A new study has confirmed the practical advantages and marketing potential of Admedus Limited’s (ASX:AHZ) unique CardioCel heart reconstruction technology.
A preclinical trial undertaken at KU Leuven University in Belgium indicated successful valve reconstructions and supported the use of CardioCel in the complete reconstruction of aortic heart valves.
The study is important in that it clearly show the benefits of reconstructing heart valves with CardioCel compared to using a bio-prosthetic valve. It also illustrated the benefits of Admedus’ ADAPT tissue engineering process and its ability to produce superior regenerative tissue products.
“The results from the study are very positive and some of the best results we have seen in this model,” KU Leuven lead researcher Professor Bart Meuris said.
This report aims to address the disadvantages found with existing bio-prosthetic valves and emphasises the unique potential for CardioCel to penetrate a global, underserviced market.
CardioCel is currently on the market in the U.S., Canada, Singapore and Europe, and is available to surgeon via special access schemes in Australia and other parts of Asia.
It is used in in 110 heart centres.
CardioCel is a type of cardiovascular bio-scaffold that can be used to repair congenital heart deformities and more complex heart defects.
It is used to repair diseased paediatric and adult hearts. These repairs range from routine hole-in-the-hear operations to major vessel outflow tract repairs.
A step forward
Specifically, the latest CardioCel study focused on aortic tri-leaflet reconstruction and examined nine leaflets replaced in three sheep. Leaflets are cusps connected to the aortic valve.
The results showed either no or minimal calcification. Only minimal calcification was seen around the sutures and a commissure. In addition, the valves were competent, demonstrating positive haemodynamics, with no leakage and excellent coaptation of the leaflets post reconstruction.
After six months, new collagen had formed on both sides of the leaflet as a clear sign of post-surgery remodelling around CardioCel, with host fibroblasts detected within the CardioCel bio-scaffold.
The six month time-frame in sheep is representative of more than 10 years of data in adult patients.
This work will support a recently announced follow-on study on aortic tri-leaflet heart valve reconstruction using CardioCel in Europe and the U.S.
KU Leuven has already received ethics approval to participate in this clinical trial.
The case for CardioCel
CardioCel overcomes problems associated with current materials on the market by providing surgeons with a tissue bio-implant that is not only durable, but its natural flexibility and elasticity makes it easier to handle and use and so allows surgeons to more easily work on complex cardiac repairs and their continuum of care.
The lack of calcification in the patients addresses one of the key issues with other existing tissue products and is a key milestone for the technology.
Although traditional treatment using prosthetic valves have improved on earlier technologies, they still do not enable full motion of the aortic valve and root. They therefor result in suboptimal haemodynamics and can require multiple replacements throughout a patient’s life.
In contrast, reconstructing the heart valve with CardioCel has the potential to be a life-long solution and patients can be treated by earlier intervention before requiring a replacement bio-prosthetic or mechanical valve.
In addition, a combination of improved haemodynamics, lack of calcification and post-implant remodelling as also seen with reconstructing the valves with CardioCel in previous studies, has the potential to address all of the disadvantages of existing bio-prosthetic valves and reconstruction techniques that utilise other tissues including autologous tissue.
Recent progress in adapting CardioCel to specialise uses has included the development and release in September of a smaller, 2cm by 2cm model. This adds to the existing manufactured and commercially available 4cm by 4cm, 5cm by 8cm and 2cm by 8cm materials.
The release of the 2cm x 2cm model was part of a strategy to offer a complete range of CardioCel products for all cardiovascular repairs and reconstructions.
Along with this latest research, validation for Admedus’ ADAPT platform has included a recent collaboration with leading regenerative stem biology institute Ear Science Institute Australia (ESIA) on delivery of stem cells on ADAPT tissue in both in vitro and in vivo models.
The studies will investigate a range of bone marrow derived mesenchymal stem cells and adipose derived stem cells delivered on a variety of ADAPT treated tissues.
On identifying the most suitable stem cell population, Admedus will undertake separate models of tissue regeneration, including functional remodelling of the heart after myocardial infarct (heart attack).
These studies are in line with Admedus’ strategy to bring a range of ADAPT based products to market.
Progress in applying adapt in bio-scaffold tissue engineering as well as a delivery platform for stem cells and other cellular therapies demonstrates that the process can be tailored to meet market demand.
Separately, Admedus is developing a suite of vaccines that treat and prevent infectious diseases and cancers caused by Herpes Simplex Virus and Human Papillomavirus (HPV).
Admedus is focused on commercialising a new era of therapeutic vaccines, with the HPV therapeutic vaccine progressing well in preclinical studies.
The unique delivery mechanism of the vaccine ensures that there is a stronger and more effective immune response creating both a therapeutic (treat) and prophylactic (prevent) effect.
This adds value to the company given that 1 in 6 people aged between 14 and 49 in the U.S. are estimated to be infected with HSV, which has no present cure.
As such, a vaccine could potentially address a market worth more than US$6 billion.
The latest CardioCel study data is important in that it confirms the viability and variability of the ADAPT process as well as the practical advantages of Admedus’ product versus conventional heart reconstruction therapies.
The results indicate a range of treatment possibilities in both paediatric and adult patients.
Admedus has demonstrated its ability to penetrate an important global market, with commercialisation of its innovative technology on four continents.
Further technical advantages of CardioCel could be revealed with better understanding of the possible role of stem cells in tissue regeneration. The product therefor has potential to facilitate endogenous stem cells and other cells to regenerate and repair damaged tissue.
Results of the company’s ongoing HSV studies are set to further bolster the company’s market position before the end of the year.
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.