KARL STORZ Announces New Non-Muscle Invasive Bladder Cancer Detection System: Photodynamic Diagnosis (PDD) Blue Light Flexible Video Cystoscopy   

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EL SEGUNDO, Calif.–(BUSINESS WIRE)–KARL STORZ Endoscopy-America, Inc., announces the commercial launch of
the PDD Blue Light Flexible Video Cystoscopy System for enhanced
detection of non-muscle invasive bladder cancer (NMIBC). This
announcement follows the approval of a supplemental new drug application
and a Premarket Approval supplement from the U.S. Food & Drug
Administration (FDA) extending the indication for Blue Light Cystoscopy
with Cysview® (BLCC) to include use of the new KARL STORZ PDD
Blue Light Flexible Video Cystoscope. Also included in the approval is
an expanded indication for the repetitive use of Cysview within the same
patient and for the identification of Carcinoma in Situ (CIS); one of
the most challenging types of bladder cancers to detect. These new
indications greatly increase the treatment possibilities of this
innovative therapy, which has rapidly become the standard of care for
bladder cancer treatment at major medical institutions across the United
States.


Bladder Cancer affects over 708,444 patients in the US. Treatment is
difficult because NMIBC tumors can look similar to normal healthy
tissue, and can be missed or incompletely removed. Unfortunately,
patients have a high probability of cancer recurrence, and in 2018 it is
estimated that there will be 17,240 patient deaths due to bladder cancer1
KARL STORZ PDD Blue Light Flexible Video Cystoscopy completes the 2-part
system, which also includes Rigid Blue Light Cystoscopy. The flexible
and rigid PDD Blue Light Cystoscopy systems are designed to improve the
visualization and resection of deadly NMIBC tumors. The new flexible
system expands upon the rigid platform, enabling comfortable, anesthesia
free examinations to confirm suspected lesions from a previous
cystoscopy and for ongoing monitoring of NMIBC when used in conjunction
with Cysview® an optical imaging agent manufactured and
distributed in the U.S. by Photocure. Blue Light Cystoscopy with Cysview®
enables cancerous tumors to fluoresce in a bright pink color improving
tumor visibility and enhancing florescence guided resection with the
KARL STORZ UH 400 electrosurgical system.

The FDA approval of KARL STORZ PDD Blue Light Flexible Cystoscopy with
Cysview® (BLFCC) is based on results from a large Phase III
study using the KARL STORZ blue-light-enabled rigid and flexible
cystoscopes and blue light video system. During the Phase III clinical
trial for Blue Light Flexible Cystoscopy, the following significant
clinical findings were documented:2

  • BLFCC significantly improves the detection of patients with recurrence
    of bladder cancer (20.6%, p<0.0001).
  • BLCC significantly improves the detection of patients who recurred
    with CIS (34.6%, p<0.0001).
  • Repeat use of BLCC improves tumor detection in 46.2% of the patients
    and is safe.

“Use of the KARL STORZ PDD system for Blue Light Cystoscopy with Cysview®
procedures continues to offer vital new capabilities to physicians,”
says John Martineau Director Marketing Urology, KARL STORZ
Endoscopy-America, Inc. “It is also the only FDA-approved technology
shown to improve detection of NMIBC tumors, leading to improved and more
comprehensive florescence guided tumor resection. In the 2016 Guidelines
for the management of NMIBC, the American Urological Association and
Society for Urologic Oncology included Blue Light Cystoscopy as
recommended for increasing the detection and reducing recurrence of
NMIBC. We are certain that use of Blue Light Cystoscopy with Cysview®
will be positioned to provide enhanced diagnostic and treatment
capabilities to physicians and support improved outcomes for patients.”

“This expanded approval in both rigid and flexible blue light cystoscopy
(BLC) means that Cysview® can now be used during
transurethral resection of bladder cancer surgery for diagnosis and
staging, as well as with follow-up surveillance of NMIBC. Patients with
NMIBC, especially high grade, require careful and frequent follow-up due
to the high rate of recurrence and progression. Blue light cystoscopy
with Cysview®, will enable physicians to provide appropriate
and more accurate treatment earlier, which in my experience results in
improved outcomes for my patients. In my high-risk NMIBC clinical
practice, I recognize the benefit of using BLC with Cysview®
to more readily detect carcinoma in-situ, i.e. aggressive high-grade
flat lesions. In this study, an additional 35% of CIS patients were
found by using BLC with Cysview® alone and missed with white
light,” says Gary Steinberg, M.D., The Bruce and Beth White Family
Professor, Vice Chairman and Director of Urologic Oncology, University
of Chicago Medicine.

About KARL STORZ

KARL STORZ Endoscopy-America, Inc., is an affiliate of KARL STORZ SE &
Co. KG, an international leader for more than 70 years in reusable
endoscope technology, encompassing all endoscopic specialties. Based in
Tuttlingen, Germany, KARL STORZ SE & 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 Web site at www.karlstorz.com.

About Photocure

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

Cysview® is a registered trademark of Photocure, ASA

1 Cancer Facts and Figures 2017, American Cancer Society:
Cancer Facts & Figure

2 Efficacy and Safety of Blue Light Flexible Cystoscopy with
Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III,
Comparative, Multicenter Study; Sia Daneshmand, M.D., et.al: The Journal
of Urology, ISSN: 1527-3792. Vol: 199. Issue: 5, Page: 1158-1165.

Contacts

KARL STORZ Endoscopy-America, Inc.
Susan Jaffy Marx, 424-218-8701
Marketing
Communications

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