Aria CV

Key People

• Dan Gladney - President & CEO
• John Scandurra - Chief Scientific Officer
• Karl Vollmers - Vice President of Research and Development
• Gary Graham - Vice President of Operations

Assessment

Team

Aspect: First-time physician innovator
Summary: The founding team comprises first-time physician innovators with significant experience in medical device development.

While the founders have substantial medical and technical expertise, their lack of previous entrepreneurial success in the MedTech sector may pose challenges in navigating commercialization and scaling processes.

Clinical Need

Aspect: Very Strong
Summary: Pulmonary hypertension is a severe condition with limited treatment options, indicating a very strong clinical need.

Pulmonary hypertension leads to high morbidity and mortality, and current treatments are often inadequate. Aria CV's device offers a novel approach that could significantly improve patient outcomes, underscoring a very strong clinical need.

Competition

Aspect: First mover
Summary: Aria CV appears to be a first mover in implantable devices for pulmonary hypertension.

As a pioneer in this specific treatment modality, Aria CV has the advantage of setting industry standards but also faces the challenge of establishing market acceptance and overcoming initial skepticism.

Technical Challenge

Aspect: Complex
Summary: Developing an implantable device without batteries or electronics presents a complex technical challenge.

Creating a device that operates solely on the heart's motion without external power sources involves intricate engineering and material science challenges, which could impact development timelines and costs.

Patent

Aspect: Strong
Summary: Aria CV holds strong patents, including exclusive licenses from the University of Minnesota.

Holding strong patents, especially exclusive licenses from reputable institutions, can protect the company's innovations and deter competitors, enhancing its market position.

Financing

Aspect: Well-funded
Summary: Aria CV has secured substantial funding, including a $31 million Series B round.

With significant financial backing from reputable investors, Aria CV is positioned to advance its product development, conduct clinical trials, and pursue regulatory approvals effectively.

Regulatory

Aspect: Pivotal Trial
Summary: The device has received FDA Breakthrough Device Designation, indicating a pivotal trial stage.

Achieving Breakthrough Device Designation is a significant milestone, as it can expedite the regulatory process. However, the company must still successfully complete pivotal trials to demonstrate safety and efficacy before market approval.

Opportunity Rollup

Odds of Success

2.85

Peak Market Share

3.6

Segment CAGR

5.8%

Market Segment

Cardiac Assist Devices

Market Sub Segment

Implantable Pulmonary Hypertension Devices

Key Takeaway

Aria CV's innovative device addresses a significant unmet need in pulmonary hypertension treatment, but faces challenges in technical development, market adoption, and regulatory approval.