After a period of travel restrictions, Realheart intends to resume its animal studies. They are conducted at the Medanex Clinic in Belgium, the same place where previous trials have been done.
This spring, Realheart had to cancel the animal studies due to the corona crisis travel restrictions. Since then, Realheart has worked intensively with adjusting the heart pump based on FDA requirements and conducting research focusing on blood tests among other things. Before the turn of the year, trials on animals are planned to be resumed with the aim of moving over to long-term trials during the first half of 2021. The surgeries, where Realheart's artificial heart is transplanted into sheep, take place at Medanex Clinic in Belgium, one of few clinics in Europe approved by FDA.
Belgium's borders are currently open, but covid-19 is a difficult-to-predict pandemic and new restrictions may be imposed. The company is in close dialogue with the clinic and if it is not possible to start before Christmas, there is readiness to temporarily perform the trials at another clinic or find new dates further on.
For more information please contact:
Azad Najar, CEO
Phone: +46(0)736 673 463
Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atriums and two chambers) which provides the opportunity to generate a physiologically adapted blood flow that mimics the body's natural circulation. A unique concept in the medical technology world.