Market assessment of white cell inactivation capabilities of the Mirasol PRT system

Team Masters Projects 2007-2008

April 30, 2008

TMP Sponsor: Gambro BCT Company Advisors: Dr. Ray Goodrich Dr. Helena Bunkens

Navigant Biotechnologies, a wholly-owned subsidiary of Gambro BCT, is focused on developing pathogen reduction methods that are based on the addition of riboflavin to blood products followed by exposure to light before transfusion. Navigant's flagship product, the Mirasol Pathogen Reduction Technology (PRT) system has recently received CE marking, indicating that it has met certain requirements for sale in Europe for platelet products, and other applications of this technology are now being sought. Navigant is currently generating clinical data for FDA approval of Mirasol.

The focus of this TMP was to assess the viability of various business strategies and approaches intended to expand and accelerate global market penetration of Mirasol beyond 2008. The team focused on determining a potential positioning strategy primarily based on white cell inactivation by Mirasol. The team investigated:

• The clinical benefits over current techniques of white cell inactivation
• The overall incidence of adverse transfusion events as an indication of potential market size
• Potential target patient populations
• The cost-to-benefit requirements for system implementation
• Reimbursement issues The UK as a model for US market entry