Medical devices company Opto Circuits continues to face regulatory hurdles for entering into the lucrative US and Japanese stent markets.

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Vinod Ramnani, chairman and managing director, said entry into the US stent segment will take two to three years while Japan will take even longer.

“We are already present in the US with non-invasive products category including sensors and patient monitoring devices. But for stents and catheters, it will still take a while,” Ramnani said.

The company had anticipated nod for the entry into the US stent market by the end of calendar year 2010. The entire process of getting US FDA approval for one stent, including application and conducting clinical trials, costs about $20 million.

Currently, the US market for stents and catheters is pegged at about $4 billion while the Asia Pacific stent market, where Japan is a key player, is estimated to touch $2.3 billion by 2017.

Stents and catheters constitute about 25% of Opto’s turnover and are expected to touch about Rs1,600 crore by March 2011. The non-invasive products like sensors, patient and monitoring devices contributes 75% of Opto’s turnover.

While catheters are tube that can be inserted into a body cavity, duct, or vessel to allow drainage, administration of fluids, or access by surgical instruments, a stent is a mesh tube used to treat narrowed arteries which carry blood in the body.

Ramnani said the company, which has been growing at about 27-30% in the last two years, should continue in the same momentum and entry into Japan and the US stent markets should further accelerate the growth.

Bhavin Shah, analyst with Dolat Capital Market, said even after getting regulatory clearances, Opto will face tough competition from Abbott, Boston Scientific, Medtronic, and Johnson & Johnson.

“These players have been there for a long time and are brands which enjoy a great level of comfort and recall value with medical practitioners. So, for a new player like Opto to actually make a dent into the market will take a lot of time,” said an analyst.

Currently, the company is looking at capitalising on its existing presence in markets such as EU, Latin America, Africa, and Asia.