SUNNYVALE, Calif., March 31 CardioMind, Inc., a developerof stents for small, difficult-to-treat blood vessels, announced today that ithas begun a First-in-Human clinical trial of its drug-eluting stent. The CAREII trial, as it is called, began in February at St. Vincent's Hospital inMelbourne, Australia, and, so far, has led to successful implantations in 12patients.
With a .014-inch crossing profile, the CardioMind stent, known as theSparrow(TM) Drug-Eluting Coronary Stent System, is 70% smaller in diameterthan any other currently-approved stent. It targets treatment of blood vesselssmaller than 2.75 mm in diameter, which currently constitute nearly 40% of allstent implants. The tightness of fit of conventional stents, as well as theirinflexibility and the forces delivered by balloon expansion, however, maycontribute to increased vessel trauma, which in turn leads to less favorablelong term results. Beyond the range of current stenting practice, moreover,the CardioMind stent may also find use in vessels smaller than 2.25 mm andthus expand by up to 20% the worldwide market for stents, now over $4-billionannually.
"We view the Sparrow system as a platform technology for a gentler stentdelivery system that will both improve safety and efficacy for currentlyperformed procedures and also extend treatment to new areas of the coronary,neurovascular and peripheral artery system," says Charles Maroney, Presidentand CEO of CardioMind.
How the CardioMind Stent Works
The unique design of the CardioMind Sparrow stent permits it to travelwithin the guidewire lumen to the site of the lesion. There the cardiologistreleases the stent and allows it to self-expand to the vessel wall. Bycontrast, conventional balloon-expandable stents travel over guidewires to thelesion, and thus, by their very design, occupy more volume. The Sparrow stentalso offers more flexibility than current stents, making it especiallyadaptable to treatment of the small, tortuous blood vessels often associatedwith diabetes.
To coat the Sparrow stent, CardioMind has licensed the rights to theSynBiosys(TM) biodegradable polymer system from SurModics, Inc.(Nasdaq: SRDX). "The SynBiosys polymer allows the Sparrow stent to graduallyreturn to a bare metal state, where we as an industry have 15 years of datashowing no increase in late stent thrombosis," says Maroney.
The multi-site CARE II study, which will eventually enroll 220 patients,is a randomized trial of three different stents -- both bare-metal anddrug-eluting versions of the Sparrow, plus a competitive stent.
According to Dr. Robert Whitbourn, associate professor and director of theCardiovascular Research Center at St. Vincent's Hospital and one of thestudy's lead investigators: "Thus far, the first cases in this study are veryencouraging. All our implanted patients are doing well, and I am impressedwith the overall deliverability and performance of this new stent deliverysystem." Dr. Whitbourn expects to report first full follow-up results ineight months.
Overall, says Dr. Whitbourn, "The CardioMind Sparrow System represents apromising technology in interventional cardiology. The concept of a trueguidewire-delivered stent opens up the possibilities of stenting in smallvessels, branch vessels and other difficult-to-access vessels. It could,thus, expand the types of lesions in coronary artery disease that can betreated in more difficult patient populations."
By reaching its First-in-Human milestone, CardioMind triggered the secondtranche closing of a $33-million venture capital round raised in June 2007.That round, CardioMind's third since it was founded in 2003, included aninitial $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