InspireMD Reports Second Quarter 2024 Financial Results and Provides Business Update

In This Article:

InspireMD, Inc.
InspireMD, Inc.

- Announced positive outcomes from the C-GUARDIANS IDE clinical trial of the CGuard™ Prime carotid stent system demonstrating a one-year primary endpoint event rate of 1.95%, the lowest for any carotid stent or embolic protection device pivotal trial –

- On track to submit a Premarket Approval (PMA) application to the FDA this quarter -

- Raised gross proceeds of $17.9 million from full exercise of Series H warrants triggered by announcement of C-GUARDIANS data -

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Management to host investor conference call today, August 6th, at 8:30am ET
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TEL AVIV, Israel and MIAMI, Aug. 06, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating results for the second quarter ended June 30, 2024.

Second Quarter 2024 and Recent Developments:

  • Announced one-year outcomes from the C-GUARDIANS IDE clinical trial of CGuard™ Prime demonstrating a primary endpoint event rate of 1.95% through one year, the lowest such event rate for any carotid stent or embolic protection device pivotal clinical trial.

  • Announced the full exercise of 12.9 million Series H warrants issued pursuant to the transformational public financing of up to $113.6 million announced in May 2023. The Series H warrants were exercised primarily into pre-funded warrants and resulted in gross proceeds of $17.9 million, or $16.9 million after fees.

  • Generated second quarter 2024 CGuard EPS revenue of $1.74 million, an increase of 5.4% over the second quarter of 2023, on 2,969 CGuard stents sold, up nearly 6% over the second quarter of 2023.

  • Engaged with a leading MedTech search firm, The Mullings Group, to accelerate build-out of world-class operations and commercial teams in the United States.

  • Announced completion of enrollment in groundbreaking CREST-2 clinical trial, with 23 patients in the stenting arm treated with CGuard, the only investigational device allowed by FDA for inclusion in the trial.

  • Advanced preparation activities for initiation of the CGUARDIANS II Transcarotid Arterial Revascularization (TCAR) clinical trial in the back half of 2024.

Marvin Slosman, CEO of InspireMD, commented: “The clear highlight since our last quarterly report was the announcement of best in class one-year outcomes data from our pivotal C-GUARDIANS clinical trial of the CGuard Carotid Stent System, which was designed to support a Premarket Approval (PMA) application to FDA later this year. The data demonstrated a primary endpoint event rate of 1.95% through one year, the lowest such rate for any carotid stent or embolic protection device pivotal clinical trial, thus adding to the significant body of data that we have compiled demonstrating the outstanding performance of CGuard both short- and long-term. With these results in hand, we intend to proceed with a PMA application this quarter while continuing to build out a world-class US commercial infrastructure in anticipation of FDA approval in the first half of 2025.