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Admedus in maiden sale of CardioCel® in U.S.A.

Published: 01:47 07 May 2014 EDT

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Admedus (ASX: AHZ) has made the maiden sale of its lead regenerative tissue product CardioCel® in the U.S. ahead of the expected mid-year timing it had previously forecast.

This follows the company receiving U.S. Food and Drug Administration clearance in February this year to begin marketing.

Separately, it noted that CardioCel® has been used in 8 of the 15 target cardio-thoracic centres in Europe and that it expects several more to come on stream by mid-year, which is on par with our initial expectations.

Admedus is currently seeking approval in a number of other jurisdictions to meet its global launch plans.

“This is an important milestone for the Company as we look to grow our revenue over the coming 12 months and beyond,” chief executive officer Lee Rodne said.

“We are aiming for CardioCel® to be in use in 15 key centres in Europe and the U.S. over the next 12 months, which will provide us with a significant presence in the market.”

CardioCel®

Admedus had received FDA clearance in February 2014 and the European CE Mark in August 2013, allowing it to sell CardioCel® in those jurisdictions.

It has recently presented the cardiac and vascular defects repair product to U.S. cardio-thoracic surgeons during the recent American Association of Thoracic Surgeons conference in Toronto.

In Europe, surgeons who have used CardioCel® in surgical procedures have not reported any issues.

It is also used in Australia under the Authorised Prescriber Scheme with over 100 patients implanted.

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.

Notably, the first patient from its Phase II study has recently had their 6 year follow up and the results show there is still no detectable calcification.

Other patients in the study also continue to show no signs of calcification or follow up surgeries after 3 to 5 years.

The lack of calcification addresses one of the key issues with other existing tissue products

Admedus is also prepared to ramp up production of CardioCel®, having completed early this year the acquisition of an established manufacturing site in Western Australia.

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

That Admedus has secured its first U.S. sale of CardioCel® is a testament to its clear advantages over other cardiac repair products – namely its ability to be used offs-the shelf and the lack of calcification.

Progress in Europe is also on track and taken together are expected to drive sales of CardioCel®.

There is much to look forward to as Admedus continues to progress marketing of CardioCel® and deliver 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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