Mesoblast Receives TGA Regulatory Approval to Commercially Manufacture Adult Stem Cell Products

By Mesoblast, PRNE
Tuesday, July 20, 2010

MELBOURNE, Australia, July 21, 2010 - Australian regenerative medicine company, Mesoblast Limited (ASX:MSB;
ADR:MBLTY), today announced that the Australian Therapeutic Goods
Administration (TGA) has issued a licence to Mesoblast to manufacture and
supply its proprietary Mesenchymal Precursor Cell (MPC) products.

Under this licence, Mesoblast will now make commercially available to
doctors and hospitals across Australia manufactured MPC products for a
patient's own, or autologous, use in the repair and regeneration of their
damaged tissues. The cells will be manufactured under an agreement between
Mesoblast and the TGA-licensed contractor Cell Therapies Pty Ltd.

Mesoblast will initially target major bone repair markets, including long
bone fractures after trauma, stress fractures following sporting injury, and
vertebral fractures due to osteoporosis.

"Gaining a licence from the TGA, one of the world's foremost regulatory
bodies, to manufacture our adult stem cell products for supply to Australian
patients is a major validating step in Mesoblast's history," said Mesoblast
Chief Executive Professor Silviu Itescu. "It underscores the robustness of
our manufacturing process and the excellent safety profile of our products in
patients.

"To our knowledge, this is the first culture-expanded adult stem cell
product that has received manufacturing approval anywhere in the world," he
added.

Professor Itescu said that Australian TGA approval will mean early
revenue generation for Mesoblast, faster product adoption and branding, and
accrual of clinical outcome data for use by the Company in subsequent local
and international filings for product registrations.

In addition, it will position Australia as a global leader in the use of
regulated stem cell therapies.

About Mesoblast Limited

Mesoblast Limited (ASX:MSB; ADR:MBLTY) is a world leader in
commercialising biologic products for the broad field of regenerative
medicine. Mesoblast has the worldwide exclusive rights for a series of
patents and technologies developed over more than 10 years relating to the
identification, extraction, culture and uses of adult Mesenchymal Precursor
Cells (MPCs). www.mesoblast.com

For further information, please contact:

    Julie Meldrum
    Corporate Communications Director
    T: +61(03)9639-6036
    E: julie.meldrum@mesoblast.com

Julie Meldrum, Corporate Communications Director of Mesoblast, +61(03)9639-6036, julie.meldrum at mesoblast.com

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