Admedus (ASX:AHZ) yesterday released results from the Phase II extension study of its CardioCel regenerative used to repair congenital heart defects in pediatric patients, touting no signs of calcification or need for repeat procedures.
Admedus’ CardioCel bio-scaffolds are regenerative tissue patches designed for cardiac and vascular repairs and reconstructions and promote autologous growth.
“This is a significant progression in the congenital heart surgery market. It is well known that other tissue patches on the market can calcify within 18 months post-implantation in pediatrics, making the results from our long-term CardioCel study exciting,” interim CEO Wayne Paterson said in prepared remarks.
The lead patient in the trial has been implanted for 8.5 years, with another 4 patients at 7 years, 6 patients over 6 years and 3 for greater than 5 years, Australia-based Admedus said. The company touted data from the trial as the longest term reported follow up study of congenital defect pediatric patients.
“This is very important data as we continue to roll-out CardioCel globally, and push into the adult cardiac and vascular markets. We are confident that we have a best in class product and this data will assist our ongoing global sales push,” CEO Paterson said in a prepared statement.
In May, Admedus said it won a supply contract with the new Royal Adelaide Hospital for the installation of the Arcomed chroma infusion pump systems.
Swiss infusion technology company Arcomed’s Chroma infusion pumps are designed to provide a whole-of-hospital system and include LCD touch screens, drug error reduction systems and on-screen color coding of medication, Admedus said.
The supply tender includes ongoing technical and clinical support as well as consumable products for the systems over the next 5 years.