Stockholm, December 16, 2019 – IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, today announced the launch of its Hummingbird^® ICP Monitoring product family in the United States.

These products, which were acquired by IRRAS in May 2019, include proprietary single and multi-lumen cranial access bolts, parenchymal intracranial pressure (ICP) monitoring, and a cranial access kit. The Hummingbird family of products helps clinicians diagnose and manage patients’ intracranial pressure after traumatic brain injury, a subarachnoid hemorrhage, and/or a stroke. The Hummingbird ICP Monitoring product line is designed for accuracy, reliability, and ease of use to address the needs of both the hospital and the patient.

 “The launch of the Hummingbird product line deepens our continued commitment to deliver innovative technologies and improved medical treatments for neurocritical care. It is known that elevated intracranial pressure during traumatic brain events can cause major complications and even death,” said Kleanthis G. Xanthopoulos, Ph.D., President & CEO. “Our Hummingbird line of products significantly improves a physician’s ability to manage intracranial pressure, leading to better overall treatment outcomes.”

“Multimodal monitoring brings a lot of value and options when treating patients with traumatic brain injury,“ said Dr. Andrew Carlson, Assistant Professor of Neurosurgery at the University of New Mexico. “The Hummingbird system’s ability to drain fluid, measure pressure and provide additional lumens all from one bolt, gives us a unique and simplified approach to guide our management of the most critical patients in the neuro intensive care unit.”

“As we add the Hummingbird ICP Monitoring product family to our lead commercial product, IRRAflow^®, IRRAS will now offer the most advanced portfolio of products for the neuro intensive care unit,” said Will Martin, Chief Commercial Officer of IRRAS. “From the diagnosis of traumatic brain injury to needed drainage that removes blood and reduces excess pressure, Hummingbird and IRRAflow bring needed innovation to the entire spectrum of neurocritical care.”

Physicians or hospitals in the United States who are interested in learning more about IRRAS or the Hummingbird ICP Monitoring products should contact your 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 and IRRAflow.

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 +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 December 16, 2019 at 08:00 a.m. (CET).

 Release

Breakthrough medical device that transforms treatment of intracranial bleeding recognized as most innovative new medical device from southern California

Stockholm, Sweden, December 9, 2019 – IRRAS AB (NASDAQ Stockholm: IRRAS), a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that IRRAflow has been selected as the 2019 winner of CONNECT’s Most Innovative New Product award in the medical device category. CONNECT, a premier nonprofit helping entrepreneurs with innovative startups in the technology and life sciences sectors, continues its thirty-two-year tradition of celebrating innovation leaders in the broader San Diego area.

IRRAflow, the company’s initial commercial product, has a unique mechanism of action that 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, all into one system.

“Our IRRAS team has worked extremely hard to build the foundation for a legacy company, and it was an honor to be recognized by our entrepreneurial peers,” said Will Martin, IRRAS’ Chief Commercial Officer. “At IRRAS, we are committed to bringing needed innovation to neurocritical care and this recognition confirms our commitment.”

IRRAflow was awarded in the medical device category at the annual Innovation Awards event held on Thursday, December 5^th, at the Hyatt Regency La Jolla at Aventine. Winners were selected in the following seven categories: Big Data; Cleantech; Defense; Medical Device; Life Science and Healthtech; Smart City & Transportation, and Software.

For a complete list of winners and additional information, please visit the CONNECT’s website.

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 +46 8 121 576 90.

ABOUT CONNECT

For more than 30 years, CONNECT has focused on elevating entrepreneurs in the San Diego region. The organization has a long history as a powerhouse of resources for innovators, including mentorship, education, and connection to capital. CONNECT serves entrepreneurs and startups throughout their growth journey, from early stage to capital raise, with a suite of curated programs and events aimed to help companies grow, gain access to capital, and scale.
  

For more information, please contact:

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

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

The information was released for public disclosure, through the agency of the contact person above, on December 9, 2019 at 8.00 a.m. (CET).

Stockholm, November 21, 2019 – IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the US FDA has cleared a new 510(K) for IRRAflow. The application provided the FDA with supporting data demonstrating that extending the time of use of the product is safe and has the potential to be beneficial for patients.

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. IRRAflow incorporates intracranial pressure or ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels. IRRAS received initial clearance from the US FDA for IRRAflow in July 2018.

“We are very pleased to have received this new clearance from the FDA. The extended time of use will further enhance the usability of the transformative IRRAflow product for the benefit of neurocritical care patients. We are equally very pleased to continue to build a very good relationship with the FDA that has acted in an expeditious matter to award us this new 510(K) clearance” said Kleanthis G. Xanthopoulos, Ph.D., Chief Executive 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 currently markets and sells its IRRAflow and Hummingbird product lines to hospitals worldwide through its direct sales organizations in the U.S. and select European countries and a network of distribution partners in other markets.  

IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit www.irras.com. 

IRRAS AB (publ) is listed on Nasdaq First North Premier Growth Market (ticker: IRRAS). Redeye AB is certified adviser of the company with email certifiedadviser@redeye.se or phone +46 8-121 576 90.

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

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 November 21, 2019 at 8:30 p.m. (CET).

 Release

IRRAflow Gaining Traction in US

” Since the US is the world’s largest market for neurosurgical procedures, we have focused much of our team’s resources toward supporting a successful early market introduction. Response to our IRRAflow technology remains strong, and our sales funnel is full. Patient treatments with IRRAflow continued to increase, and multiple hospital systems moved from evaluating IRRAflow into the approval and purchasing phase.”

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

 

Third quarter, July – September 2019

• Net revenue amounted to SEK 0.9 million (0.0)
• Operating loss (EBIT) amounted to SEK -35.9 million (-40.0)
• Loss after tax amounted to SEK -35.7 million (-41.8)
• Earnings per share before and after dilution amounted to SEK -1.24 (-1.75)

Period January – September 2019

• Net revenue amounted to SEK 1.9 million (6.0)
• Operating loss (EBIT) amounted to SEK -115.7 million (-93.2)
• Loss after tax amounted to SEK -114.6 million (-88.8)
• Earnings per share before and after dilution amounted to SEK -4.36 (-3.74)

 

Important events during the quarter

• Issuance of new patent for core IRRAflow technology
  The patent includes both system and method claims for performing and regulating fluid exchange in IRRAflow. The new patent complements the existing patent portfolio and broadens the IP protection for the company´s core technology further.
• Key hires to the company
  In September, IRRAS announced the appointments of a Head of Regulatory Affairs and a Director, Project Engineering to drive IRRAS´ continued growth and that Vinny Podichetty VP, Clinical, Regulatory Affairs & Quality, resigned for personal reasons.

Other key accomplishments

• During the quarter, the initial clinical experience with IRRAflow in the United States was published in the peer-reviewed World Neurosurgery journal. The peer-reviewed article by Dr. Sumeet Vadera and his team from the University of California, Irvine highlights the use of IRRAflow in chronic subdural hematoma patients and reinforces key messages about the system’s safety, treatment impact, and cost effectiveness.

Important events after the end of the quarter

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

 

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

About IRRAS

IRRAS AB is a global healthcare company focused on delivering innovative medical technologies to our customers and their patients. IRRAS designs, develops and commercializes products that improve patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methods in neurocritical care. IRRAS currently markets and sells its IRRAflow and Hummingbird product lines to hospitals worldwide through its direct sales organizations in the U.S. and select European countries and a network of distribution partners in other markets. 

IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit www.irras.com.

IRRAS AB (publ) is listed on Nasdaq First North Premier Growth Market (ticker: IRRAS). Redeye AB is certified adviser of the company with email certifiedadviser@redeye.se or phone +46 8 121 576 90.

 

For more information, please contact:

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

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

 

This 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 November 14, 2019 at 8:00 a.m. (CET).

 Release

Stockholm, November 11, 2019 – IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, today announced the hiring of Dr. Coenraad Tamse as Vice President, International Sales. Dr. Tamse brings more than 20 years of commercial, marketing, and executive experience in the medical device field to IRRAS with expertise in driving aggressive global revenue growth for multiple product platforms using both direct sales and distribution models.

“We’re thrilled to welcome Coenraad to the IRRAS team as we accelerate the commercial planning for the European launch of our IRRAflow^® and Hummingbird ICP^® product lines,” said Will Martin, Chief Commercial Officer of IRRAS. “Coenraad’s leadership experience and strong relationships with physicians and potential distribution partners will be important as we reintroduce IRRAflow to Europe and other global markets after the completion of our CE Mark recertification process.”

Dr. Tamse added, “I am excited to join IRRAS, an exciting company that is bringing cutting-edge products to patients around the world. After receiving my medical degree, I decided to dedicate my career to launching difference-making medical technologies, and I am pleased to continue this work with both IRRAflow and Hummingbird ICP. We have a tremendous opportunity to establish IRRAS as the innovation leader in neurocritical care, and I look forward to working with our team to accomplish these goals.”

Most recently, Dr. Tamse served as the Director of Europe, Middle East, and Africa (EMEA) for Mentice, a leader in global surgical simulation training. In this role, Dr. Tamse oversaw relationships with global medical device companies and was responsible for defining and owning the business strategy with key industry partners across the EMEA geography.

Prior to Mentice, Dr. Tamse was Commercial Director for Delacroix – Chevalier, where he refined the commercial strategy for the company’s activities outside of its home market, France, and restructured the business to better meet the needs of its customers and distribution partners. He has also held a key leadership role as Managing Director, at Tava Surgical and led the business unit’s equity carve-out from Brasseler USA until its acquisition 5 years later.  

 

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 November 11, 2019 at 8.00 a.m. (CET).

On Thursday November 14, at 04.00 p.m. CET IRRAS will host a conference call and an online presentation of its Q3 2019 interim report (which will have been published earlier on the 14^th at 08.00 a.m. 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 74

The presentation will be webcast and can be accessed from the following web address: https://financialhearings.com/event/11742

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

About IRRAS

IRRAS AB is a global healthcare company focused on delivering innovative medical technologies to our customers and their patients. IRRAS designs, develops and commercializes products that improve patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methods in neurocritical care. IRRAS currently markets and sells its IRRAflow and Hummingbird product lines to hospitals worldwide through its direct sales organizations in the U.S. and select European countries and a network of distribution partners in other markets. 

IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit www.irras.com.

IRRAS AB (publ) is listed on Nasdaq First North Premier Growth Market (ticker: IRRAS). Redeye AB is Certified Adviser of the company with email certifiedadviser@redeye.se or phone +46 8 121 576 90.

For more information, please contact:

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

Europa
Sabina Berlin
CFO
+46 73 951 9502
sabina.berlin@irras.com

The information was released for public disclosure, through the agency of the contact person above, on October 31, 2019 at 8:00 a.m. (CET).