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Blue Light Flexible Cystoscopy followed by tumor treatment with Laser results in less patient burden, improved satisfaction and cost reduction

Oslo, Norway, April 3rd, 2018, Photocure ASA (OSE: PHO), is pleased to announce that a new study on Blue Light Cystoscopy (BLC™) with Hexvix® using the KARL STORZ flexible videoscope system in the outpatient setting for the laser treatment of Low-Grade bladder tumors was published in Scandinavian Journal of Urology.

Link to publication: https://bit.ly/2IlpylQ.
This study, by Drs Hermann, Mogensen and Susanne Rosthoj, MSc, established that the method of removing lesions with the laser diode in an outpatient setting provides a well tolerated treatment of low-grade non-invasive tumor recurrences, and allows for the patients to leave immediately after treatment.

The study involved 21 patients who had histology verified, low-grade bladder tumors smaller than 1.5 cm in the bladder identified during outpatient surveillance flexible cystoscopy. Patients underwent the BLC with Hexvix assisted laser procedure and had a 1-month follow-up cystoscopy and biopsy guided by Blue Light Cystoscopy (BLC™) and the KARL STORZ flexible videoscope. Follow up of patients was for 12–16 months. The measurement of pain was with a validated visual analog method from the European Organization for the Research and treatment of Cancer Quality of Life Questionnaire for the Non-Muscle Invasive Bladder Cancer.

“Use of BLC™ with Hexvix® to identify the tumors when they are small makes it possible to treat more patients in the office setting. The laser treatment of lesions caused limited pain and patients were able to return to their daily activities immediately after the procedure. We found that this method is effective for the treatment of Ta low-grade tumors. Treating more patients on an outpatient basis results in considerable quality of life benefits to the patients and economic benefits to the health care system. Following the results of this methods validation study we are now evaluating the method in a randomized controlled trial,” said Dr Gregers G. Hermann, Consultant Urologist, DM Sc. F.E.B.U. Herlev and Gentofte Hospital, University of Copenhagen and main investigator of the study.

“In this proof of principle study of BLC™ with Hexvix® to detect and control, and the laser technique to remove Ta low-grade lesions in the outpatient setting, it was estimated that 25% of the TURBT procedures could be performed in the outpatient (office) basis without general anesthesia. This resulted in an estimated direct cost savings of €140,976 per million inhabitants. Using Blue Light Flexible cystoscopy during this procedure makes the urologists confident that all tumors are detected and removed and patients can avoid an operating room surgery while receiving effective treatment for this recurrent and progressive disease. It is exciting to see the emerging developments in bladder cancer and the new role that Hexvix can play to offer patients improved management of their disease,” said Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.

About Bladder Cancer
There are 167 000 new cases of bladder cancer in Europe and more than 59 000 deaths from the disease annually. Approx. 75% of all bladder cancer cases occur in men1. It has a high recurrence rate with an average of 61% in year one and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest amongst all. Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence3,4. A recent paper on the economic burden of bladder cancer across the European Union estimates that bladder cancer cost the EU 4.9 Billion Euro in 20122. Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.5

1. Globocan. Incidence/mortality by population. Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx
2. Leal et al, Eur Urol 2016; 69: 438-447
3. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, et al. EAU Guidelines on
    non-muscle-invasive bladder cancer (Ta, T1 and CIS). Eur Urol. 2016 Guidelines Edition:1-40.
4. Sievert KD et al. World J Urol 2009;27:295–300
5. Bladder Cancer. American Cancer Society https://www.cancer.org/cancer/bladder-cancer.html    About Bladder Cancer

About Hexvix®/Cysview®
Hexvix®/Cysview® is a drug that is selectively taken up by cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLCTM with Hexvix®/Cysview® improves the detection of tumors and leads to more complete resection, less residual tumors and better management decisions.

Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US and the Nordic region, and has strategic partnerships for the commercialization of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.

About Photocure ASA
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company focusing on urology. Based on its unique proprietary Photocure Technology® platform, Photocure is committed to developing and commercializing highly selective and minimally invasive solutions to improve health outcomes for patients worldwide. The company is listed on the Oslo Stock Exchange (OSE: PHO). More information about Photocure is available at www.photocure.com, www.hexvix.com, www.cysview.com

For more information, please contact:

Company contacts:

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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