Dawn A. Lissy
Blood Will Tell
As more tissue-based products enter the market, innovators and regulators work to keep pace.
For more than 20 years, I’ve been in- trigued by the increasingly creative technology and inspiring designs
that have emerged in the medical device
industry. In 1999, when the U.S. Food
and Drug Administration (FDA) approved
the first intervertebral body fusion device
(IBFD) manufactured from a non-metallic material, the market and patient care
changed direction. This shift continued
when the FDA reclassified IBFDs from a
Class III into a Class II designation in 2007.
Then came rhBMP-2 Infuse Bone Graft in
2002, another breakthrough. Today there
are three major categories for bone grafting
options: ceramic, allograft, and bone morphogenetic proteins. Each is yet another
example of how technology is advancing.
Now I smell blood. As tissue-based
applications, materials, and devices continue their upward market trajectory and
increase in popularity with surgeons and
patients, once again I’m enjoying my view
of history in the making.
I turn to Michael Bauer, M.D., president
of MJ Bauer and Associates, for an expert
preview of how that history will develop.
A nationally recognized medical expert
in tissue banking, infectious disease con-
sulting, and laboratory medicine, Bauer is
a certified tissue bank specialist. Bauer’s
Denver, Colo.-based company provides
professionals who serve as laboratory di-
rectors of record as well as medical direc-
tors of tissue banks. He is my go-to source
for all things blood-, tissue-, and stem
cell-related. From his perspective, we’re
on the cusp of a third wave of innovation,
one that continues the convergence be-
tween medical device and tissue.
The first wave was the use of tissue-based substances to speed healing.
“It’s kind of becoming standard now
to have some kind of tissue component
available that’s rich in some kind of bone-stimulating protein, something to help the
bone heal and now in addition to that,
we’re seeing an increased demand for
wound coverings,” Bauer said. “No matter what they say, it’s going to be tissue,
whether it’s liquid tissue or frozen tissue.”
From a regulatory standpoint, the FDA
has a well-defined process for evaluating
and granting approval to those kinds of
applications, Bauer said.
The second wave is amnion-based fluids—materials that are rich in growth factors
and bone proteins such as the substances
now being added to pastes and putties.
“Amniotic fluid was designed by God
for one thing, and that’s to grow things,”
Bauer said.“Everything you could possibly
dream you might need for wound care or
healing—everything—is in that material.”
Several companies now have such
products, he said.
“We’ve got a number of amnion banks
that are popping up across the country,”
Bauer said.“It’s truly the‘soup of the day.’I
can’t think of a traditional processor that’s
not thinking of bringing amnion in-house
now, whether or not they actually do so.”
Despite ethical gray areas and ques-
tions from a regulatory standpoint, most
of his clients continue to focus resources
on these amnion-based fluids, he said.
“Most of those who have offered such
a product are under an untitled letter with
the FDA, which just means FDA doesn’t
know what the heck to do with them,”
Bauer said. “In some places, FDA has told
them to cease and desist. Other places
they’re under advisement—‘One slight
misstep we’re going to shut you down.’
That’s not intimidating anybody. Every-
body’s still moving forward.”
The third wave is one that could turn
the tide of modern medicine but is awash
in controversy: stem cells.
“In my opinion, the sky’s the limit,”
Bauer said. “That’s the third wave and
cutting edge of where orthopedic tissue
transplantation is heading right now.”
“[The stem cells would] go wherever
they want to go then wherever they land,
if there’s a need, they’d differentiate into
whatever’s there,” he said. “It’s not that it
would cause cancer, but it could be‘pour-
ing fuel on the fire,’ so to speak.”
Proper regulation and transparency are
critical for this third wave.
“Until someone actually makes it very
clear what’s in their stem cell ‘soup,’ all
bets are off,” he said. “The problem with
stem cells is FDA doesn’t know what to
do with them. They know they’re not a device, but we all think there’s going to be
a middle of the road for stem cells, more
like bone marrow cells, red blood cells, or
white blood cells used to fight infection.”
“If FDA takes too much time, there
probably are some big banks out there
that might try to go down a device pathway for their more complex products like
stem cells,” Bauer said. “One company did