First patient enrolled in SESAR study on lung protection

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that that the first patient has been included in SESAR, the world's largest multicenter study with AnaConDa to evaluate whether inhaled sedation via AnaConDa has lung-protective properties, promotes shortened ventilator time and higher survival in intensive care patients with acute respiratory failure. An addendum to the study has recently been made to study covid-19 patients in a separate sub-study.

As previously announced, Sedana Medical provides financial support to SESAR, a prospective, randomized and controlled study comparing inhaled sedation and intravenous sedation. The study is conducted in 30 different intensive care units in France and covers 700 patients with Acute Respiratory Distress Syndrome acute (known as ARDS). Up to 30 percent of mechanically ventilated patients in an intensive care unit suffer from ARDS, a serious condition with 35-45 percent mortality. In addition, ARDS is a condition that often affects severely ill covid-19 patients. After an addendum to the study protocol, covid-19 patients with ARDS will be included as a subpopulation in the study.

“It is gratifying that the Clermont-Ferrand research team was able to get the study started on schedule despite the ongoing pandemic. If this large study turns out positive, it will dramatically change the view of inhaled sedation in relation to intravenous sedation. If the results of the study support the hypothesis that inhaled sedation via AnaConDa has therapeutic effects, leads to shorter ventilator treatment and a higher survival rate, it is an important breakthrough for ICU patients with severe lung disease worldwide," said Christer Ahlberg, CEO of Sedana Medical.

The study compares the current intravenous standard therapy propofol with inhaled sedation with sevoflurane via AnaConDa. A previous smaller study from the same research group showed that inhaled sedation was associated with improved lung function in patients with ARDS. The same effects have also been shown in several animal studies.

“There are reasons to believe that the effects studied in this trial are class effects of inhaled anesthetics. It is of minor importance that the study is conducted with sevoflurane and not isoflurane that IsoConDa contains. It is also very interesting that a study now prospectively and randomized investigates the effects of inhaled sedation in Covid-19 patients with ARDS,” said Peter Sackey, CMO of Sedana Medical.

The study is mainly funded through a grant from the French Ministry of Health. Sedana Medical will provide the investigators in this study with AnaConDa and related equipment, but also with education in the therapy before and during the study. The main study is expected to take three years to complete. Sedana Medical has previously provided support for studies that, in addition to its own pivotal studies, in the long term contribute to a strong scientific support for inhaled sedation with AnaConDa.

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

Peter Sackey, CMO, Sedana Medical AB
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 May 15, 2020 at 10.00 a.m. (CET).

About Sedana Medical

Sedana Medical AB (publ) has developed and sells the medical device AnaConDa, for the administration of volatile anaesthetics to mechanically ventilated patients. A major pivotal study is currently ongoing to obtain market approval in Europe for inhaled sedation in intensive care units with the pharmaceutical IsoConDa® (isoflurane). The company expects the registration of IsoConDa in Europe to take place during the second half of 2021. Three years thereafter Sedana Medical expects sales of SEK 500 million in Europe and an EBITDA margin of about 40 percent.

The market for Sedana Medical’s sedation therapy of AnaConDa and IsoConDa consists primarily of sedation of mechanically ventilated intensive care patients. Today, these 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. The company has initiated a process to obtain market approval in the US in 2024. Registration activities are also 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.

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About Us

Sedana Medical AB (publ) has developed and sells the medical device AnaConDa, for the administration of volatile anaesthetics to mechanically ventilated patients.A major clinical registration study is currently ongoing to obtain market approval in Europe for inhalation sedation in intensive care units with the pharmaceutical IsoConDa® (isoflurane) Sedana Medical has direct sales in the Nordic countries, Germany, France and Spain as well as external distributors in the rest of Europe, Middle East, Canada, Australia and South Korea. The company headquarters are based in Stockholm, Sweden with R&D operations in Ireland.

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