Då tyvärr en felaktig information om tidplan vad gäller kliniska prov på människa förekommer i media så förtydligar vi härmed den korrekta tidplanen.
Vi planerar, som vi tidigare kommunicerat, att under våren 2017 genomföra ytterligare korta prover på senaste hjärtpumpen modell 11 innan vi går vidare till långa djurtester. Långa djurtester planeras med start tidigast i maj 2017.Om utfallet efter dessa prover är positiva kommer vi att starta upp de nödvändiga processerna inför kliniska studier på människa.
Kliniska prov på människa kräver lång förberedelse inklusive långstidsprov på certifierat laboratorium.Vi bedömer därför att människoprover tidigast sker under andra halvan av 2018 i enlighet med vad vi tidigare har kommunicerat.
Mer detaljerad korrekt information om nuläget och våra framtida planer finns uppdaterad på vår hemsida, www.realheart.se.
För mer information kontakta:
Azad Najar, VD
Telefon: 021-475 55 50
e-post: azad.najar@realheart.se
Denna information är sådan information som Real Heart är skyldig att offentliggöra enligt EU:s marknadsmissbruksförordning.Informationen lämnades, genom ovanstående kontaktpersons försorg för offentliggörande den 8 februari 2017.
Om Scandinavian Real Heart AB – Endast cirka 5 000 hjärttransplantationer sker årligen i hela världen och tillgången på donerade hjärtan är mycket begränsad. Behovet är stort och patienter med hjärtsvikt avlider i väntan på ett nytt hjärta. Scandinavian Real Heart AB utvecklar en hjärtpump (TAH) som efterliknar kroppens naturliga cirkulation och som ska kunna användas som en övergångslösning för patienter som väntar på en hjärttransplantation.
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