Cardionomic, Inc.
- Industry
- Medical Devices
- Founded Year
- 2011
- Headquarters
- <em>Unknown</em>
- Employee Count
- 0
Key People
- David Jenkins - CEO of Catheter Precision, Inc.
Assessment
- Team
-
Aspect: First-time 10+ yrs
Summary: The team comprises experienced professionals with over a decade in the medical device industry.
A team with over 10 years of experience in the medical device sector brings valuable insights and expertise, positioning the company favorably in the competitive landscape.
- Clinical Need
-
Aspect: Very Strong
Summary: The CPNS System addresses a significant unmet need in treating acute decompensated heart failure (ADHF).
ADHF affects over 1 million Americans annually, with high in-hospital morbidity and frequent rehospitalization. The CPNS System's approach to restoring autonomic balance offers a novel solution to this pressing issue.
- Competition
-
Aspect: First mover
Summary: The CPNS System represents a novel approach with limited direct competition.
The CPNS System's unique method of treating ADHF through neuromodulation positions it ahead of potential competitors, allowing for market leadership and brand establishment.
- Technical Challenge
-
Aspect: Moderate
Summary: The development of the CPNS System involves moderate technical challenges.
Developing a catheter-based neuromodulation device involves challenges such as ensuring precise nerve stimulation and patient safety. However, these challenges are manageable with the right expertise and resources.
- Patent
-
Aspect: Very Strong
Summary: The company holds a robust patent portfolio for the CPNS System.
With 49 issued patents and 46 patent applications, the company secures its innovative technology, deterring competitors and attracting potential investors.
- Financing
-
Aspect: Medium
Summary: The company has secured moderate funding but may require additional capital.
While initial funding has been obtained, the company anticipates the need for additional financing within 3-6 months to sustain operations and advance the CPNS System through regulatory processes.
- Regulatory
-
Aspect: Pivotal Trial
Summary: The CPNS System is approaching pivotal clinical trials.
The device has shown promising results in initial studies, but it must undergo pivotal trials and obtain FDA approval before commercialization, which involves time and regulatory scrutiny.
Opportunity Rollup
- Odds of Success
- 3.9
- Peak Market Share
- 5.5
- Segment CAGR
- 5.8%
- Market Segment
- Cardiac Assist Devices
- Market Sub Segment
- Neuromodulation Devices for Heart Failure
| Year Post Launch | Market Penetration (%) |
|---|---|
| 1 | 0.28 |
| 2 | 0.82 |
| 3 | 1.92 |
| 4 | 3.85 |
| 5 | 5.50 |
Key Takeaway
The CPNS System offers a promising solution for ADHF, addressing a significant unmet need with strong patent protection and initial positive clinical results, but requires further funding and regulatory approval.