Sedana Medical submits market approval application for the drug Sedaconda

Sedana Medical AB (publ) announced that the company has submitted an application for market approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care. The application has been submitted to the German Medicines Agency BfArM and a number of other European Medicines Agencies through a so-called DCP procedure.

The application is the starting point of the review process of Sedaconda in 15 of the EU member states, including Norway. If all goes well, Sedana Medical expects an approval in the second half of 2021. After that, an application for a second group of EU countries can be submitted. Normally, it takes about six months to obtain approval for a second group of countries.

"When we get market approval for Sedaconda, we can exclusively launch the treatment inhaled sedation in Europe. The treatment consists of our drug Sedaconda, which is then approved for administration only via our medical device AnaConDa. We have chosen the name Sedaconda to strengthen the connection to Sedana Medical and to the drug's unique area of use, sedation. At the same time, we want to communicate that the drug will be given via AnaConDa by keeping CONDA in the name," said Christer Ahlberg, CEO of Sedana Medical.

In the United Kingdom, which due to Brexit has its own national application process, the application will be submitted separately in the first quarter of 2021. Switzerland also has its own national process, and the application will be submitted in 2021.

"As this is our first application for marketing approval for a drug, it is a crucial milestone for us as a company, but also for making the treatment inhaled sedation available for intensive care worldwide. A European approval will be a very good support in future registration processes in other markets when we work to make inhaled sedation a standard method in intensive care," said Christer Ahlberg.

The market approval application is based on the strong results in Sedana Medical's pivotal phase III study, SED-001. The topline results, announced in July 2020, showed that the study reached its primary goal; to show that Sedaconda (isoflurane), administered with AnaConDa, is an effective sedation method, for ventilator-intensive care patients, which is non-inferior to propofol. The results show that Sedaconda is an effective and safe sedation method.

About Sedana Medical

Sedana Medical AB (publ) has developed and sells the medical device AnaConDa for the administration of volatile anaesthetics. Through a combination of AnaConDa and the candidate drug IsoConDa (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated intensive care patients. The company is working to obtain market approval in Europe for inhaled sedation in intensive care with the pharmaceutical IsoConDa® (isoflurane) during the second half of 2021.

Today, mechanically ventilated intensive care patients are sedated intravenously which leads to several challenges for both patients and care givers. Challenges that are solved by inhaled sedation. Based on an estimate of seven to eight million patients being sedated in intensive care due to mechanical ventilation globally, on average three to four days, Sedana Medical estimates the total market potential to SEK 20-30 billion, evenly distributed between the US, Europe and Asia. Three years after market approval in Europe Sedana Medical expects sales of SEK 500 million in Europe and an EBITDA margin of about 40 percent. The company has initiated a process to obtain market approval in the US in 2024. Registration activities have also been initiated in other markets outside the EU.

Sedana Medical has direct sales in the Nordic countries, Germany, Benelux, France, Great Britain and Spain as well as external distributors in parts of the rest of Europe, Australia, Canada, China, India, Israel, Japan, Mexico and South Korea. The company was founded in 2005 and is headquartered in Stockholm, Sweden, with medical device development in Ireland.