Cardiac Dimensions
- Industry
- Medical Devices & Equipment
- Founded Year
- 2001
- Headquarters
- Kirkland, Washington, USA
- Employee Count
- 65
Key People
- Rick Wypych - President and CEO
- Dr. Steven Goldberg - Chief Clinical Officer
Assessment
- Team
-
Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises experienced professionals with a strong background in medical technology and business management.
The leadership team, including CEO Rick Wypych and Chief Clinical Officer Dr. Steven Goldberg, brings a wealth of experience in medical technology and business management. Their backgrounds suggest a strong capability to navigate the complexities of the MedTech industry and drive the company's growth.
- Clinical Need
-
Aspect: Very Strong
Summary: Functional mitral regurgitation (FMR) is a prevalent condition among heart failure patients, with limited effective treatment options.
FMR affects a substantial portion of heart failure patients, leading to increased hospitalizations and mortality. The Carillon Mitral Contour System offers a minimally invasive solution, addressing this critical need and potentially improving patient outcomes.
- Competition
-
Aspect: Somewhat crowded
Summary: The market for mitral valve repair devices includes several competitors, but the Carillon system offers unique advantages.
While there are multiple devices available for mitral valve repair, the Carillon system's minimally invasive approach and favorable clinical outcomes provide a competitive edge. However, the presence of established competitors necessitates strategic positioning and continuous innovation.
- Technical Challenge
-
Aspect: Predictable
Summary: The Carillon system utilizes established catheter-based techniques, reducing technical complexity.
The device's design and deployment are based on well-understood catheterization procedures, which simplifies training and adoption among clinicians. This predictability enhances the likelihood of successful implementation and patient outcomes.
- Patent
-
Aspect: Strong
Summary: Cardiac Dimensions holds multiple patents protecting the Carillon system's unique features.
The company's patent portfolio covers key aspects of the Carillon system, providing a competitive barrier and supporting long-term commercial success. This strong IP position deters potential competitors and adds value to the company's offerings.
- Financing
-
Aspect: Well-funded
Summary: Recent successful funding rounds have provided substantial capital for clinical trials and commercialization.
The $53 million Series E financing, led by Ally Bridge Group, along with previous rounds, has equipped the company to complete pivotal trials and expand market presence. This financial stability enables sustained investment in research, development, and commercialization efforts.
- Regulatory
-
Aspect: Pivotal Trial
Summary: The Carillon system is undergoing a pivotal trial in the U.S. and has received MDR certification in Europe.
The ongoing EMPOWER Trial aims to secure FDA approval, while the MDR certification allows continued sales in Europe. These regulatory milestones are critical for market expansion and demonstrate the device's safety and efficacy.
Opportunity Rollup
- Odds of Success
- 3.65
- Peak Market Share
- 4.5
- Segment CAGR
- 15.1%
- Market Segment
- Cardiovascular Devices
- Market Sub Segment
- Transcatheter Heart Valves
| Year Post Launch | Market Penetration (%) |
|---|---|
| 1 | 0.22 |
| 2 | 0.67 |
| 3 | 1.57 |
| 4 | 3.15 |
| 5 | 4.50 |
Key Takeaway
Cardiac Dimensions is well-positioned to address a significant clinical need with its Carillon Mitral Contour System, supported by strong leadership, robust funding, and favorable industry trends, though it faces challenges in a competitive and regulatory landscape.