Admedus Ltd
ABN 35 088 221 078
ASX ANNOUNCEMENT
REGISTERED OFFICE:
26 Harris Road Malaga Western Australia 6090
PO Box 6879
East Perth Western Australia 6892
T +61 (0)8 9266 0100
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ADMEDUS VASCUCELTM RECEIVES FDA CLEARANCE FOR LAUNCH IN NOVEMBERVascuCelTM receives FDA clearance for market approval
Launch scheduled for November 2016
Initial launch of 2 product sizes
Targeting $500M global vascular repair market
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.
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For more information, please contact:Dr Julian Chick | Chief Operating Officer | Admedus Limited Tel: +61 (0)8 9266 0100
Media EuropeFTI Consulting
Simon Conway / Victoria Foster Mitchell Tel: +44 (0) 20 3727 1000
admedus@fticonsulting.com
US InvestorRx Communications Group, LLC Melody A. Carey
+1 917 322 2571
mcarey@rxir.com
About Admedus LimitedAdmedus (ASX: AHZ) is a specialist healthcare company. Our focus is on investing in and developing next generation technologies with world class partners, acquiring strategic assets to grow product and service offerings and expanding revenues from our existing, profitable medical sales and distribution business. The Company has assets from research & development through clinical development as well as sales, marketing and distribution.
Admedus has commercialised its innovative tissue engineering technology for regenerative medicine in four continents. We also have a major interest in developing the next generation of vaccines with a Brisbane-based research group led by Professor Ian Frazer. The vaccine programmes target disease with significant global potential, such as Herpes and Human Papillomavirus.
Further information on the company can be found on www.admedus.com
Admedus Ltd. published this content on 17 October 2016 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 16 October 2016 22:48:01 UTC.
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