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 first patient, implanted with DurAVR™ 3D single-piece aortic valve on March 26, 2020, is doing well, over a month post-implantation and patient two is recovering as expected.
“Given the challenges that the COVID-19 pandemic is presenting for hospitals, it is encouraging to see the second surgery completed.
“We are grateful to the surgeon and the patient for undergoing the procedure.”
Fifteen patients are to be enrolled in the study and followed up for six months after implantation.
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