The board of directors of IRRAS AB (“IRRAS” or the “Company”), has resolved to carry out a new share issue of up to SEK 350 million (the “Offering”) in order to finance IRRAS’s next phase of commercialization, expand the IRRAflow™ platform and diversify the ownership structure. The board of directors has also applied for the Company’s shares to be admitted to trading on Nasdaq First North Premier, Stockholm. On 13 November 2017, Nasdaq Stockholm decided to admit the Company’s shares to trading subject to the fulfilment of certain customary conditions, including that the requirement of distribution of shares is met not later than by the first day of trading, which is expected to be 22 November 2017.

IRRAS in brief

IRRAS is a commercial stage medical technology company focused on designing, developing and commercializing innovative solutions for various brain pathologies, with a goal of dramatically improving patient outcomes, reducing patient-time in the intensive care unit and medical ward, and providing significant health economic benefits to hospitals and healthcare providers.

The Company’s initial product focus is on intracranial fluid management solutions that utilize its proprietary platform technology, IRRAflow™, which is a CE-marked, fully integrated, closed-circuit medical device system that enables intelligent intracranial fluid management as well as accurate, real-time monitoring of intracranial pressure.

The Offering in brief 

• The Offering consists of an offering to the general public[1] in Sweden and an offering to institutional investors[2] in Sweden and abroad.
• The price per share in the Offering will be determined by way of a book-building process within the range of SEK 45 – 50.
• The Offering comprises the maximum number of newly issued shares in IRRAS that provides the Company with gross proceeds of not more than SEK 350 million. Assuming that the price in the Offering is set to SEK 45 per share, corresponding to the low end of the price range, the new share issue will comprise 7,777,777 shares. If the final price is set to SEK 50 per share, corresponding to the high end of the price range, the new share issue will comprise 7,000,000 shares.
• In order to cover potential over-allotment in relation to the Offering, the Company has, at the request of the Sole Global Coordinator (as defined below), committed to issue not more than 1,166,666 new shares[3], corresponding to approximately SEK 52.5 million before issue expenses or 15 percent of the total number of shares in the Offering (the “Over-allotment Option”).
• If the Offering is fully subscribed and the Over-allotment Option is exercised in full, the total value of the Offering will be approximately SEK 402.5 million, comprising of a minimum of 8,050,000 and a maximum of 8,944,443 newly issued shares, corresponding to approximately 31.9 and 34.2 percent of the total number of shares in the Company (before dilution) after completion of the Offering.
• Assuming that the Offering is fully subscribed and the Over-allotment Option is exercised in full, the number of shares in the Company (before dilution) will amount to a minimum of 25,267,419 and a maximum of 26,161,862 shares, corresponding to a market value for the total number of shares in the Company after the completion of the Offering of approximately SEK 1,177 – 1,263 million. 
• Existing shareholders Serendipity Ixora AB (publ) and Vandel Medical Equipment Ltd. have agreed to subscribe for shares to a total value of SEK 35 million, corresponding to a minimum of 700,000 and a maximum of 777,777 shares and approximately 10.0 percent of the total number of shares in the Offering before exercise of the Over-allotment Option, or 8.7 percent of the total number of shares in the Offering, provided that the Overallotment Option is exercised in full.
• A prospectus with full terms and conditions is published today 13 November 2017.
• The application period for the general public in Sweden is expected to be 14 – 20 November 2017, and the application period for institutional investors is expected to be 14 –21 November 2017
• The first day of trading in the Company’s shares on Nasdaq First North Premier is expected to be 22 November 2017 and the shares will trade under the ticker “IRRAS”.
• The expected settlement day of the Offering is 24 November 2017.
• The Offering is conditional upon it generating proceeds of a minimum of SEK 260 million after issue expenses.

Kleanthis G. Xanthopoulos, Ph.D, President and CEO of IRRAS:
”IRRAS has designed, developed, and recently commercialized the flagship product IRRAflow™ in the EU, that greatly improves the way intracranial bleedings, including hemorrhagic strokes, are treated. IRRAflow™ also brings much needed innovation to the neurosurgery field. Since the commercial launch, we have seen steady sales growth and have demonstrated efficacy in more than 70 life-threatening clinical cases, bringing clear benefits to patients, physicians and payors alike. With our core proprietary technology, broad intellectual property, and key human capital that stem from Sweden, we are proud to list IRRAS on Nasdaq First North Premier, Stockholm. The IPO will provide us with the necessary capital to grow sales of IRRAflow™ in the EU, and when receiving FDA approval, launch the product in the US, expand our core technology into new applications in neurosurgery, body pathologies and drug delivery, which we believe will create significant long-term value for our shareholders.”

Background to the Offering
Due to the significant interest and uptake of IRRAflow™ since the commercial launch, the Company believes that significant value can be created from an accelerated commercialization strategy. In addition, the Company believes its IRRAflow™ platform has multiple expansion opportunities in addition to the patient populations that IRRAflow™ is already addressing (hemorrhagic stroke and chronic subdural hematoma). The product pipeline includes a smaller version of IRRAflowTM, an add-on feature to the IRRAflowTM for continuous monitoring of brain elastance, an IRRAflowTM version for body pathologies (outside the CNS) and a novel drug delivery system.

The execution of IRRAS’s marketing initiatives and expansion strategy will require significant investments during the years to come. To secure the financing needed to deliver on its growth strategy, further develop the product pipeline and to support the Company’s working capital needs until the Company becomes self-sufficient, IRRAS has decided to carry out a new share issue in connection with the listing on Nasdaq First North Premier. Assuming that the Offering is fully subscribed, the gross proceeds will amount to SEK 350 million and net proceeds to SEK 316 million after expenses related to the Offering. The Company intends to use such proceeds as per the following order of priority:

• Commercial expansion of the neurosurgical operations, including entry to the US market and reinforcement of the sales organization in the EU – approximately SEK 90 million
• Development of IRRAflow™ for new functions within neurosurgery, including a smaller version of the IRRAflow™ catheter – approximately SEK 40 million
• Development of IRRAflow™ for new indications in the body – approximately SEK 40 million
• Development of a new drug delivery system for IRRAflowTM – approximately SEK 90 million
• Buffer for unforeseen costs and delays in the execution of the commercial strategy and the Company’s research and development strategy – approximately SEK 55 million

It is the objective of IRRAS’s board of directors to, subject to, inter alia, prevailing market conditions, list the Company on Nasdaq Stockholm’s main market within twelve months from the completion of the listing on Nasdaq First North Premier.

Prospectus and subscription terms

A prospectus containing the full terms of the Offering is published today. The prospectus is available on IRRAS’s website (www.irras.com), ABG Sundal Collier’s website (www.abgsc.com) and Avanza’s and Nordnet’s websites, (www.avanza.se) and (www.nordnet.se).

Preliminary timetable

Application period for the general public in Sweden:	14 November 2017 – 20 November 2017
Application period for institutional investors:	14 November 2017 – 21 November 2017
Publication of the outcome of the Offering:	22 November 2017
First day of trading on Nasdaq First North Premier:	22 November 2017
Settlement day:	24 November 2017

Advisors

ABG Sundal Collier AB is Sole Global Coordinator. Vator Securities AB is Financial Advisor. Setterwalls Advokatbyrå AB is legal advisor to the Company and Baker McKenzie Advokatbyrå KB is legal advisor to the Sole Global Coordinator and Vator Securities AB as to Swedish and US law.

For further information, please contact:
Kleanthis G. Xanthopoulos, Ph.D., President and CEO
kleanthis@irras.com

Fredrik Alpsten, CFO and Deputy CEO
fredrik@irras.com

Important information
This announcement is not being made in and copies of it may not be distributed or sent, directly or indirectly, into the United States, Australia, Canada, Hong Kong, Japan, New Zeeland, Singapore, South Africa or any other state or jurisdiction in which release, publication or distribution would be unlawful.

This announcement is not an offer of securities for sale in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. IRRAS has not, and does not intend to, register any of the securities in the United States or to conduct a public offering of the securities in the United States.

This announcement does not constitute an offer of the securities to the public in the United Kingdom. No prospectus has been or will be approved in the United Kingdom in respect of the securities. This announcement is being distributed to and is directed only at (i) persons who are outside the United Kingdom or (ii) persons who are investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) and (iii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “Relevant Persons”). Any investment activity to which this announcement relates will only be available to and will only be engaged with, Relevant Persons. Any person who is not a Relevant Person should not act or rely on this document or any of its contents.

Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialise or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward‐looking statements in this presentation are free from errors nor does it accept any responsibility for the future accuracy of the opinions expressed in this presentation or any obligation to update or revise the statements in this presentation to reflect subsequent events. Undue reliance should not be placed on the forward-looking statements in this document.

The information, opinions and forward-looking statements contained in this announcement speak only as at its date and are subject to change without notice. The Company does not undertake any obligation to review, update, confirm or to release publicly any revisions to any forward‐looking statements to reflect events that occur or circumstances that arise in relation to the content of this announcement.

In connection with the Offering, the Sole Global Coordinator may carry out transactions in order to provide support for the shares’ market price at a level higher than that which might otherwise prevail on the market. Such stabilization transactions may be carried out on Nasdaq First North Premier, the OTC market or otherwise, and may be carried out at any time during the period beginning on the first day when the shares are traded on Nasdaq First North Premier and ending no later than 30 calendar days thereafter.

However, the Sole Global Coordinator is under no obligation to carry out stabilization of any kind, nor is there any guarantee that stabilization will be carried out. Moreover, where undertaken, stabilization may be discontinued at any time without prior notice. No transactions will be carried out under any circumstances in order to provide support for the shares’ market price at a level higher than the price set in the Offering. Within a week of the expiry of the stabilization period, the Sole Global Coordinator, through the Company, will publish information on whether or not any stabilization has been carried out, the date when stabilization was undertaken, the last date when stabilization was carried out, as well as the price range within which stabilization was undertaken for all of the dates when stabilization transactions were carried out.

[1] The general public includes private individuals and legal persons in Sweden who register to subscribe for a maximum of 22,500 shares.

[2] Institutional investors include private individuals and legal persons who register to subscribe for more than 22,500 shares. 

[3] Based on the low end of the price range. 

 Press release (PDF)

LA JOLLA, Calif., LAICHINGEN, Germany and STOCKHOLM, Sept. 13, 2017 /PRNewswire/ — IRRAS, a commercial-stage medical technology company developing breakthrough devices for a broad range of intracranial bleeding applications and procedures, today announced two key appointments to its executive and commercial teams: Karl-Matthias Moehlmann as Senior Vice President Commercial Operations, General Manager Europe and a member of the executive management team and Klemens Fölling as Director of International Sales.

Collectively, Mr. Moehlmann and Mr. Fölling bring over 40 years of experience in developing, launching, marketing and selling medical devices for neurological applications. Prior to their appointments as full-time employees, Mr. Moehlmann and Mr. Fölling served as senior advisors to IRRAS.

“I am very pleased to have both Matthias and Klemens join the IRRAS team,” said Kleanthis G. Xanthopoulos, Ph.D., Chairman and CEO of IRRAS.  “Matthias’ executive management experience, marketing expertise and proven commercial track record in medical devices, coupled with Klemens’ vast experience in neurological product sales, will assist IRRAS to achieve our major commercial growth milestones for our products based on our IRRAflow™ technology.”

Mr. Moehlmann added, “The treatment of intracranial bleedings and life-threatening hemorrhagic strokes has not advanced during the last two decades and innovation is desperately needed.  The IRRAflow™ product is a first-in-class device that provides an elegant solution for these patients with less invasiveness and more efficacy.  I am truly excited to join the IRRAS team and look forward to advancing our platform of medical devices to transform the field of neurosurgery.”

Mr. Moehlmann brings more than fifteen years of experience as an executive or advisor for leading medical device companies in the neurological, trauma and orthopedic categories to IRRAS. Prior to joining IRRAS, Mr. Moehlmann was Director of Marketing at Kyphon B.v.B.a, (acquired by Medtronic) and was VP of Business Development at Bonesupport AB.  Prior to that, Mr. Moehlmann held leadership and consultancy roles at aap Bioimplants, Benvenue Medical, CRA DePuy Spine, X-Spine, Miedke Hydrocephalus Solutions and Mimedx Biologics. He holds a M.Sc. in Biochemistry from University of Hanover, an M.B.A in Economics and Master of Public Health from the University of Graz.

Mr. Fölling has amassed more than 25 years of neurosurgery and spinal device sales, holding key national and international sales positions at Olympus Medical, B.Braun Aesculap, Medtronic and Simpirica Spine.  Throughout his career, Mr. Fölling has implemented sales structures in direct and distributor businesses worldwide in over 20 countries and has established relationships with neurosurgical key opinion leaders (KOLs) in Europe which will be beneficial to IRRAS.  Mr. Fölling received his B.A degree from Münster University.

About IRRAflow™

IRRAS has developed and commercialized a revolutionary intelligent brain fluid management device stemming from its core IRRAflow™ technology that addresses the complications associated with the occurrence of hemorrhagic stroke.  Currently available devices do not address the complications that lead to death because they do not prevent occlusion (or blockage) in the catheter during treatment and they do not accurately monitor intracranial pressure (ICP). IRRAS’ products provide a transformative solution for stroke and hematoma patients with less invasiveness and more efficacy, through the integration of aspiration, targeted infusion and intracranial pressure monitoring in a single robust device.

About IRRAS

IRRAS AB is a commercial-stage medical technology company formed to develop and commercialize breakthrough devices for a broad range of intracranial bleeding applications and procedures. IRRAflow™ is the company’s flagship commercial medical device that provides intelligent, dynamic control of CNS fluids to address the complications associated with the occurrence of hemorrhagic stroke. With its unique product portfolio, protected by key intellectual property patents and patent applications, IRRAS is well-positioned to improve patient outcomes and establish a leadership position in the medical device market. IRRAS is operational in Sweden and Germany with corporate headquarters in La Jolla, CA, USA.  For more information, please visit www.irras.com.

CONTACT: 
Amy Conrad
Juniper Point
858-914-1962

-Mr. Alpsten will Lead the Development of IRRAS’ Global Finance Strategies-

Stockholm, Sweden August 30, 2017 – IRRAS, a commercial-stage medical technology company developing breakthrough devices for a broad range of intracranial bleeding applications and procedures, today announced the appointment of Fredrik Alpsten as Chief Financial Officer and Deputy Chief Executive Officer and a member of the executive management team. Mr. Alpsten brings approximately 20 years of operational, financial, and strategic business experience as an executive in the medical technology field. In his new role, Mr. Alpsten will report directly to the CEO of IRRAS, Kleanthis G. Xanthopoulos, Ph.D., from the Stockholm, Sweden site. IRRAS expects Mr. Alpsten to join during early 2018 at the latest.

“We are very pleased to welcome Fredrik to the executive team of IRRAS,” said Kleanthis G. Xanthopoulos, CEO of IRRAS. “Over the last two decades, Fredrik has amassed a deep understanding of the healthcare industry, having served as both a public company CEO and CFO, and his breadth of experience in operations, finance, and strategy are well suited to help advance IRRAS to the next phase of the company’s growth.”

Mr. Alpsten commented, “IRRAS is an exciting company with a unique combination of intelligent medical device and drug delivery technology, world-renowned thought leaders in neurosurgery, and a proven leadership team. The opportunity to work at a company that has commercialized an innovative medical device to treat hemorrhagic strokes and the possibility to develop additional transformative products is very attractive. I am excited to join the company and help bring the IRRAflow™ technology to patients in need across the globe.”

Most recently, Mr. Alpsten, as a member of the executive management team, served as Senior Vice President and CFO of Boule Diagnostics AB (Boule), a Swedish publicly-traded diagnostics company. During his six years in this role, Mr. Alpsten was responsible for overseeing multiple global departments including finance, investor relations, administration, IT, legal, human resources, and facilities. During his time at Boule, Mr. Alpsten also served as President and CEO of Clinical Diagnostic Solutions Inc., a US subsidiary of Boule. Prior to that, for three years he was President and CEO of Doxa AB (Doxa), a publicly-traded medical technology company located in Sweden, where he grew the company from a research and development company to commercial-stage marketing organization with a robust sales presence in the EU and the US. Before serving as President and CEO at Doxa, Mr. Alpsten was VP, CFO of Doxa for eight years and prepared the company for an Initial Public Offering on the Nasdaq exchange. Mr. Alpsten also served as Finance Director of N&T Argonaut AB, a publicly-traded company on the Stockholm Stock Exchange, for nine years.

In addition to different board assignments for the Boule group, Mr. Alpsten currently serves as Chairman of the Board of Personlig Almanacka Nordic AB and board member and chairman of the audit committee of Oniva Online Group Europe AB. Mr. Alpsten received a Master of Science degree from the Stockholm School of Economics.

About IRRAflow™
IRRAS has developed and commercialized a revolutionary intelligent brain fluid management device stemming from its core IRRAflow™ technology that addresses the complications associated with the occurrence of hemorrhagic stroke. Currently available devices do not address the complications that lead to death because they do not prevent occlusion (or blockage) in the catheter during treatment and they do not accurately monitor intracranial pressure (ICP). IRRAS’ products provide a transformative solution for stroke and hematoma patients with less invasiveness and more efficacy, through the integration of aspiration, targeted infusion and intracranial pressure monitoring in a single robust device.

About IRRAS 
IRRAS AB is a commercial-stage medical technology company formed to develop and commercialize breakthrough devices for a broad range of intracranial bleeding applications and procedures. IRRAflow™ is the company’s flagship commercial medical device that provides intelligent, dynamic control of CNS fluids to address the complications associated with the occurrence of hemorrhagic stroke. With its unique product portfolio, protected by key intellectual property patents and patent applications, IRRAS is well-positioned to improve patient outcomes and establish a leadership position in the medical device market. IRRAS is operational in Sweden and Germany with corporate headquarters in La Jolla, CA, USA. For more information, please visit www.irras.com.

-C. Lance Boling to Spearhead Global Expansion of IRRAflow™ Technology Portfolio-

La Jolla, CA, USA and Stockholm, Sweden April 10, 2017 – IRRAS, a commercial-stage medical technology company developing breakthrough devices for a broad range of brain pathology therapeutic applications and procedures, today announced the appointment of C. Lance Boling as Vice President, Product Development and a member of the executive management team. Mr. Boling brings over 25 years of experience in medical device development, manufacturing, and operations to IRRAS, where he will be responsible for expanding the IRRAflow™ technology portfolio in both the EU and U.S. In his role, Mr. Boling will report directly to the Chairman and CEO of IRRAS, Kleanthis G. Xanthopoulos, Ph.D., from one of the company’s U.S. sites.

“I am excited to welcome Lance as a member of the IRRAS executive management team as we expand our commercial footprint and advance our IRRAflow™ technology,” said Kleanthis G. Xanthopoulos, Ph.D., Chairman and CEO of IRRAS. “Lance has very impressive credentials – in addition to his deep medical device development expertise, he also brings valuable manufacturing and operations experience that will greatly enhance our ability to transform the way strokes and brain hematomas are treated.”

“Each year in the U.S. and EU, approximately two million people suffer strokes and almost three hundred thousand have a hemorrhagic stroke, with almost half of these instances ending in death. Unfortunately, the current available medical devices cannot address the complications that lead to death and the need for innovation in this field is urgent,” said C. Lance Boling, Vice President, Product Development of IRRAS. “Because of this, I am extremely pleased to join the IRRAS team to combat this global health issue. We plan to aggressively expand and advance our core IRRAflow™ technology to provide patients, physicians and payors with an intelligent solution for the management of strokes and brain hematomas.”

Prior to joining IRRAS, Mr. Boling was Director of Nano Technology Development at Abbott Laboratories where he was responsible for leading numerous development efforts from inception through commercialization. Before Abbott, Mr. Boling held leadership positions at Nanostim, Nevro Corporation, NeuroPace, Inc., and Autonomic Technology. Mr. Boling holds a BA in Business Management from the University of Phoenix and has participated in Post Graduate studies in Manufacturing Technology at Stanford University. He holds over 40 pioneering patents – granted and pending in the medical device industry – and is a regular guest lecturer on product development at local universities and high schools.

About IRRAflow™
IRRAS has developed and commercialized a revolutionary catheter device stemming from its core IRRAflow™ technology that addresses the complications associated with the occurrence of hemorrhagic stroke. According to the WHO, there are 15 million stroke patients annually and complications from these strokes result in more than 6 million annual deaths, almost 1 every 10 seconds. Currently available devices do not address the complications that lead to death because they do not prevent occlusion (or blockage) in the catheter during treatment and they do not accurately monitor intracranial pressure (ICP). IRRAS’ clinical strategy is to provide a transformative solution for stroke and hematoma patients with less invasiveness and more efficacy, through the integration of aspiration, targeted infusion and intracranial pressure monitoring in a single robust device.

About IRRAS 
IRRAS AB is a commercial-stage medical technology company formed to develop and commercialize breakthrough devices for a broad range of brain pathology therapeutic applications and procedures. IRRAflow™ is the company’s flagship commercial medical device that provides intelligent, dynamic control of CNS fluids to address the complications associated with the occurrence of hemorrhagic stroke. With its unique product portfolio, protected by key intellectual property patents and patent applications, IRRAS is well-positioned to improve patient outcomes and establish a leadership position in the medical device market. IRRAS is operational in Germany and La Jolla, CA, USA with corporate headquarters in Stockholm, Sweden. For more information, please visit www.irras.com.

Contact:
Amy Conrad
1-858-914-1962
amy@juniper-point.com