Enhanced market access to Cysview® in the US market

Photocure announces FDA approval of upgraded Karl Storz blue light cystoscope for use with Cysview. This will significantly enhance the market access to Cysview in the US market.

Cysview® product image
 

 

 

 

 

 

 

 

Oslo, Norway, May 7, 2012. Photocure ASA announces today approval by the US FDA of the upgraded Karl Storz blue light cystoscopy equipment for use in combination with Photocure's flagship product Cysview for the improved detection of bladder cancer.

Karl Storz Photodynamic Diagnostic D-Light C (PDD) SystemKarl Storz Photodynamic Diagnostic
D-Light C (PDD) System

This approval marks a significant milestone for Photocure's commercialization of Cysview in the US and paves the way for a significant increase in market access. The launch of Cysview by Photocure's own commercial operations was initiated in January 2012 and the approval of the upgraded equipment will enable the placement of further blue light cystoscopes in leading urology centres across the US.

Cysview (hexaminolevulinate hydrochloride), the first significant advance for the improved detection of bladder cancer, was approved for use in combination with the blue light cystoscopy equipment (Karl Storz D-Light C PDD System) in May 2010. After the initial approval, an upgrade to enhance the blue light system, which corresponds to the version on the market in Europe, was filed to the FDA by Karl Storz Endoscopy America.

Kjetil Hestdal, President and CEO of Photocure said: "We are delighted that our collaborator, Karl Storz Endoscopy America, has received approval of its upgraded blue light cystoscopy equipment. We are confident that this will drive an increase in number of hospitals obtaining the blue light cystoscopy equipment and therefore drive the increased use of Cysview. We look forward to working closely with Karl Storz to bring Cysview Photodynamic Diagnosis to many more bladder cancer patients in the US."

For further information, please contact:
Photocure
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: kh@photocure.no
M:Communications
Mary Clark, Amber Bielecka, Hollie Vile
Tel: +44 207920 2361, Email: photocure@mcomgroup.com