Photocure Provides Update on Anticipated Commercial Availability of Karl Storz’s New Blue Light System in the United States
Oslo, Norway, July 27, 2022: Photocure ASA, The Bladder Cancer Company, announces that it has been informed by Karl Storz that the U.S. launch of the new high-definition blue light system has been delayed due to supply disruptions of certain capital equipment components. Based on current information, Photocure now expects commercial availability of the upgraded blue light system in late Q3 2022.
The Company reports that five flexible blue light cystoscopy (BLC®) towers were installed in the U.S. during the second quarter of 2022. While no rigid BLC towers were available for placement during the second quarter, the demand for blue light capital equipment remains strong.
“While the delayed launch of Karl Storz’s new blue light system is disappointing, we continue to grow our revenue and market penetration with the current installed base of BLC equipment, as awareness of the benefits of blue light cystoscopy is growing with uro-oncologists,” said Dan Schneider, President and CEO of Photocure. “The pre-launch demand from our customers for the new blue light system continues to be robust, and we are looking forward to regaining momentum with new accounts once this upgraded equipment becomes available. We remain dedicated to serving our physician customers and their patients, and we will keep our stakeholders informed on the launch timing.”
This release contains certain forward-looking statements relating to inter alia the business, financial performance and results of the Company and the industry in which it operates. The terms "anticipates", "assumes", "believes", "can", "could", "estimates", "expects", "forecasts", "intends", "may", "might", "plans", "should", "projects", "targets", "will", "would" or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statements. Forward-looking statements concern future circumstances and results and other statements that are not historical facts. These statements are based on Photocure's current expectations and are subject to changes in circumstances. Any forward-looking statements contained in this release, including assumptions, opinions and views of Photocure or cited from third party sources, are subject to risks, uncertainties and other factors that may cause actual results and events to be materially different from those expected or implied by the forward-looking statements. Photocure cannot provide any assurance that the assumptions underlying such forward-looking statements are free from errors nor accept any responsibility for the future accuracy of opinions expressed in this release or the actual occurrence of forecasted developments.
This information is subject to the disclosure requirements pursuant to sections 5-12 of the Norwegian Securities Trading Act.
Note to editors
Hexvix®/Cysview® and BLC® are registered trademarks of Photocure ASA. IMAGE1 S™ and Saphira™ are registered trademarks of KARL STORZ Endoscopy.
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About Bladder Cancer
Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths annually in 2020.1b
Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate, with up to 61% in year one and up to 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3
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 cases and include the subtypes Ta, carcinoma in situ (CIS), and T1 lesions. In MIBC, 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.4
1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: https://gco.iarc.fr/today, accessed [January 2022].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html
About Hexvix®/Cysview® (hexaminolevulinate HCl)
Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC®). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions.
Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, and New Zealand. Please refer to https://photocure.com/partners/our-partners for further information on our commercial partners.
About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at www.photocure.com, www.hexvix.com, www.cysview.com