CardioMind Launches First-in-Human Trial of Small Vessel, Drug-Eluting Stent

Triggers $22-million Tranche of Venture Capital Funding

SUNNYVALE, Calif., March 31 /PRNewswire/ -- CardioMind, Inc., a developer
of stents for small, difficult-to-treat blood vessels, announced today that it
has begun a First-in-Human clinical trial of its drug-eluting stent. The CARE
II trial, as it is called, began in February at St. Vincent's Hospital in
Melbourne, Australia, and, so far, has led to successful implantations in 12
patients.
With a .014-inch crossing profile, the CardioMind stent, known as the
Sparrow(TM) Drug-Eluting Coronary Stent System, is 70% smaller in diameter
than any other currently-approved stent. It targets treatment of blood vessels
smaller than 2.75 mm in diameter, which currently constitute nearly 40% of all
stent implants. The tightness of fit of conventional stents, as well as their
inflexibility and the forces delivered by balloon expansion, however, may
contribute to increased vessel trauma, which in turn leads to less favorable
long term results. Beyond the range of current stenting practice, moreover,
the CardioMind stent may also find use in vessels smaller than 2.25 mm and
thus expand by up to 20% the worldwide market for stents, now over $4-billion
annually.
"We view the Sparrow system as a platform technology for a gentler stent
delivery system that will both improve safety and efficacy for currently
performed procedures and also extend treatment to new areas of the coronary,
neurovascular and peripheral artery system," says Charles Maroney, President
and CEO of CardioMind.
How the CardioMind Stent Works
The unique design of the CardioMind Sparrow stent permits it to travel
within the guidewire lumen to the site of the lesion. There the cardiologist
releases the stent and allows it to self-expand to the vessel wall. By
contrast, conventional balloon-expandable stents travel over guidewires to the
lesion, and thus, by their very design, occupy more volume. The Sparrow stent
also offers more flexibility than current stents, making it especially
adaptable to treatment of the small, tortuous blood vessels often associated
with diabetes.
To coat the Sparrow stent, CardioMind has licensed the rights to the
SynBiosys(TM) biodegradable polymer system from SurModics, Inc.
(Nasdaq: SRDX). "The SynBiosys polymer allows the Sparrow stent to gradually
return to a bare metal state, where we as an industry have 15 years of data
showing no increase in late stent thrombosis," says Maroney.
Clinical Trials
The multi-site CARE II study, which will eventually enroll 220 patients,
is a randomized trial of three different stents -- both bare-metal and
drug-eluting versions of the Sparrow, plus a competitive stent.
According to Dr. Robert Whitbourn, associate professor and director of the
Cardiovascular Research Center at St. Vincent's Hospital and one of the
study's lead investigators: "Thus far, the first cases in this study are very
encouraging. All our implanted patients are doing well, and I am impressed
with the overall deliverability and performance of this new stent delivery
system." Dr. Whitbourn expects to report first full follow-up results in
eight months.
Overall, says Dr. Whitbourn, "The CardioMind Sparrow System represents a
promising technology in interventional cardiology. The concept of a true
guidewire-delivered stent opens up the possibilities of stenting in small
vessels, branch vessels and other difficult-to-access vessels. It could,
thus, expand the types of lesions in coronary artery disease that can be
treated in more difficult patient populations."
Venture Funding
By reaching its First-in-Human milestone, CardioMind triggered the second
tranche closing of a $33-million venture capital round raised in June 2007.
That round, CardioMind's third since it was founded in 2003, included an
initial $11-million for research and development and the just-released
$22-million for completion of the CARE II Study and further development.
Co-leaders of the round were SV Life Sciences and De Novo Ventures, with
additional funding coming from existing investors InterWest Partners,
Latterell Venture Partners, Morgenthaler Ventures, and Onset Ventures.
About CardioMind
CardioMind is a developer of a unique stent delivery platform that allows
interventionalists to treat very small blood vessels of 2.75 mm-diameter and
less. Such vessels, often tortuous, have proven especially vulnerable to
injury from conventional stent delivery systems. The small crossing profile
and flexibility of the CardioMind platform promise to increase both stent
safety and efficacy in such vessels and to extend the range of vessels in
which stents can be deployed throughout the coronary, neurovascular and
peripheral artery systems.
SOURCE CardioMind, Inc.

Charles Maroney, CEO of CardioMind, Inc., +1-415-999-8618; or Tom Gibson of
The Gibson Network, +1-216-320-1520, tgibson1@ameritech.net, for CardioMind,
Inc.