MAPLE GROVE, Minn.

明尼苏达州梅普尔格罗夫

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Nov. 10, 2026

2026年11月10日

/PRNewswire/ -- Francis Medical, Inc., a medical device company dedicated to advancing minimally invasive therapies for urological cancers, today announced that it has entered into an agreement for financing led by Johnson & Johnson through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc (JJDC).

/美通社/ -- 弗朗西斯医疗公司（Francis Medical, Inc.）是一家致力于推进泌尿系统癌症微创疗法的医疗器械公司，今日宣布已与强生公司达成融资协议，该轮融资由强生旗下企业风险投资机构强生创新——JJDC公司（JJDC, Inc.）领投。

This financing agreement represents an important milestone in Francis Medical's long-term growth strategy and provides sufficient capital support to scale commercial infrastructure, expand market access initiatives, and strengthen physician training and education programs to drive broader adoption of the Vanquish System.

本融资协议是Francis Medical长期增长战略的一个重要里程碑，提供了充足的资本支持，以扩大商业基础设施、拓展市场准入计划，并加强医生培训与教育项目，从而推动Vanquish系统的更广泛应用。

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Importantly, the investment provides sufficient capital to support the company through its planned Premarket Approval (PMA) submission to the FDA for the management of clinically localized prostate cancer.

重要的是，此次投资提供了充足的资金，以支持公司向美国食品药品监督管理局（FDA）提交用于临床局限性前列腺癌治疗的上市前批准（PMA）申请。

'This is a pivotal moment in Francis Medical's evolution as we prepare to transition from a limited commercial launch to a broader U.S. market presence,' said Mike Kujak, President and CEO of Francis Medical. 'With the support of JJDC, we are positioned to accelerate the development of our commercial organization, expand physician access to our technology, and establish the infrastructure necessary to support sustainable growth.

“随着我们准备从有限的商业发布过渡到更广泛的美国市场布局，这是弗朗西斯医疗公司发展历程中的一个关键时刻。”弗朗西斯医疗公司总裁兼首席执行官迈克·库贾克表示。“在JJDC的支持下，我们有望加速商业团队的建设，扩大医生对我们技术的可及性，并建立支持可持续增长所需的基础设施。

At the same time, we remain passionately committed to advancing the clinical evidence and regulatory milestones required to pursue an indication for the management of prostate cancer. Our vision is to make Vanquish an important minimally invasive treatment option for men facing prostate cancer.'.

与此同时，我们依然满怀热情地致力于推进必要的临床证据积累和监管里程碑的实现，以寻求获批用于前列腺癌的治疗适应症。我们的愿景是让 Vanquish 成为面临前列腺癌困扰的男性患者的重要微创治疗选择。

Vanquish is a transurethral, ultrasound and electromagnetically guided thermotherapy system designed to ablate targeted prostate tissue using convective water vapor energy. The platform enables targeted delivery of thermal energy within the prostate, with the goal of achieving effective tissue ablation while minimizing impact to surrounding structures associated with urinary and sexual function.

Vanquish 是一种经尿道、超声及电磁引导的热疗系统，旨在利用对流式水蒸气能量消融靶向前列腺组织。该平台能够将热能精准递送至前列腺内部，旨在实现有效的组织消融，同时最大限度地减少对与排尿和性功能相关的周围结构的影响。

The Vanquish System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in November 2025 that was supported by positive interim follow-up data in the company's ongoing VAPOR 2 pivotal study..

Vanquish系统于2025年11月获得美国食品药品监督管理局（FDA）的510(k)许可，该许可得到了公司正在进行的VAPOR 2关键性研究中积极的中期随访数据的支持。

Francis Medical continues to advance its clinical development program through the VAPOR 2 pivotal study, a prospective, multicenter, single-arm trial enrolling 235 patients with intermediate-risk, localized prostate cancer across 26 U.S. clinical sites. Initial results from the first 110 patients, recently published in The Journal of Urology, demonstrated that 91% had no clinically significant MRI-visible cancer in the treated area following a single procedure, with no device-related serious adverse events reported.

Francis Medical 通过 VAPOR 2 关键性研究持续推进其临床开发计划。该研究是一项前瞻性、多中心、单臂试验，在美国 26 个临床中心招募了 235 名中危局限性前列腺癌患者。近期发表在《泌尿学杂志》（The Journal of Urology）上的前 110 名患者的初步结果显示，91% 的患者在接受单次治疗后，治疗区域无具有临床意义的 MRI 可见癌症，且未报告与器械相关的严重不良事件。

The procedure was also well tolerated with 93% of patients indicating that they were satisfied or extremely satisfied, and 94% said that they believed that receiving the procedure was a wise decision. The study will continue to follow patients to five years, gathering longer-term outcomes..

该手术耐受性良好，93%的患者表示满意或非常满意，94%的患者认为接受该手术是明智的决定。研究将继续对患者进行为期五年的随访，以收集更长期的结局数据。

'Francis Medical was founded on the belief that men facing prostate cancer deserve treatment options that address their disease while preserving their quality of life,' said Michael Hoey, Founder and Chief Technology Officer of Francis Medical. 'Behind every diagnosis is a person, a family, and a future worth protecting.

“Francis Medical 的创立基于这样一种信念：面对前列腺癌的男性理应获得既能治疗疾病又能保障其生活质量的治疗方案。”Francis Medical 创始人兼首席技术官 Michael Hoey 表示。“每一个诊断背后，都是一个值得守护的人、一个家庭以及一份未来。”

That belief inspired the development of Vanquish and continues to drive everything we do. This investment brings us closer to realizing our vision, enabling us to expand access to our technology and advance our mission to improve the future of prostate cancer care.'.

这一信念激发了Vanquish的研发，并持续驱动着我们的各项工作。此项投资使我们更接近于实现我们的愿景，让我们能够扩大技术的可及性，并推进我们改善前列腺癌护理未来的使命。

Piper Sandler served as exclusive financial advisor to Francis Medical in relation to the transaction.

派珀·桑德勒担任了弗朗西斯医疗在此次交易中的独家财务顾问。

Disclosure:

披露：

The Vanquish Water Vapor Ablation System has been cleared as a tool for the thermal ablation of targeted prostate tissue via a transurethral approach. The FDA has not evaluated the Vanquish System for the treatment of any disease, including prostate cancer, or evaluated the Vanquish System for any long-term prostate cancer treatment outcomes..

Vanquish 水蒸气消融系统已获批准，作为一种通过经尿道途径对靶向前列腺组织进行热消融的工具。美国食品药品监督管理局（FDA）尚未评估 Vanquish 系统用于治疗任何疾病（包括前列腺癌）的疗效，也未评估该系统在前列腺癌长期治疗结果方面的表现。

About Francis Medical

关于弗朗西斯医疗

Francis Medical is committed to developing urological cancer treatments that are tough on cancer and gentle on patients, driven by compassionate belief and clinical data supporting minimally invasive therapies that safely and effectively treat cancerous tissue. For more information on Francis Medical, visit the company website .

Francis Medical 致力于开发对癌症强效、对患者温和的泌尿系统癌症治疗方案，秉持仁心信念，并依托支持微创疗法的临床数据，以安全有效地治疗癌变组织。欲了解更多关于 Francis Medical 的信息，请访问公司网站。

https://www.francismedical.com

https://www.francismedical.com

Forward-Looking Statements

前瞻性陈述

This press release contains forward-looking statements regarding anticipated financing, future regulatory submissions and clearances, commercial expansion, clinical development, and potential indications for the Vanquish System. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially.

本新闻稿包含有关Vanquish系统预期融资、未来监管申报和批准、商业扩张、临床开发以及潜在适应症的前瞻性陈述。这些陈述基于当前预期，并涉及可能导致实际结果产生重大差异的风险和不确定性。

Francis Medical undertakes no obligation to update these statements except as required by applicable law..

Francis Medical 不承担更新这些声明的义务，除非适用法律另有要求。

SOURCE Francis Medical, Inc.

来源：Francis Medical, Inc.