Using the ADAPT engineering process to create durable tissue scaffolds
8, July, 2016
Admedus is an Australian-based healthcare company leading the world in regenerative medicine and tissue engineering research. Using its proprietary ADAPT® tissue engineering technology, Admedus can transform xenograft (animal) tissue into durable bio-scaffolds that can be used for soft tissue repair within patients.
The medical technology was first brought to Australia over 20 years ago by cardiothoracic research scientist Professor Leon Neethling, whose career has been spent finding ways to enable xenograft tissues to be tolerated by the human body. In particular, Professor Neethling wanted to find an alternative to glutaraldehyde treated pericardial tissue, which is known to result in calcification (hardening) at the site of repair, leading to complications for patients such as rejection of the patch and the need for repeat surgery.
Through a series of patented steps (covered in the diagram below), the ADAPT® tissue engineering process decellularises xenograft tissue, leaving behind a durable, bio-compatible scaffold which can be implanted in the body and facilitate a reparative healing process.
The first ADAPT® tissue product commercialised by Admedus is CardioCel®, a cardiovascular bio-scaffold used to repair and reconstruct heart defects. CardioCel® is now approved for sale and used by leading heart centres in Europe, the US, Canada, Hong Kong, Malaysia, Singapore, Middle East and North Africa Region. CardioCel® is also available under the special access scheme in Australia and other select countries. Long-term implantation data shows that CardioCel® exhibits no detectable calcification after 7 years which is important for a durable repair. CardioCel® has been increasingly used by surgeons to reconstruct heart valves, rather than replacing them with a bio-prosthetic, due to the improved natural function/movement the ADAPT® treated tissue offers.
The ADAPT® tissue engineering process
Admedus’ proprietary ADAPT® technology relies on a unique process for eliminating phospholipids from harvested bovine pericardium, followed by treatment to remove antigens and glutaraldehyde processing to enhance durability. Finally, a detoxification procedure is performed to remove any residual treatment materials, and the samples are rinsed in a final sterilisation solution that also serves as a packaging solution for transport and storage at the surgical facility.
ADAPT® treated tissue offers a wide range of applications, and its core patents are protected beyond 2030.
Benefits of ADAPT® treated tissue
Tissue bio-scaffolds developed using the ADAPT® tissue engineering process more closely mimic the characteristics of normal human tissue, including a more tolerant immune response and improved tissue ingrowth post-implant. One of the most important benefits of ADAPT® treated tissue is that it does not calcify, meaning that is has significantly improved functionality and longer-term durability over glutaraldehyde treated tissue. With the potential for a product lifespan free from calcification, clinicians can potentially intervene across a broader age spectrum and provide their patients with a solution for life.
ADAPT® regenerative tissue product portfolio
CardioCel®, a cardiovascular bio-scaffold, is the first in a suite of implantable tissues to be generated using the ADAPT® engineering process. CardioCel® is used by surgeons around the world to repair congenital heart deformities and more complex heart defects, it is also used to reconstruct dysfunctional heart valves and valve leaflets. Admedus hopes that in the future, CardioCel® may also be used for the manufacture of replacement tissue heart valves.
Ongoing tissue engineering research and development is underway to develop additional ADAPT® products over the coming years for various applications including vascular repair, dura mater repair and even for transplanting stem cells around the body. The commercialisation of a vascular product franchise would complement CardioCel® sales in the cardiovascular surgical repair and reconstruction market, and is intended for procedures such as repairing the carotid arteries to reduce the incidences of stroke. The vascular repair market represents a significant potential market with an estimated 180,000 carotid endarterectomies performed each year in the USA.