Admedus Ltd (ASX:AHZ) has begun a preclinical study which will compare anti-calcification properties of its proprietary ADAPT® treated tissue with other bovine and porcine tissues used in commercially available SAVR and TAVR valves.
Calcification plays a significant role in the failure of bioprosthetic and other tissue heart valve substitutes.
The study will be conducted in Minneapolis, USA, at a world-renowned preclinical facility with the aim being to evaluate anti-calcification properties in the established subcutaneous rat model.
Around 48 rats will be implanted and harvested implants will be processed for histological and calcium/phosphorus analysis initially at the end of four months.
Step towards commercialisation
Chief executive officer Wayne Paterson said: “Collecting and building data proving superiority of ADAPT® tissue against current treatments in the TAVR market is an important step towards ultimate commercialisation.
“Such data builds a positive benefit-risk profile for new ADAPT® treated tissue products, for which regulatory initiatives may reveal a fast path to market.”
Second patient implanted in SAVR trial
Earlier this month Admedus implanted an ADAPT® treated DurAVR 3D single-piece aortic valve in a second patient at the University Hospitals Leuven, Belgium, in its first-in-human surgical aortic valve replacement (SAVR) study.
The first patient was implanted in April and Admedus chief executive officer Wayne Paterson said both patients were recovering well.
He said: “The firstRead More – Source