Tel Aviv, Israel— December 7, 2017 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that Professor Ralf Kolvenbach, head of the Vascular Surgery and Endovascular Therapy Department, and Medical Director of the Catholic Hospital, Düsseldorf, Germany, presented the preliminary results of a 50 patient study at the 7th Munich Vascular Conference, which demonstrated improved outcomes using CGuard™ EPS versus carotid endarterectomy (CEA).
Key highlights of this preliminary study include:
⦁ The gold standard more invasive CEA surgical procedure did not show show any clinical benefit versus CGuard™ EPS
⦁ Cranial nerve injury was significantly lower in patients with CGuard™ EPS versus patients undergoing CEA
⦁ Hospital discharge was faster in the CGuard™ EPS group compared to CEA
In contrast to conventional stents, CGuard™ EPS has been designed to deliver post-procedural long term protection for treatment of carotid lesions. The transcervical carotid stenting (T-CAR ) method was used in the CGuard™ EPS group, and is a less invasive method than CEA. TCAR is a method used by many vascular surgeons to facilitate direct stent implanation into the carotid artery.
Professor Kolvenbach commented, “I am very pleased with the preliminary results in this study. Our goal is to demonstrate with long term data that the CGuard™ EPS when implanted with the TCAR method will continue to perform as it did in this preliminary cohort of patients and ultimately show better results to CEA.”
50 consecutive symptomatic patients were evaluated. In one study group, 31 patients were treated with CGuard™ EPS using the TCAR method, and in the other group 19 patients were treated with CEA. The study did not find advantages for CEA in clinical endpoints or in DW-MRI postprocedural images, while cranial nerve injury was significantly more frequent in the CEA group compared to the CGuard™ EPS group. Hospital discharge in the CGuard™ EPS group was an average of 1.5 days earlier compared to CEA.
James Barry, PhD, Chief Executive Officer of InspireMD, commented, “The results of this trial further demonstrate the effectiveness of our technology. These results continue to support the protective role of CGuard™ EPS in the treatment of carotid artery disease.”
The 7th Munich Vascular Conference (MAC), held on December 7-9, 2017, is a platform for mutual exchange between vascular clinicians from all vascular medical specialties and colleagues from translational and basic research. The 7th MAC addresses aortic, carotid, venous and peripheral arterial diseases, featuring the latest advances in clinical and translational vascular research, including the newest open and endovascular technologies, biological mechanisms of atherosclerosis and the latest imaging modalities.
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.
InspireMD intends to pursue applications of this MicroNet technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS.
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
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