Stockholm, November 4, 2021 – On Tuesday, November 9, at 09.00 CET, IRRAS will host a conference call and an online presentation of its Q3 2021 interim report (which will have been published earlier on November 9 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 59
Rest of the world: +44 33 33 00 92 71

The presentation will be webcast and can be accessed from the following web address:

https://tv.streamfabriken.com/irras-q3-2021

Speakers: President and CEO Will Martin, Interim CFO Griffen Stapp, and Head of Investor Relations Sten Gustafsson

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:

Sten Gustafsson
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

The information was released for public disclosure, through the agency of the contact person above, on November 4, 2021 at 8:00 (CET).

Stockholm, October 28, 2021 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the initial patient enrollment in the ARCH (Active Removal of IntraCerebral Hematoma via active irrigation of ventricular system) clinical trial. The ARCH study will compare the ability of the company’s IRRAflow system to clear the blood collected in a patient’s ventricles after an intraventricular hemorrhage (IVH) more effectively than traditional passive drainage.  The ARCH investigators hypothesize that IRRAflow’s active irrigation, when combined with thrombolytic medication, will reduce the time needed to clear blood from the intraventricular space, thereby improving patient outcomes. 

The ARCH study is a controlled, randomized clinical trial that is expected to enroll 60 patients across a number of sites in both Europe and the United States.  The team at Helsinki University Hospital, led by neurosurgeon Dr. Behnam Rezai Jahromi and Dr. Jari Siironen, Head of Neurosurgical ICU, will lead the international collection of leading neurosurgical centers that will participate in the study.

"We are extremely excited to start and lead the international ARCH clinical study and confirm that using irrigation to deliver medication can actively change the composition of cerebrospinal fluid (CSF) and improve the poor prognosis of patients with IVH,” said Dr. Rezai Jahromi. “Our encouraging preliminary data was recently presented at the Congress of Neurological Surgeons (CNS) 2021 annual meeting, and we believe that the ARCH study can build upon these results and have a tremendous impact on IVH treatment decisions.”

The study’s three-arm design will compare IRRAflow versus traditional ventricular drainage when treating IVH in conjunction with tissue plasminogen activator (tPA), a medication used in stroke to dissolve clot.

• Arm 1 – Use of standard, passive EVD with manual bolus introduction of tPA according to the protocol outlined in the previously published CLEAR trial series.  
• Arm 2 – Use of IRRAflow system with manual bolus introduction of tPA according to the CLEAR protocol, followed by IRRAflow’s active irrigation.  
• Arm 3 – Use of IRRAflow system with continuous infusion of tPA via IRRAflow’s active irrigation mechanism of action.  

Additional sites are expected to be added to the ARCH study in coming months, and patient enrollment is expected to continue throughout 2022.  The trial has been designed for interim results to be announced at various intervals during patient enrollment.

“The initiation of the ARCH study is pivotal inflection point in the growth of IRRAS,” said Will Martin, President and CEO of IRRAS. “Early adopters of the system believe IRRAflow is a transformational step forward in improving IVH outcomes, and, now, our company is investing in the comparative data that will serve as a critical next step toward making IRRAflow a standard of 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
Will Martin
President and CEO
ir@irras.com 

Europe
Sten Gustafsson
Director, Investor Relations
ir@irras.com

The information was released for public disclosure, through the agency of the contact person above, on October 28, 2021 at 08:30 (CET). 

Stockholm, October 22, 2021 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the initial project from its previously announced collaboration with Aarhus University Hospital in Aarhus, Denmark, one of the world’s leading medical institutions. In conjunction with the Aarhus University’s Technology Transfer Office (TTO) and Department of Electrical and Computer Engineering (ECE), and neurosurgeon Dr. Anders Korshøj, IRRAS will work to develop brain compliance monitoring software that resides on its flagship product, IRRAflow. When combined with IRRAflow’s active treatment, such software would improve decision-making by providing physicians real-time information regarding the effectiveness and completion of treatment.

“Our mission at IRRAS is to develop innovative technologies that fundamentally change how neurocritical care patients are treated, and being able to measure brain compliance in real-time is a perfect example,” said Will Martin, President and CEO of IRRAS.  “Partnering with leading experts in this field to advance their patient treatment with IRRAflow and collaboratively develop groundbreaking technology is critical to our long-term success.”

Intracranial compliance expresses the capability of a patient’s brain to withstand an increase in intracranial volume without experiencing a corresponding rise in intracranial pressure (ICP). Measuring intracranial compliance can provide physicians a real-time predictive and quantitative value that helps determine the extent of damage to the brain and how well the patient is responding to therapy. 

Dr. Anders Korshøj, Associate Professor of Neurosurgery at Aarhus University Hospital, will lead the collaboration together with Naveed Ur Rehman, Assistant Professor in the Department of Electrical and Computer Engineering at Aarhus University, utilizing specialists from IRRAS, the hospital’s neurocritical care team, and data analytics experts from the Signal Processing and Machine Learning group at Aarhus University. 

“We are truly excited to engage in this multidisciplinary collaboration between IRRAS and our academic institutions,” said Dr. Korshøj. “At Aarhus University Hospital, we set the highest standards to bring innovative treatments like IRRAflow to patients and aim to advance treatments to the next level. This project is a strong example of our dedicated collective focus and close collaboration with leading experts in medical engineering to realize our ambition.”

Signal processing experts from the Department of Electrical and Computer Engineering at Aarhus University will play a key role in developing this novel technique to estimate brain compliance in real-time. Assistant Professor, Naveed ur Rehman, who heads the nonstationary signal processing group at ECE, will lead this specific activity.

“Our active participation in this interdisciplinary project is in line with our department’s mission to not only create new knowledge but to also shape these creations into workable solutions that better society,” said ur Rehman. “We strongly believe that this collaborative project will result in new ways to better treat neurotrauma patients, which is a goal that excites and motivates us as engineers.”

The Technology Transfer Office is a division of Aarhus University that provides resources and partnership opportunities to achieve commercialization of research projects. As part of this collaborative project, IRRAS shall retain an exclusive option to license the resulting technology. Eoin Galligan, Senior Business Development Manager, worked with Dr. Korshøj on the negotiations with IRRAS.

“TTO Business Development is very happy to complete this process and support this partnership with IRRAS,” said Galligan. “This project highlights how innovation partnerships can create ‘research impact,’ access corporate sponsorship for research, and bring next-generation technology into the clinic.”

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). 

About Aarhus University and Aarhus University Hospital

Aarhus University Hospital belongs to the elite of university hospitals. Aarhus University Hospital develops and provides highly specialized medical treatment, research, and education at an international level. Aarhus University Hospital serves the citizens from across the central Denmark region in need of highly specialized treatment. For the last 14 years, Aarhus University Hospital has been appointed Denmark’s best hospital, and it currently ranks #32 on the Newsweek ranking of the world’s best hospitals.

Aarhus University (AU) is a dynamic, modern and highly international university. Since its founding in 1928, it has grown to become a leading public university with international impact and reach across the entire research spectrum. Out of over 17,000 universities worldwide, AU ranks among the top 100 universities in the world in several research areas and is considered among the top 25 universities in the European Union. AU stands out in particular in terms of research quality and the quality of degree programs. Regarding internationalization, AU is ranked in the top as well as no. 45 on THE’s ranking “Most International Universities in the World”.

The Department of Electrical and Computer Engineering at Aarhus University focus on research into hardware and software technologies that play a vital role in defining modern society, its digitalization and human behavior therein.

For more information, please contact:

USA
Will Martin
President and CEO
ir@irras.com 

Europe
Sten Gustafsson
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

The information was released for public disclosure, through the agency of the contact person above, on October 22, 2021 at 08:30 (CET). 

Stockholm, October 15, 2021 – IRRAS, a global medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that it will be participating in-person at the Congress of Neurological Surgeons’ annual meeting (CNS 2021), in Austin, TX, on October 16-20, 2021, as well as the Neurocritical Care Society’s annual meeting (NCS 2021), in Chicago, IL, on October 26-29, 2021. In addition, at CNS 2021, clinical data regarding the use of its IRRAflow system in the treatment of intracerebral hemorrhage (ICH) and intraventricular hemorrhage (IVH) will be presented in a case series poster by Dr. Behnam Rezai Jahromi from Helsinki University Hospital.

Both the CNS and NCS annual meetings are well-respected global medical conferences that connect neurosurgeons, neurointensivists, and related healthcare professionals, and IRRAS will be well represented with its exhibitor booth, live product demonstrations, and the poster presentation. 

The poster presentation, titled “Active CSF Exchange is Effective for IVH Treatment – Active Removal of Intracerebral Hemorrhage,” will be available for review, both in-person and virtually, for registered participants of CNS 2021 beginning on Monday, October 18.

“Having the opportunity to participate in person at both the Congress of Neurological Surgeons and Neurocritical Care Society annual meetings is an important next step in our company’s emergence from the COVID-19 pandemic,” said Will Martin, President and Chief Executive Officer of IRRAS. “We are excited to connect with our customers in person, and we welcome all attendees to visit our IRRAS booth to learn more about our cutting-edge technologies.”

Conference attendees are encouraged to visit IRRAS’ booth #957 at CNS and booth #406 at NCS to learn more about IRRAflow®, the world’s first and only active fluid exchange system, as well as the Hummingbird Neuromonitoring product line.

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
Will Martin
President and CEO
ir@irras.com 

Europe
Sten Gustafsson
Director, Investor Relations
ir@irras.com 

The information was released for public disclosure, through the agency of the contact person above, on October 15, 2021 at 08:30 (CET). 

Stockholm, October 12, 2021 – IRRAS, a global medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that Aarhus University Hospital in Aarhus, Denmark, one of the world's leading medical institutions, has initiated commercial use of its IRRAflow system for a variety of neurocritical applications. 

The ACTIVE (Use of Active Fluid Exchange to Treat Intraventricular Hemorrhage (IVH)) clinical study will document the hospital’s use of the IRRAflow system and will compare it to the use of traditional passive ventricular drainage in EVD patients.  Dr. Anders Korshøj, Associate Professor of Neurosurgery from Aarhus University Hospital, will serve as the study’s Principal Investigator and will coordinate the study, with expected expansion to multiple sites across Denmark. 

"We are excited to finally begin treating patients with the IRRAflow system after lengthy delays due to COVID-19,” said Dr. Anders Korshøj.  “As we treat more patients, we look forward to presenting the data from the ACTIVE trial to show how the system's combination of automated irrigation and controlled drainage may reduce complications and improve long-term clinical outcomes.”

"Beginning commercial use of our IRRAflow system at Aarhus University signifies an important milestone for IRRAS," said Will Martin, President and Chief Executive Officer of IRRAS. "Our team has worked hard throughout the COVID-19 pandemic to train the Aarhus team, and we look forward to this hard work resulting in positive patient outcomes and compelling clinical data with the ACTIVE trial.”

Traditional treatment options for IVH patients generally utilize an external ventricular drainage (EVD) system, which is a passive approach that relies solely on gravity to facilitate drainage.  An EVD is currently the most common treatment option for intracranial bleeding or elevated intracranial pressure (ICP), but the technology’s shortcomings are well documented in scientific literature.  Complications such as catheter blockage, infections, and incomplete drainage occur regularly and negatively impact patient outcomes, lengthen required treatment time, and significantly increase the overall cost of care.  

The Department of Neurosurgery at Aarhus University Hospital is one of the leading neurosurgical departments in Denmark. The department is responsible for general neurosurgery and highly specialized neurosurgical procedures in Central Denmark Region. Moreover, the department is responsible for diagnostics, treatment, and care of patients with certain neurosurgical conditions in the entire country.

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). 

About Aarhus University and Aarhus University Hospital

Aarhus University Hospital belongs to the elite of university hospitals. Aarhus University Hospital develops and provides highly specialized medical treatment, research, and education at an international level. Aarhus University Hospital serves the citizens from across the central Denmark region in need of highly specialized treatment. For the last 14 years, Aarhus University Hospital has been appointed Denmark’s best hospital, and it currently ranks #32 on the Newsweek ranking of the world’s best hospitals.

Aarhus University (AU) is a dynamic, modern and highly international university. Since its founding in 1928, it has grown to become a leading public university with international impact and reach across the entire research spectrum. Out of over 17,000 universities worldwide, AU ranks among the top 100 universities in the world in several research areas and is considered among the top 25 universities in the European Union. AU stands out in particular in terms of research quality and the quality of degree programs. Regarding internationalization, AU is ranked in the top as well as no. 45 on THE’s ranking “Most International Universities in the World”.

For more information, please contact: 

USA
Will Martin
President and CEO
ir@irras.com 

Europe
Sten Gustafsson
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172 

The information was released for public disclosure, through the agency of the contact person above, on October 12, 2021 at 08:30 (CET). 

Stockholm, October 7, 2021 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the approval for an enhanced IRRAflow dual-lumen catheter in Europe. DEKRA, the company’s notified body, recently approved upgrades to the catheter, which is placed in the intracranial space as part of the IRRAflow system to perform active fluid exchange. This enhanced catheter is already being used commercially in the United States.

IRRAflow, the company’s initial commercial product, is a transformative medical device that offers intracranial fluid exchange by combining controlled irrigation and ongoing fluid drainage to better manage neurocritical care patients. The new IRRAflow 2.0 catheter now incorporates improved kink resistance, which improves catheter deliverability, and an upgraded dual-lumen design that results in optimized irrigation and drainage rates.

“We are pleased to receive CE Mark approval for our enhanced IRRAflow catheter in Europe,” said, Will Martin, President and Chief Executive Officer of IRRAS. “We have received positive feedback from the early clinical experience with this new catheter in the US, and we are excited to offer our growing list of European customers the latest IRRAflow innovations.”

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
Will Martin
President and CEO
ir@irras.com 

Europe
Sten Gustafsson
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172 

The information was released for public disclosure, through the agency of the contact person above, on October 7, 2021 at 08:30 (CET). 

Stockholm, September 29, 2021 – IRRAS, a global medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the publication of a case series in the Neurosurgery Open medical journal that demonstrates the ability of its IRRAflow system to treat aggressive brain infections by delivering needed antibiotics directly to the infection site.  The published patient treatments were performed by Dr. Behnam Rezai Jahromi at Helsinki University Hospital (HUH), one of the world’s leading hospitals for neurosurgical treatment.

The case series documents the survival of two patients that were diagnosed with pyogenic ventriculitis, a rare and debilitating infection of the lining of the ventricles in the brain that store cerebrospinal fluid (CSF).  Patients suffering from such infections face mortality and long-term disability rates of 60% and 80%, respectively.  Typically, ventriculitis is treated with long-term treatment of IV antibiotics, but the blood-brain barrier (BBB) makes it difficult for such drugs to reach therapeutic levels in the brain.

In the case series, Dr. Rezai Jahromi concluded that, with IRRAflow treatment, “the drainage of purulent fluid caused by healthcare associated ventriculitis or meningitis is now possible without harming brain tissue and intracranial pressure (ICP), while also changing the composition of CSF to an antibiotic-consisted fluid.”

This published case series is the first deliverable from the previously announced long-term collaboration between IRRAS and the neurosurgery team from Helsinki University.  HUH Neurosurgery is world-famous for its expertise in all subsections of neurosurgery and is considered one of the leading centers in Europe in the microneurosurgical treatment of cerebral blood vessel diseases and complex brain tumors.  Each year, more than 3,200 patients undergo neurosurgical treatment at Helsinki, and nearly 200 neurosurgeons from all around the world visit the facility to learn the latest techniques in neurosurgery.  

“Previously, leading neurosurgeons published their successful experience of delivering drugs that reduce spasm or prevent blood clot formation using IRRAflow’s irrigation,” said Will Martin, President and Chief Executive Officer.  “This case series is the first time that IRRAflow’s ability to irrigate with antibiotics has been documented in scientific literature, and it further validates the versatility of IRRAflow in treating a wide range of intracranial pathologies.  These critically ill patients have historically experienced extremely poor life expectancy, and we are pleased that IRRAflow may provide an option to improve their prognosis.”

With this case series now published, IRRAS’ partnership with HUH will now focus upon the ability to treat patients with intraventricular hemorrhage (IVH) with IRRAflow by irrigating thrombolytic medication to enhance clot removal.  Dr. Rezai Jahromi will present his IVH treatment experience with IRRAflow in a poster presentation at the upcoming Congress of Neurosurgical Surgeons (CNS) annual meeting in Austin, TX, from October 16 -20, 2021, and he will also serve as the Primary Investigator (PI) in the upcoming ARCH clinical study that will study IVH treatment using IRRAflow to irrigate thrombolytic medication.

A link to the publication, “Active Cerebrospinal Fluid Exchange System for Treatment of Pyogenic Ventriculitis,” can be found here: https://doi.org/10.1093/neuopn/okab030.

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
Will Martin
President and CEO
ir@irras.com 

Europe
Sten Gustafsson
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172 

 

The information was released for public disclosure, through the agency of the contact person above, on September 29, 2021 at 08:30 (CET). 

“Q2 2021 marks the fourth consecutive quarter of growth for IRRAS despite the challenges of the COVID-19 pandemic, and the company is positioned to continue this positive growth trajectory."

“This is an exciting time for IRRAS as our forward progress accelerates. A record number of patients were treated with our products during Q2, and published clinical data and surgeon feedback both support our company’s positive impact on critically ill patients.”

Will Martin, President and CEO of IRRAS

Second Quarter, April – June 2021, Results

• Net revenue amounted to SEK 5.1 million (1.2)
• Operating loss (EBIT) amounted to SEK -26.7 million (-31.2)
• Loss after tax amounted to SEK -27.1 million (-32.5)
• Earnings per share before and after dilution amounted to SEK -0.40 (-0.55)

Period, January – June 2021, Results

• Net revenue amounted to SEK 9.1 million (2.8)
• Operating loss (EBIT) amounted to SEK -66.0 million (-66.5)
• Loss after tax amounted to SEK -66.9 million (-66.9)
• Earnings per share before and after dilution amounted to SEK -0.99 (-1.52)

Important events during the quarter

Strengthened Balance Sheet

• A directed share issue in June generated proceeds of SEK 66 million before fees.
• The company received forgiveness for the 832,055 USD (6.9M SEK) loan received as part of the US COVID-19 Paycheck Protection Program (PPP).

Key Quality System Certifications Received

• IRRAS transitioned its notified body partnership for global regulatory and quality system oversight to global leader, DEKRA.
• IRRAS received quality system certification under the EU Medical Device Regulation (MDR) 2017/745 and the Medical Device Single Audit Program (MDSAP), which allows the company to seek regulatory approval in key markets, such as Australia and Brazil.

Publication of case report

• Buffalo General Medical Center published a case report that documented clinical superiority of the IRRAflow system versus traditional passive drainage systems.

Management Transition Announced

• IRRAS announced that Kleanthis G. Xanthopoulos, Ph.D. would step down as CEO and remain on company’s Board of Directors.
• CFO Sabina Berlin departed IRRAS, and Griffen Stapp, the company’s Controller, assumed the role of Interim CFO.

Important events after the end of the quarter

New CEO Appointed

• Will Martin, the company’s President and Chief Commercial Officer, assumed the role of President and CEO.

Loan Agreement with European Investment Bank (EIB) Announced

• IRRAS signed a 10M EUR loan agreement that provides non-dilutive financing for IRRAS to accelerate product development and clinical data generation in the EU.

Quality System Certifications Expanded

• After an on-site audit, IRRAS’ new in-house manufacturing facility was added to its ISO 13485:2016 certification, and the MDSAP certificate was extended for 3 years.

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
Will Martin
President and CEO
ir@irras.com

Europe
Sten Gustafsson
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

This information is information that IRRAS is obliged to disclose pursuant to the EU market Abuse Regulation and the Swedish Securities Market Act. The information was released for public disclosure, through the agency of the contact person above, on August 26, 2021 at 08:00 (CET).

 IRRAS AB (publ) interim report for January to June 2021

Stockholm, August 19, 2021 – On Thursday, August 26, at 09.00 CET, IRRAS will host a conference call and an online presentation of its Q2 2021 interim report (which will have been published earlier on August 26 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 54
Rest of the world: +44 33 33 00 92 73

The presentation will be webcast and can be accessed from the following web address:
https://tv.streamfabriken.com/irras-q2-2021

Speakers: President and CEO Will Martin, Interim CFO Griffen Stapp, and Head of Investor Relations Sten Gustafsson

 

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: 

Sten Gustafsson
Head of Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

 

The information was released for public disclosure, through the agency of the contact person above, on August 19, 2021 at 8:00 (CET).

Stockholm/Luxembourg, July 29, 2021 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, has signed a loan financing agreement with the European Investment Bank (EIB), amounting to €10 million. The financing agreement with the EIB will provide non-dilutive financing for the company to accelerate product development and clinical data generation for its IRRAflow platform in the European Union. The financing from the EIB falls under the new venture debt programme of the European Guarantee Fund, set up in 2020 to assist European companies that have come under strain due to the COVID-19 pandemic.

Through the financing agreement, the company will be able to borrow up to €10 million in two loan tranches over the coming years based upon the achievement of agreed performance criteria. The initial loan amounts will be received during 2021 and will be allocated to fund next generation product development and clinical trial efforts based in the European Union. Utilising these funds for product development and clinical data generation will allow funds raised during the company’s recent direct share issue to be used to support continued acceleration of commercial launch activities. The specific terms and conditions of the financing agreement are not disclosed.

EIB Vice-President Thomas Östros stated: “IRRAS is a very innovative company whose growth plans were negatively impacted by the restrictions that were needed to fight COVID-19. Under the European Guarantee Fund we now have more possibilities to get financing to this type of company, which will help us support important home-grown European technologies in the wake of the pandemic.”

“The funding commitment by the EIB is the result of extensive due diligence over several months and serves as confirmation of IRRAS' ability to build a global leader in neurocritical care,” said Will Martin, President and Chief Executive Officer of IRRAS. “This investment enables us to collect additional clinical evidence to confirm the superiority of IRRAflow to traditional drainage, while also developing next generation systems that are tailored for targeted drug delivery and treatment in other clinical scenarios.”

Background information:

The European Investment Bank (EIB) is the long-term lending institution of the European Union owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals. In 2020, the Bank made available in excess of €2 billion for Swedish projects. The EIB borrows money on the capital markets and lends it to projects that support EU objectives, with about 90% of all loans being granted within the European Union.

The European Guarantee Fund (EGF) was set up by the EIB Group with contributions from Sweden and other EU Member States to shield companies suffering from the COVID-19 crisis. Using nearly €25 billion in guarantees, the EGF enables the EIB and the EIF to quickly make loans, guarantees, asset-backed securities, equity and other financial instruments available to mostly small and medium-sized enterprises. The EGF is part of the European Union’s recovery package aiming to provide a total of €540 billion to boost those parts of the EU economy that have been hit the worst.

IRRAS is a global medical care company focused on innovative medical solutions to improve the lives of critically ill patients. IRRAS designs, develops, and commercialises 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 organisation 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).

IRRAflow®, the company’s lead commercial product, is used to drain blood and excess cerebrospinal or irrigation fluids and simultaneously monitor intracranial pressure in patients with haemorrhagic strokes and chronic subdural hematomas [1]. Both are serious conditions with high rates of mortality. IRRAflow® addresses complications that commonly arise from current treatment methods. At the same time, the company’s Hummingbird® ICP Monitoring family of products also offers an important diagnostic tool to monitor patients’ conditions after a traumatic brain injury has occurred. This tool is utilised to determine when intervention with a therapeutic tool, such as IRRAflow®, will be required and is more accurate and easier to use than other ICP monitoring systems.

[1] A subdural hematoma (SDH) is a type of bleeding in which a collection of blood—usually associated with a traumatic brain injury—gathers between the inner layer of the dura mater and the arachnoid mater of the meninges surrounding the brain.

 

For more information, please contact:

Sten Gustafsson
IR
sten.gustafsson@irras.com
+46 102 11 5172

Webiste: www.irras.com

 

Press contacts:

EIB: Tim Smit, t.smit@eib.org, tel.: +352 4379 89076, mobile: +352 691 286 423
Website: www.eib.org/press – Press Office: +352 4379 21000 – press@eib.org

 

The information was released for public disclosure, through the agency of the contact person above, on 29 July 2021 at 18:00 (CET)

 IRRAS receives loan financing under European Guarantee Fund