Global Pharma Management

Harvard Bioscience, Inc., a global developer, manufacturer and marketer of a broad range of specialized products used to advance life science research, launched its ORGANIZER™ Series Model 100 "In Breath" bioreactor. This bioreactor was used to grow the bronchus used in the landmark clinical transplantation performed by Professor Paolo Macchiarini of the Department of General Thoracic Surgery, Hospital Clinic, Barcelona, Spain.

David Green, President of HBIO, commented, "This bioreactor allows Harvard Bioscience to pursue new opportunities within the emerging field of regenerative medicine. The cost of a major organ transplant is estimated to be roughly $180,000 per procedure in the USA. These economics are causing an increasing amount of research to provide better medical solutions.

Harvard Bioscience's strategy in the regenerative medicine market is to supply tools to researchers and clinicians. We have also recently announced our intention to seek FDA approval to sell a version of our core syringe pump technology for use on humans. That product is designed to provide cell therapy by injecting stem cells for the repair of damaged organs."

Harvard Bioscience believes that this bioreactor will make possible a wide range of research, and potentially clinical, applications of tissue engineered hollow organs. Other hollow organs that we believe are of interest to researchers include trachea and blood vessels.

This bioreactor is the first in a series of products that Harvard Bioscience is developing to address what we believe is a long-term growth opportunity in the emerging field of regenerative medicine. Regenerative medicine is a new field that uses stem cells to repair damaged organs (e.g., spinal cord and heart) and also to grow tissue (e.g., bladder and bronchus) and organs (e.g., heart and lung) outside the body for transplant.

The U.S. Department of Health and Human Services in its report, "2020 Vision -- A Future for Regenerative Medicine" states:
"This revolutionary technology has the potential to develop therapies for previously untreatable diseases and conditions. Examples of diseases that regenerative medicine can cure include diabetes, heart disease, renal failure, osteoporosis and spinal cord injuries." and "The current world market for replacement organ therapies is in excess of $350 billion and the projected US market for regenerative medicine is estimated at $100 billion."

The use of the bioreactor for the world's first human transplant of a regenerated airway was reported in the leading medical journal, The Lancet, in November 2008*. The bioreactor itself was developed by Dr. Sara Mantero and Adelaide Asnaghi of the Department of Bioengineering, Politecnico di Milano, Milan, Italy. The intellectual property is exclusively licensed to Harvard Bioscience. U.S. patents are pending.

In this surgery Professor Macchiarini and colleagues removed a trachea from a human cadaver, decellularized it (i.e., removed all cellular material leaving the extra cellular matrix scaffold behind) and, using the bioreactor, recellularized the scaffold with adult stem cells cultured from a biopsy of the patient's own tissue. After four days in the bioreactor the tissue engineered airway was implanted in the patient replacing her defective left main bronchus. The patient made a full recovery, showed a substantial improvement in quality of life and showed no immune rejection of the new airway.

About Harvard Bioscience

Harvard Bioscience ("HBIO") is a global developer, manufacturer and marketer of a broad range of specialized products, primarily apparatus and scientific instruments, used to advance life science research at pharmaceutical and biotechnology companies, universities and government laboratories worldwide. HBIO sells its products to thousands of researchers in over 100 countries primarily through its 850 page catalog (and various other specialty catalogs), its website, through distributors, including GE Healthcare, Thermo Fisher Scientific and VWR, and via our field sales organization. HBIO has sales and manufacturing operations in the United States, the United Kingdom, Germany and Spain with additional facilities in France and Canada. For more information, please visit www.harvardbioscience.com .