Photocure ASA将收购 Vesica Health Inc.，巩固其在膀胱癌诊断领域的领导地位-动脉网

Photocure ASA to Acquire Vesica Health Inc., Strengthening Leadership in Bladder Cancer Diagnostics

CISION 等信源发布 2026-06-04 23:49

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OSLO, Norway

挪威奥斯陆

，

June 4, 2026

/PRNewswire/ --

/美通社/ --

Photocure ASA

(OSE: PHO)

（OSE：PHO）

, a leader in bladder cancer diagnostics, today announced the signing and successful completion of its acquisition of Vesica Health, a U.S. established precision diagnostics company advancing AssureMDx, a urine-based molecular test for the early detection of bladder cancer, in a transaction designed to expand Photocure's position across the bladder cancer care continuum..

，膀胱癌诊断领域的领导者，今日宣布签署并成功完成对美国精准诊断公司Vesica Health的收购。Vesica Health致力于推进AssureMDx——一种用于早期检测膀胱癌的尿液分子检测技术。此次交易旨在扩大Photocure在膀胱癌全程诊疗服务领域的市场地位。

Transaction Highlights

交易摘要

USD 30.5M in total cash + stock transaction

总计3050万美元的现金加股票交易

Of which USD 3.0M equity investment made during Q1 2026.

其中300万美元的股权投资于2026年第一季度完成。

Net consideration of approx. USD 28.5M accounting for USD 2M of cash in Vesica Health

净对价约为2,850万美元，已计入Vesica Health的200万美元现金

USD 13.75M due at close, comprised of USD 11.0M cash and USD 2.75M in Photocure equity.

1,375万美元于交割时支付，包括1,100万美元现金和275万美元Photocure股权。

USD 13.75M due based on two future milestones related to Medicare reimbursement, comprised of USD 5.5M cash and USD 8.25M in Photocure equity.

基于与医疗保险报销相关的两项未来里程碑，应付金额为1,375万美元，包括550万美元现金和825万美元的Photocure股权。

Advanced Diagnostic Laboratory Test (ADLT) milestone - USD 2.75M of Photocure Equity if company achieves ADLT status designation on or prior to 1 October 2026 (if this is not achieved by that date, the USD 2.75M roll into the second milestone).

高级诊断实验室检测（ADLT）里程碑——若公司在2026年10月1日或之前获得ADLT资格认定，将获得价值275万美元的Photocure股权（若在该日期前未达成，则这275万美元将并入第二个里程碑）。

Centers for Medicare and Medicaid Services (CMS) milestone - USD 5.5M of cash and USD 5.5M of Photocure equity if Vesica Health is awarded CMS reimbursement prior to end of December 2029 (assuming the ADLT milestone rolls, then the full milestone is USD 5.5M in cash and USD 8.25M in Photocure Equity)..

美国医疗保险和医疗补助服务中心（CMS）里程碑：若Vesica Health在2029年12月底之前获得CMS报销批准，将获得550万美元现金及价值550万美元的Photocure股权（假设ADLT里程碑触发，则总里程碑奖励为550万美元现金及价值825万美元的Photocure股权）。

All equity considerations will be based on Volume Weighted Average Price (VWAP) of Photocure on the Oslo Stock Exchange over the 30 trading days prior to Close, which is concurrent with this announcement.

所有股权对价将以本公告发布之日为截止日，此前30个交易日内Photocure在奥斯陆证券交易所的成交量加权平均价（VWAP）为基础确定。

Consideration due at Close will be funded through cash and treasury shares on hand. Consideration due for milestones will be funded with available cash and facilities.

交割时应支付的对价将通过手头现金及库存股支付。里程碑节点应支付的款项将由可用现金及融资额度支付。

The equity consideration due for milestones may, pursuant to the agreement with the sellers, be settled with the issuance of new shares or delivery of treasury shares to the sellers.

根据与卖方达成的协议，因里程碑事件而应付的股权对价可以通过向卖方发行新股或交付库存股的方式进行结算。

There are no financing conditions for the acquisition.

本次收购不设融资条件。

Strategic Rationale

战略依据

The acquisition of Vesica Health adds a complementary noninvasive molecular diagnostic capability to Photocure's precision diagnostics bladder cancer portfolio, extending further reach upstream in the patient evaluation pathway. Vesica Health offers AssureMDx, a multi-omic urine-based biomarker test designed to support risk stratification and identify hematuria patients at increased risk for bladder cancer to improve early detection.

收购Vesica Health为Photocure的精准诊断膀胱癌产品组合增添了互补的无创分子诊断能力，进一步延伸至患者评估路径的上游。Vesica Health提供AssureMDx，这是一种基于尿液的多组学生物标志物检测，旨在支持风险分层，并识别出具有较高膀胱癌风险的血尿患者，以改善早期检测。

AssureMDx integrates six epigenetic and somatic biomarkers to help inform urologic evaluation through a urine-based testing approach..

AssureMDx 整合了六种表观遗传和体细胞生物标志物，通过基于尿液的检测方法为泌尿系统评估提供参考。

Approximately seven million patients in the U.S. present with hematuria annually, highlighting a substantial opportunity to improve patient identification and risk stratification. AssureMDx has been validated in prospective multicenter studies, including a large study of 838 hematuria patients demonstrating 96% sensitivity, 99.7% Negative Predictive Value (NPV), and 0.96 Area Under the Curve (AUC) for bladder cancer detection.

美国每年约有700万患者出现血尿，这凸显出在改善患者识别和风险分层方面存在巨大机会。AssureMDx已在前瞻性多中心研究中得到验证，其中一项包含838名血尿患者的大型研究显示，其在膀胱癌检测方面的敏感性为96%，阴性预测值（NPV）为99.7%，曲线下面积（AUC）为0.96。

The assay was recognized in American Urological Association (AUA) guidelines in September 2025 for the evaluation of microhematuria, received an American Medical Association (AMA) Proprietary Laboratory Analyses (PLA) code effective January 2026, and was granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation (BDD) in February 2026.

该检测于2025年9月被纳入美国泌尿外科学会（AUA）指南，用于微血尿的评估；自2026年1月起获得美国医学会（AMA）专有实验室分析（PLA）代码；并于2026年2月获得美国食品药品监督管理局（FDA）突破性器械认定（BDD）。

As of May 14, 2026, a proposed Medicare ruling may expedite future reimbursement pathway..

截至2026年5月14日，一项拟议的医疗保险裁决可能会加快未来的报销路径。

AssureMDx's commercialization can be significantly accelerated through Photocure's established bladder cancer leadership, commercial infrastructure, urology footprint, and payer relationships. For Photocure, the addition of AssureMDx expands its portfolio with complementary noninvasive and procedural diagnostic technologies across the bladder cancer care pathway.

借助 Photocure 在膀胱癌领域的领先地位、成熟的商业基础设施、泌尿科市场覆盖以及支付方关系，AssureMDx 的商业化进程可显著加速。对于 Photocure 而言，引入 AssureMDx 使其产品组合得以扩展，在膀胱癌诊疗路径中增加了互补的无创及介入诊断技术。

The acquisition also expands Photocure's reach into the large and rapidly growing hematuria evaluation market, supporting earlier patient risk stratification across existing urology call points. In addition, AssureMDx is expected to create meaningful operational and commercial synergies through expanded laboratory capabilities, attractive gross margins, and leverage of Photocure's existing customer relationships and commercial organization..

此次收购还扩大了 Photocure 在规模庞大且快速增长的血尿评估市场中的覆盖范围，支持在现有泌尿科诊疗环节中对患者进行更早的风险分层。此外，AssureMDx 预计将通过扩展实验室能力、提供可观的毛利率，以及利用 Photocure 现有的客户关系和商业组织，创造显著的运营和商业协同效应。

'This transaction represents a significant step forward in our strategy to build a comprehensive bladder cancer platform,'

“此次交易是我们构建全面膀胱癌平台战略的重要一步，”

said Dan Schneider, Chief Executive Officer of Photocure.

Photocure 首席执行官 Dan Schneider 表示。

'We believe that Photocure can expand on progress with Blue Light Cystoscopy by building a portfolio of complementary precision diagnostics to inform physician decision-making and provide value for patients at different stages of the diagnostic pathway. By combining Vesica Health's best-in-class hematuria early detection capabilities with our established diagnostic solution and commercial infrastructure, we are well positioned to accelerate growth and deliver improved outcomes for patients with urological cancers.'.

“我们相信，Photocure 可以通过构建互补的精准诊断产品组合，在蓝光膀胱镜检取得的进展基础上进一步拓展，从而为医生决策提供依据，并为处于诊断路径不同阶段的患者创造价值。通过将 Vesica Health 业界领先的血尿早期检测能力与我们成熟的诊断解决方案及商业化基础设施相结合，我们有望加速增长，并为泌尿系统癌症患者带来更佳的诊疗结果。”

'AssureMDx represents a highly differentiated molecular assay designed to support risk stratification and earlier evaluation of hematuria patients,'

“AssureMDx 是一种高度差异化的分子检测，旨在支持血尿患者的风险分层和早期评估。”

said Christopher Thibodeau, Chief Executive Officer of Vesica Health.

Vesica Health 首席执行官克里斯托弗·蒂博多说。

'Noninvasive genomic testing and blue light cystoscopy are highly complementary technologies within the bladder cancer care continuum, and bringing these approaches together through Photocure's established platform has the potential to accelerate clinical adoption, support more informed clinical decision-making, and expand access to advanced noninvasive bladder cancer diagnostics.'.

“在膀胱癌诊疗全程中，无创基因组检测与蓝光膀胱镜检查是高度互补的技术。通过 Photocure 公司成熟的平台将这两种方法相结合，有望加速临床应用的推广，支持更加明智的临床决策，并扩大先进无创膀胱癌诊断技术的可及性。”

'As the evaluation of hematuria continues to evolve, there remains a significant need for tools that can help identify patients at increased risk for bladder cancer earlier in the diagnostic pathway,'

“随着血尿评估方法的不断演进，在诊断路径的早期阶段识别膀胱癌高风险患者所需的工具仍然具有显著需求。”

said Dr. Sam S. Chang, Professor of Urology and Chief Surgical Officer at Vanderbilt-Ingram Cancer Center.

范德比尔特-英格拉姆癌症中心泌尿学教授兼首席外科官萨姆·S·张博士说。

'The combination of noninvasive molecular testing such as AssureMDx with advanced visualization technologies such as Blue Light Cystoscopy has the potential to support more informed clinical decision-making and improve patient management across the bladder cancer care continuum.'

将AssureMDx等非侵入性分子检测技术与蓝光膀胱镜等先进可视化技术相结合，有望为更明智的临床决策提供支持，并改善膀胱癌全程诊疗中的患者管理。

Business Outlook

业务展望

For full year 2026, Photocure continues to expect product revenue growth in the range of 7% to 11% on a constant currency basis, alongside continued expansion of adjusted EBITDA margins.

对于2026年全年，Photocure公司继续预计，在恒定汇率基础上，产品收入增长将在7%至11%的范围内，同时调整后的EBITDA利润率将持续扩大。

Assuming Medicare reimbursement by mid-2028 and positive clinical readouts supporting commercialization, Photocure expects initial AssureMDx revenues in 2027 and positive adjusted EBITDA contribution from AssureMDx operations by 2030, with market access and commercialization costs funded through free cash flow..

假设到2028年年中获得医疗保险报销批准，并获得支持商业化的积极临床数据，Photocure预计AssureMDx将在2027年产生初始收入，并且到2030年，AssureMDx业务将对调整后息税折旧摊销前利润（EBITDA）做出正向贡献，市场准入和商业化成本将通过自由现金流提供资金。

Modest Vesica Health operating losses expected in the near-term, quickly ramping to segment EBITDA margins north of 30%.

Vesica Health 业务预计在短期内将出现小幅运营亏损，随后迅速攀升至分部 EBITDA 利润率超过 30% 的水平。

The consolidated business is expected to accelerate revenue growth from a standalone mid-to-high teens CAGR to above 25% CAGR from 2026-2030, while maintaining strong profitability with consolidated adjusted EBITDA margins above 25% by 2030 and additional upside potential.

预计合并后的业务将推动收入增速从独立运营时的中高十几%复合年增长率加速提升至2026-2030年期间的25%以上复合年增长率，同时在2030年前保持强劲的盈利能力，实现合并后调整后EBITDA利润率超过25%，并具备额外的上行潜力。

Importantly, completion of FDA down-classification, entry of additional scope manufacturers into the U.S. market including reintroduction of flexible scopes, will provide further upside to the standalone growth outlook.

重要的是，完成美国食品药品监督管理局（FDA）的降级分类，以及更多内窥镜制造商进入美国市场（包括重新引入柔性内窥镜），将为独立增长前景带来进一步的上升空间。

Conference Call and Webcast

电话会议和网络直播

Photocure will host a

Photocure 将举办一场

conference call

电话会议

on June 5, 2026 at 11.00 CEST to discuss the transaction. A company presentation is made available on the Photocure's website,

于2026年6月5日中欧夏令时11:00讨论该交易。公司演示文稿已在Photocure网站上提供，

www.photocure.com

。

Advisers

顾问

DNB Carnegie, a part of DNB Bank ASA, acted as financial adviser. Morgan, Lewis & Bockius LLP is acting as US legal adviser and Advokatfirmaet Selmer is acting as Norwegian legal adviser to Photocure for this acquisition.

DNB Carnegie（DNB Bank ASA 旗下机构）担任财务顾问。Morgan, Lewis & Bockius LLP 担任美国法律顾问，Advokatfirmaet Selmer 担任挪威法律顾问，为 Photocure 在此次收购中提供法律服务。

Note to editors

致编辑的说明

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..

本新闻稿中提及的所有商标均受法律保护，且为 Photocure ASA 的注册商标。本新闻稿可能包含在您所在国家/地区无效的产品详情和信息，或者相关产品在您所在国家/地区无法获取。请注意，Photocure 不对访问此类可能不符合您原籍国任何法律程序、法规、注册或使用规定的信息承担任何责任。

About Photocure ASA

关于 Photocure ASA

Photocure is a commercial diagnostic company with global reach, committed to driving progress in uro-oncology precision diagnostics, delivering meaningful advances for patients with urological cancers. Our unique core technology has led to better health outcomes for patients worldwide. The company aims to provide an array of transformative solutions that help physicians with timely diagnostic information, to inform more personalized decisions on how best to manage each individual patient.

Photocure 是一家具有全球影响力的商业诊断公司，致力于推动泌尿肿瘤精准诊断的进步，为泌尿系统癌症患者带来有意义的进展。我们独特的核心技术已改善了全球患者的健康结局。公司旨在提供一系列变革性解决方案，帮助医生及时获取诊断信息，从而为每位患者的个性化管理决策提供更佳的依据。

Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit .

Photocure 总部位于挪威奥斯陆，并在奥斯陆证券交易所上市（股票代码：OSE: PHO）。如需更多信息，请访问。

www.photocure.com.

www.photocure.com。

About Vesica Health, Inc.

关于 Vesica Health, Inc.

Vesica Health is a privately held precision diagnostics company pioneering noninvasive solutions for the early detection and management of bladder cancer. Headquartered in Irvine, California, Vesica operates a CAP-accredited, CLIA-certified laboratory and holds worldwide commercialization rights for AssureMDx.

Vesica Health 是一家私营的精准诊断公司，致力于开创用于膀胱癌早期检测和管理的无创解决方案。公司总部位于加利福尼亚州尔湾，运营着一家获得 CAP 认可、CLIA 认证的实验室，并拥有 AssureMDx 的全球商业化权利。

The company is led by an experienced team with a proven track record in diagnostic development, clinical evidence generation, and commercial execution. Learn more at: .

公司由一支经验丰富的团队领导，该团队在诊断产品开发、临床证据生成以及商业化执行方面拥有经证实的卓越业绩。了解更多详情，请访问：.

www.vesicahealth.com.

www.vesicahealth.com。

About Bladder Cancer

关于膀胱癌

Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – with 1 949 000 prevalent cases (5-year prevalence rate)

膀胱癌是全球第8大常见癌症，在男性中为第5大常见癌症，现有病例数为1,949,000例（5年患病率）。

, 614 000 new cases and more than 220 000 deaths in 2022.

2022年新增病例614,000例，死亡人数超过220,000人。

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.

约75%的膀胱癌病例发生在男性中。¹ 其复发率较高，第一年可达61%，五年内可达78%。

Bladder cancer has the highest lifetime treatment costs per patient of all cancers.

膀胱癌是所有癌症中每位患者终身治疗费用最高的。

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.

膀胱癌是一种治疗费用高昂且可能进展的疾病，由于复发风险高，患者需要接受多次膀胱镜检查。为了惠及患者和医疗卫生体系，亟需改善膀胱癌的诊断与管理。

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.

膀胱癌根据其在膀胱壁中的浸润深度，分为非肌层浸润性膀胱癌（NMIBC）和肌层浸润性膀胱癌（MIBC）两类。NMIBC局限于膀胱内层的尿路上皮细胞层。这类癌症在所有膀胱癌病例中最为常见（占75%），包括Ta型、原位癌（CIS）和T1型病变等亚型。

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..

在肌层浸润性膀胱癌（MIBC）中，癌细胞已生长至膀胱壁的更深层。这些癌症，包括T2、T3和T4亚型，更容易扩散且更难治疗。

Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: https://gco.iarc.fr/today, accessed [February 2024].

Globocan。a) 5年患病率 / b) 按人口统计的发病率/死亡率。获取网址：https://gco.iarc.fr/today，访问日期[2024年2月]。

Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657

Babjuk M 等. 《欧洲泌尿学杂志》. 2019; 76(5): 639-657

Sievert KD et al. World J Urol 2009;27:295–300

西弗特 KD 等. 《世界泌尿外科杂志》2009;27:295–300

Bladder Cancer. American Cancer Society.

膀胱癌。美国癌症协会。

https://www.cancer.org/cancer/bladder-cancer.html

For more information, please contact:

如需更多信息，请联系：

Dan Schneider

丹·施耐德

President and CEO

总裁兼首席执行官

Photocure ASA

Email:

电子邮件：

[email protected]

Priyam Shah

普里扬·沙阿

Vice President Investor Relations

投资者关系副总裁

Tel: +17176815072

电话：+17176815072

Email:

电子邮件：

[email protected]

Media and IR enquiries:

媒体及投资者关系咨询：

Geir Bjørlo

盖尔·比约洛

Corporate Communications (Norway)

企业传播（挪威）

Tel: +47 91540000

电话：+47 91540000

Email:

电子邮件：

[email protected]

Important Information

重要信息

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 Dick Peters, Corporate Controller of Photocure ASA at the time and date stated above..

根据欧盟《市场滥用条例》，该信息被视为内幕信息，并须遵守挪威《证券交易法》第5-12条规定的披露要求。本证券交易所公告由Photocure ASA的公司控制总监Dick Peters于上述时间和日期发布。

This announcement is not and does not form a part of any offer to sell, or a solicitation of an offer to purchase, any securities. The distribution of this announcement and other information may be restricted by law in certain jurisdictions. Copies of this announcement are not being made and may not be distributed or sent into any jurisdiction in which such distribution would be unlawful or would require registration or other measures.

本公告不构成且不属于任何出售证券的要约，亦不构成购买证券要约的招揽。在某些司法管辖区，分发本公告及其他信息可能受到法律限制。不得制作本公告的副本，也不得将其分发或发送至任何此类分发行为属违法或需进行注册或采取其他措施的司法管辖区。

Persons into whose possession this announcement or such other information should come are required to inform themselves about and to observe any such restrictions..

凡取得本公告或其他相关信息者，须自行了解并遵守任何此类限制。

Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as 'believe', 'expect', 'anticipate', 'strategy', 'intends', 'estimate', 'will', 'may', 'continue', 'should' and similar expressions.

本公告中讨论的事项可能构成前瞻性陈述。前瞻性陈述是指非历史事实的陈述，通常可通过“相信”、“预期”、“预计”、“战略”、“打算”、“估计”、“将”、“可能”、“继续”、“应当”等词语及类似表述加以识别。

The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although Photocure believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control..

本新闻稿中的前瞻性陈述基于各种假设，其中许多假设又进一步依赖于其他假设。尽管 Photocure 认为这些假设在作出时是合理的，但这些假设本质上会受到重大已知和未知风险、不确定性、偶发事件以及其他重要因素的影响，这些因素难以或无法预测，且超出其控制范围。

The information, opinions and forward-looking statements contained in this announcement speak only as at its date and are subject to change without notice. Photocure ASA undertakes no obligation to review, update, confirm, or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this announcement, other than as required by law..

本公告所载资料、意见及前瞻性陈述仅反映公告发布之日的情况，且可能在不另行通知的情况下发生变更。Photocure ASA 没有义务审查、更新、确认或公开发布对任何前瞻性陈述的修订，以反映与本公告内容相关的事件发生或情况变化，除非法律另有要求。

This announcement is for information purposes only and is not to be relied upon in substitution for the exercise of independent judgment. It is not intended as investment advice and under no circumstances is it to be used or considered as an offer to sell, or a solicitation of an offer to buy any securities or a recommendation to buy or sell any securities of Photocure.

本公告仅供信息参考，不应替代独立判断而加以依赖。本公告不构成投资建议，在任何情况下均不得被用作或视为出售要约、购买任何证券的要约邀请，或买卖Photocure任何证券的建议。

Neither Photocure nor its advisors accept any liability arising from the use of this announcement..

Photocure 及其顾问均不对因使用本公告而产生的任何责任承担责任。

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

本信息须根据《挪威证券交易法》第5-12条的披露要求进行公开。

This information was brought to you by Cision

本信息由 Cision 提供

http://news.cision.com

https://news.cision.com/photocure/r/photocure-asa-to-acquire-vesica-health-inc--strengthening-leadership-in-bladder-cancer-diagnostics,c4358110

The following files are available for download:

以下文件可供下载：

https://mb.cision.com/Main/17498/4358110/4135258.pdf