Admedus Limited (ASX:AHZ) has started a clinical study into aortic tri-leaflet heart valve reconstructions using its cardiovascular bio-scaffold CardioCel following a successful pre-clinical study.
The study will address aortic stenosis, or narrowing, which is the most common valvular heart disease in developed countries.
It gives surgeons access to a bio-prosthetic tissue that can withstand this high pressured area within the heart, not calcify and facilitate host tissue regeneration.
The pre-clinical study was undertaken in conjunction with KU Leuven University in Belgium.
The study, which will further support the use of CardioCel in heart valve repair and reconstructions, will be undertaken in four leading heart centres in Europe and the U.S.
A total of 80 adult patients will be recruited with initial cases already enrolled.
The primary safety endpoint for the clinical study is to ensure same rates of in-hospital survival, while also looking for superior long-term benefits for patients, better haemodynamic outcomes, cell infiltration, regrowth of native tissue and long-term durability without calcification.
Admedus has already been very successful in its initial launch strategy of introducing CardioCel to leading congenital centres in the U.S. and Europe with over 95 centres now using it to treat congenital heart defects.
Lee Rodne, chief executive officer, commented:
“Off the back of a very successful pre-clinical study, we have now commenced a clinical study to provide further data to use CardioCel for complete aortic valve reconstructions.
“This is an important study in aortic valve reconstruction, which has never been done before with a bio-prosthetic tissue like CardioCel.
“We believe the results will highlight the patient benefits of completely reconstructing the aortic valve with CardioCel compared to the current industry need of replacing it multiple times throughout a patient’s life.”
The study involves surgeons using CardioCel to reconstruct the three leaflets of the aortic valve as an alternative to replacing it with a bio-prosthetic valve.
This provides an opportunity for autologous repair and the potential for patients to have a ‘native’ valve with better haemodynamic outcomes and overall improved health benefits compared to a replacement valve.
Aortic stenosis is the most common valvular heart disease in developed countries, with the incidence rate of around 25% in people over the age of 65 and prevalence increasing with age.
Last year, there were 165,000 aortic valve replacement surgeries undertaken in the U.S. alone.
While these were symptomatic patients, Admedus expects the market size for valve reconstruction will be larger once the benefits of treating patients earlier and more effectively is recognised.
Domenico Mazzitelli, cardiac surgeon and clinical study lead at the German Heart Centre Munich, commented:
“As a surgeon, you often ask yourself are we really repairing the valve or are we just delaying the next heart valve operation or replacement.
“Where most patients with symptomatic aortic valve disease will be delayed to surgery, this study could prove that CardioCel could offer earlier intervention, with possible life-long benefits.”
The study will enrol 80 adult patients at two European and two U.S. sites, with initial cases already enrolled in the first week post ethics approval.
Ethics approval has been received for the two European centres, KU Leuven University in Belgium and the German Heart Centre Munich, with U.S. ethics approval expected in the coming months.
“While a majority of current aortic valve procedures follow the replacement strategy, we hope to show that reconstructing the valve with CardioCel is superior to replacing the valve and provides patients with long-term health benefits,” Rodne added.
Patients in the clinical study will be reviewed 6, 12 and 24 months post-surgery to evaluate safety data and primary and secondary endpoints.
The clinical study into complete aortic valve reconstruction using CardioCel represents the introduction of a disruptive technology into an existing multi-billion dollar market.
It has the potential to provide a long term benefit for patients instead of an ongoing cycle of replacement after replacement.
This is a key milestone in Admedus’ commercial strategy of launching CardioCel initially in the top paediatric centres in treating congenital heart defects and then expanding into the larger adult markets.
Notably, it could expand the use of CardioCel, which will in turn generate more revenue for Admedus.
Demonstrating this potential, the market in the U.S. along is around 165,000 procedures per annum compared to 60,000 for congenital heart disease.
This could build CardioCel as the gold standard regenerative tissue product for adult heart valve reconstructions and will provide further data for global surgeons to be able to repair a heart valve with CardioCel vs the need for these patients to have go through multiple replacement valves throughout their lifetimes.
In addition, most of the procedures are carried out on adults and the study could complement other heart valve markets such as the mitral valve repair market where about 180,000 procedures are performed annually.
Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.