MEDICAL DEVICE INNOVATION - Medical Device Daily

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Attendees at meeting enjoy
its targeted, intimate setting
By HOLLAND JOHNSON
Medical Device Daily Managing Editor
SAN FRANCISCO — While much of the action in town
this week was down the street at the packed J.P. Morgan
Healthcare conference, only a block up Powell Street at the
Sir Francis Drake Hotel, the OneMedPlace Finance Forum
gave attendees a glimpse at some private and smaller public
companies that are on the cutting edge of medicine, and
in a much more intimate setting.
Attempting to bring to market a product to improve the
surgical repair of mitral valve regurgitation is a company
called Neochord (Minnetonka, Minnesota). John Seaberg,
the company’s president/CEO said the company has developed
a device that eliminates the need for a sternotomy
and cardiopulmonary bypass.
The company licensed the technology from the Mayo
Clinic (Rochester, Minnesota) that was invented by a cardiac
surgeon while in practice there. The tool is designed to
allow for the use of minimally invasive use surgical techniques
for the implantation of artificial chordae tendineae
on a beating heart.
During normal function, the chordae tendineae tether
the mitral valve leaflets, ensuring correct closure during
ventricular contraction. Rupture of the chordae due to
myocardial infarction or degenerative disease is a common
cause of mitral leaflet prolapse and subsequent mitral
regurgitation.
Seaberg said the company is currently looking for
investors to top off a $3.5 million Series A round, the funds
of which will be used to carry the company through the
completion of its human feasibility trial which it intends to
begin in May 2009.
While the company plans to pursue those people who
are already prime surgical candidates, Seaberg said
NeoChord’s ultimate goal is to tap into the U.S. patient population
of more than 2 million people with mitral regurgitation
who have not been treated because the risks of the
current procedure are currently deemed to be too high
compared to the severity of their disease. These people, he
said, are in need of a minimally invasive treatment option.
“Current patients will be treated with less trauma,
lower risk and less cost and frankly, that more patients will
be treated because of the less invasive technology.”
According to Seaberg, the clinical literature has shown
that it is much better to treat patients in this sector while
they are still relatively symptom-free. He noted that nearly
42% of asymptomatic patients died from complications
related to this disease within five years. “It is a silent killer,”
he said.
Seaberg said the company is hoping to have FDA
approval for the technology sometime in 2012.
MEDICAL DEVICE INNOVATION 2010
Developing a photonic-based platform technology for
the diagnosis and treatment of various diseases is
InfraReDx (Burlington, Massachusetts). The private company
is initially focusing on the creation of a system that
will enable the diagnosis of lipid-core containing plaques in
the coronary arteries.
The company received FDA clearance for its catheterbased
LipiScan coronary imaging system last April (Medical
Device Daily, April 30, 2008). The LipiScan device uses nearinfrared
(NIR) spectroscopy to identify lipid core containing
plaques of interest in the coronary arteries in patients
already undergoing cardiac catheterization. Such plaques,
which cannot be detected by commonly used tests such as
a treadmill exam and even coronary angiography, are suspected
to be the cause of most sudden cardiac deaths and
non-fatal heart attacks. This condition recently attracted
heightened attention due to the death last June of Meet the
Press host Tim Russert.
James Muller, company founder and president/CEO
said that NIR spectroscopy is used to measure the chemical
composition of unknown substances. The LipiScan system
uses optical technology, much of it developed for telecom
uses, to deliver and retrieve NIR light from coronary
plaques.
Muller said the light reflected back at different wavelengths
is analyzed to detect the chemical composition of
the coronary plaques. At the completion of the catheter
pullback, the LipiScan console instantly displays the scan
results on a “chemogram,” a digital color-coded map of the
location and intensity of lipid core containing plaques of
interest in the artery.
The company believes that the vulnerable plaque
diagnostic market will exceed $2 billion by 2013. Muller
said the company’s primary customers include interventional
cardiologists, and its secondary market extends its
reach to clinical research for drug and medical device
development.
According to Muller, the company is preparing a second
generation of the device that can visualize and determine
the chemical composition of lipid-rich plaques.
InfraReDX has currently raised more than $87 million in
private funds and is in the process of raising a $20 million
C-2 round that Mueller said “will get us to financial
breakeven.”
Symphony Medical (Laguna Hills, California) is looking
to treat heart failure, post-operative atrial fibrillation
and other cardiac abnormalities with its biopolymer and
biotherapeutic devices.
The company’s CEO, Raymond Cohen, noted that the
company’s goal is to deliver biocompatible polymers to
specific areas of the heart during either open chest surgery
or via a minimally invasive procedure. He said the biopolymers
are engineered to achieve clinical benefit by locally
modifying cardiac physiology.
The company currently has two products in its late-
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