OSLO, Norway, May 16, 2018 /PRNewswire/ -- Photocure
ASA (OSE: PHO), May 16, 2018,
announced today the launch of Blue Light Cystoscopy (BLC™) with
Cysview for a new indication of surveillance cystoscopy of bladder
cancer.
The new FDA approved indication was a result of a large Phase 3
study using blue light rigid and flexible cystoscopes from KARL
STORZ Endoscopy of America Inc., which showed that BLC with Cysview
significantly (p<0.0001) improves detection of patients
with recurrent bladder cancer. Click here for the Prescribing
Information.
"We are pleased that we have commenced the first commercial sale
of Cysview for surveillance cystoscopy. This launch into the
flexible cystoscopy segment is an important milestone for patients
with bladder cancer and the urology community. The availability of
Blue Light Cystoscopy with Cysview, for rigid and flexible
cystoscopy means that Cysview can now be used for both Bladder
Cancer surgery and follow-up cystoscopy, allowing physicians to
detect patients with the disease earlier and manage it more
appropriately," says Kjetil Hestdal, MD, PhD, President and CEO,
Photocure ASA. "I would like to thank all the investigators,
our partner KARL STORZ Endoscopy of America Inc. and the patients
who made the approval of this new indication possible."
Both companies are exhibiting at the 2018 American Urological
Association Annual meeting in San
Francisco, May 18 to 21,
Photocure on booth 1825.
About Bladder Cancer
Bladder cancer is the fifth most
commonly diagnosed cancer in the US and is the fourth most common
cancer found in men in the US1, 2, 3. It is
estimated that in 2018 there will be 81,190 new cases of bladder
cancer will occur along with 17,240 deaths due to bladder cancer.
Risk factors for bladder cancer include advancing age, cigarette
smoking, occupational exposure to dyes, tar, rubber and solvent,
chronic bladder irritation and infections, and prior diagnosis of
bladder cancer. Bladder cancer is one of the most expensive
cancers to manage, accounting for approximately $3.7 billion in direct costs each
year.4,5
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.2
NMIBC is still in the inner layer of cells. 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.2
About
Hexvix®/Cysview®
Hexvix®/Cysview®
(hexaminolevulinate hydro-chloride), is an optical imaging agent
used in the diagnosis and management of non-muscle-invasive bladder
cancer. It is designed to selectively target malignant cells in the
bladder and induce fluorescence during a cystoscopic procedure
using a blue light enabled cystoscope. Using Cysview® as
an adjunct to standard white light cystoscopy enables the urologist
to better detect and remove lesions, leading to a reduced risk of
recurrence.
Hexvix® is the tradename in Europe, Cysview® in US and
Canada. Hexvix® is
marketed and sold by Photocure in the Nordic countries and in the
US with the trade name Cysview®. Photocure has a
strategic partnership with Ipsen for the commercialization of
Hexvix in Europe, excluding the
Nordic region. Please refer to http://bit.ly/PHO-Partnering
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, which makes 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). The US headquarters for Photocure Inc.,
are in Princeton, New Jersey. For
more information, please visit us at www.photocure.com,
www.hexvix.com or www.cysview.com
About KARL STORZ Endoscopy-America, Inc.
KARL STORZ
Endoscopy-America, Inc., is an affiliate of KARL STORZ GmbH &
Co. KG, an international leader for more than 70 years in reusable
endoscope technology, encompassing all endoscopic specialties.
Based in Tuttlingen, Germany, KARL
STORZ GmbH & Co. KG is a family-owned company that designs,
engineers, manufactures, and markets all its products with an
emphasis on visionary design, precision craftsmanship and clinical
effectiveness. For more information, call (800) 421-0837 or visit
the company's website at www.karlstorz.com.
For more information, please contact:
Company contacts:
Kjetil Hestdal
President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no
US President:
Ambaw
Bellete
President
Photocure Inc.
Tel: + 1-609-759-6515
Email: ab@photocure.com
Media Relations:
Amanda
Hudson
MCS Healthcare Public Relations
Tel: +1 908 234 9900
Email: amandah@mcspr.com
References:
1. SEER Cancer Statistics Factsheets:
Bladder Cancer. National Cancer Institute. Bethesda, MD.
https://seer.cancer.gov/statfacts/html/urinb.html. Accessed
April 2018.
2. Bladder Cancer. American Cancer Society.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf.
Accessed April 2018.
3. Hall M, Chang S, Dalbagni G et al. Guideline for the Management
of Nonmuscle Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007
Update. J Urol. 2007;178 (6):2314-2330.
4. Avritscher EB et al., Clinical model of lifetime cost of
treating bladder cancer and associated complications. Urology.
2006; 68:549-553.
5. Botteman et al. Clinical model of lifetime costs of treating
bladder cancer: a comprehensive review of the published literature.
Pharmacoeconomics. 2003; 21:315-1330.
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SOURCE Photocure