MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
SFC Fluidics wins $5M contract
to make TBI diagnostic device
By AMANDA PEDERSEN
Medical Device Daily Staff Writer
SFC Fluidics (Fayetteville, Arkansas) says it has
received a $5 million contract from U.S. Army under the
Congressionally Directed Medical Research Program to
develop a handheld device for rapid diagnosis of traumatic
brain injury (TBI). The device is scheduled to begin clinical
trials for FDA approval in the summer of 2013, the company
said.
“When there are concussive injuries or other brain trauma
the brain produces certain proteins which get into the
blood stream and those proteins can be related to the type
and severity of the brain injury,” Calvin Goforth, president
of SFC Fluidics, told Medical Device Daily. “So from the
quantitative concentrations . . . of the blood proteins you
can make diagnosis of traumatic injuries.”
Gorforth said that quantitative is the key word for this
type of diagnostic device because it is important to know
how much of the protein is present.
According to the company, more than 1.5 million
Americans suffer head injuries each year, and TBI has
become a signature injury for U.S. troops serving in the
wars in Iraq and Afghanistan.
“With a suspected brain injury, every second counts,”
said Dr. Chris Evans, VP of SFC Fluidics. “We are developing
a first-of-its-kind ‘lab on a chip’ as well as associated handheld
instrumentation to revolutionize the way military and
civilian medics diagnose and treat traumatic brain injury.”
Using only a pinprick sample of blood similar to a
blood glucose test for diabetes, the device is designed to
conduct rapid, detailed blood analysis within a single
sealed, disposable chip. Quantitative levels of specific biomarkers
released by the brain when injured will be displayed
on an easy-to-read screen, along with an indicator
alerting the operator to the degree of injury – none, mild,
moderate or severe, the company said.
Goforth said that ultimately the device would be used
in the field – both on the battlefield for triage decisions and
during sporting events, such as football games, to determine
if an injured player needs to be sent to the hospital or
not. However, he added, it may be a two-step process with
the first step being to get the device into the laboratory
environment first.
“It’s easier to develop a device that is in the laboratory
because the constraints are fewer [compared to the environmental
challenges of using the test in the field],”
Goforth said.
SFC Fluidics won the $5 million contract through a
competitive process. Goforth said the U.S. Army Medical
Research Acquisition Activity office in Fort Detrick,
121
Maryland released a request for proposals which attracted
“many hundreds of proposals.” Only about 3% of those proposals
were selected, including SFC Fluidics’, he said.
“Obviously for a field deployable device size and
weight and automation are all key, that’s where SFC
Fluidics’ strengths are; we have unique technologies that
allow us to do things on [a smaller scale],” Goforth said.
“That’s why we won the award and that’s where our real
strengths are.”
According to the company the device can be used by
first responders without any specific training or medical
expertise, and the information will assist caregivers in
quickly choosing the proper course of action for the patient
in combat situations, at the scene of an accident, in an
emergency room or at a sporting event. The device and
chip also will provide real-time information about the effectiveness
of intervention strategies with successful treatments
resulting in a return of biomarker indicators to normal
levels, SFC Fluidics noted.
SFC Fluidics is a privately-held company in the emerging
market for microfluidic devices.
(This story originally appeared in the Sept. 30, 2009,
edition of Medical Device Daily)
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