avisadx产品代理

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avisadx产品代理

Avisa是一家处于临床阶段的医疗设备公司,开发了Avisa BreathTest™,这是一种新型的药物/设备生物标记技术平台,能够超快速检测致命的细菌病原体,检测和监测患者通过专有的输送系统吸入或摄入药物底物后的细菌负荷。公司通过囊性纤维化、肺结核、社区获得性肺炎的临床试验,建立了临床概念验证,证明了良好的安全性和临床疗效。Avisa计划在covid -19后支气管扩张症和呼吸机相关性肺炎方面进行关键试验,并计划于明年向美国FDA提交这些试验的研究器械豁免申请
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The Avisa BreathTest

Previous Clinical Studies

Planned Clinical Studies


Avisa is a clinical-stage medical device company developing the Avisa BreathTest™, a novel drug/device biomarker technology platform that enables the ultra-rapid detection of virulent bacterial pathogens, detecting and monitoring bacterial load after the patient inhales or ingests its drug substrates via proprietary delivery systems. The Company has established clinical proof-of-concept through trials in cystic fibrosis, tuberculosis and community-acquired pneumonia, which demonstrated positive safety and clinical efficacy results. Avisa is planning pivotal trials in Post-COVID-19 bronchiectasis and ventilator-associated pneumonia and plans to submit Investigational Device Exemption applications to the U.S. FDA for these trials next year