By David Ingram
WASHINGTON, March 22 A U.S. appeals court ruled
on Friday that the Food and Drug Administration acted correctly
when it denied fast-track approval of two stem cell-related
medical devices made by Cytori Therapeutics Inc.
The FDA had reasonable evidence to find that the devices
were not substantially equivalent to devices already on the
market, according to the unanimous ruling from the U.S. Court of
Appeals for the District of Columbia Circuit.
The FDA's decision meant that Cytori had to conduct
extensive clinical research as part of premarket approval.
Tom Baker, Cytori's director of investor relations, said the
court ruling does not change the status quo because the company
has a clinical trial under way.
"That will continue to be our priority and primary path to
market," Baker said in a phone interview on Friday.
The clinical trial started last year and the company plans
to have initial data in the first half of 2014, he said.
Cytori is hoping to develop a treatment for heart failure in
which regenerative stem cells from a patient's own fat tissue
would be injected into heart muscle, all in one procedure.
The appeals court ruling relates to two medical devices
designed to extract stem cells from fat tissue, the Celution 700
and the StemSource 900.
Cytori and the FDA disagreed over how similar the devices
are to existing devices that extract stem cells from blood or
bone marrow. Devices that are similar to already approved ones
require less testing.
Judge Brett Kavanaugh wrote for a three-judge panel that the
appeals court must be careful when questioning the scientific
judgment of an agency such as the FDA.
"FDA concluded and explained that fat is not blood and that
the difference matters. A court is ill-equipped to second-guess
that kind of agency scientific judgment," Kavanaugh wrote.
An FDA spokeswoman declined to comment.