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

Triggers $22-million Tranche of Venture Capital Funding

Mar 31, 2008, 01:00 ET from CardioMind, Inc.

    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
     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
     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.