July
Moving up worldwide
CE Marking of the SoKinox device has been delivered
The certificates for CE Marking of SoKINOX, ISO13485 and MDSAP certification of iNOsystems (ALMS affiliates dedicated to NO) were received on July 25th after 15 months of procedures. This means that iNOsystems is now able to commercialize the SoKINOX within countries that recognize CE marking (France, Poland, Spain, Italy, Portugal, Nordics, BeNeLux, Germany, Austria). CE marking was also a prerequisite to start registration of the SoKINOX in countries such as Argentina, Switzerland and Tunisia. This step is the final conclusion of the technology acquisition process done from Getinge / Macquet group except for US where certification is expected later this year.
June
Starting up worldwide
KINOX-Therapy offer’s pilots successfully done in 3 countries
What is the iNO value offer, KINOX-Therapy? The offer is made of the drug (KINOX and VasoKINOX), the medical device (SoKINOX) that ensures an extremely accurate delivery of the therapeutic dose, and services (such as training on device, molecules and indications). Focusing on medical support and usage, and it is charged by therapy and not by volume of gas, the offer was successfully launched last year under a pilot mode in Spain, Switzerland and Tunisia with 19 contracts signed. In June, pilots were closed and offer final design was finalized. On July 8th the KINOX-Therapy offer was launched with all affiliates involved with NO. Detailed deployment and ramp-up plans are now being set-up and followed.
