Visby Medical
- Industry
- Medical Diagnostics
- Founded Year
- 2012
- Headquarters
- San Jose, California, United States
- Employee Count
- 464
Key People
- Adam de la Zerda, PhD - Founder & CEO
- Gary Schoolnik, MD - Chief Medical Officer
- Beth Lingenfelter - SVP of Quality, Regulatory, and Clinical Affairs
- Shaunak Roy, PhD - SVP of Research & Development
- Bill Meyer - VP of Finance
- Dylan Taylor - VP of Legal Affairs
- Chris Weaver - VP of Commercial Operations
Assessment
- Team
-
Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises experienced professionals with backgrounds in medical diagnostics and business operations.
The leadership team at Visby Medical includes individuals with extensive experience in medical diagnostics and business operations, contributing to the company's strategic direction and growth.
- Clinical Need
-
Aspect: Very Strong
Summary: Rapid, accurate diagnostics for infectious diseases are crucial for timely treatment and public health management.
The demand for rapid and accurate diagnostic tools for infectious diseases is high, as they enable timely treatment decisions and help in controlling disease spread, addressing a significant clinical need.
- Competition
-
Aspect: Very crowded + Strategics
Summary: The diagnostic market is highly competitive with numerous established players and emerging technologies.
The market for diagnostic devices is saturated with both large corporations and innovative startups, making it challenging for new entrants to capture significant market share without a unique value proposition.
- Technical Challenge
-
Aspect: Predictable
Summary: Developing portable PCR devices involves manageable technical challenges with established solutions.
The development of portable PCR diagnostic devices, while complex, follows established scientific principles and engineering practices, making the technical challenges predictable and solvable.
- Patent
-
Aspect: Strong
Summary: Visby Medical holds patents that protect its proprietary diagnostic technologies.
The company's patents provide a competitive edge by safeguarding its unique diagnostic technologies, though the strength of these patents in preventing competition is not fully detailed.
- Financing
-
Aspect: Well-funded
Summary: The company has secured substantial funding from reputable investors to support its growth and product development.
With over $135 million raised in its Series E financing round, Visby Medical is well-capitalized to scale operations and expand its product offerings.
- Regulatory
-
Aspect: 510k/PMA
Summary: Visby Medical has obtained FDA clearance for its diagnostic tests, facilitating market entry.
The company's FDA-cleared tests for sexually transmitted infections and respiratory infections demonstrate compliance with regulatory standards, enabling commercialization.
Opportunity Rollup
- Odds of Success
- 3.3
- Peak Market Share
- 3.9
- Segment CAGR
- 1.9%
- Market Segment
- In Vitro Diagnostics
- Market Sub Segment
- Point-of-Care Testing
| Year Post Launch | Market Penetration (%) |
|---|---|
| 1 | 0.20 |
| 2 | 0.58 |
| 3 | 1.36 |
| 4 | 2.73 |
| 5 | 3.90 |
Key Takeaway
Visby Medical's innovative rapid PCR diagnostics address a critical clinical need, but success depends on navigating a competitive market and achieving broad adoption.