MDT-Q3-Report-Extract.pdf CardioCel is an implantable...

MDT-Q3-Report-Extract.pdf

CardioCel is an implantable bio-prosthetic patch developed using Admedus’s ADAPT tissue engineering
process, which creates tissue that mimics the characteristics of normal human tissue. This process
promotes a more tolerant immune response with improved tissue growth.
CardioCel is a single-ply, bio-scaffold material that remains functional, durable and free from calcification.
The bio-scaffold is used to repair congenital heart deformities and more complex heart defects, as well as
to reconstruct dysfunctional heart valves and valve leaflets. The next generation version of the device,
CardioCel 3D, has a pre-shaped curve which provides physicians immediate access to an off-the-shelf arch
reconstruction solution with non-antigenic response and calcification resistance.
CardioCel 3D was first approved in Europe in November 2015. CardioCel 3D received 510(k) clearance
from the U.S. Food and Drug Administration (FDA) in April 2017 for aortic arch repair, and was launched
in the U.S. in February 2018. A month later in March 2018, Admedus received regulatory approval for the
CardioCel 3D in Canada.
Admedus expects to receive Australian Therapeutic Goods Administration (TGA) approval for the
CardioCel 3D in third quarter of 2018. This Australian approval is significant because it allows Admedus to
launch ADAPT products in Australia, which are currently only available under the TGA's Special Access
Program. The first successful implantation under this program was performed at the Melbourne's Royal
Children's Hospital in Australia in June 2017. While the Australian market size is limited by its population
size, the TGA approval will facilitate faster regulatory approvals in much larger market opportunities in
Asia and the Middle East.
TGA approval is expected to occur, especially since CardioCel 3D is already being used in Australia under
the Special Access Program. Also, the recent U.S. and Canadian approvals will most likely be a factor in
the TGA decision making, and its successful use abroad will support the Australian approval. With
CardioCel 3D already available in multiple regions, this TGA approval decision will be the last major
milestone in launching CardioCel 3D globally.

Imo the next week or two