Venova Medical, Inc. Company Profile

Background

Venova Medical, Inc. is a privately held company dedicated to advancing vascular access solutions for patients requiring hemodialysis. The company's mission is to develop innovative, minimally invasive technologies that improve patient outcomes and reduce healthcare costs. Venova's primary focus is on the creation of percutaneous arteriovenous fistulas (pAVFs) for hemodialysis access, addressing the limitations of traditional surgical methods.

Key Strategic Focus

Venova Medical's strategic objectives include:

• Development of the Velocity™ pAVF System: A next-generation percutaneous AVF technology designed to create durable and functional fistulas with minimal need for reinterventions.

• Clinical Validation: Conducting comprehensive clinical studies to demonstrate the safety and efficacy of the Velocity System.

• Regulatory Approval: Pursuing FDA approval to bring the Velocity System to market in the United States.

• Market Expansion: Targeting patients with chronic kidney disease and end-stage renal disease who require hemodialysis, aiming to provide a superior alternative to existing vascular access methods.

Financials and Funding

In September 2024, Venova Medical secured a $30 million Series B funding round. The financing was co-led by Catalyst Health Ventures and a leading medical device company, with participation from ShangBay Capital, Mirae Asset Capital, KOFA Healthcare, Cadence Healthcare Ventures, Aphelion Capital, and other investors. The capital is allocated for further development of the Velocity pAVF System and to support clinical studies necessary for FDA regulatory approval.

Pipeline Development

Venova Medical's development pipeline centers on the Velocity pAVF System:

• VENOS-1 Study: A prospective, single-center, single-arm clinical trial (NCT05757726) evaluating the safety and feasibility of the Velocity System in hemodialysis patients. Results were presented at the Controversies in Dialysis Access Conference (CiDA) on October 5, 2024.

• VENOS-2 Study: A multi-center, prospective early feasibility study (NCT06712251) conducted under an Investigational Device Exemption (IDE) granted by the FDA. Enrollment was completed in April 2025, with plans to submit an IDE application for a multicenter U.S. pivotal trial in Q2 2025.

Technological Platform and Innovation

The Velocity pAVF System is designed to create arteriovenous fistulas using a minimally invasive, percutaneous approach. Key features include:

• Minimally Invasive Procedure: Enables AVF creation without the need for open surgery, potentially reducing patient recovery time and associated risks.

• Optimized Fistula Flow: Aims to provide durable and functional fistulas suitable for hemodialysis, minimizing the need for secondary interventions.

• Versatile Application: The procedure can be performed in various settings, including offices, surgery centers, or outpatient hospital environments.

Leadership Team

• Erik van der Burg: CEO and Co-founder. Leads the company's strategic direction and operations.

• Darshana Zaveri: Managing Partner at Catalyst Health Ventures. Appointed to the Board of Directors in September 2024, bringing extensive experience in healthcare investments.

Leadership Changes

In September 2024, Darshana Zaveri joined Venova Medical's Board of Directors, enhancing the company's leadership with her expertise in healthcare venture capital.

Competitor Profile

Market Insights and Dynamics

The vascular access market for hemodialysis is evolving, with a growing emphasis on minimally invasive procedures. The demand for effective and durable AVF solutions is increasing, driven by the rising prevalence of chronic kidney disease and end-stage renal disease.

Competitor Analysis

Key competitors in the pAVF space include:

• Company A: Focuses on endovascular AVF creation devices with a strong presence in the U.S. market.

• Company B: Offers a range of vascular access solutions, including percutaneous devices, and has established partnerships with major healthcare providers.

Strategic Collaborations and Partnerships

Venova Medical has established strategic partnerships with leading investors and medical device companies to support the development and commercialization of the Velocity pAVF System. These collaborations provide financial resources and industry expertise essential for advancing clinical studies and achieving regulatory milestones.

Operational Insights

Venova Medical's competitive advantages include:

• Innovative Technology: The Velocity System's minimally invasive approach addresses the limitations of traditional surgical AVF creation.

• Clinical Focus: Commitment to rigorous clinical validation to demonstrate safety and efficacy.

• Experienced Leadership: A leadership team with a strong track record in medical device development and commercialization.

Strategic Opportunities and Future Directions

Venova Medical's strategic roadmap includes:

• Completion of Clinical Trials: Finalizing the VENOS-2 study and initiating a multicenter U.S. pivotal trial to support FDA approval.

• Regulatory Approval: Achieving FDA clearance to market the Velocity pAVF System in the United States.

• Market Penetration: Establishing the Velocity System as the new standard of care for AVF creation in hemodialysis patients.

• Product Expansion: Exploring additional applications of the Velocity technology to address other vascular access challenges.

Contact Information

For more information, visit Venova Medical's official website.