InspireMD Supports CMS’ Final National Coverage Determination (NCD) Expanding Coverage of Carotid Stenting (CAS) to Include Both Asymptomatic and Standard Risk Patients

Provides additional treatment options for patients and treating physicians; likely expands CAS addressable market

Potentially accelerates conversion of carotid interventions from surgery (carotid endarterectomy) to minimally invasive CAS and TCAR procedures

InspireMD advancing both CAS and TCAR stent delivery platforms along U.S. and E.U. regulatory pathways leveraging proven CGuard EPS stent system

TEL AVIV, Israel and MIAMI, Oct. 12, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced its support for the Centers for Medicare and Medicaid Services (CMS) final National Coverage Determination (NCD) which expands coverage of carotid artery stenting (CAS) and transcarotid artery revascularization (TCAR) to include both asymptomatic and standard risk patients.

Marvin Slosman, Chief Executive Officer of InspireMD, stated, “We support CMS’s final decision on the expansion of coverage of CAS to include both symptomatic and asymptomatic carotid artery disease patients considered to be either standard or high risk for surgery. This decision offers a new treatment alternative to patients and their treating physicians and, we believe, will accelerate the ongoing shift toward an endovascular ‘stent first’ approach and away from more invasive surgery, the current standard of care.

“Importantly, at InspireMD, we continue to advance our mission, focusing on the importance of the implant first in both our CAS and TCAR programs, which are advancing through regulatory pathways in the U.S. and E.U. These programs both feature our next-generation CGuard EPS stent that has demonstrated unmatched clinical outcomes across nine clinical trials that have enrolled more than 1,850 patients, as well as over 40,000 real-world procedures performed to date. The CGuard EPS stent remains the cornerstone of our business, and this decision by CMS will broaden access to what we regard as this best-in-class technology, with anticipated FDA approval.”

In June 2023, InspireMD announced completion of enrollment in the C-GUARDIANS investigational device exemption (IDE) clinical trial of its CGuard EPS stent system. Thirty-day safety results from the trial will be presented as a Late Breaking Clinical Trial at the VIVA (Vascular InterVentional Advances) conference on November 1, 2023, in Las Vegas. The company anticipates filing for Premarket Approval (PMA) in the second half of 2024 when one-year follow up has been completed.