InspireMD Secures $113.6 Million Financing to Advance Next-Generation Embolic Prevention System for Peri- and Late-Procedural Stroke Protection

According to the World Health Organization, stroke is the second leading cause of death globally. An academic paper by M. Bosiers et al., published in the European Journal of Vascular and Endovascular Surgery, points out that traditional carotid artery stenting carries a significant risk of embolism, with approximately two-thirds of neurovascular events, such as stroke and transient ischemic attack (TIA), occurring after carotid artery stenting (CAS).

InspireMD is dedicated to providing sustained stroke prevention therapy during carotid artery stenting (CAS), leveraging its proprietary MicroNet technology to offer innovative solutions for embolic protection and neurovascular safeguarding.

InspireMD is a commercial-stage medical device company founded in 2005 and headquartered in Tel Aviv, Israel. Leveraging its proprietary MicroNet technology, the company developed its flagship product, the CGuard Embolic Prevention System (hereinafter referred to as “CGuard EPS”). CGuard EPS is the world’s only carotid stent system utilizing patented MicroNet technology. It captures potential embolic debris against the arterial wall while maintaining perfusion of the external carotid artery, thereby preventing both peri-procedural and late-term embolism.

In high-risk lesions, traditional single-layer stents used for revascularization have many limitations.

On one hand, the use of single-layer stents in heavily calcified stenotic vessels is prone to causing a risk of perforation. In such vessels, significant calcium salt deposition on the vascular wall leads to arteriosclerosis and luminal narrowing. In this scenario, dilation with conventional stents may damage the vessel wall, resulting in hemorrhage or perforation. Furthermore, inadequate stent expansion can compromise blood flow patency and increase the likelihood of restenosis.

On the other hand, traditional stent designs tend to prioritize either conformability or plaque coverage, making it difficult to achieve both simultaneously. Traditional stents for embolic therapy are mainly categorized into two types: “open-cell” and “closed-cell.” The former offers high flexibility but low plaque coverage. When used for vasodilation, it may push thrombi into smaller arterial branches, causing distal embolism and leading to vascular ischemia or necrosis. Although the latter provides superior coverage, its rigid material and poor conformability prevent it from adapting to varying vessel sizes and anatomical structures.

Meanwhile, carotid artery revascularization is increasingly favoring carotid artery stenting (CAS) over carotid endarterectomy. However, studies have demonstrated that CAS is associated with perioperative risk factors for stroke, which can significantly increase patient disability and even mortality. Therefore, there is an urgent clinical need for a novel carotid stent designed to reduce perioperative stroke and accommodate the majority of carotid anatomies. Furthermore, this stent should exhibit strong versatility, enabling its use via carotid artery revascularization (CAR), transfemoral, transradial, or other approaches to access the carotid artery.

Due to a lack of technological innovation, the treatment of carotid artery disease remains predominantly surgical, with very slow updates to therapeutic paradigms. CGuard EPS, however, has driven innovation in the management of this condition. Supported by its dual-layer design, MicroNet technology, and SmartFit technology, CGuard EPS employs minimally invasive procedures to treat vascular embolism, effectively reducing both procedure time and patient recovery time, while lowering the risk of stroke for patients.

MicroNet is a micromesh on the CGuard EPS, and it is the foundation that enables the CGuard EPS to innovate embolization therapy methods.

MicroNet is an ultrafine mesh made of polyethylene terephthalate (PET), with pore sizes typically ranging from 150 to 180 µm. This pore size is meticulously designed to effectively capture thrombi and plaques while maintaining adequate blood perfusion.

When the stent is placed within the carotid artery, MicroNet prevents plaque or thrombus from passing through the stent struts, thereby avoiding embolization into the intracranial or systemic circulation. Meanwhile, MicroNet maintains perfusion of the external carotid artery without compromising normal blood flow. MicroNet is connected to the proximal and distal crowns of the stent, ensuring its stability within the vessel.

In calcified lesions, the vessel wall is often rigid and resistant to expansion. If conventional balloon angioplasty is used, it may result in incomplete stent apposition to the vessel wall or cause vascular injury. In contrast, MicroNet offers superior sealing performance, allowing for stent expansion with larger balloon diameters and higher pressures. This ensures better apposition to the vessel wall even in the presence of calcification, thereby preventing plaque debris embolization and subsequent stroke.

John Paul II Hospital in Krakow initiated a multicenter, multidisciplinary study. The study aimed to validate the feasibility, safety, and efficacy of using MicroNet for embolization protection in consecutive high-risk iliac artery stenosis lesions. MicroNet optimized angiographic outcomes without embolization or other complications. Within 6 months, a 100% primary patency rate was achieved without in-stent restenosis. Furthermore, MicroNet has been proven to play a significant role in maintaining post-procedural cerebral protection.

Building on MicroNet technology, the CGuard EPS further overcomes the limitations of traditional stents through its double-layer design and SmartFit technology, thereby redefining the treatment paradigm for vascular embolism.

The dual-layer stent is the standout feature of the CGuard EPS, serving as the foundation for overcoming the limitations of traditional stents, which suffer from single-functionality and an inability to balance conformability with coverage.

CGuard EPS is a dual-layer stent composed of an inner open-cell laser-cut nitinol stent and an outer MicroNet mesh, achieving a combination of “open-cell” and “closed-cell” structures. This dual-layer design provides high radial strength and compression resistance, enabling easy dilation of stenotic carotid arteries. It effectively prevents neointimal hyperplasia and in-stent restenosis, thereby improving long-term vessel patency.

Furthermore, the double-layer design enhances stent stability and apposition, reducing the risk of stent migration, deformation, or fracture, thereby maintaining the stability and durability of carotid artery stents. Meanwhile, the double-layer stent increases coverage area, preventing plaque from protruding through stent struts and migrating into cerebral arteries.

Dr. Andrey Karpenko and colleagues conducted a randomized controlled trial to compare the efficacy of traditional stents (Acculink, Abbott Vascular) versus MicroNet-covered stents (CGuard, InspireMD) in preventing cerebral embolism during carotid artery stenting (CAS). The results demonstrated that MicroNet-covered stents significantly reduced perioperative cerebral embolism associated with CAS compared to traditional carotid stents. Furthermore, MicroNet-covered stents eliminated cerebral embolism from 48 hours to 30 days post-CAS, whereas cerebral embolism persisted in the control group treated with traditional single-layer stents.

The Rapid Exchange (Rx) system is an integral component of the CGuard EPS. This technology enables stent delivery into blood vessels, allowing for rapid stent deployment from the catheter without the need for catheter exchange. During the procedure, the Rapid Exchange (Rx) system delivers the self-expanding CGuard EPS into the carotid artery, enabling it to conform to the vessel diameter, thereby eliminating the need for a tapered design.

Tapered design is a type of carotid artery stent design, characterized by differing diameters at the proximal and distal ends to accommodate variations in vessel diameter. This stent lacks “self-adaptability” to vessel diameter, requiring physicians to select the appropriate size based on the shape and dimensions of the blood vessel, thereby increasing procedural complexity. Furthermore, compared with the CGuard EPS, tapered-design stents exhibit larger gaps between the stent and the vessel wall, failing to achieve close apposition.

The self-expanding CGuard EPS employs SmartFit technology. This intelligent adaptive technology leverages the shape-memory properties of nitinol to enable the stent to change its shape in response to varying temperatures. SmartFit technology automatically adjusts the stent’s length and diameter to conform to the vessel’s geometry and size, thereby reducing procedural complexity, shortening operation time, and lowering the rate of post-procedural restenosis.

On May 15, 2023, InspireMD announced the completion of a $113.6 million post-listing equity financing round. The round was led by Marshall Wace and LifeSci Capital, with participation from Velan Capital, Rosalind Capital Partners, and others. The proceeds will be used to support regulatory approval applications for CGuard EPS in the United States, expand the indications for CGuard EPS, and continue business expansion in approved markets outside the United States.

InspireMD’s Q2 2023 financial report disclosed that the company sold a total of 2,804 CGuard EPS units in the second quarter of 2023, representing a 7.8% increase from the 2,602 units sold in the second quarter of 2022 and a 38% increase from the 2,033 units sold in the first quarter of 2023. Revenue from CGuard EPS reached a record high of $1,649,000 in the second quarter of 2023, marking a 9.6% year-over-year increase and a 33% quarter-over-quarter growth.

On June 26, 2023, InspireMD announced the completion of enrollment in its exempted clinical trial for CGuard EPS, aimed at facilitating marketing approval in the United States. Notably, full enrollment was achieved in less than two years, including the first-in-human case using CGuard EPS. The company expects to announce primary and secondary endpoints shortly and, if successful, plans to submit a Premarket Approval (PMA) application to the FDA in the second half of 2024. Meanwhile, InspireMD continues to advance its pre-commercialization activities in the U.S., with plans to launch CGuard EPS in the first half of 2025 following approval.