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Photocure and Intelligent Scopes Corporation partner on development of AI for blue light cystoscopy
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.
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,
said Anders Neijber, Chief Medical Officer of Photocure.
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Bladder cancer ranks as the 8 most common cancer worldwide – the 5 most common in men – with 1 949 000 prevalent cases (5-year prevalence rate) , 614 000 new cases and more than 220 000 deaths in 2022.
Approx. 75% of all bladder cancer cases occur in men. It has a high recurrence rate with up to 61% in year one and up to 78% over five years. Bladder cancer has the highest lifetime treatment costs per patient of all cancers.
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.
Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: https://gco.iarc.fr/today, accessed [ February 2024 ].
Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
Sievert KD et al. World J Urol 2009;27:295–300
Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html
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.
The following safety information is solely included to comply with U.S. regulatory requirements: Important Risk & Safety Information for Cysview (hexaminolevulinate HCl)
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/news.
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.
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.
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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