06.10.14
The U.S. Food and Drug Administration has given Admedus Ltd. its blessing to market a regenerative tissue product in the United States that can repair and treat cardiovascular and vascular defects in adults and children.
“This is a significant milestone for the company as we expand into global markets and further develop our range of regenerative tissue products for commercialization and sale,” Admedus CEO Lee Rodne said. “CardioCel is an important addition to the surgeon’s armoury in the treatment of congenital heart disease, as well as for the repair of heart valves and other cardiac defects.”
Having won approvals for CardioCel from both the United States and Europe, Admedus now will work to enter the Asian market as well as other jurisdictions.
“Admedus is looking forward to 2014/15 as we launch CardioCel globally and continue to grow our sales revenue and cardiovascular teams in these regions,” Rodne said.
CardioCel is a cardiovascular scaffold that can be used to repair congenital heart deformities and more complex heart defects. The CardioCel scaffold potentially can be used to repair and reconstruct dysfunctional heart valves and valve leaflets, with longer term possibilities for use in the manufacture of replacement tissue heart valves. CardioCel provides surgeons with a tissue bio-implant that is durable, naturally flexible and easy to handle, according to the Australian company. The product was created using the company’s ADAPT technology, which allows animal tissue to be prepared for human use without calcification issues.
Admedus has three business segments: the medical products segment, which earned about $750,000 from revenue of $7.39 million in FY 2013, (a 10 percent profit margin); the CardioCel division; and the segment working to develop a Herpes Simplex Virus (HSV-2) vaccine. HSV-2 is the virus that commonly causes genital herpes; Admedus hopes the vaccine also could help people who already have contracted HSV-2.
In Australia, CardioCel was approved for the correction of congenital heart defects in children. In FY 2013, the company booked revenue of $12,000 from sales of CardioCel, and six surgeons used CardioCel in “around 60” operations from October 2012 to June 2013.
Admedus Ltd. is based in Perth, Western Australia.
“This is a significant milestone for the company as we expand into global markets and further develop our range of regenerative tissue products for commercialization and sale,” Admedus CEO Lee Rodne said. “CardioCel is an important addition to the surgeon’s armoury in the treatment of congenital heart disease, as well as for the repair of heart valves and other cardiac defects.”
Having won approvals for CardioCel from both the United States and Europe, Admedus now will work to enter the Asian market as well as other jurisdictions.
“Admedus is looking forward to 2014/15 as we launch CardioCel globally and continue to grow our sales revenue and cardiovascular teams in these regions,” Rodne said.
CardioCel is a cardiovascular scaffold that can be used to repair congenital heart deformities and more complex heart defects. The CardioCel scaffold potentially can be used to repair and reconstruct dysfunctional heart valves and valve leaflets, with longer term possibilities for use in the manufacture of replacement tissue heart valves. CardioCel provides surgeons with a tissue bio-implant that is durable, naturally flexible and easy to handle, according to the Australian company. The product was created using the company’s ADAPT technology, which allows animal tissue to be prepared for human use without calcification issues.
Admedus has three business segments: the medical products segment, which earned about $750,000 from revenue of $7.39 million in FY 2013, (a 10 percent profit margin); the CardioCel division; and the segment working to develop a Herpes Simplex Virus (HSV-2) vaccine. HSV-2 is the virus that commonly causes genital herpes; Admedus hopes the vaccine also could help people who already have contracted HSV-2.
In Australia, CardioCel was approved for the correction of congenital heart defects in children. In FY 2013, the company booked revenue of $12,000 from sales of CardioCel, and six surgeons used CardioCel in “around 60” operations from October 2012 to June 2013.
Admedus Ltd. is based in Perth, Western Australia.