IRRAS introduces IRRAflowTM v 2.5 with several upgrades including an updated battery configuration

San Diego, CA, USA, Laichingen, Germany and Stockholm, Sweden January 18, 2018 – IRRAS AB (NASDAQ Stockholm: IRRAS), a commercial-stage, medical technology company focused on designing, developing and commercializing innovative solutions for various brain pathologies, today announced the launch of a significantly improved version of its flagship IRRAflow product in the European Union (EU). IRRAflow version 2.5 incorporates several aesthetic and mechanical upgrades, as well as an updated battery configuration. The new battery configuration was optimized in response to a voluntary recall and temporary hold on selling the device following an isolated incident of a battery malfunction that occurred in December 2017. The hold has now been lifted.

IRRAS has transitioned to a new manufacturer for the battery pack contained in all IRRAflow devices. The new manufacturer is based in Germany, and the specific battery pack chosen has been used since 2012 in tens of thousands medical devices and by over a dozen medical device companies. In February 2018, the first IRRAflow v 2.5 units will be ready for shipment to customers. IRRAS will re-introduce the optimized devices to the current customers and will begin to record sales shortly thereafter.

“The rapid response to the IRRAflow single battery malfunction incident during a sales demonstration reflects IRRAS’ ongoing commitment to developing quality medical technology products. We are pleased to have introduced an updated medical grade battery configuration from a qualified German vendor,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS. “Looking ahead, we are sharply focused on accelerating our commercial plans to expand sales in the EU markets, in the United States pending approval by the FDA, and in other selective worldwide markets.”

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 intracranial bleedings. 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 AB

IRRAS (NASDAQ Stockholm: IRRAS), is a publicly-traded, 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.

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

Investor and Media Contact:

Fredrik Alpsten
CFO and Deputy CEO
+46 706 67 31 06
fredrik@irras.com

   

This information is 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 18 January 2017 at 08.30 a.m. (CET).

Tags:

Subscribe

Documents & Links