STOCKHOLM, Jan. 7, 2020 /PRNewswire/ -- IRRAS, a global
healthcare company with a comprehensive portfolio of innovative
solutions for neurocritical care, today provides an update on
the launch of its products in the United
States (US) and product portfolio objectives for
2020.
"We are excited to report on the growth and expansion of IRRAS'
IRRAflow® and Hummingbird ICP monitoring product
lines," said Kleanthis G.
Xanthopoulos, Ph.D., President & CEO of IRRAS. "The CE
Mark recertification of IRRAflow and the US launches of
IRRAflow and Hummingbird provide IRRAS with good
opportunities to meet our 2020 goals and accelerate our progress
toward becoming a global leader in neurocritical care."
IRRAflow Updates and 2020
Goals
IRRAflow, a commercially available medical device system
for the treatment of intracranial bleeding, is the world's first
"irrigating ventricular drain," and its unique mechanism of action
addresses the complications associated with the current methods of
managing intracranial fluid by using a dual lumen catheter that
combines active irrigation with ongoing fluid drainage.
Additionally, IRRAflow incorporates ICP monitoring and
uses a proprietary software to regulate treatment based on desired
pressure levels.
- In the US, the launch of IRRAflow continues to progress
as planned, and IRRAS has now generated physician support at
approximately 70 stroke centers in the US. Of these 70, more
than 15 have purchased IRRAflow components or are actively
evaluating the system, including locations in the high-volume
neurocritical care markets of Illinois, New
York, and California.
Training is underway to introduce IRRAflow at
approximately 10 additional hospitals early in 2020. As the IRRAS
commercial team expands during 2020, resources will be in place to
train the remaining 45+ US hospitals that have expressed interest
in IRRAflow.
- During the 4th quarter of 2019, four new centers in the US
placed orders for the company's IRRAflow system. Of
these four new purchasing customers, three of the hospitals
represent IRRAS' first customers to successfully complete an
IRRAflow product evaluation and stock the system's capital
equipment moving forward. Additionally, three of these new US
customers added have received certification as comprehensive stroke
centers and treat the most complex stroke patients.
- Currently in the US, IRRAS has deployed seven direct sales
professionals focused on building brand awareness and physician
support and training new customers. They have generated physician
support to evaluate IRRAflow at approximately 25 of the top
100 neurosurgical centers in the US, and, as the size of the
company's US team grows in 2020, the ability to train and generate
revenue from a larger customer base is expected to
increase.
- In December 2019, IRRAS received
CE Mark approval for its IRRAflow catheter, enabling IRRAS
to commercially market the system in the European Union. With
this CE Mark back in place and additional regulatory approvals,
IRRAS now markets IRRAflow in the
United States, the European Union, Costa Rica, Argentina, Israel, Kuwait, and Hong Kong. To date, patient
treatments have been completed in the
United States, Germany,
Finland, Austria, Hong
Kong, Israel, and
Kuwait.
- In the second half of 2019, IRRAS introduced the
IRRAflow Laser Level, the IRRAflow Drainage
Collection System, a software usability upgrade for the
IRRAflow Control Unit, and the IRRAS Cranial Access Kit to
enhance the user's experience with the IRRAflow system.
- In 2020, IRRAS' target is to commercially introduce IRRAflow in
at least 4 additional markets globally.
- In 2020, IRRAS' target is to introduce at least three
additional line extensions to the IRRAflow family of products.
These expected introductions include usability improvements to the
IRRAflow Tube Set and performance enhancements to expand the
line of IRRAflow catheters.Hummingbird Product Updates and 2020
Goals
- IRRAS' Hummingbird® ICP Monitoring product family is now
commercially available in the US and includes a proprietary
zero-drift Intracranial Pressure (ICP) monitoring system and both
single and multi-lumen cranial access bolts and catheters to
provide the most accurate parenchymal ICP monitoring on the
market.
- With the US launch of Hummingbird accelerating in 2020, IRRAS'
target is to expand its customer base for the Hummingbird products
to more than 25 customers during the year.
- With the CE Mark for IRRAflow back in place, in 2020,
IRRAS plans to work closely with global regulatory agencies to
expand the Hummingbird regulatory approval to additional markets
outside the US.
"With our CE Mark in place again, our international sales team
is excited to bring IRRAflow to customers globally in 2020,"
said Will Martin, IRRAS' Chief
Commercial Officer. "We are beginning to execute upon our
product relaunch strategies, and we look forward to reintroducing
IRRAflow initially to customers in Germany and initiating training in additional
countries in the near future. The global introduction of IRRAflow,
combined with the continued US launch of IRRAflow and the US
product introduction of Hummingbird ICP Monitoring, sets the stage
for an exciting 2020 for IRRAS."
About IRRAS
IRRAS AB is a global healthcare company focused on delivering
innovative medical technologies to our customers and their
patients. IRRAS designs, develops and commercializes products that
improve patient outcomes and decrease the overall cost of care by
addressing complications associated with current treatment methods
in neurocritical care. IRRAS markets and sells its products to
hospitals worldwide through its direct sales organizations in the
U.S. and select European countries and a network of distribution
partners in other markets.
IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in
Munich, Germany, and San Diego, California, USA. For more
information, please visit www.irras.com.
IRRAS AB (publ) is listed on Nasdaq First North Premier Growth
Market (ticker: IRRAS). Redeye AB is certified adviser of the
company with email certifiedadviser@redeye.se or phone
+46-8-121-576-90.
For more information, please contact:
USA
Kleanthis G. Xanthopoulos, Ph.D.
President and CEO
ir@irras.com
Europe
Sabina Berlin
CFO
+46-73-951-95-02
sabina.berlin@irras.com
The information was released for public disclosure, through
the agency of the contact person above, on January 7, 2020 at 08:00
a.m. (CET).
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