Profound Medical Corp. a commercial-stage medical device company that develops and markets artificial intelligence (“AI”)-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, is pleased to announce that it has entered into an exclusive distribution and supply agreement for its TULSA-PRO® and Sonalleve® technologies in Saudi Arabia with Al Faisaliah Medical Systems Co.

Profound Medical Corp.是一家处于商业化阶段的医疗器械公司，致力于开发和销售由人工智能（“AI”）驱动、核磁共振成像（MRI）引导、无需切口的疾病组织消融疗法，该公司欣然宣布已与Al Faisaliah Medical Systems Co.达成其TULSA-PRO®和Sonalleve®技术在沙特阿拉伯的独家分销和供应协议。

(“FMS”), a subsidiary of one of the Kingdom’s most prominent business conglomerates, Al Faisaliah Group (“AFG”)..

“FMS”是沙特阿拉伯王国最著名的商业集团之一阿尔法萨利亚集团（“AFG”）的子公司。

Profound is the only company that combines the real-time imaging and thermography capabilities of magnetic resonance (“MR”) with AI-driven treatment designs to allow physicians to precisely and gently address diseased tissue without any incision, associated tissue boiling or charring, blood loss, severe/prolonged pain, or need for overnight hospital stay..

Profound是唯一一家将磁共振（“MR”）的实时成像和热成像功能与人工智能驱动的治疗设计相结合的公司，使医生能够精确且温和地处理病变组织，且无需任何切口、相关组织沸腾或烧焦、出血、严重/长期疼痛，也无需过夜住院。

U.S. commercialization of TULSA-PRO, designed specifically for the treatment of prostate disease (prostate cancer and/or benign prostatic hyperplasia, “BPH”), remains the top priority for the Company’s direct sales team. The TULSA Procedure™, performed using Profound’s TULSA-PRO system, is a significant advancement in prostate care.

TULSA-PRO 的美国商业化仍然是公司直销团队的首要任务，该产品专为治疗前列腺疾病（前列腺癌和/或良性前列腺增生，“BPH”）而设计。使用 Profound 的 TULSA-PRO 系统进行的 TULSA 手术™ 是前列腺护理领域的重大进步。

Instead of surgery or radiation, the TULSA procedure is performed inside an MRI suite to precisely and gently heat prostate tissue to ‘kill temperature’ (55-57°C) with directional ultrasound, while protecting surrounding nerves and anatomy. By intention-to-treat, while TULSA-PRO has the flexibility to be used for all ablations, including focal and hemi-gland, the majority of TULSA Procedures are either whole-gland or near-whole-gland ablations.

TULSA 手术并非通过外科手术或放疗，而是在核磁共振成像（MRI）室内进行，利用定向超声波将前列腺组织精准且温和地加热至“杀灭温度”（55-57°C），同时保护周围的神经和解剖结构。根据治疗意图，虽然 TULSA-PRO 可灵活用于所有类型的消融，包括局部和半腺体消融，但大多数 TULSA 手术为全腺体或接近全腺体的消融。

In late 2024, the U.S. Centers for Medicare & Medicaid Services (CMS) issued its outpatient prospective payment system (OPPS) final rule (“Final Rule”) for the three new CPT® Category 1 codes and their descriptors covering the TULSA procedure, which became effective on January 1, 2025. With the Final Rule, TULSA reimbursement was established at Urology Level 7 Ambulatory Payment Classification (APC).

2024 年底，美国医疗保险和医疗补助服务中心 (CMS) 发布了其门诊前瞻性支付系统 (OPPS) 的最终规则（“最终规则”），其中涵盖了三个新的 CPT® 第一类代码及其描述符，涉及 TULSA 手术，并于 2025 年 1 月 1 日生效。根据最终规则，TULSA 的报销被设定为泌尿外科第 7 级门诊支付分类 (APC)。

To-date, more than 4,000 men have undergone the TULSA Procedure, and as of last report (October 2025), Profound’s TULSA-PRO installed base stood at 67 systems..

迄今为止，已有4000多名男性接受了TULSA手术，截至上次报告（2025年10月），Profound的TULSA-PRO装机量为67套系统。

Profound’s second product, Sonalleve, which is offered primarily as a one-time capital sale, is also gaining increasing commercial interest, particularly outside of the United States. Sonalleve uses the same MR imaging and thermographic technology as TULSA-PRO, and combines that with focused ultrasound from outside the body to treat disease.

Profound的第二款产品Sonalleve也获得了越来越多的商业关注，主要作为一次性资本销售的产品，尤其是在美国以外的地区。Sonalleve采用了与TULSA-PRO相同的MR成像和热图技术，并结合体外聚焦超声波来治疗疾病。

There are currently ten Sonalleve devices operational in parts of Europe, China and Southeast Asia – where over 4,000 women have already been treated with the technology for adenomyosis and uterine fibroids, diseases of the uterus that can cause chronic pain and heavy and/or prolonged menstruations.

目前，在欧洲、中国和东南亚的部分地区已有十台Sonalleve设备投入使用，通过该技术治疗了4000多名患有子宫腺肌症和子宫肌瘤的女性，这些子宫疾病可能导致慢性疼痛以及月经量多和/或经期延长。

Treatment with Sonalleve has demonstrated pain and symptom relief without affecting the ovarian reserve, and with reports of women preserving their fertility. Sonalleve is also now being used in research and clinical trials in Europe for the ablation of pancreatic cancer tissue and other oncological disease.

Sonalleve治疗已证明可以在不影响卵巢储备的情况下缓解疼痛和症状，并有报告显示女性能够保持生育能力。Sonalleve目前也在欧洲用于胰腺癌组织和其他肿瘤疾病的消融研究和临床试验。

Over the last five years, approximately $10 million has been granted by research organizations in Europe and Canada to further conduct clinical research using Sonalleve for multiple, often life-threatening, diseases..

在过去的五年中，欧洲和加拿大的研究机构大约拨款了1000万美元，用于进一步使用Sonalleve进行多种常危及生命的疾病的临床研究。

As user interest in Profound’s technologies continues to build, the Company is deploying its own direct sales team in North America, while partnering with select strategic distribution partners to support the business potential and the customer base in other parts of the world.

随着用户对Profound技术的兴趣持续增长，该公司正在北美部署自己的直销团队，同时与选定的战略分销合作伙伴合作，以支持世界其他地区的业务潜力和客户群。

“We’re honored to partner for the distribution of both TULSA-PRO and Sonalleve with FMS, one of the leading medical device distributors in the Kingdom of Saudi Arabia,” commented Profound’s CEO and Chairman, Arun Menawat. “Successfully marketing and distributing our incision-free therapies for the ablation of diseased tissue requires a deep understanding of regional market dynamics and the specific needs of local clinicians and patients.

“我们很荣幸能与沙特阿拉伯王国领先的医疗设备分销商之一FMS合作，负责TULSA-PRO和Sonalleve的分销，”Profound的首席执行官兼董事长Arun Menawat评论道。“成功推广和分销我们无切口的病灶组织消融疗法需要对区域市场动态以及当地临床医生和患者的特定需求有深入的了解。”

With its proven track record in introducing advanced oncological procedures and other medical technologies in the Kingdom, we’re confident that FMS is the ideal partner for us.”.

凭借其在王国引入先进肿瘤手术程序和其他医疗技术的可靠记录，我们相信FMS是我们理想的合作伙伴。

FMS’ GM, Mr. Abdullah Al Melik, said, “As Saudi Arabia moves toward economic diversification under Vision 2030, both FMS and our parent company, AFG, are committed to playing a crucial role in shaping the country’s future. The group is a major provider of equipment and services to existing hospitals, and also actively owns and operates its own specialized medical facilities.

FMS总经理阿卜杜拉·阿尔·梅利克先生表示：“随着沙特阿拉伯在2030愿景下推动经济多元化，FMS及其母公司AFG都致力于在塑造国家未来中发挥关键作用。该集团是现有医院设备和服务的主要供应商，同时积极拥有并运营自己的专业医疗设施。”

With our partnership with Profound, we're extremely excited to bring its unique, incision- and radiation-free ablative technologies to Saudi hospitals and treatment centers that aim to be worldwide leaders in patient outcomes. We look forward to working closely with the Profound team.”.

通过我们与Profound的合作，我们非常兴奋能够将其独特的、无需切口和辐射的消融技术引入沙特阿拉伯的医院和治疗中心，这些机构致力于成为全球患者疗效的领导者。我们期待与Profound团队密切合作。

About with Al Faisaliah Medical Systems Co.

关于与Al Faisaliah医疗系统公司的合作

Founded in 1973, FMS was initially the healthcare division of AFG, until its establishment as an independent company in 1993. Its broad portfolio of partners and products enables it to deliver complex, integrated, single-source healthcare equipment solutions to the largest healthcare providers in the region.

成立于1973年的FMS，最初是AFG的医疗保健部门，直到1993年才成为一家独立公司。其广泛的合作伙伴和产品组合使其能够为该地区最大的医疗保健供应商提供复杂、集成、单一来源的医疗设备解决方案。

With operations across the Kingdom of Saudi Arabia, FMS is a major provider of diversified healthcare solutions, supplying state-of-the-art equipment and solutions for various uses such as oncology, operations, monitoring and critical care, cardiovascular and others. For further information, visit www.tibbiyah.com/fms..

FMS 在沙特阿拉伯王国全境开展业务，是多元化医疗保健解决方案的主要提供商，为肿瘤学、手术、监测和重症监护、心血管等各类用途提供最先进的设备和解决方案。欲了解更多信息，请访问 www.tibbiyah.com/fms。

About Al Faisaliah Group

关于Al Faisaliah集团

AFG is a privately held holding company headquartered in Riyadh, Saudi Arabia, operating across the wider Middle East. Its name is derived from the name of its founder, Abdullah Al Faisal, eldest son of the late King Faisal. Founded in 1971, the Group holds leading positions in multiple industries including Dairy, Electronics, Healthcare and Food Service.

AFG是一家私人控股公司，总部位于沙特阿拉伯利雅得，在整个中东地区开展业务。其名称源自创始人阿卜杜拉·阿尔·费萨尔的名字，他是已故国王费萨尔的长子。集团成立于1971年，在乳制品、电子产品、医疗保健和食品服务等多个行业中占据领先地位。

AFG also operates a corporate venture capital arm (Al Faisaliah Ventures) that invests in global and regional disruptive players. The Group is recognized across the region for its strongly-held values, professional management and decades-long strategic partnerships with leading local and global firms including notably Sony, Danone and Philips.

AFG还运营着一个企业风险投资部门（Al Faisaliah Ventures），该部门投资于全球和地区性的颠覆性企业。该集团因其坚定的价值观、专业的管理以及与包括索尼、达能和飞利浦在内的领先本地和全球公司长达数十年的战略合作伙伴关系而在整个地区受到认可。

For further information, visit www.alfaisaliah.com..

欲了解更多信息，请访问 www.alfaisaliah.com。

About Profound Medical Corp.

关于Profound Medical Corp.

Profound is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue.

Profound是一家处于商业化阶段的医疗器械公司，致力于开发和销售由人工智能驱动、核磁共振引导、无需切口的病灶组织消融疗法。

Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The TULSA Procedure™, performed using the TULSA-PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer.

Profound公司正在将TULSA-PRO®技术商业化，该技术结合了实时核磁共振成像、人工智能增强规划、机器人驱动的经尿道超声以及闭环温度反馈控制。使用TULSA-PRO系统进行的TULSA手术™有潜力成为覆盖整个前列腺疾病谱的主流治疗方式；包括低、中、高风险的前列腺癌；同时患有前列腺癌和良性前列腺增生（“BPH”）的混合患者；仅患有BPH的男性；以及需要针对放射复发性局部前列腺癌进行补救治疗的患者。

The TULSA Procedure employs real-time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55-57°C. The TULSA Procedure is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours.

TULSA 手术采用实时磁共振引导，以精确定位来保护患者的尿控能力和性功能，同时通过精确的声音吸收技术杀死目标前列腺组织，将其温和加热至 55-57°C。TULSA 手术是一种无切口、无辐射的“一次性”手术，在单次治疗中完成，耗时数小时。

Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with the TULSA Procedure. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S.

几乎所有前列腺形状和大小都可以通过TULSA手术安全、有效且高效地治疗。该手术没有出血，不需要住院，而且大多数TULSA患者报告称能快速恢复到正常生活。TULSA-PRO已获得CE认证、加拿大卫生部批准，并通过了美国FDA的510(k)审查。

Food and Drug Administration (“FDA”)..

食品药品监督管理局（“FDA”）。

Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. Sonalleve has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma.

Profound公司还在推广Sonalleve®，这是一款创新的治疗平台，已获得CE认证，用于治疗子宫肌瘤、腺肌症、骨转移疼痛缓解、硬纤维瘤和骨样骨瘤。Sonalleve还获得了中国国家药品监督管理局的批准，用于无创治疗子宫肌瘤，并在美国食品药品监督管理局（FDA）的人道主义器械豁免下获批用于治疗骨样骨瘤。

Profound is in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy..

Profound公司正处于探索Sonalleve其他潜在治疗市场的早期阶段，该技术已被证明在临床应用上具有潜力，例如用于腹部癌症的非侵入性消融和癌症治疗的热疗。

Forward-Looking Statements

前瞻性声明

This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma; the extent and timing of Profound’s completion of TULSA-PRO® system sales from its qualified sales pipeline; Profound’s expectations for future revenues; and the success of Profound’s commercialization strategy and activities for TULSA-PRO.

本发布包含有关Profound及其业务的前瞻性声明，可能包括但不限于对Profound技术在治疗前列腺癌、良性前列腺增生（BPH）、子宫肌瘤、姑息性疼痛治疗和骨样骨瘤方面的有效性预期；Profound从其合格销售管道中完成TULSA-PRO®系统销售的程度和时间；Profound对未来收入的预期；以及Profound针对TULSA-PRO的商业化战略和活动的成功与否。

Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved.

通常（但并非总是），前瞻性陈述可以通过使用诸如“计划”、“预计”、“期望”、“安排”、“打算”、“考虑”、“预期”、“相信”、“提议”等词语或这些词语和短语的变体（包括否定形式）来识别，或者通过声明某些行动、事件或结果“可能”、“能够”、“将会”、“或许”或“必将”被采取、发生或实现来体现。

Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition.

此类声明基于Profound管理层的当前预期。本新闻稿中讨论的前瞻性事件和情况，可能不会在特定日期或根本不会发生，并且由于影响公司的已知和未知风险因素及不确定性，可能会出现重大差异，这些风险包括医疗器械行业的风险、监管审批、报销、经济因素、股权市场总体情况以及与增长和竞争相关的风险。

Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended.

尽管Profound已尝试找出可能导致实际行为、事件或结果与前瞻性陈述中所述内容存在重大差异的重要因素，但可能还有其他因素会导致行为、事件或结果与预期、估计或计划的内容有所不同。

No forward-looking statement can b.

任何前瞻性声明都无法。

For further information, please contact:

如需更多信息，请联系：

Stephen Kilmer

斯蒂芬·基尔默

Investor Relations

投资者关系

[email protected]

电子邮件地址

T: 647.872.4849

电话：647.872.4849

Source: globenewswire.com

来源：globenewswire.com