Cala Health
- Industry
- Medical Devices & Equipment
- Founded Year
- 2014
- Headquarters
- San Mateo, California, United States
- Employee Count
- 109
Key People
- Deanna Harshbarger - CEO
- Kate Rosenbluth - Founder, Chief Scientific Officer and Board Director
- Tim Gallagher - CFO
- Doug Biehn - Chief Commercial Officer
- Greg Schulte - VP of Hardware
- Steve Higa - Vice President, Manufacturing & Quality
- Ali Samiian - Senior Director, Reimbursement
- Dustin Bouch - Director Of Product Development
Assessment
- Team
-
Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises experienced professionals with backgrounds in major medical device companies.
The leadership team includes individuals with significant experience in the medical device industry, such as Deanna Harshbarger (CEO) with over 20 years in the field, and Doug Biehn (CCO) with experience at iRhythm and AliveCor. This depth of experience is a strong asset for the company's growth and innovation.
- Clinical Need
-
Aspect: Very Strong
Summary: Cala Health addresses essential tremor, a condition affecting over seven million people in the U.S.
Essential tremor is a prevalent neurological disorder, and Cala Health's non-invasive therapy offers a novel treatment option. The large affected population underscores the substantial clinical need and market opportunity for effective treatments.
- Competition
-
Aspect: First mover
Summary: Cala Health's wearable neuromodulation device is the first non-invasive prescription therapy for essential tremor.
As the first company to offer a non-invasive, wearable therapy for essential tremor, Cala Health has a significant advantage in establishing market leadership and brand recognition, potentially setting the standard of care in this segment.
- Technical Challenge
-
Aspect: Predictable
Summary: The technology involves wearable neuromodulation, which is complex but within the realm of current medical device capabilities.
Developing wearable neuromodulation devices requires integration of neuroscience and technology. Given the team's expertise and advancements in the field, these challenges are predictable and can be effectively managed.
- Patent
-
Aspect: Strong
Summary: Cala Health has secured patents for its wearable neuromodulation technology.
Holding patents for its technology provides Cala Health with intellectual property protection, reducing the risk of competition and supporting its market exclusivity.
- Financing
-
Aspect: Well-funded
Summary: Cala Health has raised approximately $263 million in funding from reputable investors.
The significant capital raised from investors like Johnson & Johnson and GV indicates strong financial backing, enabling the company to invest in research, development, and market expansion.
- Regulatory
-
Aspect: 510k/PMA + Reimbursement
Summary: Cala Health's therapy has received FDA clearance and Medicare coverage.
Achieving FDA clearance and securing Medicare coverage are critical milestones that facilitate broader adoption of the therapy, ensuring patients have access and providers are reimbursed.
Opportunity Rollup
- Odds of Success
- 3.75
- Peak Market Share
- 5.1
- Segment CAGR
- 4.9%
- Market Segment
- Neurology Devices
- Market Sub Segment
- Wearable Neuromodulation Devices
| Year Post Launch | Market Penetration (%) |
|---|---|
| 1 | 0.26 |
| 2 | 0.76 |
| 3 | 1.78 |
| 4 | 3.57 |
| 5 | 5.10 |
Key Takeaway
Cala Health's innovative, non-invasive therapy for essential tremor addresses a significant clinical need with strong market potential, supported by experienced leadership and substantial funding.