Admedus Limited (ASX:AHZ) is expanding its regenerative tissue portfolio into additional large target repair markets following successful initial results from a pre-clinical study of ADAPT® treated tissue in the repair of dura mater.
Dura mater is the outer membrane enveloping the brain and spinal cord which is often damaged during traumatic brain injuries.
The company will progress this program into the next study as it advances the product towards market approval.
“Expansion of our regenerative tissue portfolio into dura mater repair is an exciting and important step in the development and growth of Admedus,” chief executive officer Lee Rodne said.
“With the commercial success that we're achieving with our lead product CardioCel®, it's now an opportune time to expand our regenerative tissue portfolio into additional large target repair markets such as dura mater repairs.
“These initial results are very encouraging and show the potential for ADAPT® tissue engineered dura mater in this market.
“The results are consistent with what we already know about ADAPT® treated tissue, with its improved biocompatibility, strength and handling properties combining to give this product a definite edge in the dura mater repair market”
Dura Mater Study
The study was undertaken in conjunction with Charles Sturt University in Wagga Wagga and a neurosurgeon from Melbourne University. It investigated the use of ADAPT® tissue in the repair of dura mater.
The results demonstrated excellent post-operative responses with no longer term negative outcomes, no fluid leakage or post-operative infections, while proving to be an excellent replacement for surgical procedures.
The initial results of Admedus’ pre-clinical study showed that after one month post implantation, the ADAPT® treated tissue repairs demonstrated:
- No signs of post-operative infection;
- No leakage of cerebrospinal fluid (CSF);
- No signs of post-operative chemical meningitis; and
- No signs of tissue rejection.
Post-operative infections, CSF leakage, meningitis and tissue rejection are all issues which affect the existing, on-market products used in the repair of dura mater, and the results of this study show the potential of the product in the market.
ADAPT® treated tissue has the added benefit of being ready to use off the shelf without the need for pre-implant preparation or rehydration.
Furthermore, after one month, the repairs showed the initial stages of integration into and around the implanted ADAPT® treated tissue, a key factor in the longer term treatment of patients who have undergone dura mater repair.
Admedus will complete additional histology studies on the explanted tissues while progressing to the next study to support a product regulatory filing for market approval.
Additional study data will be prepared for presentation at a conference in the future.
Market for expansion
The dura mater is the outer membrane enveloping the brain and spinal cord which is often damaged during traumatic brain injuries (TBI).
In the US alone, it is estimated that there are almost 1.7 million traumatic brain injuries each year, with the Centre for Disease Control estimating around 275,000 hospitalisations per annum.
Following on the commercial success of its CardioCel® product for the repair of congenital heart deformities and complex heart defects, Admedus is now expanding its ADAPT® tissue products into the repair of dura mater - the outer membrane enveloping the brain and spinal cord.
This is now being advanced towards market approval.
Admedus continues to advance the process to produce implantable tissue scaffolds for use in various soft tissue repair applications.
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