French startup Dianosic nets CE mark for nosebleed-stopping balloon

The balloon can be used to treat spontaneous bleeds, or left in for up to three days for more serious cases, such as following sinus surgeries or rhinoplasties. (Dianosic)

A French startup has received a CE mark for a small, inflatable device designed to apply gentle pressure and halt nosebleeds.

The Strasbourg-based Dianosic plans to eventually make its bloodstopping balloon available in hospitals throughout Europe, the U.S., Japan and China.

After being inserted into the nostril, the company’s CAVI-T device expands to conform to the shape of the cavity and provide light amounts of compression to help stop the bleeding, including at the front or back of the airway. 

It can be used for spontaneous bleeds or left in place for up to three days in more serious cases, including after operations such as sinus surgeries or rhinoplasties.

“Following this major step in our development, we are ready to prepare the commercial launch of the product in Europe, which is expected to take place during the second quarter of 2020,” CEO Philippe Bastide said in a statement. 

“Dianosic’s entry into the market represents a prime opportunity for growth, with the potential to reach close to 5 million patients across Europe and the United States,” Bastide added. 

The balloon halted nosebleeds in 90% of participants in a pilot study, while demonstrating relatively low scores in patient-reported pain scales during both its insertion and its removal.

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