The expanded access program is to ensure that the company gathers as much useful case data as possible before the product’s commercial introduction.
Admedus is already working in four key reference centres in the U.S. and this will increase to 10 prior to full launch later this year.
Wayne Paterson, CEO, commented: “The progress to date on CardioCel 3D has been excellent and the current user feedback from our surgeons is extremely promising.
“This is a pioneering new product – applying our proprietary ADAPT® technology – for an important market segment, and so we are making every effort to launch CardioCel® 3D right from the start in a phased and prudent way working closely with physicians.”
The company’s flagship product is CardioCel, which is becoming a surgeon-preferred biomaterial for heart valve repair surgeries.
CardioCel 3D is the first product of its kind and is for heart procedures that require more than a single dimension patch material to optimise cardiac and vascular repair.
The first units of CardioCel 3D started coming off the production line in early May at the company’s state-of-the art manufacturing facility, which is ready to scale production to meet market demand.
Admedus holds assets from research and development, through clinical development as well as sales, marketing and distribution.
Its flagship product CardioCel represents a disruptive technology in the $2.5 billion heart valve repair and replacement market, which is dominated by products commercialised by large medical device companies.
It is now being sold in Canada, Australia, Asia, the Middle East, and North Africa, covering 135 medical centres.
Furthermore, 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.
Admedus has two main streams of revenue, its infusion products distribution business and its ADAPT product portfolio.
Its ADAPT product portfolio includes:
- CardioCel®: On market in U.S, EU, MENA and Asia;
- VascuCel®: Launched in U.S in Feb ’17;
- CardioCel Neo®: Launched in US in Mar ’17;
- 3D Curve®: Launch 2H, ’17; and
- TAVR: Prototype research and development.
The company forecasts $21 million in revenue for the recently concluded FY17.
Admedus reported $17.2 million revenue through the first three quarters of FY17.