Admedus Ltd gets FDA clearance to launch VascuCel in the U.S....

Admedus Ltd gets FDA clearance to launch VascuCel in the U.S.

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12:00 17 Oct 2016
VascuCel will be targeting the $500 million global vascular repair market.
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VascuCel will be targeting the $500 million global vascular repair market.
Admedus Ltd (ASX:AHZ) has received FDA 510(k) clearance to market its vascular product, VascuCelTM in the U.S.
VascuCel will be targeting the $500 million global vascular repair market.
The product launch is scheduled for November, 2016.
Admedus will launch VascuCel through the existing U.S. sales team into the peripheral vascular market where there are an estimated 250,000 vascular repair procedures performed each year.
Wayne Paterson, interim CEO, commented: “The FDA clearance for VascuCel 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.”

VascuCelTM
VascuCel is used in the repair of vascular surgical procedures.
The Perth based factory will supply VascuCel alongside its current output of CardioCel.
Based on feedback from surgeons, Admedus will initially launch two sizes of VascuCel, 2x8 centimetres and 0.8x8 centimetres.
Admedus believes VascuCel will take significant market share in the U.S. vascular market as it offers a premium next generation collagen scaffold for restorative vascular repair.
VascuCel 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 sterilised.

Background
Admedus' flagship product is CardioCel®, a bio-engineered tissue scaffold to repair congenital heart defects, and expanding into the heart valve market.
CardioCel is becoming a surgeon-preferred biomaterial for heart valve repair surgeries.
It represents a disruptive technology in the $2.5 billion heart valve repair and replacement market, which is dominated by products commercialized by large medical device companies.
It is now being sold in Canada, Australia, Asia, the Middle East, and North Africa, covering 135 medical centres.
The Admedus infusion portfolio has over 800 customers providing hospital-wide infusion solutions across the Australian and New Zealand healthcare systems.
Beyond CardioCel and infusion sales, Admedus is developing a DNA-based therapeutic vaccine for HSV-2 and HPV.

Analysis
The launch of VascuCel will provide Admedus with another avenue to generate sales revenue.
With the recent $18.3 million capital raising complete, Admedus is in a strong financial position to drive growth and sales this financial year.
The restructure that occurred in June shows that Admedus is committed to reduce costs and focus on near-term revenue growth to create a clear path to being a sustainable, profitable, global healthcare company.
Admedus recently achieved on target sales growth, with first quarter revenue being the strongest in the history of the company.
The stock is trading at around A$0.325, which represents a large discount to its broker price targets of A$1.48, A$1.95 and A$2.00.