Regulatory Filings • Sep 28, 2022
Regulatory Filings
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Photocure Announces the Commercial Availability of Karl Storz's New Blue Light System in the U.S.
Karl Storz and Photocure to collaborate on commercializing the high-definition
system
Press Release - Oslo, Norway, September 28, 2022: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces the commercial availability of Karl Storz's
New Blue Light equipment powered by SaphiraT in the U.S. As part of the rollout,
Karl Storz plans to host a Virtual Launch event for the medical community
streamed from its El Segundo, California office where Sia Daneshmand M.D. and
Kristin Scarpato M.D. M.P.H. will discuss the clinical benefits of using BLC[®]
with Cysview[® ]for NBMIC*, while sharing their perspectives on the advantages
that the New Blue Light system provides over the original system for TURBT**.
The Virtual Launch event is scheduled to take place on October 13, 2022 at
4:00pm Pacific Time.
"We are pleased to share that Karl Storz has begun filling Obsolescence
Protection Program (OPP) orders for customers who purchased New Blue Light
system upgrades last year," said Geoff Coy, Vice President and General Manager,
North America. "Orders for the new Saphira system appear to be outpacing orders
from the past signaling pent up demand for the advanced technology, and we
expect to begin filling new account orders in the fourth quarter. Given the
strong demand, we continue to believe that BLC is on its way to becoming the
standard of care for endoscopic visualization of bladder cancer."
"Uro-oncologists and their staff have expressed a strong desire to have the new
Blue Light system at their hospitals, and the upcoming Virtual Launch Event is
an opportunity to showcase the system's benefits and broaden awareness of BLC in
the market," said Ken Pugh, Head of North America Marketing and Alliance
Management. "Accordingly, we are working diligently with our partners to ensure
that all customers who want The New Blue Light, have it for all appropriate
patients with NMIBC."
Dr. Sia Daneshmand, M.D., is Professor of Urology with Clinical Scholar
designation and serves as director of clinical research as well as the urologic
oncology (SUO) fellowship director at the University of Southern California
(USC) in Los Angeles.
Dr. Kristin Scarpato, M.D., M.P.H., is Associate Professor Department of Urology
residency program director and vice chair of education for the Department of
Urology, Division of Urologic Oncology at Vanderbilt University Medical Center
in Tennessee.
*NMIBC: Non-muscle invasive bladder cancer
**TURBT: Transurethral resection of bladder tumor
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 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 BC 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]
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