This approval allows for the immediate commercial sale of CardioCel in India, a healthcare market worth $158 billion and growing rapidly.
CardioCel is the company’s flagship product and is becoming a surgeon-preferred biomaterial for heart valve repair surgeries.
Admedus has appointed Syncronei Medical India Pvt Ltd as its exclusive commercial partner managing all sales, marketing and distribution.
Wayne Paterson, chief executive, said
“We are excited to partner with Syncronei Medical to offer Indian hospitals and surgeons our clinically superior ADAPT® technology with CardioCel.
“This is a clinically meaningful offering for them and a significant long-term opportunity for Admedus.”
A market with a need for CardioCel
India has circa 50 million cardiac patients.
Heart problems continue to be a challenge for the Indian healthcare system with 280,000 babies being born annually with a congenital heart defect.
The Indian market is a growth opportunity
The regulatory approval is a result positive pre-market research to determine the demand for CardioCel.
Results showed strong interest from Indian key opinion leaders who are eager to start using CardioCel as soon as possible.
Furthermore, pre-market assessment for VascuCel® and CardioCel 3D is now in the final stages.
During 2018, Admedus plans to move up the value chain with the entire platform of ADAPT products in the large Indian market.
An emerging healthcare company
Admedus has two key revenue streams which totalled $22.3 million in FY17.
These include ADAPT®, the company's clinically superior regenerative tissue technology.
Sales for the ADAPT® portfolio of products for the period climbed 30% to $6.9 million
The second is the company's infusion business in Australia and New Zealand, where revenue increased 74% to $15.5 million.