Medical Tubing and Extrusion

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InspireMD

InspireMD brings in $58M, adds former Axonics CEO to board

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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

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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

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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

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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

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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

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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

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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

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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

InspireMD wins FDA approval for carotid stent system study

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InspireMD today said it received FDA approval to proceed with a pivotal study of its CGuard Carotid Stent System. The investigational device exemption from the FDA will allow the company to study the device for the prevention of stroke in patients in the U.S. “This is a key milestone in the history of our company as it helps pave the way for … [Read more...] about InspireMD wins FDA approval for carotid stent system study