Periodic Reporting for period 1 - NVCD (Minimally invasive suturing for vascular bore closure and heart defect repair)
Reporting period: 2024-08-01 to 2025-05-31
Cardiovascular diseases are the leading cause of death worldwide, claiming approximately 18 million lives annually, according to the World Health Organization. In recent years, many of these conditions have become treatable through transcatheter interventions such as valve replacement, aneurysm repair, and intracardiac structure repairs. While these innovative procedures offer significant benefits, they require the creation of large access sites in the femoral vessel, increasing the risk of bleeding and vascular complications when closure is inadequate. This challenge creates the pressing need for a reliable, efficient, and cost-effective solution for large access closure.
Novelrad has developed a proprietary micro-suturing technology capable of deploying a range of continuous suture patterns percutaneously with a simple click of a button. This versatile platform replicates the surgical ‘gold standard’ and is designed to address multiple indications within the cardiovascular system and beyond, offering substantial scalability across diverse markets. The company’s first product is specifically designed to provide effective closure and repair of vascular access sites following large-bore catheterization procedures, ultimately reducing complication rates, shortening recovery times, and lowering healthcare costs. Future applications of our technology will extend to the repair of intracardiac structures e.g. Patent Foramen Ovale (PFO) a high-prevalence conditions associated with an increased risk of stroke.
Novelrad has developed a proprietary micro-suturing technology capable of deploying a range of continuous suture patterns percutaneously with a simple click of a button. This versatile platform replicates the surgical ‘gold standard’ and is designed to address multiple indications within the cardiovascular system and beyond, offering substantial scalability across diverse markets. The company’s first product is specifically designed to provide effective closure and repair of vascular access sites following large-bore catheterization procedures, ultimately reducing complication rates, shortening recovery times, and lowering healthcare costs. Future applications of our technology will extend to the repair of intracardiac structures e.g. Patent Foramen Ovale (PFO) a high-prevalence conditions associated with an increased risk of stroke.
During the first reporting period (August 1st 2024 to May 31st 2025 – “RP1”), Novelrad, after several years of research & development, successfully completed the design of its first product—a large-bore vascular closure device. In RP1 the company has completed the majority of verification and validation testing and conducted an extensive preclinical study, which demonstrated the device’s safety and efficacy in closing large vascular access sites.
With these fundamental achievements in hand, Novelrad is now preparing to initiate its First-In-Human (FIH) clinical trials, a pivotal step toward clinical validation and broader adoption in interventional cardiology and vascular catheterization.
Main activities and achievements
First article systems production
• Modify and transfer production line to clean room (Class 7)
• Build of article systems for the verification and validation
• Packaging and labeling design and production – completed
• Biocompatibility validation rationale, protocol and first test (By Namsa)
• Sterilization validation protocol and feasibility test (by Taryag -external vendor) – end of July
• Packaging integrity (Peel and Dye) – end of July
Mechanical bench testing
• Developed bench testing protocols
• Design and build test apparatus
• Developed semi-automated FTP procedure
• Completed 14 of 19 tests
Preclinical study
• Completed all the R&D phase pre-clinical labs aimed at evaluating the final design prior to design freeze
• Completed all pre-clinical validation study labs (7 acute animals and 7 chronic)
• The first animal completed follow-up with very good results. All other chronic animals’ follow-up are underway
• Final report is expected by the end of July 25
IP
• Two patents were granted in Europe and Japan
• All other patents are in the National phase
With these fundamental achievements in hand, Novelrad is now preparing to initiate its First-In-Human (FIH) clinical trials, a pivotal step toward clinical validation and broader adoption in interventional cardiology and vascular catheterization.
Main activities and achievements
First article systems production
• Modify and transfer production line to clean room (Class 7)
• Build of article systems for the verification and validation
• Packaging and labeling design and production – completed
• Biocompatibility validation rationale, protocol and first test (By Namsa)
• Sterilization validation protocol and feasibility test (by Taryag -external vendor) – end of July
• Packaging integrity (Peel and Dye) – end of July
Mechanical bench testing
• Developed bench testing protocols
• Design and build test apparatus
• Developed semi-automated FTP procedure
• Completed 14 of 19 tests
Preclinical study
• Completed all the R&D phase pre-clinical labs aimed at evaluating the final design prior to design freeze
• Completed all pre-clinical validation study labs (7 acute animals and 7 chronic)
• The first animal completed follow-up with very good results. All other chronic animals’ follow-up are underway
• Final report is expected by the end of July 25
IP
• Two patents were granted in Europe and Japan
• All other patents are in the National phase
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.
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.