This was developed based on feedback from global congenital surgeons who felt the smaller scaffold could potentially be valuable.
It will initially be released to global congenital surgery Key Opinion Leaders to gain further clinical experience of the material with a view to undertaking a broader commercial launch.
This adds to the existing manufactured and commercially available 4cm by 4cm, 5cm by 8cm and 2cm by 8cm materials that are used in over 95 centres internationally.
Earlier this year, the company shipped 2cm by 8cm CardioCel® bio-scaffold materials to the US for use in vascular repairs such as carotid endarterectomies.
In June, Admedus announced positive long-term data from the CardioCel® Phase II clinical trial, which showed no evidence of calcification after 7 years.
Importantly, there have been no repeat heart procedures related to CardioCel for the monitored patients in the study and there are no signs of CardioCel calcification.
Lee Rodne, chief executive officer, commented:
“The release of a 2cm x 2cm CardioCel® bio-scaffold is part of our continued strategy to offer a complete range of CardioCel® products for all cardiovascular repairs and reconstructions.
“We are excited to make the new size available to our key surgeons, as we work closely with them to advance the management of congenital heart defects internationally and offer patients the clinical benefits of the ADAPT® tissue engineering process.”
“We believe the development of different sizes of the CardioCel® product perfectly demonstrates how the ADAPT® tissue engineering process can be tailored to meet market demand and provide multiple product revenue streams in the company and drive sales growth.
“With CardioCel® now used in over 95 centres across the US, Canada, Asia, Australia and Europe, we will continue to investigate the development of additional regenerative tissue products across a range of surgical applications.”
The smaller 2cm by 2cm sized bio-scaffold material was developed based on feedback from global congenital surgeons who felt the smaller scaffold could potentially be valuable across the spectrum of congenital heart defects repair and reconstruction procedures.
These and other sizes of CardioCel® bio-scaffold materials are created using Admedus’ ADAPT® tissue engineering process, which removes DNA and RNA from animal pericardium tissue to create a collagen matrix used for treatment and repair within the body.
CardioCel® has proven utility and importance in the surgical repairs of cardiovascular defects with 11 patients now past 5 years post implantation with no sign of calcification.
Notably, the first patient in the Phase II clinical trial has no sign of calcification after over 7 years.
Four other patients are past the 6 year mark while the company is following another 4 patients who are past 4 years.
This is a key benefit given that most implanted tissues have calcification within an 18 month timeframe in paediatrics.
Admedus’ release of the new smaller CardioCel bio-scaffold clearly highlights how its ADAPT® tissue engineering process can be tailored to meet market demand.
This product has now being released to key surgeons that are global thought leaders in treating congenital heart defects with commercial launch expected in early 2016.
In addition, its other regenerative tissue products like Dura Mater repair are also progressing through regulatory studies to get onto the market in the coming 12-24 months.
These are key in Admedus’ strategy to continue developing and bringing to market additional regenerative tissue products for large applications, growing both revenue and value.
Separately, the company’s Herpes Simplex 2 vaccine Phase II study continues to progress after an independent Safety Review Committee (SRC) unanimously recommended that no changes were needed.
This adds value to the company given that 1 in 6 people aged between 14 and 49 in the U.S. are estimated to be infected with HSV, which has no present cure.
As such, a vaccine could potentially address a market worth more than US$6 billion.
Share Price Catalysts:
- Growing number of global heart centres using CardioCel to repair heart defects including repairing heart valves;
- Additional regulatory approvals in Asia for CardioCel;
- Initiation of an aortic valve repair study to show CardioCel’s utility and advantages in aortic repair vs aortic valve replacement (aortic valve market today is large and mostly using replacement procedures as they haven’t had suitable tissue to repair);
- Expanded ADAPT pipeline in areas such as vessel repairs, cellular therapies and progressing our dura mater product towards studies for market approvals;
- Interim results from the HSV-2 Phase II study expected towards the end of 2015; and
- HPV vaccine progressing into clinical studies this year.
Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.