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DGAP-News News vom 20.11.2018

TNI medical achieves approval for the US market

DGAP-News: TNI medical AG / Key word(s): Market launch

20.11.2018 / 15:24
The issuer is solely responsible for the content of this announcement.


TNI medical AG, based in Wuerzburg, Germany, has received approval to sell its TNI softFlow 50 high-flow ventilator in the USA. The U.S. Food and Drug Administration (FDA) has granted the company approval for the use of TNI softFlow for the clinical treatment of patients with respiratory distress syndrome. The approval covers use of the devices during inpatient treatment. The devices can be put into operation in US hospitals effective immediately.
 


Ewald Anger, CEO of TNI medical, says: "In the USA about 12 million people are treated with respiratory distress syndrome each year. With the approval of the TNI softFlow 50, we can help alleviate their breathing difficulties with our innovative high-flow respirators. As such, the successful completion of the FDA approval process is a major and important milestone in our growth strategy. The TNI softFlow device is ideal for treating patients also outside the intensive care unit due to its low noise level, autonomous supply of water and air, high efficiency and low weight. We therefore expect this to further accelerate our internationalization process. We also expect the TNI softFlow to be approved in other markets in the near future, specifically in the large Chinese market."


In respiratory distress syndrome, the functioning of the lungs is considerably restricted and can no longer adequately provide for the exchange of oxygen and carbon dioxide. According to current figures from the World Health Organization (WHO), the widespread respiratory distress syndrome COPD is the fourth leading cause of death worldwide. According to an international analysis, 3.2 million people died around the world in 2015 as a result of the disease. Experts predict that the number of patients with respiratory diseases, especially COPD, will continue to rise globally. The need for effective and, above all, more comfortable treatment options is therefore continuously increasing. Patients are generally averse to today's standard treatment methods, which consist of closed nose or face masks.


The ventilators in the TNI softFlow family provide respiratory distress syndrome patients a warm, moist air flow directly into the nose through a thin, heated and noise-optimized nasal cannula without condensation. The air flow rate and humidity can be precisely adjusted and, if necessary, oxygen can be added. This results in effective patient treatment. The products are also simple to use, as the nasal cannula is easy to put on and take off. Patients have complained of the limited comfort afforded by many conventional ventilators with closed nose and face masks. During treatment with TNI ventilators, patients can continue to perform everyday tasks like eating, drinking, speaking or taking medication. TNI medical's novel treatment method not only achieves very good clinical results, but also provides better tolerability for patients compared to traditional mask therapy.

A photo of the TNI softFlow 50 high-flow ventilator can be downloaded here

 

About TNI medical AG
TNI medical AG develops, produces and sells respiratory therapy devices for patients with respiratory distress syndromes such as chronic obstructive pulmonary disease (COPD). For over ten years now, the Wuerzburg-based company has focused on a single goal: the consistent further development of nasal high-flow treatment to offer respiratory support with maximum efficiency and comfort to patients with respiratory insufficiency. Based on intensive research and realized through precise development work in treatment with nasal insufflation (TNI), the TNI softFlow system generation offers the highest treatment quality for all age groups, both at the hospital and at home.
 

Further information:
Benedikt Nesselhauf
IWK Communication Partner
Tel.: +49 (0)89 2000 30 35
benedikt.nesselhauf@iwk-cp.com
www.iwk-cp.com

 



20.11.2018 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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