US REGISTRY SHOWS THAT BLUE LIGHT CYSTOSCOPY (BLC) WITH CYSVIEW®/HEXVIX® LEADS TO IMPROVED DETECTION AND CLASSIFICATION OF BLADDER CANCER

Photocure ASA (PHO-NO) announced today new data from a prospective multicenter real world study that included 338 patients, 415 BLC procedures and 1060 lesions from nine study sites in the United States. BLCC as an adjunct to white light cystoscopy (WLC) resulted in the detection of an additional 151 lesions and 45 patients uniquely with the addition of blue light. This resulted in upgrading or upstaging of 52 (15%) of the patients. Correct staging and grading impacts the management of bladder cancer patients and may have an impact on patient outcomes

Please see abstract for more information. The registry data were presented at the SUO 17th Annual Meeting, November 30th to December 2nd, 2016, San Antonio, Texas, USA.

The BLCC registry continues to provide additional data from real world clinical practice.  BLC with Cysview® has identified additional high grade cancers and thus change the management of bladder cancer patients from a diverse group of urologic oncologists from around the country.  With additional follow-up these data may undoubtedly affect cancer specific outcomes.  In my clinical practice, the inclusion of BLCC in the AUA/SUO guidelines and the data coming out from this registry study provide additional strong evidence that BLCC should be considered as standard of care by most urologists”, says study participant Trinity J. Bivalacqua, M.D., Johns Hopkins, R. Christian B. Evensen Professor of Urology and Oncology and Director of Urologic Oncology at the James Buchanan Brady Urologic Institute.

 In addition, a second poster was presented at the SUO meeting on the safety of repeat use of BLC with Cysview®. This retrospective review from two institutions in the United States compared the incidence and grade of Adverse Events (AE’s) after initial and subsequent BLCC procedures. 35% of the patients underwent BLCC more than once; 2 patients five times. No statistically significant difference in AE’s between those patients undergoing first versus two or more repeat procedures were found.  Please see abstract for more information.

 “Many studies have shown that BLCC has clear benefits over WLC alone in improving the detection and management of patients with non-muscle invasive bladder cancer (NMIBC).  The registry study is demonstrating how BLCC is changing patient management and clinical outcomes in different patient types in daily clinical practice.  Additionally, the safety data on the repeat use of BLC and Cysview® in the US are supportive of the current clinical practice in Europe, and demonstrate that using BLC with Cysview®repeatedly in the same patient has no safety concerns,” says Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.

About Photocure ASA
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology® platform, Photocure develops and commercializes highly selective and effective solutions within disease areas with high unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions and skin conditions. Our aim is to provide solutions which can improve health outcomes for patients worldwide. Photocure is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at www.photocure.com.

For more information, please contact:

Kjetil Hestdal
President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no

Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no

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