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software with blue light cystoscopy (BLC[®]). Initial testing shows promising
performance results.
Photocure and ISC have signed a development agreement on AI software and BLC for
the detection of bladder tumors. Photocure is a pioneer in the bladder cancer
diagnostics market with its Hexvix[®]/Cysview[®] products, supported by robust
clinical evidence and treatment guidelines. ISC, based in the U.S., is a
subsidiary of Claritas HealthTech Limited, based in the UK. Claritas and its
affiliates, together with ISC, develop leading endoscopy solutions that ISC
commercializes.
In the current development phase, Photocure and ISC are collaborating to develop
an AI software which can support the physician in real-time during blue light
cystoscopy, improving early-stage bladder cancer detection, diagnosis, and
resection completeness. The initial testing results were based on approximately
200 blue light procedures with more than 80,000 images. These results support
the benefits of AI enabled blue light cystoscopy by detecting high risk
cancerous lesions earlier in the patient pathway and more accurately.
Photocure will support the development collaboration through an initial clinical
study, with the aim to collect blue light videos and images from bladder cancer
patients, at multiple sites in the U.S. and Europe, to train the blue light AI
software. Details of the study (ENAiBLE) can be found on clinicaltrials.gov
(https://clinicaltrials.gov/study/NCT07144319).
Upon completion of the development, Photocure and ISC intend to pursue FDA
clearance for the AI software compatible with any blue light cystoscope system.
Regulatory clearances will be pursued in parallel across Europe and other
markets. The next milestone would be the beta-version of the new Blue light AI
detection software within 12-18 months, ahead of regulatory review.
Based on the terms of the agreement, Photocure will have exclusive, perpetual
rights to commercialize the new solution via its direct sales force,
distributors or partners, as well as license to device manufacturers in any
given country upon regulatory clearance.
“Our partnership with ISC is part of Photocure’s strategic focus on advancing
precision diagnostics in uro-oncology. Building on its strong track record and
established credibility in bladder cancer diagnostics, Photocure aims to
leverage leading innovative technologies to grow a portfolio of complementary
diagnostic solutions to address the evolving needs of patients, physicians, and
the broader healthcare community. This initiative underscores Photocure’s
commitment to drive the progress towards more personalized and data-driven
management in uro-oncology, enabling better clinical outcomes. Recent
publications indicate that the global AI cancer diagnostic market is
experiencing significant growth due to the rising prevalence of cancer,
increasing demand for precision diagnostics to increase accuracy, and a growing
awareness for the importance of early and more precise diagnosis. BLC has become
the reference point for next-generation cystoscopy technologies - it is not just
enhancing what we see, but also redefining what is possible in detecting
previously easy to miss but aggressive disease. We envision that ISC’s AI
technology will support transforming diagnostic approaches using BLC and will
create a strategic shift towards integrated precision medicine,” said Dan
Schneider, President and CEO of Photocure.
Dr. Rajesh Nair, Urological Surgeon at Guy’s and St. Thomas’, UK, and Chief
Medical Officer at ISC, commented, “As a practicing bladder cancer surgeon,
where I regularly face the challenge of accurate detection and complete
resection of tumors, I am excited about the prospect of a new solution that
combines ISC’s proven track record in state-of-the-art AI solutions for
cystoscopy with the detection capabilities of blue light cystoscopy that
Photocure provides. With the evidenced improvement in accuracy achieved with
ISC’s existing AI technology for bladder tumor detection, the application of its
cutting-edge technology together with the enhanced detection capability of blue
light cystoscopy from Photocure marks a significant leap forward in bladder
cancer diagnostics with the potential to transform bladder cancer management,
significantly enhancing patient care and outcomes.”
“The integration of AI will ensure BLC continues to out-perform white light
cystoscopy, as initial performance data indicate blue light AI has the potential
to detect more tumors, especially high-grade flat carcinoma in situ (CIS)
lesions, than white light AI. However, assisting urologists in the detection of
tumors with AI-enhanced blue light cystoscopy is just a first development step.
We also intend to explore the blue light AI software to assist with real-time
tumor characterization and mapping of CIS lesions for enhancing risk
stratification and precision monitoring. Such additional aims expand the utility
of our technology to further help urologists achieve their bladder cancer
management goals with BLC. These next iterations could drive practice-changing
applications that blue light cystoscopy can uniquely deliver,” said Anders
Neijber, Chief Medical Officer of Photocure.
Note to editors:
All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA.This press release may contain product details and
information which are not valid, or a product 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 1 949 000 prevalent cases (5-year prevalence rate)[1a],
614 000 new cases and more than 220 000 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 Our partners for further information on our
commercial partners.
The following safety information is solely included to comply with U.S.
regulatory requirements: Important Risk & Safety Information for Cysview[®]
(hexaminolevulinate HCl) (https://packageinsert.s3.us-east
-2.amazonaws.com/Cysview+PI+2020.pdf)
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
w (http://www.photocure.com/news)ww.photocure.com/news (http://www.photocure.com/
news).
About Intelligent Scopes Corporation
Intelligent Scopes Corp provides state-of-the-art image processing and
enhancement software medical devices and AI diagnostic tools for the fields of
urology and gastroenterology. The company focuses on the strategic R&D of image
processing, image enhancement, AI diagnostic tools, and robotic guidance systems
for endoscopy procedures to improve detection rates, reduce unnecessary biopsies
and enhance patient outcomes. For more information, please
visit: www.intelligentscopes.com (https://www.globenewswire.com/Tracker?data=-
-hcG4yELYcYewvrcUuxGXcaovuAFGlEFAhCpHPruCc6dpjqPab_Nc8XtiLhZ4_bT5lhXFFH__b6GZumdm
HjdPo7oLcLpshjTcYbicIoGR1-LkdIx4qZ8fNwlX4O4q_A).
About Claritas HealthTech Limited
Claritas conducts research and development in the fields of image enhancement,
machine vision and artificial intelligence (“AI”) with a focus on medical image
processing and AI-assisted interpretation and diagnostics. Claritas aims to
transform the diagnostics industry with powerful and effective software products
created using image enhancement and AI technology, to enable and assist doctors
in medical diagnostics. For more information, please
visit www.claritashealthtech.com (https://www.globenewswire.com/Tracker?data=-
-hcG4yELYcYewvrcUuxGdD5UG9afP_FXPMyAjukXMDlkRgqI4gX4K-xhfgimvw5IWQXxDcBKB
-S_3g3n7morWk8YeoMzs1QG5SOGVcUxEOmpLbvvZ1htt1A4v5qLjSr).
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
Priyam Shah
Vice President Investor Relations
Tel: +17176815072
Email: priyam.shah@photocure.com
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no
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