Regulatory Filings • Jul 27, 2022
Regulatory Filings
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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
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."
Important information:
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 ST and SaphiraT are registered trademarks of KARL STORZ Endoscopy.
This press release may contain product details and information which are not
valid, or a product that is not accessible, in your country. Please be aware
that Photocure does not take any responsibility for accessing such information,
which may not comply with any legal process, regulation, registration, or usage
in the country of your origin.
About Bladder Cancer
Bladder cancer ranks as the 8[th] most common cancer worldwide - the 5[th] 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
For further information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Email: [email protected]
Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: [email protected]
David Moskowitz
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: [email protected]
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: [email protected]
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