Alleviant Medical

Key People

• Adam Berman - Chief Executive Officer
• Mary Byron - Chief Financial Officer
• Jacob Kriegel, MD - Co-founder & Chief Medical Officer
• Michael McCully - Senior VP, Market & Clinical Development
• Sara Vidmar - Senior VP, Clinical, Regulatory & Quality
• Tom Pate - VP, Research & Development
• Lisa Diehl - VP, Therapy Development, North America
• Stacia Kraus - VP, Clinical Affairs
• Dana Mester - VP, Technical Operations
• Mark Perkins - VP, Clinical Marketing

Assessment

Team

Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises experienced professionals with a strong track record in the medical device industry.

The leadership team includes individuals with significant experience in the medical device sector, such as Adam Berman, who has held executive roles in multiple MedTech companies. This depth of experience positions the company well for navigating the complexities of product development and market entry.

Clinical Need

Aspect: Very Strong
Summary: Heart failure remains a leading cause of mortality and hospitalizations, indicating a significant unmet clinical need.

Heart failure affects millions globally, with limited effective treatment options. Alleviant Medical's no-implant atrial shunt offers a novel approach to alleviate symptoms and reduce hospital readmissions, directly addressing this substantial clinical need.

Competition

Aspect: Somewhat crowded
Summary: The market for heart failure treatments includes several established players and emerging technologies.

The cardiovascular device market is competitive, with numerous companies developing treatments for heart failure. Alleviant Medical's unique no-implant approach differentiates it, but the company must effectively demonstrate superior outcomes to gain market share.

Technical Challenge

Aspect: Moderate
Summary: Developing a no-implant atrial shunt involves moderate technical challenges, including ensuring safety and efficacy.

Creating a device that effectively reduces atrial pressure without leaving an implant requires precise engineering and thorough clinical validation. While challenging, the company's progress in clinical trials suggests these challenges are being addressed.

Patent

Aspect: Strong
Summary: The company holds multiple patents covering its technology, indicating a strong intellectual property position.

Alleviant Medical has been granted several U.S. patents (e.g., U.S. Patent Nos. 11,304,753; 11,612,432; 11,871,987), providing protection for its innovative no-implant atrial shunt technology. This strong IP position supports the company's market differentiation and potential for licensing opportunities.

Financing

Aspect: Well-funded
Summary: The company has secured significant funding, including a recent $90 million round led by Gilde Healthcare.

With total funding of approximately $189 million, including a $90 million round in January 2025, Alleviant Medical is well-positioned to advance its clinical programs and expand operations. This financial strength enables sustained R&D and market entry efforts.

Regulatory

Aspect: Pivotal Trial
Summary: The company is conducting pivotal trials for its no-implant atrial shunt, indicating progress in regulatory pathways.

Alleviant Medical has received FDA Breakthrough Device Designation and is actively conducting pivotal trials, such as the ALLAY-HFrEF trial. These steps are crucial for obtaining regulatory approval and eventual market entry.

Opportunity Rollup

Odds of Success

3.75

Peak Market Share

4.7

Segment CAGR

4.0%

Market Segment

Cardiovascular Devices

Market Sub Segment

Interventional Cardiology

Key Takeaway

Alleviant Medical's innovative no-implant atrial shunt addresses a significant unmet need in heart failure treatment, supported by a strong team and substantial funding, positioning it well in a competitive market.