InspireMD | MedPath

4DMT Prioritizes 4D-150 and 4D-710, Extends Cash Runway into 2028

4 months ago

• 4DMT is focusing its pipeline on 4D-150 for wet AMD and DME and 4D-710 for cystic fibrosis, leveraging their strong clinical proof of concept. • Phase 3 trials (4FRONT-1 and 4FRONT-2) for 4D-150 in wet AMD are set to begin in Q1 and Q3 2025, respectively, with topline data expected in H2 2027. • The company's cash runway has been extended to 2028, supported by $506M in cash reserves and strategic resource allocation. • 4DMT will discontinue development of early-stage programs like 4D-110 for choroideremia and 4D-125 for X-linked retinitis pigmentosa.

InspireMD's CGuard Prime Stent Evaluated in CGUARDIANS II TCAR Trial

5 months ago

• InspireMD partners with NAMSA to conduct the CGUARDIANS II pivotal study, evaluating the CGuard Prime 80 cm carotid stent system in TCAR procedures. • The CGUARDIANS II trial is a prospective, multi-center, single-arm study aiming to enroll at least 50 patients at high risk for adverse events from carotid endarterectomy. • The study assesses the acute device and technical success of CGuard Prime when used with an FDA-cleared TCAR neuro-protection system. • First patient enrolled in December 2024, marking progress toward potential FDA approval and expansion into the growing TCAR market.

InspireMD Receives FDA IDE Approval for CGuard Prime Carotid Stent Pivotal Study

8 months ago

• InspireMD received FDA approval for its IDE application to begin the CGUARDIANS II pivotal study of the CGuard Prime 80cm Carotid Stent System. • The study will evaluate the CGuard Prime stent during transcarotid revascularization (TCAR) procedures for stroke prevention. • Patrick Geraghty, M.D., and Patrick Muck, M.D., will serve as lead investigators for the CGUARDIANS II trial. • InspireMD aims to secure approval for CGuard Prime in TCAR procedures and advance its next-generation TCAR Neuroprotection System.

InspireMD Submits CGuard Carotid Stent for FDA Approval

8 months ago

• InspireMD has submitted a premarket approval (PMA) application to the FDA for its CGuard Prime carotid stent system, designed for treating carotid artery stenosis. • The PMA application is based on positive one-year data from the C-GUARDIANS pivotal clinical trial, which involved 316 patients across 24 sites in the U.S. and Europe. • C-GUARDIANS demonstrated a primary endpoint major adverse event rate of 1.95% at 12 months, the lowest reported for any carotid stent pivotal trial. • The CGuard EPS system, designed to prevent stroke, previously received CE mark and utilizes MicroNet technology for strong acute results and durable, stroke-free, long-term outcomes.

InspireMD Submits FDA Premarket Approval Application for CGuard Prime Carotid Stent System

8 months ago

• InspireMD has submitted a Premarket Approval (PMA) application to the FDA for its CGuard Prime carotid stent system, aimed at preventing stroke. • The PMA is supported by positive data from the C-GUARDIANS clinical trial, which demonstrated a low major adverse event rate of 1.95% at one year. • The C-GUARDIANS trial enrolled 316 patients across U.S. and European sites, evaluating the safety and efficacy of CGuard for carotid artery stenosis. • If approved, InspireMD anticipates a U.S. commercial launch of the CGuard Prime system in the first half of 2025.

InspireMD Seeks FDA Approval for CGuard Prime Carotid Stent System After Positive Trial Results

8 months ago

• InspireMD has submitted a Premarket Approval application to the FDA for its CGuard Prime carotid stent system, designed to prevent stroke by treating carotid artery stenosis. • The application is based on the C-GUARDIANS clinical trial, which reported a low major adverse event rate of 1.95% at one year post-procedure. • InspireMD is preparing for a potential U.S. commercial launch of CGuard Prime in the first half of 2025, pending FDA approval, and is setting up commercial infrastructure. • The CGuard Prime system utilizes InspireMD's MicroNet technology and aims to become the industry standard for carotid stenting with superior acute and long-term outcomes.