Stockholm, October 19, 2019 – IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that it will be participating at the 69th Congress of Neurological Surgeons’ Annual Meeting (CNS 2019). CNS 2019 is being held at the Moscone Center, West Building, in San Francisco, CA on October 19-23, 2019.

The CNS Annual Meeting is a well-respected, highly attended conference that brings together neurosurgeons and related healthcare professionals from around the world.

IRRAS will be partnering with the Congress of Neurological Surgeons and participating in an all-day symposium focused on neurotrauma, which will be a practical update for neurosurgeons taking neurotrauma call. The symposium will include a product demonstration station, where IRRAflow®, the world’s first irrigating ventricular drainage system, and the Hummingbird Neuromonitoring product line will be showcased. Details are provided below.

Neurotrauma Update Symposium
Title: “SYM 11: Neurotrauma Update”
Date/Time: Sunday, October 20th at 8:00 am
Location: Moscone Center, Room 3022

“Having the opportunity to partner with the Congress of Neurological Surgeons at this year’s meeting is an exciting next step as we continue to strengthen our position and become a leader in the neurocritical care market,” said Will Martin, Chief Commercial Officer of IRRAS. “We welcome the CNS 2019 meeting attendees to visit our IRRAS booth to learn more about our cutting-edge technologies.”

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 in Stockholm, Sweden (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 October 18, 2019 at 9:30 p.m. (CET).

 Release

-Company is co-hosting a Breakfast Symposium with the Neurocritical Care Society-

Stockholm, October 15, 2019 – IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today its presence at the 17thNeurocritical Care Society’s annual meeting, being held at the Vancouver Convention Centre, in Vancouver, British Columbia, Canada, on October 15-18, 2019.

IRRAS will be co-hosting a breakfast symposium with the Neurocritical Care Society that will address innovation in the sector with industry-leading key opinion leaders. Details are provided below.

IRRAS’ Breakfast Symposium with Neurocritical Care Society
Title: “Bringing Needed Innovation to Neurocritical Care”
Date/Time: Thursday, October 17that 7:40 am
Location: Vancouver Convention Centre, Room 212-214

Conference attendees are encouraged to visit IRRAS’ booth #221 to learn more about IRRAflow®, the world’s first irrigating ventricular drainage system, as well as the Hummingbird Neuromonitoring product line.

For more information on this event, please visit the Media and Events tab on the IRRAS website at irras.com.

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 in Stockholm, Sweden (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 October 15, 2019 at 3:00 p.m. (CET).

 Press release (PDF)

Stockholm, September 24, 2019 – IRRAS, a medical technology company focused on commercializing innovative solutions for neurocritical care, announced today it will be exhibiting at EANS2019, the 19thEuropean Congress of Neurosurgery, hosted by the European Association of Neurological Societies. EANS2019 is being held at the Convention Center Dublin, in Dublin, Ireland, on September 24-28, 2019.

Conference attendees are invited to visit IRRAS in booth #29 to learn more about IRRAflow®, the world’s first irrigating ventricular drainage system. IRRAflow’s unique mechanism of action addresses the complications associated with the current methods of managing intracranial fluid by using a dual-lumen catheter that combines automated irrigation, controlled drainage, and continuous ICP monitoring.

Dr. Behnam Rezai Jahromi, a leading neurosurgeon from Helsinki University Hospital, in Helsinki, Finland, will lead educational sessions in the IRRAS booth each day at 10:15 am. Dr. Rezai Jahromi will present his clinical experience using the novel system and answer questions about best practices using the device.

“With nearly 1,800 health care professionals in the neurosurgical space attending EANS2019, we are excited to have the opportunity to share our cutting-edge technology with neurosurgeons from around the world,” said Will Martin, Chief Commercial Officer of 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 08-121 576 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 September 24, 2019 at 5:15 p.m. (CET).

 Press release (PDF)

Stockholm, September 13, 2019 – IRRAS AB, a commercial stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that Vinny Podichetty VP, Clinical, Regulatory Affairs & Quality has resigned for personal reasons, and two key appointments to drive IRRAS’ continued growth.

Niloufa Insanally, Ph.D., joins as Head of Regulatory Affairs. Dr. Insanally has over 15 years’ experience in the medical device, pharmaceutical and biotechnological areas with extensive expertise with both US and international regulatory approval processes. She holds a Bachelor of Science from University of Toronto, Canada, and a Ph.D. from University of North London, UK.

Dave Asbury is appointed Director, Project Engineering, and will lead product development for the company’s Hummingbird intracranial pressure (ICP) monitoring product line. Prior to joining IRRAS, Asbury was Director of R&D for InnerSpace Neuro Solutions where he played an integral role in the early design and evolution of the Hummingbird ICP product family. After IRRAS’ acquisition of the Hummingbird ICP assets earlier this year, he will now lead the integration of these new Hummingbird products into the current IRRAS product portfolio. Asbury has over 15 years’ experience in developing new technologies for medical device companies and holds a Bachelor of Science in Bioengineering Pre-Medicine from University of California, San Diego.
  

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 08-121 576 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 September 13, 2019 at 13:45 a.m. (CET).

 Press release (PDF)

Today Thursday August 29, at 04.00 p.m. CET IRRAS will host a conference call and an online presentation of its Q2 2019 interim report (which was published earlier today at 08.00 a.m. CET).  

The dial-in numbers for the conference call are:  

Sweden: +46 8 5664 27 06 
Rest of the world: +44 33 3300 9032 

The presentation will also be webcast and can be accessed from the following web address: 
https://financialhearings.com/event/11741 

Speakers: President CEO Kleanthis G. Xanthopoulos, Ph.D., CCO Will Martin and CFO Sabina Berlin 
  

About IRRAS

IRRAS AB (Nasdaq First North Premier: IRRAS) 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. Redeye AB is certified adviser of the company with email certifiedadviser@redeye.se or phone 08-121 576 90.
  

For more information, please contact:

USA
Kleanthis G. Xanthopoulos, Ph.D.
President and CEO
info@irras.com  

Europa
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 August 29, 2019 at 9:00 a.m. (CET).

 Press release (PDF)

“During the second quarter, we reached a significant milestone by recording our first IRRAflow revenue in the United States (US). The US is the world´s largest market for neurosurgical procedures, and with the ongoing CE Mark recertification process, we have focused much of our team´s resources toward supporting a successful early market introduction in the US.”

Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS
 

Second quarter, April – June 2019

• Net revenue totaled SEK 1.1 million (0.1)
• Operating loss (EBIT) amounted to SEK -40.7 million (-32.1)
• Loss after tax totaled SEK -40.2 million (-29.1)
• Earnings per share before and after dilution amounted to SEK -1.55 (-1.23)

Period January – June 2019

• Net revenue totaled SEK 1.1 million (6.0)
• Operating loss (EBIT) amounted to SEK -79.8 million (-53.2)
• Loss after tax totaled SEK -78.9 million (-47.0)
• Earnings per share before and after dilution amounted to SEK -3.15 (-1.99)

Important events during the quarter

• Acquisition of complementary medical device technology
  In April, IRRAS entered into an agreement with the Alfred E. Mann Institute for Biomedical Engineering at the University of Southern California (AMI-USC) to acquire assets and intellectual property from DermaPort Inc. 
• Position strengthened through acquisition of proprietary assets 
  IRRAS strengthened its position as a market leader by acquiring the assets of InnerSpace Neuro Solutions, including four US FDA-cleared products that complement IRRAflow.
• IRRAflow wins regulatory approval in Israel and Costa Rica
  In June, IRRAS received regulatory approval in Israel and Costa Rica for the company’s flagship product, IRRAflow. 
• Update on CE Mark re-certification of IRRAflow
  In April, IRRAS announced that the company had received a response from G-MED, its designated European Notified Body, that requested clarifications and additional information regarding the company’s CE Mark re-certification of the IRRAflow catheter. 
• New Board member
  The Annual General Meeting in May elected Catherine Gilmore-Lawless as a new Board member of IRRAS. Gilmore-Lawless is an American citizen and has 30 years of experience in the neuroscience sector.
• Changes in management group
  In June, IRRAS announced that the company’s CFO, Fredrik Alpsten, would be leaving the company and that Sabina Berlin had been promoted to the position of CFO. The company also announced that Lance Boling, VP Product Development, would revert to a consultant position for the company.
• Raising capital through directed share issue
  In May, the company completed a directed share issue and net proceeds to the company amounted to SEK 97.3 million. The subscribers in the issue were a number of Swedish and international institutional investors.

Important events after the end of the quarter

• No important events have taken place after the end of the quarter.
   

About IRRAS

IRRAS AB (Nasdaq First North Premier: IRRAS) 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. Redeye AB is certified adviser of the company with email certifiedadviser@redeye.se or phone 08-121 576 90.

For more information, please contact:

USA
Kleanthis G. Xanthopoulos, Ph.D.
President and CEO
info@irras.com  

Europa
Sabina Berlin
CFO
+46 73 951 95 02
sabina.berlin@irras.com
 

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 August 29, 2019 at 8:00 a.m. (CET).

 IRRAS AB (PUBL) INTERIM REPORT JANUARY–JUNE 2019 (PDF)

Stockholm, August 1, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, today announced the issuance of United States (U.S.) Patent No. 10,293,105 for its “Fluid Exchange Catheter System” technology upon which the company’s lead IRRAflow technology is based.

The patent includes both system and method claims for performing fluid exchange with a catheter that uses aspiration and irrigation lumens and a synchronized pattern of negative and positive pressures to remove any blockages in the aspiration lumen. The patent is part of a family of patents and patent applications that protect the core fluid management platform in the IRRAflow Fluid Management System. These patients include U.S. Patent No. 8,398,581, issued on March 19, 2013, and U.S. Patent No. 9,623,177, issued on April 18, 2017. IRRAS now has more than 45 patents granted or pending worldwide for a variety of neurocritical care innovative products.

“We are pleased to strengthen our intellectual property portfolio with the addition of our third U.S. patent for IRRAflow. Our growing patent estate protects and supports the commercialization of our products in the U.S., which we believe offers the most innovative solutions in neurocritical care”, said Will Martin, Chief Commercial Officer of IRRAS. “We look forward to further advancing our products in the U.S. market throughout the remainder of this year.”

About IRRAS

IRRAS AB (Nasdaq First North Premier: IRRAS) 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. Wildeco is certified adviser of the company. Wildeco is reached at + 46 8 545 271 00 or at info@wildeco.se.

For more information, please contact:
US
Kleanthis G. Xanthopoulos, Ph.D.
President & CEO
info@irras.com

Europe
Sabina Berlin
CFO
sabina.berlin@irras.com

The information was released for public disclosure, through the agency of the contact person above, on August 1, 2019 at 08.00 a.m. (CET).

 Press release (PDF)

Stockholm, June 25, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a commercial stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced today that it received regulatory approval for its flagship product, IRRAflow, from the Ministries of Health in Israel and Costa Rica. As a result of these approvals, IRRAS will expand its global commercialization and can now begin to market and sell IRRAflow in both countries.

“We are pleased to advance our global regulatory strategy with the approval of IRRAflow in important markets like Israel and Costa Rica,” said Vinny Podichetty, Vice President, Clinical, Regulatory Affairs & Quality at IRRAS. “These approvals are signs that our global regulatory strategy is progressing as planned, and we continue the work needed to receive clearance for IRRAflow in additional markets, including the EU.”

“The ability to commercialize IRRAflow outside of the United States represents a significant milestone in our efforts to expand IRRAS’ neurocritical care portfolio across the globe,” said Will Martin, Chief Commercial Officer at IRRAS. “With regulatory approval now in place in Israel and Costa Rica, our first Latin American country, we can build upon the enthusiastic response that we’ve seen for IRRAflow in the US by initiating patient treatments and generating revenue in these markets in the second half of 2019.”

About IRRAS

IRRAS AB (Nasdaq First North Premier: IRRAS) is a publicly-traded, commercial-stage medical technology company focused on developing and commercializing innovative solutions for neurocritical care.

The company’s flagship product, IRRAflow, is the world’s first irrigating ventricular drain. 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. IRRAS also has several other innovative neurocritical care products that are commercially available in the US, including the Hummingbird intracranial pressure (ICP) monitoring system.

With its unique and comprehensive product portfolio, protected by multiple patents and patent applications, IRRAS is well positioned to establish a leadership position in the medical device market. 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. Wildeco is certified adviser of the company. Wildeco is reached at + 46 8 545 271 00 or at info@wildeco.se.

For more information, please contact:

US
Kleanthis G. Xanthopoulos, Ph.D.
President & CEO
info@irras.com 

Europe
Sabina Berlin
CFO
sabina.berlin@irras.com

The information was released for public disclosure, through the agency of the contact person above, on June 25, 2019 at 08.00 a.m. (CET). 

 Press release (PDF)

Stockholm, June 18, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a commercial stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced today that Fredrik Alpsten, Chief Financial Officer (CFO), will leave IRRAS to pursue another opportunity outside of the company. However, he will remain at IRRAS until July 31 and will continue to support the company to ensure a seamless transition of responsibilities.

Furthermore, Lance Boling, Vice President, Product Development, will revert to a consultant position for the company, a role he previously held since 2013 before joining the management group at IRRAS in 2017.

Effective June 24, 2019, there will be a single IRRAS management group, which will replace the previous structure with both executive and extended management teams. The management team will consist of the following persons:

Mrs. Berlin, who is promoted to CFO, has been with IRRAS since 2014 and was previously Vice President, Finance, and deputy CFO. Kleanthis G. Xanthopoulos, Ph.D., President & CEO will take over the responsibility for investor relations. Adam Sampson, Vice President, Product Excellence, will assume responsibility for IRRAS’ new product development. Additionally, David Asbury, former Director of R&D at the recently acquired InnerSpace Neuro Solutions, is consulting with the company to complement the R&D team.

“The Board and I want to thank Fredrik and Lance for their major contributions and service to IRRAS during the last several years. Since they joined us, IRRAS has been transformed from an R&D company to a commercial-stage, publicly-traded company with a comprehensive portfolio of products for neurocritical care. Both Fredrik and Lance have played important roles in this process and have contributed significantly to our progress,” said Kleanthis G. Xanthopoulos, Ph.D., President & CEO of IRRAS AB.

About IRRAS

IRRAS AB (Nasdaq First North Premier: IRRAS) is a publicly-traded, commercial-stage medical technology company focused on developing and commercializing innovative solutions for neurocritical care.

The company’s flagship product, IRRAflow, is the world’s first “irrigating ventricular drain.” 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. IRRAS also has several other innovative neurocritical care products that are commercial available in the US, including the Hummingbird intracranial pressure (ICP) monitoring system.

With its unique and comprehensive product portfolio, protected by multiple patents and patent applications, IRRAS is well positioned to establish a leadership position in the medical device market. 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. Wildeco is certified adviser of the company. Wildeco is reached at + 46 8 545 271 00 or at info@wildeco.se.

For more information, please contact:

US
Kleanthis G. Xanthopoulos, Ph.D.
President & CEO
info@irras.com 

Europe
Sabina Berlin
CFO
sabina.berlin@irras.com

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 June 18, 2019 at 08.00 a.m. (CET).

 Press release (PDF)