InspireMD Stock

InspireMD, Inc., a medical device company, focuses on the development and commercialization of its proprietary MicroNet stent platform for the treatment of carotid artery disease and other vascular disease.

Products and Product Candidates

MicroNet Mesh Platform Technology

MicroNet is the company's proprietary circular knitted mesh which wraps around a stent to protect patients from plaque debris flowing downstream upon deployment. MicroNet is made of a single fiber from a biocompatible polymer widely used in medical implantations. The size, or aperture, of the MicroNet 'pore' is only 150-180 microns in order to maximize protection against the potentially dangerous plaque and thrombus. The MicroNet mesh is the core technology around which the company has developed products for specific applications.

CGuard EPS - Carotid Artery Applications

The company's CGuard EPS combines its MicroNet mesh and a self-expandable nitinol stent (a stent that expands without balloon dilation pressure or need of an inflation balloon) in a single device for use in carotid artery applications. MicroNet is placed over and attached to an open cell nitinol metal stent platform which is designed to trap debris and emboli that can dislodge from the diseased carotid artery and potentially travel to the brain and cause a stroke. This danger is one of the greatest limitations of carotid artery stenting with conventional carotid stents and stenting methods. The CGuard EPS technology is a highly flexible stent system that conforms to the carotid anatomy.

The company's CGuard EPS design provides advantages over existing therapies in treating carotid artery stenosis, such as conventional carotid stenting and surgical endarterectomy, given the superior embolic protection characteristics provided by the MicroNet. The MicroNet will provide acute embolic protection at the time of the procedure, but more importantly, CGuard EPS will provide post-procedure protection against embolic dislodgement, which can occur up to 48 hours post-procedure. It is in this post-procedure time frame that embolization is the source of post-procedural strokes in the brain. Schofer, et al. (Late cerebral embolization after emboli-protected carotid artery stenting assessed by sequential diffusion-weighted magnetic resonance imaging, Journal of American College of Cardiology Cardiovascular Interventions, Volume 1, 2008) have shown that the majority of the incidents of embolic showers associated with carotid stenting occur post-procedure.

The company's CGuard EPS original received CE mark approval in the EU in March 2013 and was fully launched in Europe in September 2015. Subsequently, it launched CGuard EPS in 30 plus countries and on February 3, 2021, the company executed a distribution agreement with Chinese partners for the purpose of expanding its presence in China. On October 13, 2021, the company announced that its CGuard EPS stent system received a positive opinion regarding reimbursement in France. The company is seeking strategic partners for a potential launch of CGuard EPS in Japan and other Asian countries.

The company's CE mark for CGuard carotid embolic prevention system (CGuard EPS) under the MDD expired on November 12, 2022 and it is in the final stages of technical documentation review by the Notified Body auditor to meet the Medical Device Regulation (MDR) requirements for recertification. In the meantime, on February 14, 2023, the company received a derogation per Article 97 paragraph 1 of Regulation 2017/745 from the Agency for Medicines and Health Products (FAMHP) allowing it to continue marketing CGuard EPS in the European Union (EU) until August 15, 2023, subject to certain procedural requirements. Subsequently, on March 20, 2023, Regulation (EU) 2023/607 was published allowing the company to continue marketing CGuard EPS in EU countries under the Medical Device Directive 93/42/EEC (MDD) until December 31, 2027. As a result of the foregoing, the company may market and sell CGuard EPS in the EU and certain other jurisdictions subject to certain procedural requirements while its MDR CE recertification is pending. The company continues to expedite the review process for recertification under the MDR.

On September 8, 2020, the company received approval from the U.S. Food and Drug Administration (FDA) of its Investigation Device Exemption (IDE), thereby allowing it to proceed with a pivotal study of the company's CGuard Carotid Stent System, C-Guardians, for prevention of stroke in patients in the United States. C-Guardians is a prospective, multicenter, single-arm, pivotal study to evaluate the safety and efficacy of the CGuard Carotid Stent System when used to treat symptomatic and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting. The trial was designed to enroll approximately 315 subjects in a maximum of 40 study sites located in the United States and Europe.

On July 23, 2021, the company announced the initiation of enrollment and successful completion of the first cases of its C-Guardian trial of CGuard EPS. The company is continuing with the enrolment phase at approximately 20 trial sites and expect it to be completed approximately at the end of the second quarter of 2023.

CGuard Prime Delivery System

The CGuard Prime System is a mesh-covered self-expanding carotid stent that is loaded into a transfemoral rapid exchange (Rx) delivery system that it is developing and that is subject to regulatory approval.

The CGuard Prime Carotid Stent is a self-expanding nitinol stent covered with a MicroNet bio-stable sleeve woven from a single strand of 23 micrometre Polyethylene Terephthalate (PET). The MicroNet sleeve is designed to trap and seal thrombus and plaque against the vessel wall, providing continuous embolic prevention. The CGuard Prime Carotid Stent is available in diameters ranging from 6.0mm to 10mm and in lengths of 20, 30, 40 and 60mm. The CGuard Prime Delivery System is a rapid exchange (Rx), delivery system with a 6Fr profile that can accommodate all stent sizes from 6mm to 10mm. The CGuard Prime Rx Delivery Systems are available in two lengths: 80 cm and 135 cm.

CGuard Prime advances the first generation CGuard transfemoral delivery system with new handle design for deployment accuracy, new catheter design for more flexible navigation of tortuous anatomy especially in acute revascularize settings, as well as two lengths, 135cm and 80cm for booth transfemoral and trans ,carotid access.

Switchguard

SwitchGuard is a Class IIa, non-invasive transcarotid artery revascularization (TCAR) device that the company is developing and that is subject to regulatory approval that is composed of medical grade tubing with male Luer lock connectors at each end and an in-line 200-micron blood filter. The device is intended as an external arterial-venous (A-V) shunt, allowing arterial blood to flow into the venous system, while filtering particulate before returning blood to the patient on the venous side.

The SwitchGuard arterio-venous extension line with filter is intended for flow circuit and particle removal when connecting arterial and/or venous introducers during interventional procedures.

SwitchGuard is being developed to answer a need of flow reversal for cerebral protection in coronary artery stenting (CAS) since symptomatic distal embolization, caused by the release of material (thrombotic, necrotic, or atherosclerotic) from the site of the lesion during the intervention, is the most frequent and important complication of CAS. Reversing blood flow has been shown to reduce stroke risk during carotid artery procedures.

Physicians frequently use extension lines constructed from blood filter transfusion sets during interventional procedures for the purpose of A-V shunting.

NGuard EPS - Acute Stroke with Tandem Lesions

CGuard EPS is optimally suited for intervention in this acute setting by way for design (flexible / low metal structure), as well as MicroNet mesh offering embolic protection both during and post procedural implantation. The company's intention is to develop CGuard EPS to mitigate strokes in this acute setting.

MGuard Prime

In 2022, the company ceased sales of its MGuard Prime embolic protection system (MGuard Prime EPS) following a phase out period.

Growth Strategy

The key elements of the company's strategy are to widen the adoption of CGuard EPS; portfolio expansion and pipeline development; grow its presence in existing and new markets for CGuard EPS; CMS approval of National Coverage Determination; continue to leverage its MicroNet technology to develop additional applications for interventional cardiologists and vascular surgeons; and establish relationships with collaborative and development partners to fully develop and market its existing and future products.

Sales and Marketing

Based on the positive CGuard EPS clinical data, the company initiated the commercial launch of CGuard EPS in CE marked countries in early 2015. In September 2015, the company announced full market launch of CGuard EPS in Europe. The company is focusing on sales of its products through local distribution partners and its own internal sales initiatives to gain greater reach into all the relevant clinical specialties and to expand its geographic coverage. The company's strategy seeks to broaden its sales efforts to increase CGuard EPS penetration within the community of interventionalists. The company has focused and it plans to continue to focus its marketing efforts primarily on key growth markets and to evaluate opportunities in new territories if and when they become available. In addition, the company is using international trade shows and industry conferences to gain market exposure and brand recognition. The company continues to work with leading physicians to enhance its marketing effort and is developing relationships with new key opinion leaders to champion its technology and work with it in clinical studies. In additional, the company has begun to sell direct to hospitals in certain markets, such as France and the United Kingdom, in order to increase its growth in the market.

Product Positioning: CGuard has potential to become the standard of care in treading carotid artery disease. It is a second-generation stent with positive patient outcomes demonstrating significant reduction in post-procedural neurological events. Additionally, the company intends to continue to evaluate potential product enhancements and manufacturing enhancements for CGuard EPS expected to provide the best-in-class performing delivery system and accessory solutions.

Intellectual Property

Patents

The company has 58 issued patents, including 16 patents issued in the U.S., and 17 pending patent applications, 6 of which are pending in the United States. Many of these patents and applications cover aspects of the company's CGuard and MGuard technology. Patents outside the U.S. have been filed in Canada, China, Europe, Israel, India, Japan, Australia, and South Africa.

Trademarks

The company has registered or applied to register the following trademarks, which it uses in connection with its products comprising InspireMD (the U.S., European Union, and the U.K.); MGuard (European Union, and the U.K.); CGuard (the U.S., European Union, and the U.K.); MGuard Prime (European Union, and the U.K.); NGuard (European Union and the U.K.); PVGuard (European Union, and the U.K.); Micronet (the U.S.); (MNP Micronet Protection logo) (European Union and the U.K.); Carenet (European Union and the U.K.); SmartFit (the U.S., the U.K. and CN); SmartFit Logo (EP, the U.K., CN); CGuard Prime (EP, the U.K., the U.S., CN, JP); SwitchGuard (EP, the U.K., the U.S., JP); True North Medical (the U.S., EP, the U.K.); MicroMesh (the U.S.); MicroMesh logo (the U.S., EP, the U.K., CN, JP); and Micronet logo (updated version) (the U.S., EP, the U.K., CN, JP).

Research and Development

For the year ended December 31, 2022, the company's research and development expenses were $7,810,000.

Government Regulation

The manufacture and sale of the company's products are subject to regulation by numerous governmental authorities, principally the European Union CE mark and other corresponding foreign agencies.

Many of the company's activities are subject to regulatory oversight by the FDA under provisions of the Federal Food, Drug, and Cosmetic Act and regulations thereunder, including regulations governing the development, marketing, labeling, promotion, manufacturing, and export of medical devices. The company's CGuard EPS is classified as a Class III medical device by the FDA.

Competition

With respect to competition for the company's carotid embolic prevention system, CGuard EPS, the manufacturers of products used in connection with CAS procedures in the United States, consisted of a number of large companies, including Abbott Laboratories, Boston Scientific Corporation, Covidien Ltd. (part of Medtronic, Inc.) and Cordis Corporation.

History

InspireMD, Inc. was founded in 2005. The company was incorporated in 2008.