Sedana Medical announces positive FDA interaction
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has completed a successful End of phase II meeting with the US Food and Drug Administration (FDA). The FDA accepted Sedana Medical's proposals for phase III program, including study design and primary endpoints for the studies. This positive outcome means that the company can enter phase III in line with the communicated schedule.
Sedana Medical is working to submit an IND during the fall and expects to receive an approval to conduct two randomized, controlled trials involving approximately 250 patients each, to confirm and ensure safety and efficacy. As previously announced, Sedana Medical aims to include the first patients in the studies at the turn of the quarter Q1/Q2 2022 and to receive market approval before the end of 2024.
"The interactions with the FDA have been very constructive and we have also received good support from the principal investigators in our upcoming phase III program. The interest in participating in the studies has been noticeable from a large number of leading US centers. We aim to include about 30 US centers and look forward to starting the inclusion of patients," said Jens Lindberg, Acting CEO of Sedana Medical.
The purpose of an End of phase II meeting is to discuss the documentation prior to phase III and to agree on the plan and design of the studies in phase III.
For additional information, please contact:
Jens Lindberg, Acting CEO, +46 72 531 11 17
Susanne Andersson, CFO, +46 73 066 89 04
ir@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.
This information is such that Sedana Medical AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person above, on July 7, 2021, at 15.00 (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 market 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 market approval in the US in 2024 and in markets outside the EU.
Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordic 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.