Admedus (ASX: AHZ) is set to grow its revenue with its lead regenerative tissue product CardioCel® receiving the milestone U.S. Food and Drug Administration clearance to begin marketing.
Shares in the company are likely to rise given that the clearance should result in a rise in both sales and revenue.
CardioCel® had received the CE Mark allowing European sales in August 2013 and made its first sale there in November.
The company will now look to complement its existing product launch in Europe with preparation for initial sales in the US.
The intended use of CardioCel® in the US is in pericardial closure and for the repair of cardiac and vascular defects in both adults and paediatrics.
“This is a significant milestone for the Company as we expand into global markets and further develop our range of regenerative tissue products for commercialisation and sale,” chief executive officer 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.”
He added the company was looking forward to an exciting 2014/15 as it launched CardioCel® globally, growing sales revenue and cardiovascular teams in the U.S. and Europe.
The company is also pursuing market approvals in Asia and other jurisdictions and will be attending the 14th Annual International Symposium on Congenital Heart Disease on the 14th of February in Florida.
CardioCel®
CardioCel® is a regenerative tissue product engineered by the group’s ADAPT® tissue engineering process to be a durable, pure collagen scaffold used to repair heart deformities including repairing and reconstructing heart valves.
It offers key benefits for patients and surgeons including showing strong levels of regeneration of self-tissue without needing external stem cells or growth factors; no cytotoxicity at the site of repair; and availability off the shelf.
Importantly, its ongoing Phase II extension study has confirmed no signs of calcification, a major issue with other existing tissue products, in all five patients monitored over a five year period post-surgery.
Supporting this, no signs of calcification have been seen in a further six patients monitored over four years and eight beyond three years.
It success opens up the potential for the development of other tissue repair product based on the same ADAPT® tissue engineering process.
The company had early this year completed the acquisition of an established manufacturing site in Western Australia to facilitate scaled-up production of CardioCel®.
The site also provides additional facilities to support the development and commercial manufacture of additional regenerative tissue products currently in the Admedus pipeline that use the ADAPT® tissue engineering process.
Analysis
Shares in Admedus are likely to trade higher today on the company securing the milestone U.S. Food and Drug Administration clearance to begin marketing of its CardioCel® regenerative tissue product.
This follows on its receiving CE Mark approval in Europe last year and is a major step for the company’s expansion into global markets.
Given CardioCel®’s advantages compared to other cardiac repair products – namely its ability to be used off-the shelf and the lack of calcification, there is strong potential for the company to secure sales in the U.S. once the product is launched.
In addition to the expected increase in CardioCel® sales, there is much to look forward to in the coming year.
This includes the full results of the Phase 1 trial for its Herpes Simplex Virus (HSV-2) therapeutic vaccine, which has already proven to be safe for use.
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