InspireMD (Nasdaq:NSPR) today announced 30-day outcomes from a study of its CGuard Prime 80cm implant for use in TCAR procedures. Miami-based InspireMD launched CGuard Prime in the U.S. in July 2025 after receiving FDA premarket approval (PMA) the previous month. As of May, it reported 70,000 successful cases worldwide, including the majority of … [Read more...] about InspireMD has positive results for CGuard Prime in TCAR
InspireMD
InspireMD recalls CGuard Prime 135 cm stent delivery system in US, gets nod to study neuroprotection tech
InspireMD (Nasdaq:NSPR) announced today that, in consultation with the FDA, it recalled its CGuard Prime 135 cm carotid stent delivery system. The company said it initiated a voluntary recall for the system. After a controlled launch, the company determined that the technical success of the delivery system during carotid artery stenting … [Read more...] about InspireMD recalls CGuard Prime 135 cm stent delivery system in US, gets nod to study neuroprotection tech
InspireMD brings in $58M, adds former Axonics CEO to board
InspireMD (Nasdaq:NSPR) announced today that it raised approximately $58 million and added an experienced executive to its board. In addition to a significant equity private placement (PIPE) financing and warrant exercise, the company appointed Raymond W. Cohen to its board of directors. Cohen brings more than 40 years of leadership experience to … [Read more...] about InspireMD brings in $58M, adds former Axonics CEO to board
InspireMD launches carotid stent in U.S. after FDA approval
InspireMD (Nasdaq:NSPR) announced today that it launched its CGuard Prime carotid stent in the U.S. after receiving FDA premarket approval (PMA) last month. The CGuard embolic prevention stent (EPS) system — designed to prevent stroke — received CE mark last month as well. It utilizes the company’s MicroNet technology for strong acute results and … [Read more...] about InspireMD launches carotid stent in U.S. after FDA approval
FDA grants PMA for InspireMD CGuard Prime carotid stent, triggers $18M milestone payment
InspireMD announced that the FDA granted premarket approval (PMA) for its CGuard Prime carotid stent system. The CGuard embolic prevention stent (EPS) system — designed to prevent stroke — received CE mark earlier this month. It utilizes the company’s MicroNet technology for strong acute results and durable, stroke-free, long-term … [Read more...] about FDA grants PMA for InspireMD CGuard Prime carotid stent, triggers $18M milestone payment
InspireMD wins CE Mark approval for CGuard Prime
InspireMD today announced it received CE Mark approval for its CGuard Prime carotid stent system for the prevention of stroke. The Miami-based company said the next-generation carotid stent system was developed based on physician feedback and features improved deliverability and deployment. It builds on the original CGuard design, which uses a … [Read more...] about InspireMD wins CE Mark approval for CGuard Prime
InspireMD announces CFO retirement, transition
InspireMD announced today that Craig Shore, the company's CFO, decided to retire after the company identifies and appoints a successor. Shore intends to remain as CFO until the stroke prevention company names his replacement to assist in a smooth and orderly transition. He spent 15 years at InspireMD, helping to build the business into "a global … [Read more...] about InspireMD announces CFO retirement, transition
InspireMD wins FDA IDE for carotid stent study
InspireMD (Nasdaq:NSPR) announced today that the FDA granted investigational device exemption (IDE) for its CGuard Prime 80cm carotid stent system. The FDA says the company can begin the CGUARDIANS II pivotal study of the system used during transcarotid revascularization (TCAR) procedures. InspireMD picked Dr. Patrick Geraghty and Dr. Patrick … [Read more...] about InspireMD wins FDA IDE for carotid stent study
InspireMD submits carotid stent for FDA premarket approval
InspireMD (Nasdaq:NSPR) announced today that it submitted a premarket approval (PMA) application to the FDA for its CGuard system. The company designed the CGuard Prime carotid stent system, made from nitinol, for the treatment of carotid artery stenosis. It based its PMA application on positive one-year data from the company's C-GUARDIANS … [Read more...] about InspireMD submits carotid stent for FDA premarket approval
InspireMD brings in $17.9M to support stent trial
InspireMD (Nasdaq:NSPR) announced today that it completed a full exercise of Series H warrants for proceeds of about $17.9 million. Tel Aviv, Israel-based InspireMD exercised 12.9 million warrants, converting primarily into pre-funded warrants. The gross proceeds for the company, which has a U.S. base in Westin, Florida, total $16.9 million … [Read more...] about InspireMD brings in $17.9M to support stent trial
