Grafix is and will continue to be available on the market for the
treatment of both acute and chronic wounds, including diabetic foot
ulcers, despite media reports suggesting otherwise. As part of the
agreement Osiris detailed in its October 21 press release, FDA
affirmed that Grafix, indicated as a wound cover for the treatment of
acute and chronic wounds, is regulated solely as a human cells,
tissues, and cellular and tissue-based product (HCT/P) under section
361 of the Public Health Service Act (PHS Act).
A Biologics License Application (BLA) is not required for Grafix to
remain on the market for the treatment of acute and chronic wounds,
despite media reports suggesting otherwise. Osiris has the opportunity
to receive approval of Grafix as a licensed biologic under the BLA
pathway. This approval, if obtained, would enhance the claims Osiris
would be able to make regarding the wound healing properties of
Grafix. Osiris believes this would create significant product
differentiation in the market place and increase the value for the
Grafix brand. Osiris is actively pursuing submission of a BLA.
Osiris has never received a “warning letter” from FDA, contrary to
media reports stating otherwise. Furthermore, Osiris Biosurgery,
including the products mentioned in the FDA letter, has been inspected
twice by the FDA without a single finding of deficiency.
COLUMBIA, Md.--(BUSINESS WIRE)--
Therapeutics, Inc. (NASDAQ: OSIR), issued a statement today
correcting certain inaccuracies in media reports following the
announcement of its favorable agreement with the United States Food and
Drug Administration (FDA) regarding Grafix®.
It should be noted that Osiris may not be aware of and may not correct
all current or future inaccuracies in media reports.
About Osiris Therapeutics
Osiris Therapeutics, Inc. is the leading stem cell company, having
developed the world’s first approved stem cell drug, remestemcel-L, for
graft versus host disease. Osiris’ products include Grafix® and Ovation®
for acute and chronic wounds, Cartiform®, a viable cartilage mesh for
cartilage repair and the latest addition to Osiris’ line of products,
OvationOS™, a viable bone matrix. Osiris is a fully integrated company
with capabilities in research, development, manufacturing and
distribution. Osiris has developed an extensive intellectual property
portfolio to protect the company's technology and commercial interests.
Osiris, Grafix, Ovation and Cartiform are registered trademarks of
Osiris Therapeutics, Inc. More information can be found on the company's