Blue Membranes and Relisys Medical announce starting the International Multi Center Registry for the porous carbon/carbon composite coated Drug-Eluting Stent.


Applied Clinical Trials

Relisys Medical Devices Ltd. announced starting of the International Multi Centre Registry of its new Drug-Eluting Stent.

Wiesbaden / Hyderabad – 2 August 2005 – Relisys Medical Devices Ltd. announced starting of the International Multi Centre Registry of its new Drug-Eluting Stent. Relisys' Chairman Dr. N. Krishna Reddy said, this advanced version of the company's Drug-Eluting Stent (DES) has been designed to eliminate the existing drawbacks of the currently available polymer coated Drug-Eluting Stent. Relisys' new DES consists of a Cobalt-Chromium Stent, coated with a porous carbon/carbon composite nano-structured matrix containing the active drug. The coating was developed and provided by Blue Membranes, the Germany based company in material and surface engineering. The coating eliminates the use of polymers thus completely reducing tissue inflammation and reaction.

N.G. Badari Narayan, Managing Director, stated, Relisys' worldwide license and supply agreement with Blue Membranes for the use of the carbon-based drug-delivery platform would enable Relisys to provide an advanced DES in the global market with unique advantages.

The animal trials for this version of advanced DES were recently completed at the Cardiovascular Research Institute, Washington D.C. The animal data have established the safety and efficacy of the advanced version of Drug-Eluting Stent, including its innovative porous carbon/carbon composite coating technology. The next step will be an Multi Centre Trial with 15 international centres involved.

Dr. Sohil Asgari, CEO and CTO of Blue Membranes, commented "The animal study results show that the Blue Membranes' porous carbon/carbon coating is free of inflammatory reactions. In combination with the deliverability of the drug that is eluted completely, the coating is the most advanced available on the market. Blue Membranes has demonstrated its technology leadership in surface and material engineering and will focus on commercialization of the carbon-based product portfolio as well as on the development and exploitation of the next generation coatings. One key application that will be addressed next is the drug-delivery coating with superior interfaces for bone and tissue in-growth for orthopaedic and traumatologic devices."

Relisys has recently completed the clinical trial of its first generation Drug-Eluting Stent at All India Institute of Medical Sciences, New Delhi, Cardio-Thoracic Centre, Military Hospital, Pune, and CARE Hospitals, Hyderabad. Dr. Krishna Reddy said that the clinical results were encouraging and the data has been submitted for publication.

Relisys has entered into a MOU with a leading pharmaceutical company for use of four of their compounds for DES application. This would enable Relisys to have a novel, patented compound with unique advantages over existing agents, in addition to the potential of realizing a Drug-Eluting Stent for the global market.

Dr. N. Ramakrishna Rao, Director, says, that the company's tie up with Andhra Bank for a Loan will facilitate the completion of the new catheter facility by December 2005 and the pilot production by January 2006.

About Blue Membranes

Blue Membranes is a leading technology company focusing on nano-structured composite materials and coatings for advanced applications in medical device, biotech-engineering and chemical processing technologies.

BlueM's unique portfolio of Nano-Carbon Systems includes:

  • Drug Delivery Coatings
  • Multifunctional Device Coatings
  • Advanced Carrier Systems for Bio-processing
  • Carbon-Ceramic and Mixed Matrix Membranes

Blue Membranes mission is to exploit its proprietary and highly innovative technology platform for materials and surface engineering of nano-structured composites. Providing a sustainable portfolio of applications in medical device engineering, bio-processing and chemical processing BlueM solutions enable its customers to acquire superior technologies for next generation applications and profitable growth.

About Relisys Medical

Relisys Medical Devices Limited is a leading Indian Device manufacturer, which has taken a lead in the indigenous development of medical devices like coronary stents, catheters and critical care products in India.

Relisys focus products includes:

  • Drug eluting stents
  • Angiographic/Angioplasty catheters
  • Occlusive devices
  • Cardiac surgery disposables
  • Critical care Products

Relisys Medical Devices mission is to make quality medical care affordable through development of cutting edge technology and competitive pricing. Relisys Manufacturing facilities include a stent coating division and an integrated catheter manufacturing facility with in-house compounding, extrusion, injection moulding, braiding, welding, tipping, grinding, sterilisation and others. Relisys has recently entered into an MOU with a leading International Pharma Company to work on four new compounds for DES application.

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