Photocure fundamentale forhold (PHO)

[myk]

Ja ser det men skjønner det ikke for SEB til sammen har mye mer enn 5%. Det må være en konto som er redusert til 4,99%.

[TekBot]

Photocure Partner Asieris announces 1[st] Patient enrolled in Hexvix Phase III trial in China

Press Release - Oslo, Norway, November 4, 2022: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:
688176) has communicated today on the treatment of the first patient in the
…

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Hexvix[®] phase III bridging trial.

The objective of the multicenter Phase III trial is to achieve regulatory
approval of Hexvix in Mainland China for use in patients with bladder cancer, by
investigating the detection rate and safety of Hexvix and blue light cystoscopy
(BLC[®]) versus white light cystoscopy in patients with non-muscle invasive
bladder cancer (NMIBC). The bridging trial is intended to confirm results from
prior clinical trials in a Chinese population. The clinical trial protocol
follows the protocols for registration studies in countries where Hexvix already
has market authorization. This study will be led by Peking Union Medical College
Hospital and the Chinese Academy of Medical Sciences.

In January 2021, Asieris entered into a license agreement with Photocure ASA to
obtain the exclusive registration and commercialization rights of Hexvix in
mainland China and Taiwan.

On December 26, 2021, Hexvix obtained initial clinical use in the Boao Lecheng
International Medical Tourism Pilot Zone in Hainan Province, when the first
patient received blue light cystoscopy with Hexvix at the Hainan General
Hospital. The phase III clinical trial obtained approval from the National
Medical Products Administration (NMPA) in the first quarter of 2022 and Hexvix
was subsequently included in the real-world clinical data pilot program.

Read Asieris’ full media release here: https://asieris.com/hexvix-a-diagnostic
-drug-for-bladder-cancer-of-asieris-completed-the-first-patient-dose-in-phase
-iii-trial/

The trial is registered here: Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer - Full Text View - ClinicalTrials.gov

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 1 720 000 prevalent cases (5-year prevalence rate)[1a],
573 000 new cases and more than 200 000 deaths in 2020.[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: Global Cancer Observatory, accessed [January 2022].
[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. Bladder Cancer

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.

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

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

Kilde

[TekBot]

Photocure: CMS improves Medicare reimbursement for Blue Light Cystoscopy with Cysview and expands access in the surveillance setting

Oslo, Norway, November 7, 2022: Photocure ASA., (OSE: PHO), announces that The
United States Centers for Medicare & Medicaid Services (CMS) has released final
payment rates in connection with the recently approved Medicare reimbursement
…

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changes for Blue Light Cystoscopy (BLC[®]) with Cysview[®] in the hospital
outpatient (HOPD) and ambulatory surgical center (ASC) sites of care. The new
complexity adjustments and resulting increase in payment provide an opportunity
to increase BLC usage in outpatient bladder cancer surveillance procedures.

Link to the CMS Rule: https://www.cms.gov/files/document/cy2023-hospital
-outpatient-prospective-payment-system-and-ambulatory-surgical-center-final
-rule.pdf

CMS confirmed that a complexity adjustment will be available for procedures
billed under CPT Code 52000, as well as CPT Code 52204 which were subject to the
adjustment in 2022. The two procedures, if also billed with the A9589 Code for
Cysview[®] and the C9738 Code for the complexity adjustment, will have higher
reimbursement beginning January 1, 2023.

In the HOPD setting, CMS for the first time has made a complexity adjustment for
CPT 52000 (cystoscopy) and will maintain the current adjustment for CPT 52204
(cystoscopy + biopsy). The new Medicare reimbursement changes increase payment
from $587.56 to $1,854.88 for CPT 52000 (cystoscopy) and from $3,140.04 to
$3,205.12 for CPT 52204 (cystoscopy + biopsy) in the HOPD site of care.

Additionally, CMS for the first time has made a complexity adjustment available
for ASC sites of care for both CPT 52000 and CPT 52204. To facilitate this, CMS
has created two new complexity adjustment C codes for BLC to be used in the ASC
place of service (C7554 with CPT 52000 and C7550 with CPT 52204). The changes
will increase payment beginning in January 2023 from $297.97 to $848.03 for CPT
52000 and from $816.76 to $1,496.56 for CPT 52204.

“The effectiveness and benefits of using Blue Light Cystoscopy with Cysview for
improved detection and management of bladder cancer are widely recognized, and
Photocure has long advocated that CMS provide appropriate reimbursement for BLC
treatment” said Dan Schneider, President and Chief Executive Officer of
Photocure ASA. “We are pleased that CMS has expanded the complexity adjustment
for Cysview in the hospital outpatient setting and will implement a complexity
adjustment for the first time in the ASC site of care. The improved
reimbursement is expected to increase patient access to blue light cystoscopy in
the surveillance setting.”

Note to editors

Hexvix[®]/Cysview[®] and BLC[®] are registered trademarks of Photocure ASA.

This press release may contain product details and information which are not
valid, or a product that 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 1 720 000 prevalent cases (5-year prevalence rate)[1a],
573 000 new cases and more than 200 000 deaths annually in 2020.[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 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 [January 2022].
[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. Bladder Cancer

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.

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

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

Kilde

[TekBot]

Major shareholder disclosure

Please see attachment on www.newsweb.no
…

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Kilde

[Bingo123]

SEB over 5% igjen.

[Tekspert]

Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

1. @Rodjer (79 likes)

@Rodjer

Ny klinikk på Cysview

2. @Snoeffelen (62 likes)

@Snoeffelen

Strålende refusjonsmelding på morgenkvisten da.

3. @Hayen (59 likes)

[quote=“Hayen, post:6944, topic:18877”]

@myk

Resten av topp 10:

4. @myk (54 likes)

5. @Savepig (54 likes)

6. @rosk82 (38 likes)

7. @kreinh (36 likes)

8. @solskimm (28 likes)

9. @nordpolen (20 likes)

10. @Meisen (12 likes)

Gratulerer!

[TekBot]

New Evidence: Positive Impact of Blue Light Cystoscopy on Recurrence in Bladder Cancer Presented at the Annual SUO Meeting

Press release - Oslo, Norway, December 5th, 2022: Photocure ASA, The Bladder
Cancer Company, announces that new evidence was presented at the 22[nd] Annual
Society of Urologic Oncology (SUO) Meeting demonstrating that Blue Light
…

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Cystoscopy (BLC[®]) decreases the risk and prolongs time to recurrence based on
Real World Evidence from the U.S. multi-institutional Blue Light Cystoscopy with
Cysview[®] Registry database.

This large, prospective, longitudinal, multisite registry collects data on
NMIBC* patients who have undergone transurethral resection of bladder tumor
(TURBT) using Blue Light as an adjunct to white light cystoscopy (WLC). The new
data represent an interim analysis of the study, which is projected to enroll
4,400 patients in total. In this study, all registry patients analyzed (n=2055)
received Blue Light. They were directly compared to a historical White-Light
(WL)-only control group (n=261) of similar age, stage, grade, and clinical
management (i.e., intravesical therapy).

Kaplan-Meier curves demonstrate recurrence-free survival (RFS) for BLC patients
compared to a WL-only arm with a mean follow up of 27.4 months for BLC and 53
months for the historical WL control arm. The overall risk of recurrence was
significantly lower following BLC compared to WLC alone (Hazard Ratio (HR) 0.33;
95% Confidence Interval (CI) 0.28-0.40, p-value=0<.0001). Authors indicate that
the lower incidence of recurrence in the BLC arm were durable, as rates tracked
over 5 years consistently out-performed WLC in the historical control group.

The data were presented at the Annual Meeting of the Society of Urologic
Oncology meeting held November 30 - December 2, 2022, in San Diego, USA. The SUO
is a congress led by internationally renowned urologic oncologists, medical
oncologists, and scientists on topics of genitourinary medicine such as bladder,
kidney, and prostate cancer. This year, Photocure has continued to partner with
KARL STORZ with a joint exhibit featuring the new blue light SAPHIRAT system, as
well as information on flexible blue light.

“These real-world data from our U.S. Cysview Registry emphasize that better
tumor detection and more complete resection using BLC can translate into more
favorable long-term patient outcomes,” said Geoff Coy Vice President and General
Manager, North America. “Interest in integrating BLC into the management of
bladder cancer is high among practicing urologists, and many stopped by the
exhibit at SUO to see the SAPHIRA demonstration unit on display and get hands-on
experience with the upgraded system for TURBT procedures. SAPHIRA became
commercially available in late September 2022, and we believe that the new
system is helping to expand the use of BLC so that more patients diagnosed with
bladder cancer have access to the benefits of enhanced cystoscopy.”

Read the abstract here: https://suo-abstracts.secure
-platform.com/a/gallery/rounds/15/details/2721

*NMIBC: non-muscle-invasive bladder cancer

Note to editors

Hexvix[®]/Cysview[®] and BLC[®] are registered trademarks of Photocure ASA.
SaphiraT is a registered trademark of KARL STORZ Endoscopy.

This press release may contain product details and information which are not
valid, or a product that 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 1 720 000 prevalent cases (5-year prevalence rate)[1a],
573 000 new cases and more than 200 000 deaths annually in 2020.[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 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 [January 2022].
[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. Bladder Cancer

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.

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

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

Kilde

[kreinh]

Oslo, Norway, 5th December 2022, Photocure ASA (OSE: PHO), The Bladder Cancer Company, announces its participation in the 7th Annual Nordic American Life Science Conference and in the DNB 13th Annual Healthcare conference in December 2022

https://photocure.com/news/photocure-to-participate-in-the-nalsc-and-dnb-healthcare-conferences-in-december-96

[TekBot]

Major shareholder disclosure in Photocure ASA

Please see attachment on www.newsweb.no
…

Vis børsmeldingen

Kilde

[kreinh]

https://photocure.com/news/photocure-partner-asieris-announces-first-patient-treated-in-hexvix-real-world-evidence-study-in-hainan-china-97

[kreinh]

https://photocure.com/news/bladder-cancer-new-meta-analysis-98

Bladder Cancer: New Meta-analysis

Oslo, Norway, December 15, 2022: Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that a new meta-analysis was published earlier this month in “Photodiagnosis and Photodynamic Therapy”. The Analysis entitled “Comparison of hexaminolevulinate (HAL)-guided versus white light transurethral resection for NMIBC: A systematic review and meta-analysis of randomized controlled trial” evaluated recurrence, recurrence-free survival and progression.

Several Meta-analyses prior to the present one included studies and trials on HAL and 5-ALA. (See Cochrane Analysis from December 2021: New Cochrane review on blue versus white light for transurethral resection of non-muscle invasive bladder cancer confirms beneficial effect of using blue light on risk of disease recurrence and progression). The new meta-analysis features HAL studies only, includes 2,775 patients and looks at both short and long-term outcomes. The analysis shows favorable outcomes on recurrence, recurrence free survival and progression for blue light (HAL-guided) cystoscopy compared to white light cystoscopy.

[Tekspert]

Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

1. @Rodjer (78 likes)

@Rodjer

Såvidt jeg kan se er det oppført en klinikk til på Cysview i løpet av helgen.

2. @Snoeffelen (57 likes)

@Snoeffelen

Skikkelig sterke resultater på Cysview Registry study da!

3. @Hayen (53 likes)

[quote=“Hayen, post:6944, topic:18877”]

@myk

Resten av topp 10:

4. @kreinh (40 likes)

5. @myk (39 likes)

6. @Savepig (36 likes)

7. @TheLion (31 likes)

8. @rosk82 (14 likes)

9. @Meisen (14 likes)

10. @Legoland (13 likes)

Gratulerer!

[TekBot]

New study publication reinforces the clinical benefits of Blue Light Cystoscopy in the ASC setting; supports ongoing initiatives to further improve reimbursement

Press release - Oslo, Norway, January 3, 2023: Photocure ASA, The Bladder Cancer
Company, announces the publication of the study "Clinical and Economic Impact of
Blue Light Cystoscopy in the Management of NMIBC* at U.S. Ambulatory Surgical
…

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Centers: What is the Site-of-Service Disparity?" in Urologic Oncology this week.
The research objective was to quantify the clinical and economic impact of the
incorporation of BLC in the management of NMIBC in ambulatory surgical centers
(ASCs) considering 2022 Center for Medicare Services (CMS) patient-physician
coverage and reimbursement.

The study authors Neal Shore**, MD, FACS and Meghan B. Gavaghan, MPH, built a
budget impact model to assess projected ASC costs for a cohort of newly
diagnosed bladder cancer patients over a 2-year follow-up comparing white light
cystoscopy (WLC) alone versus WLC + blue light cystoscopy (BLC[®]). Treatment
and surveillance intervals were based on AUA/SUO clinical guidelines. Clinical
and cost metrics for staging and biopsy rates were assessed, with cost inputs
based on Medicare reimbursement rates. Photocure supported this research with an
unrestricted grant.

In the U.S., BLC for NMIBC surveillance in the ASC setting involves a flexible
cystoscopy, an outpatient procedure without need of general anesthesia, allowing
additional OR time for other hospital procedures. In the published clinical and
health economic model, use of BLC resulted in the identification of 5 additional
NMIBC recurrences compared to white light cystoscopy alone. There was an
associated increased cost of performing BLC in an ASC setting, with a net
increase in the total cost of care for NMIBC of $110 per cystoscopy over a two
-year period. If recurrences missed using WLC alone were to progress prior to
detection, the model projects an increase in treatment costs borne by Medicare
of $9,097-$34,538 due to more intensive treatments required for more advanced
disease.

The authors conclude that due to the modeled results, “the Medicare program will
incur increased costs. . The current discrepancy in reimbursement
disincentivizing community-based ASCs from adopting BLC, resulting in suboptimal
patient care while increasing downstream treatment costs to Medicare,
necessitated when missed disease progresses to higher stage/grade disease. The
findings have important clinical implications for the optimal management of
NMIBC and should inform healthcare policies that promote cost-effectiveness and
enhanced patient outcomes.”

“The findings of this paper highlight the benefits of BLC when patients receive
this option for bladder cancer care in ambulatory surgery centers,” said Dan
Schneider, President and Chief Executive Officer of Photocure ASA. “The paper
also reinforces the need for fair and equitable reimbursement in all sites of
care, with Medicare payment rates increasing in January 2023, but favoring use
of blue light in hospital outpatient departments (HOPDs) over ASCs. While we are
pleased with the historic step by CMS to provide higher payment rates in both
settings, feedback from ASC accounts is that payment would need to be increased
further before patients treated in this site of care will be offered broad
access to BLC. As a result, Photocure will continue to partner with the medical
community to advocate for improved Medicare coverage in the ASC setting.”

Read the full article here:
https://authors.elsevier.com/a/1gI7K3r93nVECK (https://nam11.safelinks.protection
.outlook.com/?url=https%3A%2F%2Fauthors.elsevier.com%2Fa%2F1gI7K3r93nVECK&data=05
%7C01%7Cnshore%40auclinics.com%7C2a1b7f370ab0456f67b908dae3dff903%7Ca885f43f85834
92598d934669fbf0f77%7C0%7C0%7C638072848351177176%7CUnknown%7CTWFpbGZsb3d8eyJWIjoi
MC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=
cydEsyCu8Z6U50uV7TTCYZhlBkan6xi0oXXtrSW9C%2Fo%3D&reserved=0)

*NMIBC: Non-muscle invasive bladder cancer

**Dr. Shore is Medical Director for the Carolina Urologic Research Center and is
a Fellow of the American College of Surgeons. He joined Photocure’s Board of
Directors in May 2022.

Note to editors

Hexvix[®]/Cysview[®] and BLC[®] are registered trademarks of Photocure ASA.

This press release may contain product details and information which are not
valid, or a product that 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 1 720 000 prevalent cases (5-year prevalence rate)[1a],
573 000 new cases and more than 200 000 deaths annually in 2020.[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 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 [January 2022].
[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. Bladder Cancer

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.

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

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

Kilde

[Tekspert]

Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

1. @Rodjer (94 likes)

@Rodjer

2 nye klinikker lagt til i ettermiddag.

2. @Hayen (82 likes)

[quote=“Hayen, post:7211, topic:18877”]

@Hayen

3. @myk (40 likes)

@myk

Det viktige er at sykehusene og clinikene tjener på å bruke BLC og ikke som nå at de taper penger.

Resten av topp 10:

4. @kreinh (40 likes)

5. @TheLion (39 likes)

6. @Snoeffelen (34 likes)

7. @Legoland (15 likes)

8. @Savepig (15 likes)

9. @Sponplate (9 likes)

10. @Syvcys (9 likes)

Gratulerer!

[Quadruple]

Moving towards sustainably positive EBITDA

We expect a solid top line growth and a positive EBITDA in the 4Q report to be presented next week. However, we keep our Hold recommendation unchanged at a bit higher TP of NOK 120/sh (110), as we see that much is priced in post the recent share price rebound and the company is yet to report more growth in top line figures that are included in our model.

Solid growth and positive EBITDA expected for 4Q

Photocure will release its 4Q22 report on February 23rd. We estimate revenues of NOK 112m, which represents a rather solid 19% YoY growth (15% up QoQ post rather weak 3Q). This should help to bring EBITDA to a positive territory, and we estimate it to land at NOK 3m. The bottom line, however, should still be in red, as net financial items have a strong impact.

(Norne idag)

[TekBot]

Photocure ASA: Invitation to presentation of 4th quarter and preliminary full year 2022 financial results

Oslo, Norway, 16 February 2023: Photocure ASA (Photocure, PHO: OSE) will
announce the fourth quarter and preliminary full year 2022 financial results on
Thursday 23 February 2023 at 08:00 CET and will present a live webcast at 14:00
…

Vis børsmeldingen

CET the same day.

The quarterly report and presentation will be published at 08:00 CET and will be
publicly available at www.photocure.com.

The investor presentation will be streamed live and be hosted by Daniel
Schneider, CEO and Erik Dahl, CFO. The presentation will be held in English and
questions can be submitted throughout the event. The presentation is scheduled
to conclude at 14:45 CET.

The streaming event is available through
https://channel.royalcast.com/landingpage/hegnarmedia/20230223_8/.

For further information, please contact:

Photocure
Erik Dahl
CFO
Tel: +47 45055000
Email: ed@photocure.com

David Moskowitz
Vice President, Investor Relations
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

About Photocure
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

This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.

Kilde

[TekBot]

Clinical data presented at ASCO GU demonstrates reduced risk of recurrence in non-muscle invasive bladder cancer with the use of BLC

Press release - Oslo, Norway, February 20, 2023: Photocure ASA, The Bladder
Cancer Company, announces the presentation of clinical data from the Veterans
Affairs (VA) BRAVO study at the ASCO Genitourinary Cancers Symposium (ASCO GU)
…

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which was held February 16-18, 2023 in San Francisco, USA. The clinical data
demonstrated a significant decrease in the risk of recurrence & longer time to
recurrence following Blue Light cystoscopy (BLC[®]) with Cysview[®] compared to
White Light cystoscopy (WLC) alone.

ASCO GU is a meeting of up to 5 000 healthcare professionals focused on
genitourinary cancers, offering the latest information on scientific advances in
the study, diagnosis and treatment of GU malignancies. The program is known for
being highly interactive with multidisciplinary perspectives and attracts a
global audience. Presentations include the latest science and evidence-based
information on optimal patient care.

Dr. Steven Williams, University of Texas-Medical Branch, Galveston, presented
the study abstract “The Impact of Blue Light Cystoscopy Use Among Non-Muscle
Invasive Bladder Cancer Patients in an Equal Access Setting: Implications on
Recurrence and Time to Recurrence Stratified by Race”.

The study was conducted with support from Photocure and aims to describe bladder
cancer outcomes and the impact of blue light cystoscopy (BLC®) with Cysview®
among non-muscle invasive bladder cancer (NMIBC) patients in an equal access
setting, i.e., the United States Veterans Affairs Healthcare System (VA).
Patients diagnosed with NMIBC within the VA who received BLC were assessed to
determine overall recurrence rates as well as the association between race and
recurrence, progression, and overall survival outcomes.

A total of 378 patients were included in the analysis, of which 43 (11%) were
African American and 300 (79%) were Caucasian. The results showed that the
median time to first recurrence following BLC vs. WLC was significantly longer
overall (40 vs. 26 months, p<0.001) and across all time points, respectively, in
the cohort. A significant decrease in risk of recurrence following BLC
utilization compared to WLC alone was also determined (HR, 0.70, p=0.005). With
regard to race stratification, the analysis showed no significant difference
between African American and Caucasian patients for recurrence, progression and
overall survival.

“Our findings demonstrate increased support for blue light cystoscopy’s clinical
role in reducing bladder cancer recurrence, and that equal access to health care
can achieve equitable outcomes. These data support current AUA/SUO guidelines
recommending BLC usage in patients with NMIBC to increase detection and decrease
recurrence.” said Dr. Steven Williams, Professor and Chief of the Division of
Urology, at the University of Texas-Medical Branch, and one of the study
authors.

*Read about the abstract: https://meetings.asco.org/abstracts
-presentations/216732

Note to editors

Hexvix[®]/Cysview[®] and BLC[®] are registered trademarks of Photocure ASA.
This press release may contain product details and information which are not
valid, or a product that 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 8th most common cancer worldwide - the 5th most
common in men - with 1 720 000 prevalent cases (5-year prevalence rate)[1a], 573
000 new cases and more than 200 000 deaths annually in 2020.[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 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 [January 2022].
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.

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

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

Kilde

[CanonBoy]

@TekBot

the United States Veterans Affairs Healthcare System (VA)

Denne var veldig positivt for Pho.
Mener VA satte opp denne studien for noen år siden nettopp for å kartlegge hvilken løsning de skulle velge for sine sykehus/klinikker når det gjelder fremtidig behandling av NMIBC pasienter.

Dette kan fort bety at VA snart vil kunne standardisere behandlingen rundt BLC. Om så blir utfallet vil BLC virkelig kunne skyte fart i US, og andre vil følge etter.
BLC som SoC har aldri vært nærmere. Spent på hva DS sier om dette på Q4.

[TekBot]

Photocure ASA: Results for the fourth quarter of 2022

Oslo, Norway, 23 February 2023 Photocure ASA (OSE:PHO) today reported
Hexvix[®]/Cysview[®] revenues of NOK 94.9 million in the fourth quarter of 2022
(Q4 2021: NOK 94.2 million), and an EBITDA of minus NOK 16.9 million (NOK -5.5
…

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million). The total revenues increased 10% to NOK 104.2 million and there were
57 blue light towers placed in the quarter, a record high for expanding the
installed base of blue light cystoscopes. Photocure expects to deliver new
SaphiraT blue light tower installations in the range of 65 to 75, consolidated
product revenue growth above 20%, and positive EBITDA (ex-business development
spending) in 2023.

“The fourth quarter of 2022 was highlighted by a record number of Saphira tower
installations in the U.S., demonstrating ongoing high demand for blue light
capital equipment and serving as a leading indicator of the growth opportunity
ahead for Hexvix/Cysview. The fourth quarter also had its challenges as did the
full year of 2022, including a multi-quarter delay in the launch of Saphira,
healthcare worker staffing shortages which pressured urology procedure volumes,
and hospital budget tightening as staffing shortages exacerbated broader
inflationary pressures,” says Dan Schneider, President & Chief Executive
Officer of Photocure.

Photocure reported total group revenues of NOK 104.2 million in the fourth
quarter of 2022 (NOK 94.5 million), and an EBITDA* of minus NOK 16.9 million
(NOK -5.5 million). The Hexvix/Cysview revenues ended at NOK 94.9 million in the
quarter (Q4 2021: NOK 94.2 million). The EBIT was NOK -23.1 million (NOK -11.5
million) and the cash balance at the end of the third quarter 2022 was NOK 268.1
million.

“I am proud of our commercial team’s ability to facilitate the placement of the
highest number of towers ever recorded by Photocure in a single quarter, 57
installations of BLC towers. The logistics of placing this many systems in one
quarter, with most new account installations occurring toward the end of Q4,
required our commercial team to commit the majority of their time and focus on
customer relations and training. Even with the unprecedented number of new
Saphira and flexible BLC installations in the fourth quarter, the demand for
blue light capital equipment remains strong,” Schneider adds.

During the quarter, 31 new blue light towers were installed; 24 new SaphiraT
cystoscopes and 7 flexible units. In addition, 26 OPP towers were installed
during the fourth quarter. The installed base of blue light cystoscopes in the
U.S. was 370 (311) at the end of the fourth quarter, a 19% increase from the
same period last year. This includes 69 flexible cystoscopes, an increase of
44%.

“We expect to deliver Hexvix/Cysview revenue growth of 20%+ and generate
positive EBITDA excluding business development spending in 2023, given the large
number of new accounts that have recently activated blue light equipment in
their facility, as well as the strong pipeline for anticipated SaphiraT tower
installations. We are already seeing signs of positive sales trends in our North
American business in early 2023, and in Europe, German hospital ordering
patterns appear to be phasing back to normalized growth,” Schneider continues.

After the closing of the quarter, Karl Storz informed Photocure of supply issues
with components of its flexible BLC capital equipment that has paused sales of
new flexible towers. Photocure and Karl Storz are in the process of assessing
the issues and evaluating options to restore equipment availability. Photocure
plans to provide an update on the situation as progress is made on the multiple
strategies that it is undertaking to resolve the issue.

“While it is unfortunate that Karl Storz is not expected to ship additional
flexible BLC equipment for some time, we expect that the higher Medicare
reimbursement rates for blue light surveillance procedures will help us increase
the throughput on existing flexible towers. Given these new circumstances, we
will now focus on marketing Saphira rigid towers to ASC clinics so they can
treat patients in their facilities with positive economics,” Schneider says and
concludes:

“In 2022, we encountered a series of external business challenges but were able
to navigate through and make progress in broadening the access and use of blue
light cystoscopy. We generated positive sales growth for the year, successfully
worked with Karl Storz to execute a major capital equipment launch after several
quarters of delay and strengthened our European commercial readiness for a
normalized healthcare delivery environment. With account access now open in our
major markets, the Saphira system now in position to create critical mass, and
the potential for reclassification of blue light capital equipment in the U.S.
market, we believe that 2023 will be an exciting year for Photocure.”

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and
reconciled to the IFRS financial statements as a part of the APM section of the
fourth quarter 2022 financial report on page 22.

The quarterly report and presentation will be published at 08:00 CEST and will
be publicly available at www.photocure.com. Dan Schneider, CEO and Erik Dahl,
CFO, will host a live webcast at 14:00 CEST.

The presentation will be held in English and questions can be submitted
throughout the event. The streaming event is available through
https://channel.royalcast.com/landingpage/hegnarmedia/20230223_8/

The presentation is scheduled to conclude at 14:45 CEST.

For further information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Tel: + 1-609 759-6515
Email: ds@photocure.com

Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no

David Moskowitz
Vice President of Investor Relations
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

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

All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA.

This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to section 5-12 of the Norwegian Securities Trading Act. This stock exchange
announcement was published by Tolv Hillestad, Group Controller, Photocure ASA,
on 23 February 2023 at 08:00 CEST.

Kilde

[TekBot]

Photocure ASA – Major shareholding disclosure

On 23 February 2023, Briarwood Chase Management LLC, via a private investment fund under its management, sold 302,599 shares in Photocure ASA. Following this, Briarwood Chase Management LLC controls 3,858,039 shares in Photocure ASA, corresponding to 14.23% of the company’s outstanding share capital and voting rights. The shares in Photocure ASA are held through a private investment fund which is managed by Briarwood Chase Management LLC, whose Managing Member is Aalap Mahadevia.

This notification is made public pursuant to section 4-2 of the Norwegian Securities Trading Act.
…

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Kilde