FREMONT, Calif. and OXFORD, England, Sept. 7, 2017 /PRNewswire/ — Cerus Endovascular Ltd., a privately-held, commercial-stage medical device company engaged in the design and development of highly differentiated and proprietary interventional neuroradiology devices and delivery systems for the treatment of acute, life-threatening neurological conditions, specifically, intracranial aneurysm, today provided an update on its lead development programs, including the Contour Neurovascular System as well as the NEQSTENT Intra-Saccular Stent.
“The past few months have been transformational for our company, as we have moved aggressively to further advance our portfolio of clinically differentiated aneurysm treatments and begin the transition to a commercial-stage company with the roll-out of Contour Neurovascular System in CE Marking countries,” said J. Todd Derbin, founder, chairman and chief executive officer of Cerus Endovascular. “As we enter this new phase, we look forward to building upon the successful outcomes seen to date, and to planned discussions with the U.S. Food & Drug Administration (FDA) and other regulatory agencies. We strongly believe that our innovative devices have the potential to revolutionize aneurysm treatment, and we are eager to make this technology more broadly available to patients in need.”
Contour Neurovascular System
Since announcing CE Mark approval of the Contour Neurovascular System in June 2017, Cerus Endovascular has made steady and continued progress toward transforming into a commercial-stage company. To date, 25 sites in Europe have been confirmed for limited commercial release of the system on a direct sales basis. Additionally, the company has assembled a steering committee comprised of leading experts in the field of aneurysm treatment to assist in the screening of appropriate patient cases.
NEQSTENT Intra-Saccular Stent
Cerus Endovascular also announced today a highly-successful first-in-man implantation of the NEQSTENT Intra-Saccular Stent at Odense University Hospital in Denmark. Additional cases are planned. The company is in the process of finalizing its regulatory submission to European authorities and is targeting CE Mark approval in the second quarter 2018.
Cerus Endovascular has successfully completed all required chronic toxicity, genotoxicity and carcinogenicity testing for both Contour and NEQSTENT in preparation for a pre-IDE meeting with FDA in the coming months.
About Cerus Endovascular
Founded in 2013, Cerus Endovascular is a privately-held, commercial-stage medical device company engaged in the design and development of highly differentiated and proprietary interventional neuroradiology devices and delivery systems for the treatment of acute, life-threatening neurological conditions, specifically, intracranial aneurysm. The company’s first marketed product, the Contour Neurovascular System, is a pre-shaped structure of fine mesh braid with shape memory properties that is delivered to the aneurysm via an endovascular micro-catheter and is currently approved for sale across the EU. The company is also developing a pipeline of complementary devices, leveraging the design concept of the Contour Neurovascular System to address the full range of size, type and location of cerebral aneurysms with which a patient can present to the clinician.
Contacts:
Melody A. Carey
Rx Communications Group, LLC
917-322-2571
mcarey@rxir.com
SOURCE Cerus Endovascular Ltd.
