The Germany-based Cinvention, a leading technology company focusing on nano-composite materials in biomedical applications has extended its existing license and supply agreement with the Hyderabad-based medical devices manufacturer, Relisys Medical Devices for marketing of an eluting and non-eluting coronary stent.
Relisys will take up manufacturing, global marketing of the non-eluting stent with a bioactive nano-structured carbon-composite coating with pro-healing properties. Relisys new stent consists of a Cobalt-Chromium stent, coated with a porous carbon / carbon composite nano-structured matrix with a surface design for improved endothelialisation.
NG Badari Narayan, managing director of Relisys, said, the agreement would enable Relisys to provide an advanced stent which can emerge as a potential alternative for existing drug eluting stents globally. Animal studies have been carried out in Washington Heart Centre.
Relisys will be conducting a multi-centric human trial involving 15 international centres, including eight hospitals in India to evaluate the safety of both drug eluting and non-eluting stents. A New York-based company is assisting in creation of an international registry. Random trials will be conducted in India and the US. Trials will also be conducted in Brazil, Germany and Japan, he informed.
It is estimated that about 1200 patients will take part in the entire study. First in man trials are expected to begin in January 2007, and DCGI approval is already in place. First in man trials will be completed by the end of 2007. Pivotal studies may show progress by mid 2008.
The total investment by Relisys is expected to be close to Rs 40 crore, of which Rs 12 crore will be invested in conducting international clinical trials.
Relisys is planning to seek European Certification mark for the non-eluting stent during 2007 and subsequently enter the US market, Narayan added.
Commenting on the technology, Dr Soheil Asgari, CEO and CTO of Cinvention, said, the company has focused on the use of non-thrombogenic materials and a design concept that avoids potential complications that are now identified as the main concerns relating to drug eluting stents. Cinvention will focus on non-exclusive commercialisation of next generation coatings with and without drug elution.