Medical Carbon Research Institute Announces On-X Prosthetic Heart Valve CE Mark Approval.

AUSTIN, Texas--(BW HealthWire)--July 24, 1998--Medical Carbon Research Institute, LLC (MCRI) announced today that it has obtained CE Mark approval for the On-X Heart Valve prosthesis. With the CE Mark, MCRI is permitted to market the On-X Heart Valve in the European Union and all other countries that recognize European Union standards. The European Union consists of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden and the United Kingdom.

CE Mark approval signifies that MCRI's On-X Heart Valve satisfies all European Union regulatory requirements for critical, life sustaining artificial heart valves. The process for obtaining the CE Mark is much like that of obtaining a Premarket Approval from the Food and Drug Administration (FDA) in the United States. MCRI conducted preclinical engineering analyses and an investigational clinical implant series under the guidance of the European Union notified body.

These worldwide On-X Heart Valve clinical trials have been ongoing since the first implant by Professor Laczkovics of the Kliniken Bergmannsheil, Bochum, Germany, on September 12, 1996. To date, approximately 400 patients have received On-X Heart Valve implants with excellent results. The notified body, TUV Product Service, Munich, issued the CE Mark authorization following a thorough critical review of MCRI's analyses and clinical results. MCRI is conducting a similar clinical study in the United States under FDA Investigation Device Exemption regulations that began in March 1997. The U.S. study is expected to be complete by the fourth quarter of 1999.

The On-X Heart Valve is a bileaflet mechanical valve manufactured from On -X(R) Carbon, an ultra-pure, unalloyed pyrolytic carbon. On-X Heart Valve design enhancements include a shaped and lengthened orifice that reduces pressure losses, turbulence and shear stresses. Flow area is maximized by supra-annular positioning and by the increased On-X Carbon strength, which minimizes wall thickness and stiffening ring bulk.

Heart valves are one-way valves that control the direction of blood flow in the heart. Patients with diseased heart valves may suffer discomfort with exertion, fatigue and shortness of breath. If left untreated, heart valve disease can be life threatening. Surgical replacement of the damaged natural valve with an artificial valve, such as the On-X Heart Valve, is a common treatment for severe heart valve disease.

Clinical hemodynamic results demonstrate significant improvements in On-X Heart Valve performance relative to other bileaflet designs. Improved performance enhances patient quality of life. Enhanced quality of life through utilization of advanced materials technology and advanced design concepts provides the competitive edge for the On-X Heart Valve in today's 600 million dollars per year worldwide heart valve market.

MCRI plans to market the On-X Heart Valve in the European Union through a network of independent distributors. The On-X Heart Valve is assembled at MCRI-Deutschland, Langenhagen and the Authorized European Representative is Nicolai, D-30853 Langenhagen, Ostpassage 7, Germany, fax: [phone].

For information regarding valve availability and distribution, contact Customer Services MCRI, 8200 Cameron Road Ste A196, Austin, Texas, 512/339-8000.

    CONTACT:  Medical Carbon Research Institute, Austin
               Robert B. More Ph.D, 512/339-8000
               [e-mail]
               www.mcritx.com
               or
               Wohl & Company
               Kit Wohl, 504/528-9900
               [e-mail]