Photocure and Richard Wolf Enter into Agreement to Develop a High-Definition Flexible Blue Light Cystoscope for Global Commercialization

15 Jul 2024 17:52 CEST

Oslo, Norway, July 15, 2024: Photocure ASA (OSE: PHO), the Bladder Cancer
Company, today announces that it has entered into a strategic agreement with
Richard Wolf GmbH to develop and commercialize a next-generation 4K LED high
-definition (HD) reusable flexible blue light cystoscope based on Richard Wolf's
System blue technology. The partnership between Photocure and Richard Wolf is
focused on developing technologically advanced flexible blue light cystoscopy
(BLC[®]) equipment for the global market so that physicians who treat patients
with bladder cancer can offer the benefits of BLC with Hexvix[®] / Cysview[®] in
an outpatient, or surveillance setting.

Under the Agreement, Richard Wolf will develop the new flexible BLC system with
input and guidance from Photocure, tapping into Photocure's extensive knowledge
of the surveillance procedure and the Company's experience with urology
customers. The new flexible blue light system and underlying intellectual
property will be owned by Richard Wolf, who will also serve as the sponsor of
market authorizations around the world. Photocure and Richard Wolf will share
expenses for the development and regulatory activities necessary for approvals
of the HD flexible blue light system in markets where it will be commercialized.

The strategic partnership between Photocure and Richard Wolf builds off a
longstanding relationship between the two companies associated with co
-promotion, disease awareness, education, market development, and clinical
research. Photocure and Richard Wolf will co-promote the new blue light flexible
system in the U.S., Europe and other countries globally.

Photocure will leverage its existing sales organization to promote the new
reusable flex system in North America and Europe, and will rely on Richard Wolf
distributors or commercial partners to co-promote the device in other markets.
Additionally, Photocure will utilize data from existing patient registries to
leverage real-world evidence to further support the benefits of flexible blue
light cystoscopy for patients with non-muscle invasive bladder cancer. Per the
agreement, Photocure and Richard Wolf will establish two governance committees
to oversee progress of the collaboration including a Joint Development Committee
to ensure R&D milestones are successfully achieved and a Joint Commercialization
Committee to execute pre- and post-approval go-to-market strategies globally.

New flexible BLC equipment has not been available for purchase since early 2023
in the U.S., as prior systems were outdated and discontinued by the
manufacturer. As a leading company focused on the management of bladder cancer,
Photocure is dedicated to ensuring that BLC with Hexvix/Cysview is available to
physicians worldwide in both the surgical and surveillance settings so that
patients with bladder cancer can have access to the best care.

"Entering into this partnership with Richard Wolf is a milestone for Photocure,
and more importantly is the first step toward making high-definition BLC
equipment in the surveillance setting consistently available for patients
globally," said Dan Schneider, President and CEO of Photocure. "Before the phase
-down of standard-definition flexible blue light equipment in the U.S., adoption
of these systems was on a strong growth path with physicians recognizing the
significant benefits of precision monitoring of bladder tumors with BLC and
Cysview. We look forward to working with Richard Wolf on the development and
anticipated commercialization of a 4K high-definition blue light cystoscope, and
bringing a cutting edge and cost-effective solution to physicians and patients
in our commercial territories as soon as possible."

"As a full-service provider in endoscopy and a leading manufacturer of blue
light cystoscopy equipment, we are very pleased to enter into this Agreement
with Photocure, to develop and commercialize a first-in-class/best-in-class high
-definition flexible blue light system," said Florian Happe, Vice President R&D
at Richard Wolf. "The workmanship that goes into every Richard Wolf device
provides the foundation for exceptional precision and longevity in the clinical
setting, enabling our institutional and physician customers to deliver
excellence in care to their patients. Surveillance of patients with bladder
cancer is of critical importance in disease management, and we believe that a
high-definition blue light cystoscope designed for out-patient use has potential
to set a new standard in this care setting."

Note to editors:

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About Bladder Cancer
Bladder cancer ranks as the 8th most common cancer worldwide - the 5th most
common in men - with 1949 000 prevalent cases (5-year prevalence rate)1a, 614000
new cases and more than 220000 deaths in 2022.1b
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 [February 2024].

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

About Richard Wolf
Richard Wolf GmbH is a medium-sized medical technology company with over 1,800
employees, along with eighteen subsidiaries and 130 foreign agencies worldwide.
The company develops, produces, and distributes numerous products for endoscopy
and extracorporeal shock wave treatment in human medicine. Integrated operating
room systems round out the product range.

For further information, please contact:

Dan Schneider
President and CEO
Photocure ASA
Email: ds@photocure.com

Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: ed@photocure.com

David Moskowitz
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: david.moskowitz@photocure.com

Media and IR enquiries:

Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no

More information:
Access the news on Oslo Bors NewsWeb site

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