MARTINEZ, Calif.--(BUSINESS WIRE)--ExThera Medical Corporation, a healthcare company developing and manufacturing extracorporeal pathogen technologies, announces that it has received multiple Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100).

加利福尼亚州马丁内斯-（商业线）-ExThera Medical Corporation是一家开发和制造体外病原体技术的医疗保健公司，宣布其已获得美国食品和药物管理局（FDA）的多项突破性设备名称，因为其Seraph®100MicroBind®亲和血液过滤器（Seraph 100）。

The Seraph 100 is a patented blood filter containing a biomimetic surface, similar to that found in the human circulatory system that removes pathogens that could otherwise overwhelm a patient; a common source of severe/critical illness..

Seraph 100是一种含有仿生表面的专利血液过滤器，类似于人体循环系统中发现的能够去除可能压倒患者的病原体的血液过滤器；严重/危重疾病的常见来源。。

“Multiple Seraph Breakthrough Designations represent a formal identification by the US FDA that Seraph development should be expedited for patient access because of its promise for providing more effective treatment for life-threatening and debilitating diseases associated with antibiotic resistant sepsis, as well as severe SARS-CoV-2 [COVID-19] infection,” said Sanja Ilic, M.D., M.S., RAC & Chief Regulatory Officer for ExThera.

“多重Seraph突破性名称代表了美国FDA的正式确认，即Seraph的发展应该加快患者的进入，因为它有望为与抗生素耐药性败血症相关的威胁生命和衰弱的疾病以及严重的SARS-CoV-2[COVID-19]感染提供更有效的治疗，”Sanja Ilic，M.D.，M.S。，RAC和ExThera的首席监管官。

“It additionally signals that the FDA is already thinking about future pandemic preparedness, something we are keen to partner on with them and the medical community.”.

“它还表明，FDA已经在考虑未来的大流行防范，我们热衷于与他们和医疗界合作。”。

“I am very pleased that we are also making impressive progress toward USA regulatory approval and commercialization,” said Robert Ward, Chairman, President and founder of ExThera Medical. “In addition, a Breakthrough Device Designation allows for immediate coverage through Centers for Medicare and Medicaid Services (CMS) via New Technology Add-On Payment (NTAP).

ExThera Medical总裁兼创始人罗伯特·沃德（Robert Ward）说：“我很高兴我们在美国监管部门的批准和商业化方面也取得了令人瞩目的进展。”。“此外，突破性的设备名称允许通过医疗保险和医疗补助服务中心（CMS）通过新技术附加付款（NTAP）立即覆盖。

This allows for additional line-item procedural reimbursement of Seraph 100 during initial commercialization and is an important health economic driver for commercial adoption.”.

这允许在初始商业化期间对Seraph 100进行额外的项目程序报销，并且是商业采用的重要健康经济驱动因素。”。

ExThera Medical continues to make progress in the PURIFY RCT bloodstream infection clinical study, a prospective interventional multicenter randomized controlled trial, sponsored by the Department of Defense, as part of the pivotal work required by the FDA. Breakthrough Device Designations are an important addition to this ongoing activity, along with future pandemic preparedness..

ExThera Medical在PURIFY RCT血流感染临床研究方面继续取得进展，这是一项由国防部赞助的前瞻性介入性多中心随机对照试验，是FDA要求的关键工作的一部分。突破性的设备名称是这项正在进行的活动的重要补充，以及未来的大流行防范。。

About ExThera Medical Corporation

关于ExThera Medical Corporation

ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph® 100 Microbind® Affinity Blood Filter for removing a broad range of pathogens from the bloodstream of patients. Seraph can be used in hospitals, clinics, or field hospitals to address nosocomial and community-acquired infections as well as those caused by battlefield wounds and pandemics.

ExThera Medical Corporation开发并商业化体外血液过滤装置，包括Seraph®100MicroBind®亲和血液过滤器，用于从患者血液中去除多种病原体。Seraph可用于医院，诊所或野战医院，以解决医院和社区获得性感染以及战场伤口和流行病引起的感染。

ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis, COVID-19, and other severe infections. With a growing body of outcome and health economic evidence from independent clinical studies, success in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the US, the EU, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike.

ExThera Medical的体外产品已在患有败血症，COVID-19和其他严重感染的各种重症患者中证明了挽救生命的能力。随着独立临床研究，DARPA透析样治疗计划的成功以及美国，欧盟和中东的成功临床应用等越来越多的结果和健康经济证据，该公司处于服务状态医疗保健专业人员和患者都一样。

The Seraph® 100 attained CE Mark and is commercially available in the EU. The Seraph 100 has FDA Emergency Use Authorization (EUA) for treatment of COVID-19 in the USA..

Seraph®100达到CE标志，可在欧盟商购。Seraph 100在美国获得FDA紧急使用授权（EUA）用于治疗COVID-19。。

For more information visit the company’s website at www.extheramedical.com.

欲了解更多信息，请访问公司的网站www.extheramedical.com。

About Seraph 100 and the OncoBind Procedure

关于Seraph 100和OncoBind程序

As a patient's blood flows through the Seraph 100 filter, it passes over beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby subtracted from the bloodstream.

当患者的血液流过Seraph 100过滤器时，它会通过带有受体的珠子，这些受体模仿病原体侵入人体时靶向人体细胞的受体。有害物质被快速捕获并吸附到珠子的表面上，从而从血流中减去。

Seraph adds nothing to the bloodstream. It targets the pathogens that cause the infection, while it also binds and removes harmful substances generated by the pathogen and by the body’s response to the infection. Seraph’s proprietary adsorption media (the beads) constitute a flexible platform that uses immobilized (chemically bonded) heparin for its well-established blood compatibility and its unique ability to bind circulating tumor cells, bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis..

Seraph没有增加血液。它针对引起感染的病原体，同时它还结合并去除病原体产生的有害物质和身体对感染的反应。Seraph专有的吸附介质（珠子）构成了一个灵活的平台，使用固定化（化学键合）肝素，因为它具有良好的血液相容性，并具有独特的结合循环肿瘤细胞，细菌，病毒，真菌和重要脓毒症介质的能力。导致败血症期间的器官衰竭。。

For more news stories on the Seraph 100 and the OncoBind Procedure click here.

有关Seraph 100和OncoBind程序的更多新闻报道，请点击此处。

Disclaimer

免责声明

All information contained in this news release derives from plausible reliable sources, which, however, have not been independently examined. There is no warranty, confirmation or guarantee, and no responsibility or liability is taken concerning correctness or completeness. As far as it is allowed by the relevant law, no liability whatsoever is taken on for any direct or indirect loss caused by the deployment of this news release or its contents.

本新闻稿中包含的所有信息均来自合理可靠的来源，但尚未经过独立审查。没有保证，确认或保证，对正确性或完整性不承担任何责任或责任。据相关法律允许，对因部署本新闻稿或其内容而造成的任何直接或间接损失不承担任何责任。

This communication includes forward-looking statements regarding events, trends and business prospects that may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially.

本通讯包括有关可能影响我们未来运营结果和财务状况的事件，趋势和业务前景的前瞻性声明。此类陈述存在风险和不确定性，可能导致我们的实际结果和财务状况出现重大差异。

The investment and/or the revenues that arise from it can rise or fall. A total loss is possible. Persons who are in possession of this news release are requested to obtain information concerning possible legal limitations and to observe them accordingly. We assume no responsibility to update or revise any forward-looking statements contained in this news release to reflect events, trends, or circumstances after the date of this news release.

由此产生的投资和/或收入可能上升或下降。总损失是可能的。拥有本新闻稿的人员被要求获取有关可能的法律限制的信息并据此予以遵守。我们不承担更新或修改本新闻稿中包含的任何前瞻性声明的责任，以反映本新闻稿发布日期后的事件，趋势或情况。

Results from case studies (reviews) may not be predictive of future results..

案例研究（评论）的结果可能无法预测未来的结果。。