified medtech incumbent with cardiac and vascular franchises. Comparable as a strategic acquirer with the infrastructure to commercialize a structural heart HF device globally.
• AtriCure: Public structural heart and atrial fibrillation device company. Comparable as a US-based structural heart device specialist targeting interventional cardiologists and cardiac surgeons.
• LivaNova: Cardiac surgery and neuromodulation company with heart failure-adjacent therapies (e.g., VNS for HF). Comparable as a broad incumbent with overlapping HF and structural heart interest.

Emerging players

• Ancora Heart: Emerging player developing transcatheter devices for heart failure, including AccuCinch for ventricular remodeling. Comparable as a fellow private, pre-commercial HF-focused structural heart company.
• BioVentrix: Developer of the Revivent TC transcatheter ventricular enhancement system for heart failure. Comparable as a private structural-heart HF device company pursuing less-invasive alternatives to surgical HF therapies.
• Cardiac Dimensions: Developer of the Carillon System, a transcatheter mitral annuloplasty device for functional mitral regurgitation and heart failure. Comparable as a transcatheter structural-heart HF device company at a similar stage.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/alleviant
• Facebookfacebook.com/alleviantmedical
• LinkedInlinkedin.com/company/alleviant-medical

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds6 records

Investors13 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Alleviant Medical