Sedana Medical’s Sedaconda study presented at ESICM

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that outcomes from some of the secondary endpoints of the company’s pivotal study, Sedaconda (SED-001, formerly known as the IsoConDa-study) were presented at the leading congress ESICM LIVES 2020, 6-9 December, 2020.

Secondary endpoints of the study demonstrate that Sedaconda (isoflurane), delivered via AnaConDa, compared to propofol, enables

• Shorter and predictable wake-up
• Reduced need of opiates
• Higher proportion of spontaneous breathing (which increases the conditions for maintained lung function during and after ventilator treatment)

“We have seen in previous studies that inhaled sedation has faster and more predictable wake-up, but confirmation in this large randomized study is positive. The possibility of reducing the use of opiates for these patients and to enable spontaneous breathing with the help of this therapy is of great clinical importance,” said Peter Sackey, CMO of Sedana Medical.

The topline results from the Sedaconda study demonstrating that Sedaconda, delivered via AnaConDa, is an effective sedative, non-inferior to propofol, were announced in July 2020. The results of the study will be presented in full in a scientific journal in 2021.

“With these solid results as a foundation, we have taken a big step closer to our vision - to make inhaled sedation a new standard method in intensive care units around the world. We are proud that the strong results are presented at the leading congress, ESICM LIVES, arranged by the European Society of Intensive Care Medicine,” said Christer Ahlberg, CEO of Sedana Medical.

The study was conducted at 23 centres in Germany and Slovenia and included 301 critical care patients in need of sedation. Half of the patients were treated with Sedaconda, delivered via AnaConDa, and the other half were treated intravenously with propofol. The safety for Sedaconda was consistent with the known safety profile of isoflurane. The results form the basis of Sedana Medical’s marketing approval application that was submitted on November 26 to the German Medicines Agency, BfArM, and several other European medicines agencies. Sedana Medical expects an approval in the second half of 2021.

For additional information, please contact:
Christer Ahlberg, CEO, Sedana Medical
Mobile: +46 70 675 33 30
E-mail: christer.ahlberg@sedanamedical.com

Peter Sackey, CMO of Sedana Medical
Mobile: +46 70 771 03 64
E-mail: peter.sackey@sedanamedical.com

Sedana Medical is listed on Nasdaq First North Growth Market in Stockholm.
The company's Certified Adviser is Erik Penser Bank, +46 8 463 83 00, certifiedadviser@penser.se.

The information was released for public disclosure, through the agency of the contact person above, on December 8, 2020 at 08:00 am (CET).

About Sedana Medical

Sedana Medical AB (publ) develops and sells the medical device AnaConDa for the administration of volatile anaesthetics. Through a combination of AnaConDa and the drug candidate Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated intensive care patients. The company has applied for marketing approval in Europe for Sedaconda and expects an approval in 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. Globally, seven to eight million patients are estimated to be sedated in intensive care due to mechanical ventilation, evenly distributed between the US, Europe, and Asia. These patients are on average sedated three to four days. Sedana Medical estimates the total market potential to SEK 20-30 billion. Three years after marketing 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 processes to obtain marketing approval in the US in 2024 and also in markets outside the EU.

Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordics and Spain as well as external distributors in other parts 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.