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Limited () will in June launch a new CardioCel® product for vascular repairs such as carotid endarterectomies into the U.S. market.
This is part of the company’s strategy to expand the use of CardioCel across a range of surgical applications.
Besides its use for cardiac repairs and reconstructions CardioCel has already been used successfully in 10 U.S. cases of vascular repair including carotid endarterectomies and femoral artery repairs.
The vascular repair market represents a significant potential market with an estimated 180000 carotid endarterectomies performed each year in the U.S.
“The new CardioCel product is part of ’ plan to build an ADAPT™ Tissue franchise providing surgeons with a range of products for surgical repairs” managing director Lee Rodne said.
“The sales team continues to expand the number of centres using CardioCel and this new product size will help to support broader market adoption and momentum in our sales program which we anticipate will support further revenue growth in the coming year and beyond.”
CardioCel is currently used in 31 European and 35 US centres and over 70 centres globally. Over 1800 patients have been implanted with CardioCel.
recently raised $28.1 million through a $12 million placement and $16.1 million rights issue to increase sales of its lead regenerative tissue product CardioCel® support continued development of its regenerative tissue portfolio and advance its immunotherapy programs with Professor Ian Frazer.
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.
Notably the first patient from its Phase II study had their 6 year follow up earlier this year and the results show there was 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 and is a key milestone for the technology.
This provides further potential for the future treatment of congenital heart disease moving closer towards the stage where surgeons can reduce if not eliminate the need for patients to undergo repeat procedures.
In April the company announced it was expanding its regenerative tissue portfolio into additional large target repair markets following successful initial results from a pre-clinical study of ADAPT® treated tissue in the repair of dura mater.
Dura mater is the outer membrane enveloping the brain and spinal cord which is often damaged during traumatic brain injuries.
The company will progress this program into the next study as it advances the product towards market approval.
Recent Activity
recently reported revenue of $2.5 million for the quarter ended 31st March 2015 a jump of 47% over the previous corresponding period.
It has also achieved initial sales for CardioCel in Hong Kong during the period as part of its continued global launch of the product.
The company continues to work with Professor Ian Frazer and his team to progress its therapeutic vaccines portfolio.
The Herpes Simplex 2 (HSV-2) Phase II study is underway and actively recruiting study participants.
anticipates that recruitment of the Phase II HSV-2 study should be completed by the end of the quarter with interim results due to be delivered by the end of the 2015 calendar year.
Analysis
The introduction of a new CardioCel product for vascular repairs not only targets the U.S. market where an estimated 180000 carotid endarterectomies are performed each year it is also in line with ’ strategy to expand the use of CardioCel across a range of surgical applications.
This support broader market adoption and momentum for CardioCel that together with expansion in the number of centres using its products will drive further revenue growth.
The company has a pipeline of additional regenerative tissue products that it is developing based on the initial success of CardioCel and its ADAPT tissue engineering technology.
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