Volcano sets sights on OCT market with CardioSpectra

Ophthalmology has been the dominant commercial application for optical coherence tomography (OCT) for the past decade, but Volcano (San Diego, CA), a leading provider of intravascular-ultrasound (IVUS) and functional-measurement products for diagnosing and treating vascular and structural heart disease, is looking to change that with the addition of Fourier-domain OCT to its product-development portfolio.

Ophthalmology has been the dominant commercial application for optical coherence tomography (OCT) for the past decade, but Volcano (San Diego, CA), a leading provider of intravascular-ultrasound (IVUS) and functional-measurement products for diagnosing and treating vascular and structural heart disease, is looking to change that with the addition of Fourier-domain OCT to its product-development portfolio. The company announced in mid-December that it would pay $25 million cash to acquire CardioSpectra (San Antonio, TX), a small startup that has been developing OCT for cardiovascular applications since 2005. Volcano will pay CardioSpectra an additional $38 million if certain milestones related to regulatory approvals and revenue goals are met by the end of 2010.

CardioSpectra’s core product is based on technology licensed from the University of Texas and Dr. Thomas Milner, a cofounder of CardioSpectra. The current product comprises a console with advanced custom software, a pullback device, and disposable catheters. The system and accessories are not approved for human use at this time, although the company expects to file for appropriate U.S. and international regulatory clearances in 2008. CardioSpectra holds a number of issued U.S. patents on its technology, with additional patents pending.

The value Volcano has placed on CardioSpectra’s technology—more than $60 million if the regulatory milestones are met in a timely manner—speaks to the market potential its sees for OCT in cardiology. Once approved, OCT will be the only real competitor to IVUS, which is often seen as a necessary evil because of its poor image quality. IVUS, which currently has only 14% market penetration, was still reported to be a $400 million market in 2007. OCT, which produces vastly superior images to IVUS, has the potential to dramatically alter this landscape.

“We believe CardioSpectra’s OCT technology and products will be an important addition to Volcano, as we expect that it will allow us to expand our reach into clinical situations where extremely high-resolution imaging is paramount,” says Scott Huennekens, president and CEO of Volcano. “Our long-term goal is to integrate this OCT functionality directly into our s5i integrated-imaging suite of products, offering hospitals and physicians a complete, multifunctional capability that seamlessly provides IVUS, functional measurement, and OCT in one system.”

According to Volcano, CardioSpectra’s OCT technology allows fast imaging of highly detailed structures in the vasculature, including vessel-wall defects, intraluminal thrombus, and stent struts. The ability to visualize stent expansion and apposition is excellent when using OCT, and CardioSpectra’s OCT resolution is such that it is able to visualize even very thin layers of cells covering drug-eluting stent struts at followup, according to Huennekens.

“The resolution from this system is truly remarkable, providing significantly greater resolution in the near field than conventional IVUS,” he says. “Rather than competing with our IVUS offerings, OCT complements our existing business by opening up clinical indications and research opportunities beyond those available to IVUS.” —KK

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