STOCKHOLM, June 30, 2020 /PRNewswire/ -- IRRAS AB, a
commercial stage medical technology company with a comprehensive
portfolio of innovative products for neurocritical care, today
provided an update on the launch of its IRRAflow® and
Hummingbird ICP Monitoring product lines during the evolving global
COVID-19 pandemic.
"Since early March, like many other companies around the world,
covid-19 has changed IRRAS' business significantly, and our
expected revenue growth during the first and second quarters of
2020 has been negatively impacted," said Kleanthis G. Xanthopoulos, Ph.D., Chief
Executive Officer of IRRAS.
The New England Journal of Medicine recently analyzed
data on more than 231,000 patients that were imaged for a potential
stroke in the United States from
July 2019 to April 2020 and estimated that imaging was down
39% from February to early April of this year. A second study
published in Stroke showed a similar 40% decrease in stroke
admissions between February 2019 and
February 2020 in China.
"Patients with intracranial bleeding require emergent treatment,
so our current customer base where IRRAflow has been
previously evaluated and ordered have continued their use of the
system. However, overall stroke volumes have dropped globally, and
our IRRAS team's access to hospitals around the world has
understandably been restricted," added Xanthopoulos. "Hospitals
have also reallocated staff and patient beds in the neurosurgical
intensive care unit (ICU) to focus on covid-related treatments,
which has delayed the approval of new technologies. Because of
these challenges, ongoing IRRAflow evaluations and new
hospital launches were placed on hold for a period of time."
In the United States,
IRRAflow evaluations, including those at 6 comprehensive
stroke centers that were underway during Q1, were paused due to the
limitations implemented during the covid-19 pandemic. Each
hospital's covid-19 regulations differ, and the company's US direct
sales team is working closely with the staff and physicians to
prepare a strategy to restart the evaluations when possible.
Because of the varying local guidelines, the IRRAS team is
prioritizing opportunities in regions that have accelerated
reopening and have resumed their review of new product requests. At
the same time, the company has overcome the restrictions on
in-person meetings with an increased use of digital marketing.
"For a growing company like IRRAS, a significant portion of our
expected revenue is forecasted to come from new hospital customers,
and, in the short-term, the completion of product evaluations and
the resulting commercial orders have been delayed," said
Will Martin, President and Chief
Commercial Officer of IRRAS. "However, our IRRAS team has remained
remotely engaged with our customer base, and, as hospitals return
to more normal operations, our team is ready to resume our
activities with these targeted customers. Even with the challenges
caused by the covid-19 pandemic, we have been able to continue to
make progress with the global launch of both IRRAflow and
Hummingbird to better position the company for long-term
growth."
The company's IRRAflow system received its CE Mark
recertification in December 2019, and
early launch efforts were underway in Europe before the full impact of covid-19 was
felt. Now, as certain markets begin to slowly reopen, IRRAS'
commercial activities can also resume.
Recently, the initial European patients were treated with
IRRAflow since the product's CE Mark recertification. To
date, two patients have been successfully treated by Dr. António
Marques Baptista and the team at
Centro Hospitalar de Vila Nova de Gaia / Espinho in Gaia,
Portugal. While training support
could not be provided in-person due to covid-19 travel and hospital
access restrictions, IRRAS personnel was able to support the
treatments virtually using the company's digital training
tools.
"These initial patient treatments in Portugal mark an important next step for the
European launch of IRRAflow," added Xanthopoulos. "Our
team's primary focus over the past several months has been to
ensure that we are prepared for expansion as things return to
normal, and the introduction of our products into new markets is a
key part of that strategy."
In addition to the initial patient treatments in Portugal, progress has also been made with
distribution partners in other European markets to prepare for
commercial launches during the second half of 2020. Previously,
IRRAS announced its intentions to launch IRRAflow in an
additional 7 to 10 markets globally during 2020, and, even after
covid-19's impact, the company remains on track to achieve that
target. In addition to Portugal,
IRRAflow control units have now been placed in Italy, Spain,
Poland, Austria, and the United Kingdom, and distributor and customer
training is underway using IRRAS' remote training capabilities.
"We see the potential and versatility of the IRRAflow system
for the treatment of neurocritical patients in Poland, said Mariusz Tyszkewicz, Managing
Director of Biameditek Sp. z.o.o, IRRAS' distribution partner in
Poland. "IRRAflow brings
much needed innovation in intracranial fluid management and offers
safety and efficacy to physicians. The system fits in very well
with our other ICU products, and we are excited to enter into a
relationship with IRRAS." Biameditek is a wholly owned subsidiary
of Indutrade AB, a publicly-traded Swedish company.
To support the expanding European launch of its product portfolio,
IRRAS has also recently finalized the addition of personnel in key
sales and training roles. An International Training Manager has
already joined the company in Germany, and a Director of Nordic Sales and a
Director of German Sales have signed
employment agreements to join the team during the 3rd
quarter of 2020 to oversee growth in these strategic markets.
"Expanding the launch of IRRAflow to additional European
countries is a critical element of IRRAS' future success," added
Martin. "In spite of covid-19's impact, we've taken needed initial
steps to launch IRRAflow in these important markets. As
situations allow in each individual market, we look forward to
helping critically ill patients throughout Europe in coming months."
About IRRAS
IRRAS is a global medical care company focused on delivering
innovative medical solutions to improve the lives of critically ill
patients. IRRAS designs, develops, and commercializes neurocritical
care products that transform patient outcomes and decrease the
overall cost of care by addressing complications associated with
current treatment methodologies. IRRAS markets and sells its
comprehensive, innovative IRRAflow and Hummingbird ICP
Monitoring product lines to hospitals worldwide through its direct
sales organization in the United
States and select European countries as well as an
international network of distribution partners.
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 Stockholm (ticker: IRRAS).
For more information, please contact:
USA
Kleanthis G. Xanthopoulos, Ph.D.
CEO
ir@irras.com
Europe
Sabina Berlin
CFO
+46 10 211 51 71
sabina.berlin@irras.com
This information is information that IRRAS is obliged to
disclose pursuant to the EU Market Abuse Regulation. The
information was released for public disclosure, through the agency
of the contact person above, on June 30,
2020 at 10:00 (CET).
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Covid-19 delays short
term revenue, while the commercial launch of IRRAflow and
Hummingbird progresses ​​​​​​
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SOURCE IRRAS