LOS ANGELES--(BUSINESS WIRE)--Non-invasive cardiac assessment company Sensydia announced today that it has completed its 50-subject development study at the University of Minnesota (UMN). This study was conducted at UMN to collect data for its innovative AI-powered, non-invasive Cardiac Performance System (CPS™) that uses heart sound analysis to enable earlier detection and more effective therapy guidance for patients suffering from heart failure and pulmonary hypertension..

洛杉矶——（商业新闻短讯）——无创心脏评估公司Sensydia今天宣布，它已经在明尼苏达大学（UMN）完成了50个主题的发展研究。这项研究是在UMN进行的，旨在为其创新的人工智能驱动的无创心脏功能系统（CPS）收集数据™) 它使用心音分析为患有心力衰竭和肺动脉高压的患者提供早期发现和更有效的治疗指导。。

Sensydia is developing the CPS platform, which uses ultra-sensitive biosensors to provide clinicians with rapid, non-invasive measurement of ejection fraction, cardiac output, pulmonary artery pressure, and pulmonary capillary wedge pressure in a handheld device. Knowledge of these parameters is critical when caring for individuals with heart failure and pulmonary hypertension.

Sensydia正在开发CPS平台，该平台使用超灵敏生物传感器为临床医生提供手持设备中射血分数，心输出量，肺动脉压和肺毛细血管楔压的快速，无创测量。在照顾心力衰竭和肺动脉高压患者时，了解这些参数至关重要。

To obtain these measurements today, patients must undergo echocardiography and invasive right heart catheterization, which are resource intensive, restricted to medical facilities, and only provide snapshot data. In contrast, CPS measurements are fast, safe, may be repeated as frequently as indicated, and can be performed essentially anywhere with minimal training..

为了今天获得这些测量结果，患者必须接受超声心动图和有创右心导管插入术，这是资源密集型的，仅限于医疗设施，并且仅提供快照数据。相比之下，CPS测量速度快、安全，可以按照指示的频率重复进行，并且基本上可以在任何地方进行，只需最少的训练。。

'This is Sensydia’s fifth successful study, and we will continue to collect data across leading cardiac care institutions to improve the performance and utility of the artificial intelligence algorithms that power our breakthrough CPS platform,' said Anthony Arnold, President and CEO of Sensydia. “We’re working to overcome today’s barriers in acquiring vital hemodynamic measures for monitoring and managing cardiac patients, and we appreciate the participation of cardiologists and staff at University of Minnesota in working toward this goal.”.

Sensydia总裁兼首席执行官安东尼·阿诺德（AnthonyArnold）说：“这是Sensydia的第五项成功研究，我们将继续收集领先心脏护理机构的数据，以提高人工智能算法的性能和实用性，这些算法为我们突破性的CPS平台提供了动力。”。“我们正在努力克服当今在获得监测和管理心脏病患者的重要血流动力学措施方面的障碍，我们感谢明尼苏达大学心脏病专家和工作人员参与实现这一目标。”。

“The CPS platform shows promise as a non-invasive alternative to routine echocardiography and right-heart catheterization. It has the potential to positively impact the way patients with heart failure are monitored, managed, and ultimately to improve clinical outcomes,” said Tamas Alexy, MD, Associate Professor of Medicine and Principal Investigator, UMN Medical School.

“CPS平台有望成为常规超声心动图和右心导管插入术的无创替代方案。它有可能对心力衰竭患者的监测，管理方式产生积极影响，并最终改善临床结果，”UMN医学院医学副教授兼首席研究员塔马斯·阿列克西医学博士说。

“These measurements are essential in the diagnosis and ongoing management of patients with heart failure as well as pulmonary hypertension. We are pleased to help evaluate Sensydia’s platform utilizing acoustic sensing technology and advanced AI algorithms, reducing the need for repeat echocardiograms and invasive hemodynamic assessments.”.

“这些测量对于心力衰竭和肺动脉高压患者的诊断和持续管理至关重要。我们很高兴利用声传感技术和先进的AI算法帮助评估Sensydia平台，减少重复超声心动图和有创血流动力学评估的需要。”。

Sensydia previously conducted a study at the Ronald Reagan UCLA Medical Center which contributed to the FDA clearance for its ejection fraction algorithm, a study at the OHSU Knight Cardiovascular Institute for its cardiac output algorithm, and two studies at the University of Pittsburgh Medical Center for its pulmonary pressure algorithm and general clinical utility..

Sensydia之前在罗纳德·里根加州大学洛杉矶分校医学中心进行了一项研究，该研究有助于FDA批准其射血分数算法，在OHSU Knight心血管研究所进行了一项关于心输出量算法的研究，以及在匹兹堡大学医学中心进行的两项关于其肺压力算法和一般临床实用性的研究。。

In January 2022, Sensydia announced that CPS was granted Breakthrough Device Designation by the United States Food and Drug Administration (FDA). Sensydia plans to use data from this 50-subject study to develop the CPS pulmonary pressure algorithms.

2022年1月，Sensydia宣布CPS被美国食品和药物管理局（FDA）授予突破性设备称号。Sensydia计划使用这项50个主题研究的数据来开发CPS肺动脉压算法。

The achievement of this 50-subject milestone comes at a time when Sensydia is actively executing Phase I of its new NIH award. With its CPS device, Sensydia aims to make non-invasive, fast, and safe cardiac assessment broadly available to improve the life of those living with heart failure and pulmonary hypertension..

这50个主题里程碑的实现正值Sensydia积极执行其新NIH奖项的第一阶段。凭借其CPS设备，Sensydia旨在广泛提供无创，快速和安全的心脏评估，以改善心力衰竭和肺动脉高压患者的生活。。

About Sensydia

关于Sensydia

Sensydia intends to revolutionize heart failure therapy by expanding access to cardiac performance assessment outside the hospital with its non-invasive Cardiac Performance System (CPS™). Today the U.S. spends more than $30 billion annually on the diagnosis and management of heart failure, which requires costly and risky in-hospital catheterization procedures to obtain an accurate assessment of cardiac performance.

Sensydia打算通过其无创心脏功能系统（CPS）扩大医院外心脏功能评估的范围，从而彻底改变心力衰竭治疗™). 今天，美国每年在心力衰竭的诊断和管理上花费300多亿美元，这需要昂贵且有风险的院内导管插入术才能获得对心脏功能的准确评估。

Sensydia’s CPS platform delivers accurate, non-invasive assessment of cardiac performance (cardiac output, ejection fraction, and pulmonary pressures) almost anywhere in under 5 minutes. CPS utilizes proprietary waveform machine learning methods that have been trained against gold-standard measurements from in-hospital catheterization lab data..

Sensydia的CPS平台在5分钟内几乎可以在任何地方对心脏功能（心输出量，射血分数和肺动脉压）进行准确，无创的评估。CPS利用专有的波形机器学习方法，这些方法已针对医院导管插入术实验室数据的金标准测量进行了培训。。

In 2018, Sensydia received FDA 510(k) clearance for non-invasive measurement of ejection fraction using first-generation hardware. Sensydia is on a mission to improve the quality of human life by democratizing health assessment and is committed to serving the needs of patients and healthcare providers by delivering non-invasive and easy-to-use products.

2018年，Sensydia获得FDA 510（k）许可，使用第一代硬件进行射血分数的非侵入性测量。Sensydia的使命是通过健康评估的民主化来提高人类生活质量，并致力于通过提供非侵入性和易于使用的产品来满足患者和医疗保健提供者的需求。

Learn more at sensydia.com..

更多信息，请访问sensydia.com。。