STOCKHOLM, Feb. 14, 2020 /PRNewswire/ -- "The fourth
quarter of 2019 was an important period of progress for IRRAS. We
accomplished the remaining corporate milestones for the year,
highlighted by the renewed CE Mark for the
IRRAflow® catheter in the European Union (EU) and
the launch of our Hummingbird ICP Monitoring product line in
the United States (US).
Importantly, our impact to patients continues to broaden and
deepen. Since the launch of IRRAflow, we have completed successful
patient treatments in seven major markets, including the US,
Germany, Finland, Austria, Hong
Kong, Israel, and
Kuwait.
We've been pleased with the interest in IRRAflow so far
during our US launch, and we have just started the relaunch of
IRRAflow in the EU and the Hummingbird line in the US, but at this
point early in our products' commercialization, it remains
challenging to fully project the future adoption of our products.
Based on this and a slower than projected initial revenue growth in
the US, our current expectation is that our previously communicated
financial targets will be delayed. We will communicate new
financial targets as soon as we gain better clarity about our ramp
up."
Kleanthis G. Xanthopoulos, Ph.D.,
President and CEO of IRRAS
Fourth quarter, October - December
2019
- Net revenue amounted to SEK 3.4
million (0.0).
- Operating loss (EBIT) amounted to SEK
-35.7 million (-50.1).
- Loss after tax amounted to SEK -36.5
million (-50.1).
- Earnings per share before and after dilution amounted to
SEK -1.27 (-2.09).
Period January - December
2019
- Net revenue amounted to SEK 5.3
million (6.0).
- Operating loss (EBIT) amounted to SEK
-151.5 million (-143.3).
- Loss after tax amounted to SEK -151.1
million (-138.8).
- Earnings per share before and after dilution amounted to
SEK -5.61 (-5.83).
Important events during the quarter
- IRRAS received renewed CE Mark for the IRRAflow
catheter
IRRAS received CE Mark approval for its IRRAflow catheter
December 19, 2019. The CE Mark
complements the two CE Marks previously obtained for the IRRAflow
system's tube set with digital pump and control unit and allows
IRRAS to once again commercially market the IRRAflow system in the
European Union.
- FDA Clearance of new 510(K) filing to expand the time of
use of IRRAflow
November 21, 2019 the US FDA cleared
a new 510(K) for IRRAflow. The application provided the FDA with
supporting data demonstrating that extending the time of use of the
product is safe and has the potential to be beneficial for
neurocritical care patients.
Other key
accomplishments
- US Launch of Hummingbird Products for Neurocritical
Care
In mid-December IRRAS launched the Hummingbird ICP Monitoring
product line in the US. The Hummingbird family of products helps
clinicians diagnose and manage patients' intracranial pressure
after traumatic brain injury, a subarachnoid hemorrhage, and/or
stroke. The product line includes proprietary single and
multi-lumen cranial access bolts, parenchymal intracranial pressure
ICP monitoring, and a cranial access kit.
- IRRAflow wins CONNECT's "2019 Most Innovative New
Product" Award
In December 2019, CONNECT, a premier
nonprofit helping entrepreneurs with innovative startups in
technology and life science sectors, announced that IRRAS has been
selected as the 2019 winner in the medical device category.
- Key hires to the company
In November IRRAS announced the hiring of Dr. Coenraad Tamse as Vice President, International
Sales. Dr. Tamse brings more than 20 years of commercial marketing,
and executive experience in the medical device field to IRRAS.
Important events after the end of the
quarter
- No important events have taken place after the end of the
quarter.
The report is available on the company's website:
https://investors.irras.com/en/reports-presentations
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 currently markets and sells its
IRRAflow and Hummingbird product lines 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.
This document is considered 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 February 14,
2020 at 8:00 a.m.
(CET).
For more information, please contact:
USA
Kleanthis G. Xanthopoulos
Ph.D.
President and CEO
ir@irras.com
Europa
Sabina Berlin
CFO
+46-73-951-95-02
sabina.berlin@irras.com
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/irras/r/irras-ab-publishes-interim-report-for-the-period-january-to-december-2019,c3035224
The following files are available for download:
https://mb.cision.com/Main/16550/3035224/1193780.pdf
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SOURCE IRRAS