? VascuCelTM receives FDA clearance for market approval
? Launch scheduled for November 2016
? Initial launch of 2 product sizes
? Targeting $500M global vascular repair market
Brisbane, Australia 17th October, 2016
Admedus Limited (ASX: AHZ) today announced that it has received FDA 510(k) clearance to market VascuCelTM in the US.
“The FDA clearance for VascuCelTM is important for Admedus as we build on the existing ADAPT® product portfolio. It adds to the new Company strategy of focusing on products that are near to market, refining the product range and driving sales growth” said Admedus Chair and Interim CEO Mr Wayne Paterson.
Admedus believes VascuCelTM will take significant market share in the US vascular market as it offers a premium next generation collagen scaffold for restorative vascular repair. VascuCelTM provides:
? improved handling in that it is supple, yet strong and remains pliable and conformable;
? enhanced procedural efficiency as it is readily available off the shelf with no rinse required;
? ease of suturing while remaining resistant to suture line bleeding resulting in excellent haemostasis;
? improved biocompatibility with zero aldehyde toxicity;
? optimised healing and clinical performance with no stimulus for thrombosis, inflammation, or foreign body reaction, enabling rapid endothelialisation and new native tissue growth; and
? reduced risk of infection as it is terminally sterilized.
Based on feedback from surgeons, Admedus will initially launch two sizes of VascuCelTM, a 2cm X 8cm and a 0.8cm X 8cm, with the latter specifically designed for carotid endarterectomy procedures. The Admedus manufacturing team has finalised several process improvement projects and ample product inventory has been manufactured to support this launch.
Admedus will launch VascuCelTM through the existing US sales team into the peripheral vascular market where there are an estimated 250,000 vascular repair procedures performed each year.
