Market Overview

iSchemaView's RAPID™ Approved for Use in Canada


Patients Suffering Ischemic Stroke in Canada Now Have Access to the
Only Clinically Validated, Next-Generation Imaging Platform for
Assessing Treatment

iSchemaView, the leader in cerebrovascular imaging analysis, today
announced it has received final approval for the use of the RAPID
platform in Canada. The RAPID platform is designed to provide physicians
with fast, fully automated, elegant and easy-to-interpret imaging that
facilitates clinical decision-making around cerebrovascular disease,
such as stroke. Canadian approval comes after iSchemaView's quality
system was certified through the Medical Device Single Audit Program
(MDSAP) — a global approach to auditing and monitoring the manufacturing
of medical devices, in an effort to improve safety and oversight on an
international scale.

iSchemaView's RAPID platform was recently used to select patients for
two landmark stroke trials published in The New England Journal of
, DAWN and DEFUSE 3, that successfully treated patients up
to twenty-four hours after onset. RAPID was the exclusive imaging tool
used to aid in patient selection in both studies. The results of the
studies helped change the American Heart Association's and Canadian
Heart and Stroke Foundation's stroke guidelines to include CT perfusion
and MR perfusion. The prior treatment window for mechanical thrombectomy
was up to six hours. Starting in 2018, select patients with salvageable
brain tissue identified through advanced imaging are now eligible for
treatment up to twenty-four hours after they were last seen well.

"Our research use of RAPID has shown that its speed and accuracy are
very helpful in the management of patients with acute stroke," said Dr.
Frank Silver, Medical Director, Toronto West Stroke Network; Medical
Director of the Ontario Telestroke Program and Professor of Neurology at
the University of Toronto. "RAPID plays an important role in selecting
which patients should be urgently transferred to regional stroke centers
for endovascular therapy."

RAPID technology assists physicians in the analysis of brain images
using automated tools for CT ASPECTS, CT angiography, CT perfusion and
MR diffusion and perfusion for more than 85,000 stroke cases per year.
RAPID is also currently deployed in six multi-center clinical trials
globally — adding 200 hospitals to RAPID's global reach.

The RAPID neuroimaging platform creates high-quality images from
non-contrast CT, CT angiography, CT perfusion and MRI diffusion and
perfusion studies. The software provides an intuitive and easily
interpretable real-time view of brain perfusion, allowing physicians to
determine lesion volumes for a wide variety of different thresholds.

Also approved for use in Canada is RAPID ASPECTS, a validated solution
that assists clinicians in assessing early signs of brain ischemia in
stroke. RAPID ASPECTS automatically generates a standardized score —
based on clinically validated machine learning algorithms — that enables
physicians to easily communicate about the extent of a patient's
ischemic changes and to determine eligibility for thrombectomy (clot
removal). In addition, RAPID ASPECTS provides clear visualization of the
brain so that clinicians can better scrutinize each region and confirm
the automated score.

"With approval for RAPID in Canada, we will be able to greatly expand
the number of health care facilities that are able to assess stroke
patients with the only clinically validated next-generation imaging
technology," said Don Listwin, CEO of iSchemaView. "Over 575 stroke
centers in 22 countries around the world have now committed to using the
RAPID platform, and we look to increasing that number substantially by
the end of the year."

For more information about working with RAPID in Canada, contact Cynthia
Yang at +1 (949) 836-7402 or at

About iSchemaView

iSchemaView is the leader in cerebrovascular imaging analysis,
delivering the proven software tools that healthcare professionals
around the world use to successfully identify and treat more stroke
patients than ever before. Already installed in over 500 hospitals and
stroke centers, iSchemaView's RAPID (automated CTP, MR, CTA and ASPECTS)
is the most advanced brain imaging platform. In clinical trials, under
IRB, RAPID has been shown to aid in the selection of patients in early
and late-window stroke trials, including SWIFT PRIME, EXTEND IA, DAWN
and DEFUSE 3. In addition to achieving the best clinical outcomes and
largest treatment effects ever obtained, these landmark studies led to
new American Heart Association and American Stroke Association
guidelines and have dramatically altered the management of acute stroke
around the world. For more information, visit

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