Startup Dianosic (Strasbourg, France) announced today that it has obtained the CE Mark for CAVI-T, a low-pressure asymmetric balloon for treating spontaneous and post-operative intranasal bleeding.
CAVI-T is the first asymmetric intranasal balloon that stops bleeding by applying low-force compression while adapting to the anatomy of the nasal fossa, according to the company. The balloon can remain in place for 1 to 3 days.
A 2019 pilot study in France showed the balloon was effective in stopping bleeding in 90% of patients and significantly improved their quality of life. This feasibility study also demonstrated the device’s safety profile, with a mean pain score on product insertion and removal of 4.7 and 1.6 respectively, based on a visual analogue scale ranging from 1 to 10, the company added.
“Obtaining CE marking is an important recognition of Dianosic’s expertise and the ability of its team to conceive and develop innovative products to treat ENT disorders,” said company president Marc Augustin in a news release.
“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. Dianosic’s entry into the market represents a prime opportunity for growth, with the potential to reach close to five million patients across Europe and the United States,” added company CEO Philippe Bastide.