Sedana Medical is a Swedish medical technology company that was founded in 2005 after acquiring the AnaConDa from Teleflex. The AnaConDa technology was originally developed by Louis Gibeck AB, a leader in heat and moisture exchangers. Our headquarters are based in Danderyd outside Stockholm in Sweden and in Ireland, where the company has its headquarters for R&D. The company’s business includes the development, marketing and sale of medical devices and drug development for future projects around AnaConDa. The Anaconda technology enables safe and simple delivery of volatile anaesthetics to invasively ventilated patients. The company’s product range includes AnaConDa and AnaConDa-S with relevant accessories.
What have been the milestones so far in your company development?
We have achieved yet a number of important milestones in 2019:
– In March, we announced positive results from the interim analysis for our pivotal phase III study aimed at getting the candidate drug IsoConDa (isoflurane) approved for inhalation sedation in intensive care in Europe. The results imply the study will only need to cover a total of 300 patients instead of initially estimated 550 patients.
– In the beginning of the year our planned pediatric study was approved which means our filed registration documentation for the IsoConDa is now complete (i.e. also covers children) and thus a market approval in Europe would imply ten years of market exclusivity in Europe for the use of isoflurane in sedation in intensive care. During this period no competitor will have the opportunity to sell or market isoflurane for this purpose without having themselves undergone the same procedure as Sedana Medical.
– In April, we announced that the US Food and Drug Administration (FDA) is positive about the combination registration of IsoConDa and AnaConDa in the US.
– In May, we announced that the first patient in Japan was treated with AnaConDa and that the registration work for IsoConDa in Japan had been initiated.
– In June, we announced a 10-year exclusive distribution agreement with the Chinese distributor Kyuan Xinhai Medical, a subsidiary of partly state-owned Shanghai Pharma, the second largest life science company in China.
What are your most important markets, segments and customers?
We have developed and sell the medical device AnaConDa used for administration of volatile anaesthetics to mechanically ventilated patients in intensive care units, ICU, around the world. We have direct sales in the Nordic countries, Germany, France, Great Britain and Spain as well as external distributors in many countries in Europe, Canada, Australia, Japan and South Korea. Our vision is global reach which is possible as ICU:s look almost the same and follow the same procedures and routines almost all over the world.
Germany is currently our most important market (some 85 percent of sales) where we have over 500 ICU:s using our therapy. You could call Germany our test-bed. The AnaConDa has a CE-mark to be used as a medical device. However, our pharmaceutical candidate IsoConDa (isoflurane) is still off-label which means that usage is up to the treating doctor.
A major clinical registration study is currently ongoing to obtain market approval in Europe for inhalation sedation in intensive care units with IsoConDa. We have also initiated the registration process for AnaConDa and IsoConDa in USA during this year.
Where do you see the company five years from now?
Our interim goals are to register IsoConDa in Europe 2021, market approval in the US in 2024 and to establish ourselves in the major markets in Asia. The goals are a first step towards our vision to make inhalation sedation with AnaConDa and IsoConDa a standard treatment for mechanically ventilated patients in intensive care, ICU:s, throughout the world.
IsoConDa in Europe 2021
To ensure that we reach our goal of including the last patient in our pivotal phase III IsoConDa study around the turn of the year 2019/2020, we recently added three new sites in Slovenia where our therapy is already well used. At the current rate of inclusion of patients in study we expect to be able to submit an application for market approval in the summer of 2020 in 16 European countries in a first round of registration. If all goes well, we can have a European market approval in the second half of 2021.
Market approval in the US in 2024
During a pre-IND meeting this spring, the US Food and Drug Administration (FDA) was positive about the combination registration of IsoConDa and AnaConDa in the US and after the meeting we now have a clear view of measures that have to be taken in order to reach marketing authorization approval of both IsoConDa and AnaConDa in the US. The meeting also confirmed our estimate of the time and cost of a US approval that is expected to occur in 2024. Around 2022 we will decide whether to launch ourselves or together with local partners.
Major markets in Asia
We have recently taken important steps in China and Japan and will continue to build presence in other Asian countries continuously, mainly through partnerships.
What are your priorities within 2019/20?
We are working to increase awareness about and use of the AnaConDa, and to establish presence in several countries in Europe. Our plan is to be represented in several European markets with established networks and reference clinics at the time of approval of the IsoConDa in order to quickly be able to penetrate the market.
During this year we have intensified our efforts and are developing our sales and marketing department to prepare for the launch of IsoConDa with our own sales organization in the largest European markets. In the US we have initiated the recruitment of people who will focus on registration and we intend to set up a company in the US for the management of the studies, registration and market access. In close cooperation with relevant consultants and US key opinion leaders we are preparing the studies required by the FDA.
Why should one consider adding your company into their portfolio?
Our company has a unique position within a growing field. Inhalation sedation has many clinical benefits compared to intravenous sedation. Earlier this spring, we updated our estimate of the total market potential for inhalation sedation in intensive care to SEK 20-30 billion annually, evenly distributed between the USA, Europe and Asia. Three years after the registration of IsoConDa in Europe, our ambition is that annual sales should exceed SEK 500 million and the EBITDA margin be around 40 percent.