Regulatory Filings • Mar 21, 2023
Regulatory Filings
Open in ViewerOpens in native device viewer
Photocure provides update on Karl Storz's commitment to maximize the commercial adoption of SaphiraT and decision to discontinue flexible BLC tower production in the U.S.
Oslo, Norway, March 21, 2023 - Photocure ASA (OSE: PHO), The Bladder Cancer
Company, announces Karl Storz's continued commitment to blue light cystoscopy
with plans to maximize the ongoing rollout of its new high-definition rigid blue
light cystoscopy (BLC[®]) system, SaphiraT. Due to previously disclosed
component supply issues Karl Storz has decided to discontinue production of
flexible BLC equipment. Upon reclassification, Karl Storz will explore the
development of a high-quality next generation flexible blue light system.
Earlier today, Karl Storz informed Photocure that it will discontinue the
production of its current flexible BLC equipment in the U.S. Karl Storz plans to
service existing customers through the remainder of the year.
Karl Storz also stated that they remain fully committed to broadening access to
its high-definition blue light system Saphira[TM], allocating the appropriate
commercial, regulatory and engineering resources to support this Class III
device. Saphira's importance to Karl Storz future offering is further
demonstrated in the anticipated U.S. launch of the MultiLASE Thulium Fiber Laser
(TFL) platform, that is compatible with Saphira[TM].
Karl Storz will explore the development of a next generation state-of-the-art
flexible blue light system pending a positive reclassification decision by the
U.S. Food & Drug Administration (FDA).
As previously disclosed by Photocure, Cysview sales resulting from new flexible
BLC tower installations were expected to represent less than 2% of total Company
revenues in FY 2023. There are currently 69 flexible BLC towers in the U.S.
Photocure will continue to focus on expanding the installed base of rigid BLC in
the U.S. and on increasing the use of Hexvix/Cysview in TURBT* procedures on a
global basis.
"We continue to see strong demand for BLC from urologists, evidenced by the
record number of tower installations that took place in the fourth quarter of
2022 and the robust pipeline for both SaphiraT and flexible blue light equipment
that we had in early January", said Dan Schneider, President and Chief Executive
Officer of Photocure ASA. "We are disappointed that additional flexible BLC
equipment will not be available particularly given the interest that we saw
before Karl Storz's decision to discontinue production. There is a major
opportunity to expand BLC usage in the surveillance setting, and we are
evaluating several options to pursue this important market segment. Regular
surveillance with flexible BLC can help patients remain better informed about
their disease status and can help physicians determine the best treatment plan
for ongoing bladder cancer management. We will work with the 60+ sites across
the United States that currently have flexible BLC towers to give as many
patients as possible access to this solution, while working with Karl Storz and
other potential manufacturers to bring new flexible equipment to the market."
*TURBT: trans-urethral resection of bladder tumors
Note to editors
Hexvix[®]/Cysview[®] and BLC[®] are registered trademarks of Photocure ASA and
SaphiraT is a registered trademark 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.
This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.
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, New Zealand and Israel. 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]
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.