Stockholm, September 29, 2020 – IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the presentation of clinical research at the 18th Annual Meeting of the Neurocritical Care Society (NCS) that showed that the company’s IRRAflow system safely treats chronic subdural hematomas while also decreasing complications, bleeding recurrence, and length of hospitalization.

During the event that was held virtually, Dr. Jordan Davies from the University of California Irvine (UCI) Medical Center presented a poster that concludes “Novel, continuous irrigation and drainage of the subdural space following chronic subdural hematoma evacuation is safe and shows decreased recurrence, complications, and length of stay.” The research documents UCI’s treatment of their initial 6 chronic subdural hematoma patients using the IRRAflow system and shows that these patients experienced no complications or bleeding recurrence and were hospitalized for an average of 2.83 days, which is less than half of the United States’ national average of 6 days.

The poster can be viewed at the following link: https://cdn1.digitellinc.com/uploads/ncs/pages/f2507afcf423e7a7d18bd616bb1fdf1a.pdf.

Subdual hematomas are projected to become the most common cranial neurosurgical condition among adults by the year 2030 in the United States¹. IRRAflow’s potential to reduce complications and length of hospitalization could result in significant overall cost reductions as the total patient population continues to grow.

Additionally, Dr. Davies also presented a second clinical research poster on IRRAflow during the event. This poster, entitled, “Using net output to guide continuous irrigation and drainage of the subdural space following surgical evacuation can safely decrease hospital stay,” outlines UCI’s treatment approach with IRRAflow and shows that higher rates of irrigation earlier in patient treatment results in increased drainage of blood and shorter overall treatment times.

This poster can be viewed at the following link: https://cdn1.digitellinc.com/uploads/ncs/pages/f3f61e3b417f0a132a152872192c6b42.png.

“We are very pleased that the data generated from UCI’s experience with our IRRAflow system is being shared with the scientific community to demonstrate that the positive effect of irrigation does not need to end in the operating room,” said Will Martin, President and Chief Commercial Officer of IRRAS. “This early data shows that IRRAflow’s ability to irrigate throughout the patient treatment more thoroughly removes collected blood, which can result in better patient outcomes, decreased length of hospitalization, and reduced overall cost to the healthcare system. IRRAS and our physician partners look forward to expanding upon this early data with larger and more impactful data sets in the future.”

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 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 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 29, 2020 at 10:00 (CET).

 

1) Balser D, Farooq S, Mehmood T, Reyes M, Samadani U. Actual and projected incidence rates for chronic subdural hematomas in United States Veterans Administration and civilian populations. J Neurosurg. 2015;123(5):1209-1215.

In order to support the growing global launch of its IRRAflow and Hummingbird ICP Monitoring product lines, IRRAS continues to improve its sales and training capabilities by adding key talent to fill important positions within its commercial organization. In Europe, the new Sales Directors are now in place to direct the company’s sales efforts in both Germany and the Nordic countries of Sweden, Norway, Finland, and Denmark, while, in the United States, the company has added its first two Neurocritical Nurse Educators to accelerate its ability to train new customers on its product portfolio.

These changes to IRRAS’ commercial structure were made to enhance the company’s sales and education capabilities in critical geographies, while also controlling cash expenditure during the covid-19 pandemic lockdowns.

Increased focus on facilitating evaluations and training in the US

In the US, at the beginning of 2020, IRRAS’ direct sales force consisted of one Regional Sales Manager supported by six Territory Managers. During the first half of the year, covid-19 restrictions severely impacted the team’s field activities, including travel, hospital access, and customer interaction, and, during this period, steps were taken to optimize the team’s structure and focus moving forward.

Two sales territories were combined, resulting in a current US sales team structure of one Regional Sales Manager supported by five Territory Managers. In addition, two Neurocritical Nurse Educators joined the company to support the sales team’s ongoing product launches. These changes decreased the monthly operational costs for the company’s US commercial team by approximately 25% while actually increasing the team’s size by one role since the beginning of this year.

“The addition of these experienced nurse educators to our commercial team significantly improves the ability of our team to navigate the needed training process during a new hospital’s evaluation period, said Will Martin, President and Chief Commercial Officer of IRRAS. “Their firsthand experience with patient treatment carries immediate credibility with neurocritical nursing staff and enhances our training efficiency at an overall lower cost to the organization.”

“Our challenge historically has not been generating demand for our products but efficiently completing the training and evaluation processes,” continued Martin. “These recent changes to our US team help to address that challenge. By adding education resources, we can more effectively train, while also freeing up the Territory Managers to continue to identify new sales targets. We expect to see continued positive impact as our next wave of evaluations begin.”

Since the beginning of the 3^rd quarter, commercial activities in the US for the company have started to return to normal. While some parts of the US remain impacted by covid-related restrictions, many regions have resumed normal hospital operation. As a result, 4 new hospitals have approved the evaluation of the IRRAflow system, and the company’s new Nurse Education Specialists have played an integral role as training has begun at these new customers. In addition, a 2^nd hospital has become a recurring customer since the start of the Hummingbird ICP Monitoring launch.

Newly appointed Director of Sales for DACH and the Nordic markets

In the European Union (EU), the company’s remains focused on launching its IRRAflow system after receiving its CE Mark recertification in December 2019.  During Q1 2020, inventory was restocked in the company’s European distribution center, and initial customer engagement was underway when covid-19 also impacted European activities.

The European sales team, headed by Coenraad Tamse, Vice President, International Sales, began to engage direct customers in a digital manner, and the team’s focus shifted to preparing the company’s distribution markets for activity once the impact of covid-19 lessened. In the key direct market of Germany, Martin Mertens recently joined as the company’s Director of Sales, DACH, and he will manage sales activities for Germany, Switzerland, and Austria. Mr. Mertens joins IRRAS from his previous role as Global Director of Sales and Marketing for Spiegelberg, a well-established German company focused on neurocritical care.

“We are extremely excited to have Martin Mertens join IRRAS to lead our sales efforts in Germany and the surrounding areas,” said Coenraad Tamse, Vice President, International Sales, of IRRAS. “Martin’s experience in the neurocritical care space and his deep relationships with German neurosurgeons will have a unique impact on our future success, and we are already seeing his immediate impact after a short time.”   

In addition, Edmond Malek has assumed the role of Director of Sales, Nordics, after serving in a key sales role with Mentice, a leading provider of medical device simulation tools, which included a focus on the neurovascular community. Finally, the European sales organization also consists of a Director of Global Distributor Management, who manages our distribution partners in markets around the world, and a Training Manager that serves a key role in launching new customers and educating them on both IRRAflow and Hummingbird.

Expect continued investments in personnel

After the completion of the company’s recent financing during Q2 of this year, additional headcount to support commercial growth is budgeted for both the US and the EU as business conditions warrant. IRRAS plans to continue to invest in necessary personnel to meet demand and fuel growth and will do so only as momentum increases. 

In the US, Territory Manager positions in some regions where IRRAS currently has limited geographic coverage will be filled as demand warrants. In addition, the company will continue to invest in nurse education specialists.

In the EU, IRRAS expects that short-term demand will necessitate additional direct sales training resources in Germany, and an additional distribution manager will also be required to identify, train, and support IRRAS’ growing network of global distribution partners.

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 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 22, 2020 at 11:00 (CET).

Market begins to brighten after lockdowns

“In the second quarter, IRRAS made several advances in the ongoing commercialization of IRRAflow and Hummingbird, despite the fact that the extensive covid-19 restrictions were a highly disruptive and delaying factor.

The covid-19 pandemic continues to limit our commercial activities and access to hospitals in countries around the world. However, compared with the widespread lockdowns in the second quarter, the situation is starting to improve. At the beginning of the third quarter, for the first time since the lockdowns came into force, we received approval to evaluate IRRAflow and begin training in several new US hospitals as hospitals begin to open up. In addition, the training initiatives that were temporarily suspended in March were able to restart in portions of the country where restrictions began to ease.”

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

 

Second quarter, April – June 2020

• Net revenue amounted to SEK 1.2 million (1.1).

• Operating loss (EBIT) amounted to SEK -31.2 million (-40.7).
• Loss after tax amounted to SEK -32.5 million (-40.2).
• Earnings per share before and after dilution amounted to SEK -0.55 (-1.55).
   

Period January – June 2020

• Net revenue amounted to SEK 2.8 million (1.1).

• Operating loss (EBIT) amounted to SEK -66.5 million (-79.8).
• Loss after tax amounted to SEK -66.9 million (-78.9).
• Earnings per share before and after dilution amounted to SEK -1.52 (-3.15).

 

Important events during the quarter

• Nasdaq Stockholm listing
  On May 19, IRRAS was listed on Nasdaq Stockholm.

• Rights issue
  The rights issue in IRRAS AB, resulted in a contribution of SEK 217 million before fees. The number of shares increased by 37,463,366 to a total of 66,281,340.
• Paycheck Protection Program loan received
  In May, SEK 8 million were received as part of the US stimulus package Paycheck Protection Program.
• Covid-19 delayed short term sales development
  IRRAS’ sales efforts were quickly adapted to the restrictions in the health care sector, but sales slowed due to the covid-19 pandemic.

  

Other key accomplishments

• Patient treatments were successfully completed in the US, Finland, Israel, Kuwait and Portugal.

• The number of sold or placed units increased from 35 to 42 in a total of eight countries.
• Commercial capacity strengthened through both recruitments and new distribution agreements.
• Web based learning was launched in the form of IRRAS Academy.

  

Events after the end of the quarter

• Anders P. Wiklund, Chairman of the Board of Directors of IRRAS, passed away in August and was replaced by Marios Fotiadis, a current board member of IRRAS.

• CE certification was extended until 2024 for IRRAflow.
• First new hospital approvals for evaluations in the US since the covid-19 restrictions were implemented.
• Training and IRRAflow treatments were resumed at multiple comprehensive stroke centers in the US.
• First ever treatment with Hummingbird Solo ICP Monitoring system was performed.
• IRRAS was granted a sixth patent for Hummingbird ICP Monitoring product line.

The report is available on the company’s website: https://investors.irras.com/en/reports-presentations
 

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

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 27, 2020 at 8:00 a.m. (CET).

 Release

Stockholm, August 25, 2020 – IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the issuance of U.S. Patent No. 10,687,720 B2 for “Automatic Air Management System.”

“The air management system that is protected by this newest patent drives the innovation that Hummingbird brings to the ICP monitoring space,” added Will Martin, President and Chief Commercial Officer of IRRAS. “Hummingbird uses this air system to calculate a patient’s intracranial pressure and provides the most accurate ICP measurement of any commercially available system. We look forward to expanding our US launch of the product family throughout the remainder of 2020 and are working towards an EU launch.

”The patent covers claims involving an automatic air management system that is used to measure intracranial pressure (ICP) via an air pressure catheter that is placed within a patient. The patent, which provides protection until 2035, is part of a family of patents and patent applications protecting the core mechanism of action of the Hummingbird ICP Monitoring System. This product family includes the Hummingbird Quad, the only multi-lumen access bolt that combines ventricular drainage, parenchymal ICP, and sites for the placement of two additional probes, and Hummingbird Solo, the most accurate and easiest to use parenchymal ICP monitor for which IRRAS recently announced the first successful patient treatment.

“We are pleased to strengthen our intellectual property portfolio with the addition of our sixth U.S. patent for Hummingbird,” said Adam Sampson, Vice President Product Excellence of IRRAS. “When combined with the robust patents for our IRRAflow system, this patent bolsters and expands protection of IRRAS’ product portfolio, the most innovative in neurocritical care.” 

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 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 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 25, 2020 at 10:00 (CET).

On Thursday August 27, at 16.00 CET, IRRAS will host a conference call and an online presentation of its Q2 2020 interim report (which will have been published earlier on the 27^th at 08.00 CET). The presentation will be held in English.

The dial-in numbers for the conference call are:
Sweden: +46 8 50 55 83 52
Rest of the world: +44 33 33 00 92 67

The presentation will be webcast and can be accessed from the following web address:
https://tv.streamfabriken.com/irras-q2-2020

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

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

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 20, 2020 at 8:00 (CET).

Anders P. Wiklund, Chairman of the Board of Directors of IRRAS AB, has passed away after a period of illness. Anders P. Wiklund has been a board member of IRRAS since 2016 and the Chairman of the Board of Directors since 2017. Existing board member Marios Fotiadis will become the new Chairman and will serve in this capacity until the next general meeting of IRRAS.

“We are extremely sad that Anders has passed away. Anders was an incredible human being, a legendary healthcare professional with wonderful insights and vision that has been immensely helpful to our company. He has been a great mentor to me and the management during the years we have worked together. His long operational experience and strategic understanding have been enormously valuable as we built a legacy company in neurocritical care. My thoughts are with Anders’ family and relatives. He will forever be in our thoughts and hearts,” said Kleanthis G. Xanthopoulos, CEO of IRRAS.

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 is listed on Nasdaq Stockholm (ticker: IRRAS).

For more information, please contact:

Kleanthis G. Xanthopoulos, Ph.D.
CEO
ir@irras.com

The information was released for public disclosure, through the agency of the contact person above, on August 18, 2020 at 21:45 (CET).

 Anders P. Wiklund, Chairman of the Board of Directors of IRRAS AB, has passed away ​​​​​​​

Stockholm, August 5, 2020 – IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the first patient treatment using the Hummingbird Solo, an additional line extension to its innovative Hummingbird ICP Monitoring product family that was launched in December of last year.  Hummingbird Solo is a single-lumen, bolt-based monitor that measures the pressure within a patient’s brain tissue and helps diagnose and manage patients’ intracranial pressure (ICP) after traumatic brain injury (TBI), a subarachnoid hemorrhage, or stroke.

The first Hummingbird Solo patient was treated by a team, led by neurosurgeon Dr. Andrew Carlson, at the University of New Mexico (UNM) Hospital, located in Albuquerque, New Mexico.

“The Hummingbird Solo bolt’s simple insertion and set up allow us to quickly and confidently monitor critically ill patients who suffer from traumatic brain injury,” said Dr. Carlson, assistant professor of neurological surgery, UNM Hospital. “Our mission at UNM Hospital is to provide our patients with the best quality in healthcare, and we are proud to be the first hospital in the world to use this next-generation technology.”

Traumatic brain injury is defined as an impact to the head that disrupts the normal function of the brain. Worldwide, TBI is a leading cause of injury-related death and disability, with a devastating impact on patients and their families. It is estimated that the lifetime economic cost of TBI in the US alone, including direct and indirect medical costs, is over $75 billion.¹ In the United States and European Union, approximately 5.4 million people each year are affected by TBI, and 1.3 million experience injuries severe enough to require hospitalization.²

“Today marks a significant milestone for IRRAS as we celebrate the first patient treatment with the Hummingbird Solo product line,” said Will Martin, President and Chief Commercial Officer of IRRAS. “This line extension to the Hummingbird product family offers a unique and simplified monitoring solution for neurocritical care specialists, and we believe that Hummingbird Solo can grow into a market leader in the global ICP monitoring market.”

Assessment of a patient’s ICP is a critical element of managing TBI, and the Hummingbird Solo is designed to continuously monitor a patient’s ICP by placing a small sensor directly into the brain tissue. Instead of using strain gauge or fiberoptic sensors like other ICP monitors, the Hummingbird system uses a small air bladder that allows simple setup and automatic, hourly ICP recalibration. This air bladder mechanism of action eliminates challenges that plague other systems, including cumbersome setup and ICP readings that cannot be recalibrated and become increasingly inaccurate over time.

Physicians or hospitals in the United States who are interested in learning more about IRRAS or the Hummingbird ICP Monitoring product line should contact their local IRRAS sales professional or info@irras.com for additional information. IRRAS’ team of direct sales professionals is available to provide support, training, and certification for the company’s entire product family, including Hummingbird ICP and IRRAflow.

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 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 11, 2020 at 10:00 (CET).

1. Severe TBI. Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 2 Apr. 2019, www.cdc.gov/traumaticbraininjury/severe.html.

2. Traumatic Brain Injury Fact sheets and Policy brief. Center-TBI, https://www.center-tbi.eu/files/news/21571f81-20b8-4860-a3dd-1f6e27d02b3d.pdf.