Admedus has received an approval letter for CardioCel, its proprietary bio-scaffold, in Singapore. This application was based on the submission for US Food and Drug Administration (FDA) approval, which includes indications for use in cardiovascular repairs, suture buttressing and vascular and vessel repairs in both adults and children.
CardioCel has already been used in Singapore under a Special Access programme since last year and this approval will accelerate market penetration in the region.
“The Singapore approval caps off a very productive 12 months for the Admedus team, which is translating into growing sales momentum for CardioCel, the flagship product from our ADAPT platform. In addition to our already strong base in Europe, we have gained several new approvals for the product while also expanding our presence in the USA, where CardioCel is now available in 40 centres,” said Admedus chief executive officer, Lee Rodne.
CardioCel is now being used in over 80 treatment centres, including institutions in Europe, USA, Canada, Hong Kong and Singapore. The company is pursuing additional approvals in Asia and has also partnered with GenPharma for distribution in North African and Middle Eastern markets.
“CardioCel is being increasingly utilised by leading surgical groups, and continues to show compelling results and patient outcomes with respect to its ease of use, high tensile strength, low immunogenicity and strong anti-calcification properties,” said Rodne.
“Our sales team is marshalling these results to cement the strong clinical rationale for using this product and to actively support further global expansion. We are confident that this highly considered approach will successfully drive topline growth.”