Surgical suturing is the 'gold standard' for tissue repair as it provides a long-lasting tissue approximation, preserves natural anatomy, obviates the need for a bulky implant, is reliable and features minimal to no side-effects,
The Novelrad vascular closure device (NVCD) breakthrough pre-close technique is mimicking that surgical 'gold standard' by deploying a multipoint purse suture pre catheterization procedure, thereby enabling safe dilation and reliable closure at the end of the procedure.
• The current challenge with large-bore access closure devices includes high complication rates (14%-20% EVAR/TAVI), extended hospitalization time, increased healthcare costs, and dependence on interventionist skills.
• NVCD addresses this unmet need by introducing a single-device solution capable of closing large and extra-large bore sites (up to 30 Fr). The device deploys a multipoint continuous suture pattern through a simple, intuitive mechanism, mimicking the surgical gold standard while allowing percutaneous applications, potentially, reducing complications, enhancing procedural efficiency, and minimizing vessel deformation.
• Pre-clinical results demonstrate the effectiveness of NVCD in achieving rapid time-to-hemostasis, maintaining vessel patency, and reducing adverse vascular outcomes.
• The project aims to advance NVCD through first-in-human and pivotal clinical trials and the submission for a CE certification.
Potential Impacts
NVCD has the potential to transform vascular closure techniques, delivering significant benefits for hospitals, interventionists, and patients:
• Healthcare System: Expected cost savings (est. at $8,000 per complication EVAR/TAVI) due to reduced complications and shorter procedure time and hospital stays, while improving resource efficiency in catheterization labs.
• Interventionists & Surgeons: Simplifies large-bore closure with a short learning curve, single-device operation, and adaptable use for arteries and veins.
• Patients: Minimizes complications, speeds up recovery, and facilitates access to minimally invasive cardiovascular interventions.
• Market Expansion & Disruption: NVCD challenges existing solutions by offering a simpler, safer, and more effective alternative for large and extra-large vascular transcatheter procedures.
Key Needs for Further Uptake & Success
1. Further Research & Clinical Validation – Completing first-in-human and pivotal trials to validate the safety, efficacy, and adoption potential of NVCD.
2. Manufacturing Scale Up – Gradual transition from prototype to full-scale manufacturing, optimizing costs per device to ensure affordability and profitability.
3. Regulatory & Standardization Framework – Successfully obtaining CE certification, followed by FDA approval for entry into the US market.
4. IPR Support & Competitive Positioning – Strengthening patent portfolio (4 families registered globally) to ensure market exclusivity and create barriers to entry for competitors.
5. Engagement with Key Opinion Leaders (KOLs) – Leveraging medical experts and early adopters to drive clinical acceptance and accelerate adoption in interventional cardiology.
6. Commercialization & Financial Support – Establishing strategic partnerships with hospitals, distributors and strategies to accelerate market entry and secure additional funding.
