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http://www.syndication.business.gov...oduction-ramps-up-for-heart-repair-patch.aspx
Admedus’ CardioCel® is a tiny medical patch made using parts of a cow’s heart, which can repair holes and other heart defects in patients and can potentially be used across a broad range of cardiovascular repair applications. Cut to size, the patch is placed over the damaged area like the patch for a tyre tube, and eliminates the need for further surgery down the track.
So far, the patch has a perfect track record in repairing the hearts of young children.
“The first patient implanted in the Phase II study had a complex cardiac reconstruction using CardioCel® when they were only three weeks old and weighed just three kilograms,” said Chief Operating Officer Dr Julian Chick. “The patient, who is now six years of age, has no detectable calcification (using electrocardiograph imagery) in the implant and remains well.
“Now on the market in the European Union and United States for congenital heart disease and cardiovascular repair in adults and children, CardioCel® to date has shown no calcification or other complications such as rejection and research shows that it enables a ‘self’ regeneration around the tissue.”
Admedus’ CardioCel®
Some 33 years after the initial concept, the company opened its production facility in Malaga in August.
Each tiny patch takes about four weeks to make and the company says it can produce about 120 at a time.
“At full capacity we estimate that the new manufacturing site will produce over 100,000 units per year within five years,” Dr Chick said.
“CardioCel® is the first of a suite of implantable tissues that our scientists are developing from our patented ADAPT tissue engineering process,” he said.
With the company having already gained access to the US and European markets, it shipped the first patches manufactured at the facility to the USA a week prior to the opening.
Admedus received a $1.9m grant from the Australian Government in 2013 to assist with research and development during the development of CardioCel® and the process of getting FDA approval.
“The grant provided significant financial support for the preparation work required to launch CardioCel® into global markets, and we’re very grateful to the Government for this funding,” said Admedus Managing Director Lee Rodne.
The grant also generated an additional 12 production jobs for the company, bringing the total number of employees to 60, some based in Europe and the US.
“In Europe alone, there are approximately 100,000 cardiovascular surgical procedures in adults and children, in which our tissue patch could be successfully applied,” Dr Chick said.
Admedus scientists are also working with Professor Ian Frazer - widely known for his work on the development of Gardasil, the first prophylactic cervical cancer vaccine - on the development of therapeutic vaccines that combat infectious diseases and cancers, such as the Herpes Simplex virus and Human Papillomavirus.
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