Ann: Regulatory approval to launch CardioCel in India, page-2

ADMEDUS RECEIVES REGULATORY APPROVAL TO LAUNCH CARDIOCEL IN INDIA MINNEAPOLIS –


Admedus Limited (ASX:AHZ) today announced that it has received regulatory approval to launch the company’s flagship CardioCel® product in the Republic of India1 , with Syncronei Medical India Pvt Ltd appointed as exclusive commercial partner managing all sales, marketing and distribution.

This approval allows, effective immediately, the commercial sale of CardioCel in one of the world’s most important and dynamic medical markets. The overall Indian healthcare segment is $158 billion and growing rapidly. In a country with approximately 50 million cardiac patients and 28 million births per year, 1 in 1000 or 280,000 babies are being born annually in India with a Congenital Heart Defect (CHD).

“Providing life-changing outcomes for these patients and their families is the purpose of CardioCel,” says Admedus CEO Wayne Paterson. “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.”

Today’s approval is the result of Admedus working closely with Indian clinicians, health officials and key opinion leaders (KOLs) to determine demand for CardioCel, and to create productive long-term relationships focused on helping physicians heal Indian patients with heart disease. This pre-market assessment phase – which included Admedus participation at key scientific conferences – found strong interest from Indian KOLs who are eager to start using CardioCel as soon as possible.

Admedus’ agreement with Syncronei Medical followed a comprehensive due diligence process to ensure CardioCel is effectively launched and properly positioned in this major emerging market. Syncronei Medical was awarded the distribution partnership based on their credibility and experience in the Indian regenerative technology and surgical sectors, coupled with an unparalleled ability to introduce CardioCel to India’s lucrative public and private medical tourism market segments which continue to grow impressively.

via healthcare regulatory consultancy Fermish Clinical Technologies Pvt Ltd which handled the registration process and will hold the applicable licenses on behalf of Admedus. “Today’s regulatory approval for CardioCel marks the first phase of our India market entry, and the acceleration of our emerging markets strategy,” added Paterson. “Our India pre-market assessment for VascuCel® and CardioCel 3D is now in the final stages, so in 2018 we plan to move up the value chain with the entire platform of ADAPT products in a massive market where we can scale for long-term success.”