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Venova Medical

Venova Medical

San Diego, United States· Est.
venovamedical.com
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Private Company

Total funding raised: $20M

Overview

Venova Medical is a clinical-stage medical device company targeting the critical unmet need for reliable, functional vascular access in end-stage renal disease patients requiring hemodialysis. Its core technology, the Velocity pAVF System, is a minimally invasive device designed to create arteriovenous fistulas percutaneously, aiming for faster maturation and fewer follow-up interventions compared to surgical methods. The company has generated promising early clinical data from its VENOS-1 and VENOS-2 studies and has initiated a pivotal IDE study (VENOS-3) in the United States. Venova is positioned to address a large market burdened by high catheter use, poor patient outcomes, and significant healthcare costs associated with current vascular access options.

CardiovascularNephrology

Technology Platform

Percutaneous catheter-based system for creating arteriovenous fistulas (AVF) for hemodialysis access.

Funding History

1
Total raised:$20M
Series A$20M

Opportunities

The massive clinical burden of catheter-based dialysis initiation (>80% of patients) creates a urgent need for a faster, more reliable alternative.
Successful demonstration of rapid maturation and reduced reinterventions could position Velocity as a new standard of care, driving significant market adoption.
Favorable outcomes data may also support strong reimbursement arguments based on reducing costly infections and hospitalizations.

Risk Factors

The pivotal VENOS-3 trial may fail to meet its endpoints, preventing FDA approval.
The company operates in a growing and competitive pAVF segment against other well-funded developers.
As a pre-revenue private company, it remains dependent on raising capital to fund operations through regulatory approval and commercial launch.

Competitive Landscape

Venova competes in the percutaneous AVF (pAVF) market, which includes companies like LimFlow (approved for deep vein arterialization in chronic limb-threatening ischemia, exploring dialysis access) and other private developers. Traditional competition comes from surgical AVF creation and the use of arteriovenous grafts (AVG). The broader competitive set includes companies focused on endovascular AVF maturation and maintenance (e.g., drug-coated balloons, stents).

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