Artrya Limited (ASX: AYA) (Artrya or the Company), a medical technology company commercialising its Salix AI-powered cloud platform, for the near real time, point of care assessment and management of coronary artery disease, is pleased to announce it has received 510(k) clearance from the U.S. Food and Drug Administration (the FDA) for Artrya's proprietary, Salix Coronary Plaque module. This regulatory clearance is a major milestone in Artrya's U.S. market launch which commenced in July and will greatly expand the revenue opportunity with current and future customers.

Artrya Limited （ASX： AYA）（Artrya 或公司）是一家医疗技术公司，将其 Salix 人工智能驱动的云平台商业化，用于冠状动脉疾病的近实时护理点评估和管理，很高兴地宣布，它已获得美国食品和药物管理局（FDA） 用于 Artrya 专有的 Salix 冠状动脉斑块模块。此次监管许可是 Artrya 于 7 月开始在美国市场推出的一个重要里程碑，将大大扩大当前和未来客户的收入机会。

Key Points

关键点

Major milestone as Artrya receives FDA 510(k) clearance for the Salix

Artrya获得Salix的FDA 510(k)许可，这是一个重要的里程碑。

®

®

Coronary Plaque module

冠状动脉斑块模块

Salix

柳树属

®

®

Coronary Plaque module enables near real-time, point-of-care detection of high-risk plaque - a key predictor of heart attack

冠状动脉斑块模块能够实现近乎实时的、床旁的高危斑块检测——这是心脏病发作的关键预测因子。

[1]

[1]

often missed using current manual practices

经常因使用当前的手动实践而被忽略

Salix

柳树

®

®

Coronary Plaque module integrates seamlessly with FDA-cleared Salix

冠状动脉斑块模块与FDA批准的Salix无缝集成

Coronary Anatomy platform which is already commercial with Tanner Health

冠状动脉解剖平台，已与Tanner Health商业化

Significantly expands U.S. commercial launch with ability to charge a fee per scan assessed with Salix

显著扩大了美国商业发射能力，能够通过Salix评估的每次扫描收取费用。

Coronary Plaque module - U.S. Category 1 CPT reimbursement rate

冠状动脉斑块模块 - 美国第一类CPT报销率

US$950

950美元

for each assessment

对于每次评估

John Konstantopoulos

约翰·康斯坦托普洛斯

, Co-Founder and CEO of Artrya, said:

，Artrya 的联合创始人兼首席执行官，表示：

'We are thrilled to have received FDA clearance of our Salix

“我们很高兴获得FDA对我们Salix的批准

Coronary Plaque module, which opens up a much greater revenue opportunity for us in the U.S., our largest market. The team have worked tremendously hard to prepare and support the submission which we lodged on the 16th of June, and we intend to build on this as we approach our next submission for the Salix.

冠状动脉斑块模块，这为我们在美国这个最大的市场开辟了更大的收入机会。团队为准备和支持我们在6月16日提交的申请付出了巨大的努力，我们打算在此基础上继续努力，以迎接我们下一个针对Salix的提交。

Coronary Flow module.

冠状动脉血流模块。

Our momentum is definitely building, with the core Salix

我们的势头确实在增强，Salix核心产品

Coronary Anatomy platform now commercial in Tanner Health, and integration of Northeast Georgia Health System and Cone Health progressing well. Once live, we simply enable the Salix

冠状动脉解剖平台现已在塔纳健康系统投入商用，与东北乔治亚健康系统和科恩健康的整合进展顺利。一旦上线，我们只需启动Salix即可。

Coronary Plaque module in their workstream, providing their clinicians access to our highly detailed assessment of coronary artery plaque in under ten minutes. We know these clinicians tremendously value the speed, ease and efficiency that our Salix

冠状动脉斑块模块纳入了他们的工作流程，使他们的临床医生能够在十分钟内获取我们对冠状动脉斑块的详细评估。我们知道这些临床医生非常重视我们Salix提供的速度、便捷性和效率。

platform and plaque module offers, as they seek to rapidly diagnose patients and provide those in need with lifesaving treatment.

平台和斑块模块提供服务，因为他们寻求快速诊断患者并为有需要的人提供挽救生命的治疗。

As we move forward, our ability to generate revenue from our U.S. customers for each CCTA scan they assess with our Salix

随着我们向前发展，我们从美国客户那里为每次使用Salix评估的CCTA扫描获取收入的能力

Plaque module, provides us the ability to scale rapidly. This is underpinned by the ability of our customers to receive an attractive Category 1 reimbursement of

斑块模块，为我们提供了快速扩展的能力。这一点得到了我们客户能够获得有吸引力的1类报销的支持。

US$950

950美元

for each plaque assessment they perform.'

对于他们执行的每次斑块评估。

FDA 510(k) clearance of Salix

FDA 510(k) 清关 Salix

Coronary Plaque module

冠状动脉斑块模块

Artrya has received FDA 510(k) clearance of the Salix

阿特里亚公司已获得FDA 510(k)许可的Salix

Coronary Plaque module, a proprietary artificial intelligence-enabled module for detecting and quantifying coronary artery plaque. The Salix

冠状动脉斑块模块，一个专有的人工智能驱动模块，用于检测和量化冠状动脉斑块。Salix

Coronary Plaque module enables a near real-time, point-of-care assessment of plaque and stenosis for patients who have undergone a coronary CT angiogram (

冠状动脉斑块模块能够对接受过冠状动脉CT血管造影的患者进行近乎实时的、床旁的斑块和狭窄评估。

CCTA

CCTA

).  A CCTA scan is now the recommended front line diagnostic scan for assessing patients with known or suspected coronary artery disease.

冠状动脉CT扫描现在是评估已知或疑似冠心病患者的推荐一线诊断扫描。

The Salix

柳树

Coronary Plaque module is already embedded within the same user interface as the Salix

冠状动脉斑块模块已经嵌入到与Salix相同的用户界面中。

Coronary Anatomy platform and can immediately be enabled in the live version of the platform following this FDA clearance. This makes the expanded Salix

冠状动脉解剖平台，并且在获得FDA批准后，可以立即在平台的实时版本中启用。这使得扩展后的Salix

technology offering available to clinicians, with assessments available to them in less than 10 minutes and without changing or using multiple systems, as required with competing technology.

临床医生可使用的技术，评估时间不到10分钟，且无需更改或使用多个系统，这是竞争技术无法做到的。

[1] Low-Attenuation Noncalcified Plaque on Coronary Computed Tomography Angiography Predicts Myocardial Infarction: Circulation. 2020;141(18):1452-1462. doi:10.1161/CIRCULATIONAHA.119.044720

[1] 冠状动脉计算机断层扫描血管造影显示低衰减非钙化斑块预测心肌梗死：《循环》。2020；141（18）：1452-1462。doi:10.1161/CIRCULATIONAHA.119.044720

[2] Cardiovascular Business – CMS significantly increases Medicare payments for cardiac CT

[2] 心血管商业——CMS大幅增加Medicare对心脏CT的支付

Commercial opportunity for Salix

Salix的商业机会

Coronary Plaque module

冠状动脉斑块模块

Coronary artery disease (CAD) remains the leading cause of death and the largest category of U.S. healthcare expenditure, with costs projected to exceed US$1 trillion by 2035

冠状动脉疾病（CAD）仍然是导致死亡的主要原因，也是美国医疗支出的最大类别，预计到2035年其成本将超过1万亿美元。

. Coronary artery plaque remains difficult to detect with current methods and in over 50%

冠状动脉斑块用现有方法仍然难以检测，且超过50%的病例中

of the population, the first sign of the disease is sudden death. More than 4.4 million

人口中，该疾病的第一个迹象是猝死。超过440万

CCTA scans are performed each year in the U.S., growing at over 6% annually

美国每年进行CCTA扫描，且年增长超过6%。

The U.S. government has also increased reimbursement rates paid for assessing CCTA scans, due to the high incidence and benefits for earlier intervention. Now that Artrya's Salix

美国政府还提高了对CCTA扫描评估的报销率，原因是早期干预的高发生率和益处。现在Artrya的Salix

Coronary Plaque module is cleared, it automatically qualifies for a Category I CPT code for automated plaque analysis of CCTA scans, with reimbursement of

冠状动脉斑块模块已清除，它自动符合CPT I类代码的条件，用于CCTA扫描的自动化斑块分析，可报销。

US$950

950美元

per assessment from

根据评估

January 1, 2026

2026年1月1日

Artrya's go to market strategy for the U.S. is built around three strategic partnerships with mid-sized U.S. hospital systems. The first of these, Tanner Health, signed a commercial agreement for clinical use of the Salix

Artrya针对美国市场的上市策略围绕着与三家美国中型医院系统的战略合作伙伴关系。其中首家合作机构塔纳健康（Tanner Health）已签署了一项关于Salix临床使用的商业协议。

Coronary Anatomy platform in

冠状动脉解剖平台在

July 2025

2025年7月

and the integration of Northeast Georgia Health and Cone Health is progressing and will be completed in coming months. This is Artrya's most immediate commercial opportunity and will be the focus before adding additional customers.

东北乔治亚健康与科恩健康的整合正在推进中，并将在未来几个月内完成。这是Artrya最紧迫的商业机会，在增加更多客户之前，这将是关注的重点。

Artrya is also collaborating with several major U.S. hospital centres to participate in the upcoming SAPPHIRE study. These centres will use the Salix

Artrya 还与几家美国主要医院中心合作，参与即将到来的 SAPPHIRE 研究。这些中心将使用 Salix。

Coronary Plaque module and will gain awareness and understanding of the benefits that Salix

冠状动脉斑块模块，并将了解和理解Salix的好处。

can provide. A key strategy moving forward will be to build on this awareness and clinical utility to seek to transition these centres to commercial customers.

可以提供。未来的一项关键策略将是建立在这种认识和临床效用的基础上，努力将这些中心转变为商业客户。

Investor Webinar

投资者网络研讨会

The Company's Co-Founder and CEO

公司的联合创始人兼首席执行官

John Konstantopoulos

约翰·康斯坦托普洛斯

, will host an Investor Webinar at

，将举办投资者网络研讨会于

11.30am

上午11点30分

AEST (

澳大利亚东部标准时间 (

9.30am

早上9点30分

AWST) on 22 August 2025, to discuss the FDA clearance and the business outlook. A recording of the webinar will be available on the Investor Centre section of the Company's website for 60 days after the call. Shareholders will also have an opportunity to participate in a Q&A session at the end of the briefing..

美国东部时间2025年8月22日，讨论FDA的批准及业务前景。网络研讨会的录音将在会议结束后60天内于公司网站的投资者中心部分提供。股东们还将在发布会结束时有机会参与问答环节。

Date:

日期：

22 August 2025

2025年8月22日

Time:

时间：

About Artrya

关于Artrya

Artrya Limited (ASX:AYA) is an Australian medical technology company developing AI-powered solutions to improve the detection and management of coronary artery disease. Its proprietary software analyses coronary CT scans to Identify key biomarkers of heart disease, supporting clinicians in diagnosing patients more accurately and efficiently.

Artrya Limited (ASX:AYA) 是一家澳大利亚医疗技术公司，致力于开发基于人工智能的解决方案，以改进冠状动脉疾病的检测和管理。其专有软件可分析冠状动脉CT扫描，识别心脏病的关键生物标志物，帮助临床医生更准确、高效地诊断患者。

Artrya's mission is to advance cardiac care through Innovative technology, with regulatory and commercial activities underway across key international markets..

阿特里亚的使命是通过创新技术推进心脏护理，并在关键的国际市场上开展监管和商业活动。