Admedus Ltd (ASX:AHZ), in collaboration with its regional partner Genpharm, has received market approval for CardioCel® in the United Arab Emirates (UAE) and first orders.
The flagship product, CardioCel, is a bio-engineered tissue scaffold used in the heart valve repair market.
UAE is an important regional centre for healthcare and cardiovascular disease treatment and the market entry follows on from the recent approval of the product in Kuwait.
Together Admedus and Genpharm will continue to seek additional approvals in the region along with growing sales.
Wayne Paterson, interim CEO, commented: “As we continue to drive strong sales growth of CardioCel®, this approval is a significant milestone in terms of our expansion of the product franchise across emerging markets.
“The UAE is a strategically important location as a central hub in Middle East and North Africa for performing cardiovascular surgery.”
Background
Admedus holds assets from research and development, through clinical development as well as sales, marketing and distribution.
Its flagship product is CardioCel, which is becoming a surgeon-preferred biomaterial for heart valve repair surgeries.
CardioCel represents a disruptive technology in the $2.5 billion heart valve repair and replacement market, which is dominated by products commercialized by large medical device companies.
It is now being sold in Canada, Australia, Asia, the Middle East, and North Africa, covering 135 medical centres.
Admedus also recently received FDA 510(k) clearance to market its vascular product, VascuCel in the U.S.
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.
Analysis
The geographical expansion of CardioCel markets provides Admedus with an opportunity to increase product sales and brand recognition.
This will support the continued growth of the company, most recently exemplified by the September quarter revenue of $6.05 million, which was up 50% on the previous June quarter.
The UAE has over 500 cases of congenital defects per annum and an increasing number of older patients with congenital defects seeking repair.
Furthermore, Admedus recently launched VascuCel in the U.S. and generated initial sales for the product.
Admedus believes VascuCel will take significant market share in the U.S. vascular market – the global vascular repair market is estimated at $500 million.
The company is also attending the VEITH Symposium this week in New York which is focused on vascular surgery.
Admedus had a healthy cash balance of $19.5 million at the end of the September quarter.