EndoSpan News
13 articles
ENDOSPAN RECEIVES ADDITIONAL $25M FROM ARTIVION FOR NEXUS FDA APPROVAL PATH
Endospan Ltd, an Israeli-based company, has announced an agreement with Artivion, Inc for additional loans of up to $25 million to support the FDA approval process for its NEXUS Stent Graft System. This partnership aims to advance the IDE study with the FDA, offering minimally invasive solutions for patients with aortic arch disease. The NEXUS system, already CE-marked in Europe, is the first approved branched endovascular system for treating aortic arch disease, addressing a significant market opportunity. The TRIOMPHE IDE Study is currently enrolling patients to evaluate the safety and effectiveness of NEXUS. The collaboration with Artivion is expected to enhance Endospans ability to provide innovative solutions for complex aortic conditions.
InvestmentPartners
Endospan Reports Landmark Publication on the Initial Experience With the NEXUS™ Aortic Arch Stent Graft System
Endospan Enrolls First Patient in the TRIOMPHE IDE Study
Endospan Receives FDA IDE Approval to Initiate a Pivotal Study of the NEXUS™ Aortic Arch Stent Graft System
FDA Grants NEXUS™ Aortic Arch Stent Graft System Breakthrough Designation
CyroLife Signs Option to Acquire EndoSpan for up to $450 Million
CyroLife, a NYSE-listed cardiac and vascular surgery company, has signed a distribution agreement and option agreement to acquire Israeli stent graft company EndoSpan. CyroLife will pay $10 million for European distribution rights and provide up to $15 million in debt financing. The option agreement allows CyroLife to acquire EndoSpan for $350 million plus up to an additional $100 million depending on the systems commercial success.
PartnersInvestmentAcquisition
Endospan Enters Into Strategic Distribution Agreement With CryoLife
Endospan secures CE mark for Nexus stent graft system - Vascular News
Endospan has received CE mark approval for its Nexus stent graft system, which is used for branched endovascular repair in the aortic arch. The approval allows specialists in Europe to perform standardized minimally invasive repair of the aortic arch. The Nexus stent graft system provides a ready-to-treat technology solution that reduces the need for open surgery and lengthy hospitalization periods. The system is designed to achieve a durable effective repair while minimizing the risk of stroke and other cardiovascular complications. Endospan plans to expand the availability of Nexus with a limited market release across Europe and continue evaluating its long-term safety and effectiveness.
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CE mark approval for Nexus aortic arch stent graft expected in Q1 2019 - Vascular News
The article discusses the mid-term results of an investigational clinical study of the Nexus aortic arch stent graft system by EndoSpan. The study showed a 100% success rate in access, deployment, and procedural survival in 25 patients. The device demonstrated an excellent safety profile with no aneurysm-related deaths. The company expects to receive CE approval for the device in the first quarter of 2019. Longer-term data is needed to further study the performance of the Nexus stent graft system.
Customers
Endospan Elects Jeff Elkins as a Director
Endospan, an Israel-based medical device company, has announced the appointment of Jeff Elkins to its board of directors. Elkins has significant experience in the medical device industry, having served as President and CEO of Veniti Inc. since July 2015. He has also held various operations and product-development management positions at Cordis and Cordis Endovascular Systems, and Haemonetics Corp. during its IPO. Endospan is currently developing NEXUS, the first off-the-shelf endovascular approach to treating aortic arch disease.
Management Changes
Endospan Receives CE Mark for HORIZON™ EVAR System Based on Robust Clinical and Pivotal Data to Treat Abdominal Aortic Aneurysm (AAA)
Endospan, a pioneer in off-the-shelf EndoVascular Aortic Repair (EVAR), has received CE marking for its HORIZON Stent Graft System to treat Abdominal Aortic Aneurysm (AAA). The company is looking forward to working with potential partners to commercialize the HORIZON system for AAA repair.
Partners
Endospan Appoints Kevin J. Mayberry as CEO
http://www.geektime.com/2015/10/22/chinese-pharma-company-pumps-10-million-in-israeli-heart-tech/
