Solid sales in the quarter and updated CE approval partially in place
First quarter, January - March 2018
- Net revenue totaled SEK 5.9 (0.0) million.
- Operating loss (EBIT) totaled SEK -21.1 (-11.5) million.
- The result after taxes totaled SEK -17.8 (-11.5) million.
- Result per share before and after dilution was SEK -0.75 (-0.67).
Important events during the quarter
Re-launch of IRRAflow™
IRRAS launched an upgraded version of IRRAflow in February. The product was upgraded both esthetically and mechanically and received a new battery configuration. The new configuration was developed in response to a voluntary recall and temporary stop of sales for the product after a battery defect in December 2017. The launch resulted in a total sales of SEK 5.9 million in the quarter.
Strengthening of the management group
IRRAS strengthened the company's management group during the quarter. Will Martin was hired as Chief Commercial Officer and Kellie Fontes as Senior Director Human Capital. Both report to Dr. Kleanthis G. Xanthopoulos, IRRAS President and CEO and are based at the company's US offices in San Diego.
Update relating to 510 (K) application
During the quarter, the company received a response from the FDA (American Food and Drug Administration) regarding the company's 510 (K) application.
In their communication to the company, the FDA requested clarifications and updating of certain reports, primarily related to bio-compatibility, sterilization tests and software of IRRAS suppliers. IRRAS is finalizing a compilation of the respective documents and still foresees that IRRAflow will be launched in the US towards the end of 2018.
Important events after the end of the quarter
Updated ISO and CE certification
IRRAS' previous notified body Intertek had decided not to continue certifying certain products. Therefore, IRRAS and hundreds of Intertek's customers needed to obtain updated ISO certification and CE mark approval from new notified bodies.
In May, IRRAS received both an updated ISO 13485:2016 certificate and updated CE approvals for both the control unit and the cassette in the IRRAflow system. Both products are Class II products. The ISO certificate and CE approvals are valid through 2021. For Class III products, such as the IRRAS catheters, significantly more time is required for review. The company expects to receive an updated CE approval for the Class III catheter product in the near future.
Change in the company's management group
The company's scientific founder, Dr. Christos Panotopoulos, has been appointed as Special Advisor and member of the IRRAS Clinical Advisory Board. He assumes his new role on June 1, 2018, and leaves his earlier role as Chief Scientific Officer and member of the company's management group.
This is IRRAS
IRRAS AB (NASDAQ Stockholm: IRRAS) is a publicly-traded, commercial-stage medical technology company focused on developing and commercializing innovative solutions for brain surgery. The Company’s initial product, IRRAflow™, addresses the complications associated with the current treatment methods of intracranial bleeding with a dual lumen catheter that combines active irrigation with ongoing fluid drainage. Regularly during treatment, the catheter is automatically flushed to prevent common catheter occlusions from forming. Additionally, because IRRAflow is a completely closed system, it is designed to reduce the documented infection risk of these procedures.
With its unique product portfolio, protected by property patents and patent applications, IRRAS is well-positioned to establish a leadership position in the medical device market. 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
|Annual shareholders' meeting||June 1, 2018|
|Quarter 2 interim financial report||August 27, 2018|
|Quarter 3 interim financial report||November 8, 2018|
|Kleanthis G. Xanthopoulos, Ph.D. President and CEO||Fredrik Alpsten CFO and Deputy CEO|
|+1 858 247 7033||+46 706 67 31 06|