HERZELIA, Israel, July 2, 2024 /PRNewswire/ -- Endospan Ltd
("Endospan"), an Israeli-based, privately-held developer of the
NEXUS® Stent Graft System ("NEXUS"), announced today an
agreement with Artivion, Inc ("Artivion") for additional loans of
up to $25M for U.S. Food and Drug
Administration ("FDA") approval of NEXUS.
"We're excited to progress in our IDE study with the FDA and
extending options for more patients with aortic arch disease
through this agreement with Artivion," Kevin Mayberry, chief executive officer of
Endospan, said. "We share a commitment with Artivion to delivering
minimally-invasive solutions to help surgeons address the complex
challenges of this growing market."
More than 120,000 patients suffer thoracic aortic arch disease
every year in the USA and
Europe, with only about 25%
diagnosed or treated. Despite significant advancements, open
surgical aortic arch repair maintains high mortality and morbidity.
Patients with excessive perioperative risk or anatomical factors
are not indicated for surgery, yet anatomical complexity and lack
of approved devices for the arch has often prohibited endovascular
repair. This makes the choice of treatment difficult or even
impossible for some patients. Providing the alternative of
minimally invasive repair decreases the requirement for extra
corporal circulation and the possibility of hypothermia,
translating into reduced procedure and hospitalization time.
Endospan has developed NEXUS, the first and only approved
branched endovascular system to treat aortic arch disease,
including both aortic aneurysms and aortic dissections. While
minimally invasive endovascular repair has been the standard of
care for Abdominal Aortic Aneurysm (AAA) and Thoracic Aortic
Aneurysm (TAA), aortic arch disease patients with aneurysms or
dissections who receive treatment have previously had little choice
but to undergo open-chest surgery with its associated invasiveness
and risks, lengthy hospitalizations, and prolonged recuperation.
NEXUS transforms a complex surgical aortic arch repair into a
minimally invasive endovascular procedure. NEXUS addresses a
$600M global addressable market
opportunity.
Endospan is currently enrolling patients in the TRIOMPHE IDE
Study, a multi-arm, multi-center, non-randomized, prospective,
clinical study to evaluate the safety and effectiveness of NEXUS®
in treating thoracic aortic lesions involving the aortic arch. The
study will enroll up to 110 patients at up to 31 sites. Earlier
this year, Endospan shared 30-day results of the first 22 patients
enrolled in the study. This early data aligned with results
achieved during an EU clinical study, suggesting that NEXUS may
provide surgeons with a straightforward, minimally invasive
solution for aortic arch repair that allows for procedural
consistency with reliable patient outcomes.
About Endospan Ltd.
Privately held Endospan,
headquartered in Herzelia (Tel
Aviv), Israel, is a pioneer
in the endovascular repair of Aortic Arch Disease including
aneurysms and dissections. Endospan has received CE-Mark to
commercialize in Europe the NEXUS™
Stent Graft System, the first endovascular off-the-shelf system to
treat aortic arch disease which affects a greatly underserved group
of patients diagnosed with a dilative lesion in, or near, the
aortic arch. While minimally invasive endovascular repair has been
the standard of care for Abdominal Aortic Aneurysm (AAA), aortic
arch disease patients with aneurysms or dissections have not been
as fortunate and have had little choice but to undergo open-chest
surgery with its invasiveness and risks, lengthy hospitalization
periods, and prolonged recuperation. For additional
information about Endospan, visit their website,
www.endospan.com.
About Artivion, Inc.
Headquartered in suburban
Atlanta, Georgia, Artivion,
Inc. is a medical device company focused on developing simple,
elegant solutions that address cardiac and vascular surgeons' most
difficult challenges in treating patients with aortic diseases.
Artivion's four major groups of products include: aortic stent
grafts, surgical sealants, On-X mechanical heart valves, and
implantable cardiac and vascular human tissues. Artivion markets
and sells products in more than 100 countries worldwide. For
additional information about Artivion, visit our website,
www.artivion.com.
Endospan
Kevin Mayberry
Chief Financial Officer
Kevin@endospan.com
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