510k regulatory clearance for Leo Cancer Care's unique patient positioning system, Eve®, paves the way for a new approach to patient treatment

510k Leo癌症护理独特的患者定位系统Eve®的监管许可为患者治疗的新方法铺平了道路

MIDDLETON, Wis., May 9, 2024 /PRNewswire/ -- Leo Cancer Care is delighted to announce that it has gained regulatory clearance for its revolutionary upright patient positioning system for delivering radiotherapy treatment to patients. This 510(K) clearance means that the Eve System can now be used to offer 'a more human' method of treating cancer patients..

威斯康星州米德尔顿，2024年5月9日/PRNewswire/-Leo Cancer Care很高兴地宣布，其革命性的直立式患者定位系统已获得监管许可，可为患者提供放射治疗。510（K）许可意味着Eve系统现在可以用于提供“更人性化”的癌症患者治疗方法。。

The FDA ruling sees our upright technology gain 510k status* and clearance to offer the equipment to healthcare providers to treat their patients across the United States with immediate effect.

美国食品和药物管理局（FDA）的裁决表明，我们的直立式技术获得了510k的地位*并获得许可，可以立即向美国各地的医疗保健提供者提供该设备，以治疗他们的患者。

The patient positioning system enables cancer patients to receive radiation treatment seated in an upright position. The design is innovative compared to majority of radiotherapy devices today, with the patient positioning system being one part of the whole solution, but the part that holds the most potential and more importantly the patient..

患者定位系统使癌症患者能够直立坐着接受放射治疗。与当今大多数放射治疗设备相比，该设计具有创新性，患者定位系统是整个解决方案的一部分，但最具潜力的部分，更重要的是患者。。

Research has already shown that the approach is a more natural position for patients with evidence suggesting that this will contribute to less internal organ movement leading to more efficient delivery of radiotherapy.

研究已经表明，这种方法对于患者来说是一种更自然的姿势，有证据表明这将有助于减少内脏运动，从而更有效地进行放射治疗。

Studies have also shown that patients prefer to be in the upright position, rather than lying down.

研究还表明，患者更喜欢直立，而不是躺着。

CEO of Leo Cancer Care, Stephen Towe welcomed the landmark ruling.

Leo Cancer Care首席执行官斯蒂芬·托（StephenTowe）对这一里程碑式的裁决表示欢迎。

He said: 'Leo Cancer Care has always promised a lot; a new paradigm for radiation therapy with huge potential benefits for patients across the globe.'

他说：“狮子座癌症护理一直承诺很多；放射治疗的新范例，对全球患者具有巨大的潜在益处。”

'This regulatory clearance marks a turning point for the company and our ability to deliver on those promises. This will see clinical adoption of the upright treatment approach giving patients the choice they have been waiting for.'

“这一监管许可标志着该公司和我们履行这些承诺的能力的转折点。这将看到临床上采用直立治疗方法，为患者提供他们一直等待的选择。”

The FDA regulatory clearance for Leo Cancer Care's upright technology is a truly significant step in the company's evolution, and also in the way radiation therapy can now be delivered to patients.

FDA对Leo Cancer Care直立式技术的监管许可是该公司发展过程中真正重要的一步，也是放射治疗现在可以提供给患者的方式。

'This will now go from a non-clinical research solution to a fully functioning clinical device, with clinical treatments possible,' added Towe.

Towe补充道：“这将从非临床研究解决方案转变为功能齐全的临床设备，并有可能进行临床治疗。”。

Towe said that with one device cleared, Leo Cancer Care has a comprehensive development pipeline to deliver further solutions within the upright technology paradigm.

Towe说，随着一个设备的清除，Leo Cancer Care拥有一个全面的开发管道，可以在直立技术范式下提供进一步的解决方案。

Please note: The Leo Cancer Care patient positioning system has achieved 510(K) clearance for the US market. Marie, including our upright CT scanner, is not yet clinically available.

请注意：Leo癌症护理患者定位系统已在美国市场获得510（K）许可。玛丽，包括我们的立式CT扫描仪，尚未在临床上可用。

*Section 510(k) of the Food, Drug and Cosmetic Act (https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances) requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k)..

*《食品、药品和化妆品法》第510（k）节(https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances)要求必须注册的设备制造商至少提前90天通知FDA其销售医疗设备的意图。这被称为上市前通知-也称为PMN或510（k）。。

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SOURCE Leo Cancer Care

来源Leo癌症护理