Venova Medical
- Industry
- Medical Devices & Instruments
- Founded Year
- 2018
- Headquarters
- 649 University Avenue, Los Gatos, California, USA
- Employee Count
- 11
Key People
- Erik van der Burg - Co-Founder, Director & CEO
- Dr. Shant Vartanian - Co-Founder, Director & CMO
- Robert Nardelli - VP of Quality & Regulatory Affairs
- Keif Fitzgerald - VP of Engineering
Assessment
- Team
-
Aspect: First-time 10+ yrs
Summary: The leadership team comprises first-time entrepreneurs with over a decade of experience in the medical device industry.
The management team includes individuals with extensive experience in medical device development and clinical expertise, positioning the company well for navigating the complexities of the MedTech industry.
- Clinical Need
-
Aspect: Very Strong
Summary: The Velocity pAVF System addresses a critical need for safer and more efficient vascular access in hemodialysis patients.
With over 80% of patients starting dialysis with a catheter, which is associated with higher morbidity and mortality, the minimally invasive Velocity pAVF System offers a transformative solution to improve patient outcomes.
- Competition
-
Aspect: Somewhat crowded
Summary: The market for vascular access devices has several players, but Venova's technology offers distinct advantages.
While there are existing solutions for vascular access, the Velocity pAVF System's minimally invasive approach and potential for reduced reinterventions provide a competitive edge.
- Technical Challenge
-
Aspect: Moderate
Summary: Developing a percutaneous AVF system involves moderate technical challenges, but the company has demonstrated success.
The VENOS-1 clinical study reported 100% technical success, indicating that while challenges exist, they are being effectively managed.
- Patent
-
Aspect: Strong
Summary: Venova Medical has secured strong patent protection for its Velocity pAVF System.
The company's intellectual property strategy provides a competitive advantage and barriers to entry for potential competitors.
- Financing
-
Aspect: Well-funded
Summary: The company has secured significant funding to support its development and clinical studies.
The $30 million Series B funding round, led by reputable investors, positions Venova Medical well for continued growth and regulatory approval processes.
- Regulatory
-
Aspect: Pivotal Trial
Summary: Venova Medical is progressing through pivotal clinical trials to obtain regulatory approval.
The company has completed enrollment in the VENOS-1 clinical trial and is conducting further studies to support FDA approval.
Opportunity Rollup
- Odds of Success
- 3.35
- Peak Market Share
- 4.3
- Segment CAGR
- 5.9%
- Market Segment
- Nephrology and Urology Devices
- Market Sub Segment
- Vascular Access Devices
| Year Post Launch | Market Penetration (%) |
|---|---|
| 1 | 0.22 |
| 2 | 0.64 |
| 3 | 1.50 |
| 4 | 3.01 |
| 5 | 4.30 |
Key Takeaway
Venova Medical's innovative Velocity pAVF System addresses a critical need in hemodialysis access, supported by a strong team and substantial funding, positioning it well for market success.